Hyrimoz

Package leaflet: Information for the patient

Hyrimoz 20 mg solution for injection in pre-filled syringe

adalimumab
20 mg/0.4 mL
Please read all of this leaflet carefully before your child uses this medicine because it contains important information.

• Keep this leaflet. You may need to read it again.
• Your doctor will give you a Patient Reminder Card containing important safety information you need to know before your child starts treatment with Hyrimoz and during treatment with Hyrimoz. Keep this Patient Reminder Card with you or your child during treatment and for 4 months after your child’s last injection of Hyrimoz.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for your child only. Do not give it to other people, even if their symptoms are the same as your child’s, because it could be harmful.
• If your child experiences any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Hyrimoz is and what it is used for
2. What you need to know before your child uses Hyrimoz
3. How to use Hyrimoz
4. Possible side effects
5. How to store Hyrimoz
6. Contents of the pack and other information
7. Instructions for use

1. What Hyrimoz is and what it is used for

Hyrimoz contains the active substance adalimumab, a medicine that acts on the body's immune
(defence) system.
Hyrimoz is indicated for the treatment of the following inflammatory diseases:

• polyarticular juvenile idiopathic arthritis,
• enthesitis-related arthritis,
• paediatric plaque psoriasis,
• paediatric Crohn’s disease,
• non-infectious paediatric uveitis.

The active substance in Hyrimoz, adalimumab, is a human monoclonal antibody.
Monoclonal antibodies are proteins that bind to a specific target.
Adalimumab targets a protein called tumour necrosis factor (TNFα), which is involved in the immune
(defence) system and is present at higher concentrations in the inflammatory diseases listed above.
By binding to TNFα, Hyrimoz blocks its action and reduces the inflammatory process in these diseases.

Polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis
Polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis are inflammatory joint diseases
that usually first appear during childhood.
Hyrimoz is used to treat polyarticular juvenile idiopathic arthritis in children and adolescents aged 2 to
17 years, and enthesitis-related arthritis in children and adolescents aged 6 to 17 years. At diagnosis,
other disease-modifying drugs such as methotrexate may be given. If these drugs do not work
satisfactorily, patients will be given Hyrimoz for the treatment of polyarticular juvenile idiopathic
arthritis or enthesitis-related arthritis.

Paediatric plaque psoriasis
Plaque psoriasis is an inflammatory skin condition that causes red, scaly, thickened patches of skin
covered with silvery scales. Plaque psoriasis can also affect the nails, causing them to break, thicken,
or lift from the nail bed, which can be painful. Psoriasis is believed to be caused by a problem with the
body’s immune system that leads to an increased production of skin cells.
Hyrimoz is used to treat severe plaque psoriasis in children and adolescents aged 4 to 17 years when
topical treatments and UV light therapy have not worked satisfactorily or are not suitable.

Paediatric Crohn’s disease
Crohn’s disease is an inflammation of the intestine.
Hyrimoz is used to treat moderate to severe Crohn’s disease in children and adolescents aged 6 to 17
years.
Your child may first be given other medicines. If these medicines do not work satisfactorily, your child
will be given Hyrimoz to reduce the typical symptoms of their disease.

Non-infectious paediatric uveitis
Non-infectious uveitis is an inflammatory disease affecting certain parts of the eye.
Inflammation leads to reduced vision and/or the presence of floaters in the eye (black spots or thin
lines moving across the visual field). Hyrimoz works by reducing this inflammation.
Hyrimoz is used to treat children from the age of 2 years with chronic non-infectious uveitis with
inflammation affecting the front part of the eye.
Your child may first be given other medicines. If these medicines do not work satisfactorily, your child
will be given Hyrimoz to reduce the typical symptoms of their disease.

2. What you should know before your child uses Hyrimoz

Do not use Hyrimoz

• If your child is allergic to adalimumab or to any of the other ingredients of this medicine (listed in section 6).
• If your child has a serious infection, including tuberculosis, sepsis (blood poisoning), or other opportunistic infections (unusual infections associated with a weakened immune system). It is important to inform the doctor if your child has signs or symptoms of infection, such as fever, wounds, feeling tired, or dental problems (see "Warnings and precautions").
• If your child has moderate or severe heart failure. It is important to inform the doctor if there has been or currently is a serious heart condition (see "Warnings and precautions").

Warnings and precautions
Talk to your doctor or pharmacist before using Hyrimoz.

Allergic reaction

• In case of allergic reactions with symptoms such as chest tightness, wheezing, dizziness, swelling, or skin rash, do not administer Hyrimoz again and contact your doctor immediately, as these reactions may, in rare cases, be life-threatening.

Infection

• If your child has an infection, including long-term or localized infections (e.g., leg ulcers), consult your doctor before starting treatment with Hyrimoz. If you have any doubts, contact your doctor.
• Your child may be more likely to get infections while being treated with Hyrimoz. This risk may increase if your child’s lung function is reduced. These infections can be serious and may include tuberculosis, infections caused by viruses, fungi, parasites, bacteria, or other unusual infectious organisms, and sepsis (septicaemia).
• In rare cases, these infections may be life-threatening. It is important to inform the doctor if your child experiences symptoms such as fever, wounds, feeling tired, or dental problems. The doctor may advise temporarily stopping Hyrimoz.

Tuberculosis (TB)

• Cases of tuberculosis have occurred in patients treated with adalimumab. Therefore, your doctor will check whether your child shows signs or symptoms of tuberculosis before starting treatment with Hyrimoz. This will involve a detailed medical evaluation including your child’s medical history and clinical examinations (e.g., chest X-ray and tuberculin skin test). The performance and results of these tests must be recorded in your child’s Patient Reminder Card. It is very important to inform the doctor if your child has ever had tuberculosis or has been in close contact with someone who has tuberculosis. Tuberculosis may develop during treatment even if your child has received preventive treatment for tuberculosis. Contact your doctor immediately if symptoms of tuberculosis (persistent cough, weight loss, lack of energy, low-grade fever) or other infections occur during or after treatment.

Travel/recurring infection

• Inform your doctor if your child has lived in or traveled to areas where fungal infections such as histoplasmosis, coccidioidomycosis, or blastomycosis are common.
• Inform your doctor if your child has had recurring infections or has conditions that increase the risk of infection.

Hepatitis B virus

• Inform your doctor if your child is a carrier of the hepatitis B virus (HBV), has an active hepatitis B virus infection, or if you think your child may be at risk of contracting hepatitis B virus. Your doctor must test your child for hepatitis B virus infection. Taking adalimumab may reactivate hepatitis B virus infection in carriers of this virus. In rare cases, especially if your child is also being treated with other medicines that suppress the immune system, reactivation of hepatitis B virus infection may be life-threatening.

Surgery or dental procedures

• Before any surgery or dental procedures, inform the doctor that your child is taking Hyrimoz. The doctor may advise temporarily stopping Hyrimoz.

Demyelinating disease

• If your child has or develops demyelinating diseases (diseases affecting the protective covering of nerves), such as multiple sclerosis, the doctor will decide whether to start or continue treatment with Hyrimoz. Inform the doctor immediately if your child experiences symptoms such as changes in vision, weakness in arms or legs, or numbness or tingling in any part of the body.

Vaccination

• Certain vaccines contain live but weakened forms of disease-causing bacteria or viruses and must not be given during treatment with Hyrimoz, as they may cause infections. Consult your doctor before vaccinating your child. In children, it is recommended, if possible, to administer all age-appropriate vaccinations before starting Hyrimoz therapy.
• If your daughter takes Hyrimoz during pregnancy, the baby may have an increased risk of infection for up to about 5 months after the last dose your daughter received during pregnancy. It is important that you inform your daughter’s pediatrician or other healthcare provider about her use of Hyrimoz during pregnancy, so they can determine when the baby should receive any vaccinations.

Heart failure

• It is important to inform the doctor about any past or current heart problems. If your child has mild heart failure and is being treated with Hyrimoz, the doctor will need to carefully monitor heart function. If new symptoms of heart failure appear or existing symptoms worsen (e.g., shortness of breath or swelling of the feet), contact your doctor immediately.

Fever, bruising, bleeding, or paleness

• In some patients, the body may not be able to produce enough blood cells to fight infections or stop bleeding. If your child has persistent fever, bruising, easy bleeding, or paleness, contact your doctor immediately. The doctor may decide to stop treatment.

Tumors

• Very rarely, certain types of tumors have occurred in children and adults treated with Hyrimoz or other anti-TNFα medicines. Patients with long-standing, severe rheumatoid arthritis may have a higher than average risk of developing lymphoma and leukemia (cancers affecting blood cells and bone marrow). If your child takes Hyrimoz, the risk of developing lymphoma, leukemia, or other tumors may increase. In rare cases, a specific and serious type of lymphoma has been observed in patients treated with adalimumab. Some of these patients were also receiving azathioprine or mercaptopurine. Inform the doctor if your child is taking azathioprine or mercaptopurine with Hyrimoz.
• Cases of non-melanoma skin cancer have been observed in patients taking adalimumab. If areas of damaged skin appear during or after treatment, or if the appearance of existing moles or skin lesions changes, inform your doctor.
• Cases of malignancies other than lymphoma have been reported in patients with a specific type of lung disease called chronic obstructive pulmonary disease (COPD) treated with another anti-TNFα medicine. If your child has COPD or is a heavy smoker, discuss with the doctor whether treatment with an anti-TNFα medicine is appropriate.

Autoimmune diseases

• Rarely, treatment with Hyrimoz may lead to the development of a lupus-like syndrome. Inform the doctor if symptoms such as unexplained persistent skin rash, fever, joint pain, or fatigue occur.

Other medicines and Hyrimoz
Inform your doctor or pharmacist if your child is taking, has recently taken, or might take any other medicines.
Hyrimoz may be taken together with methotrexate and other disease-modifying antirheumatic drugs (sulfasalazine, hydroxychloroquine, leflunomide, and parenteral gold salts), corticosteroids, or analgesics, including non-steroidal anti-inflammatory drugs (NSAIDs).
Hyrimoz must not be taken together with medicines containing the active substances anakinra or abatacept due to an increased risk of serious infections. The combination of adalimumab with other anti-TNF medicines and anakinra or abatacept is not recommended because of the possible increased risk of infections, including serious infections, and other potential pharmacological interactions. If you have any doubts, consult your doctor.

Pregnancy and breastfeeding

• Your daughter should use an effective method of contraception to prevent pregnancy and continue using it for at least 5 months after the last dose of Hyrimoz.
• If your daughter is pregnant, suspects she might be pregnant, or is planning a pregnancy, consult her doctor about taking this medicine.
• Hyrimoz should be used during pregnancy only if necessary.
• According to a pregnancy study, no increased risk of birth defects was observed when mothers received adalimumab during pregnancy compared to mothers with the same condition who did not receive adalimumab.
• Hyrimoz may be used during breastfeeding.
• If your daughter takes Hyrimoz during pregnancy, the baby may have an increased risk of infection.
• It is important that you inform your daughter’s pediatrician or other healthcare provider about her use of Hyrimoz during pregnancy before the baby receives any vaccinations (for more information on vaccines, see the section "Warnings and precautions").

Driving and using machines
Hyrimoz may have a minor influence on the ability to drive, ride a bicycle, or use machines. After taking Hyrimoz, vision disturbances or a sensation that the surroundings are spinning (dizziness) may occur.

Hyrimoz contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per 0.4 mL dose, i.e., essentially 'sodium-free'.

3. How to use Hyrimoz

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Hyrimoz is available in 40 mg pens and 20 mg and 40 mg pre-filled syringes for
administration of a complete dose of 20 mg or 40 mg to patients.

Method and route of administration
Hyrimoz is administered by subcutaneous injection (for injection under the skin).
Detailed instructions on how to inject Hyrimoz are provided in section 7, “Instructions for use”.

If you use more Hyrimoz than you should
If you accidentally inject Hyrimoz more frequently than prescribed, contact your doctor or pharmacist and inform them that your child has received more medication than intended. Always keep the medicine carton, even if empty.

If you forget to use Hyrimoz
If you forget to give your child an injection, administer the missed dose as soon as you remember. After that, resume your child's regular dosing schedule as prescribed.

If you stop treatment with Hyrimoz
The decision to discontinue treatment with Hyrimoz should be discussed with your child's doctor. Symptoms may return after stopping treatment.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. Most side effects are mild to moderate in severity. However, some may be serious and require treatment. Side effects may occur up to 4 months or more after the last injection of Hyrimoz.
Seek urgent medical advice if you notice any of the following signs of an allergic reaction or heart failure:

• severe rash, hives;
• swelling of the face, hands, or feet;
• difficulty breathing, difficulty swallowing;
• shortness of breath during exertion or when lying down, or swollen feet.

Inform your doctor as soon as possible if you notice any of the following reactions:

• signs and symptoms of infection such as fever, feeling unwell, wounds, dental problems, burning during urination, fatigue or weakness, or cough;
• symptoms of nerve problems such as tingling, numbness, double vision, or weakness in the arms or legs;
• signs of skin cancer such as a lump or open sore that does not heal;
• signs and symptoms suggesting the onset of disorders affecting the blood-forming system, such as persistent fever, bruising, bleeding, or paleness.

The following side effects have been observed with Hyrimoz:
Very common (may affect more than 1 in 10 people)

• injection site reactions (including pain, swelling, redness, or itching);
• respiratory tract infections (including common cold, runny nose, sinusitis, and pneumonia);
• headache;
• abdominal pain;
• nausea and vomiting;
• rash;
• muscle pain.

Common (may affect up to 1 in 10 people)

• serious infections (including sepsis and influenza);
• intestinal infections (including gastroenteritis);
• skin infections (including cellulitis and Herpes Zoster infection);
• ear infections;
• mouth infections (including dental infections and herpes simplex);
• reproductive system infections;
• urinary tract infections;
• fungal infections;
• joint infections;
• benign tumours;
• skin cancer;
• allergic reactions (including seasonal allergies);
• dehydration;
• mood changes (including depression);
• anxiety;
• sleep disorders;
• sensory disturbances such as tingling, stabbing sensations, or numbness;
• migraine;
• symptoms of nerve root compression (including lower back pain and leg pain);
• visual disturbances;
• eye inflammation;
• eyelid inflammation and eye swelling;
• dizziness (sensation of the room spinning);
• sensation of rapid heartbeat;
• high blood pressure;
• hot flushes;
• haematoma (solid swelling with coagulated blood);
• cough;
• asthma;
• shortness of breath;
• gastrointestinal bleeding;
• dyspepsia (indigestion, bloating, heartburn);
• acid reflux disorder;
• dry syndrome (including dry eyes and dry mouth);
• itching;
• itchy rash;
• bruising;
• skin inflammation (such as eczema);
• breaking of fingernails and toenails;
• increased sweating;
• hair loss;
• onset or worsening of psoriasis;
• muscle spasms;
• blood in the urine;
• kidney problems;
• chest pain;
• oedema (fluid accumulation in the body, causing swelling of affected tissue);
• fever;
• reduced platelet count in the blood, increasing the risk of bleeding or bruising;
• delayed wound healing.

Uncommon (may affect up to 1 in 100 people)

• unusual infections (including tuberculosis and other infections) that occur when immune defences are reduced;
• neurological infections (including viral meningitis);
• eye infections;
• bacterial infections;
• diverticulitis (inflammation and infection of the large intestine);
• tumours, including tumours of the lymphatic system (lymphoma) and melanoma (a type of skin cancer);
• immune system disorders that may affect lungs, skin, and lymph nodes (most commonly a condition called sarcoidosis);
• vasculitis (inflammation of blood vessels);
• tremor;
• neuropathy (nerve damage);
• stroke;
• hearing loss, ringing in the ears;
• sensation of irregular heartbeat such as palpitations;
• heart problems that may cause shortness of breath or swelling of the ankles;
• acute myocardial infarction;
• formation of a sac in the wall of a major artery, inflammation and clot in a vein, blockage of a blood vessel;
• lung disease causing shortness of breath (including inflammation);
• pulmonary embolism (blockage of a pulmonary artery);
• pleural effusion (abnormal accumulation of fluid in the pleural space);
• inflammation of the pancreas causing severe abdominal and back pain;
• difficulty swallowing;
• facial oedema (swelling);
• gallbladder inflammation, gallstones;
• fatty liver (accumulation of fat in liver cells);
• night sweats;
• scar;
• abnormal muscle breakdown;
• systemic lupus erythematosus (an immune system disorder, including inflammation of the skin, heart, lungs, joints, and other organs);
• interrupted sleep;
• impotence;
• inflammations.

Rare (may affect up to 1 in 1,000 people)

• leukaemia (a cancer affecting blood and bone marrow);
• severe allergic reaction with shock;
• multiple sclerosis;
• neurological disorders (such as optic neuritis in the eye and Guillain-Barré syndrome, a condition that may cause muscle weakness, abnormal sensations, tingling in the arms and upper body);
• cardiac arrest;
• pulmonary fibrosis (scarring of the lungs);
• intestinal perforation (a hole in the intestinal wall);
• hepatitis (liver inflammation);
• reactivation of hepatitis B infection;
• autoimmune hepatitis (liver inflammation caused by the body's own immune system);
• cutaneous vasculitis (inflammation of blood vessels in the skin);
• Stevens-Johnson syndrome (a life-threatening reaction with flu-like symptoms and a blistering rash);
• facial oedema (swelling) associated with allergic reactions;
• erythema multiforme (inflammatory skin rash);
• lupus-like syndrome;
• angioedema (localized swelling of the skin);
• lichenoid skin reaction (pruritic red-purple rash).

Not known (frequency cannot be estimated from the available data)

• hepatosplenic T-cell lymphoma (a rare blood cancer that is often fatal);
• Merkel cell carcinoma (a type of skin cancer);
• Kaposi’s sarcoma, a rare form of cancer associated with human herpesvirus 8 infection. Kaposi’s sarcoma most commonly presents with purple lesions on the skin;
• liver failure;
• worsening of a condition called dermatomyositis (which presents as a rash accompanied by muscle weakness);
• weight gain (in most patients, weight gain has been low).

Some of the side effects observed with adalimumab may be asymptomatic and may only be detected through blood tests. These include:
Very common (may affect more than 1 in 10 people)

• low white blood cell count;
• low red blood cell count;
• increased blood lipids;
• increased liver enzymes.

Common (may affect up to 1 in 10 people)

• increased white blood cell count;
• reduced platelet count;
• increased uric acid in the blood;
• altered sodium levels in the blood;
• reduced calcium in the blood;
• reduced phosphorus in the blood;
• increased blood sugar;
• increased lactate dehydrogenase in the blood;
• presence of autoantibodies in the blood;
• reduced potassium in the blood.

Uncommon (may affect up to 1 in 100 people)

• elevated bilirubin levels in the blood (liver blood test).

Rare (may affect up to 1 in 1,000 people)

• low white blood cell, red blood cell, and platelet counts.

Reporting of side effects
If your child experiences any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Hyrimoz

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label/blister/box after the word "Exp".
Store in a refrigerator (2°C – 8°C). Do not freeze.
Keep the pre-filled syringe in the outer packaging to protect the medicine from light.

Alternative storage conditions:
When necessary (e.g. when travelling), Hyrimoz may be stored at room temperature (up to 25°C) for a maximum of 21 days – ensure the medicine is protected from light. Once removed from the refrigerator for storage at room temperature, the pre-filled syringe must be used within 21 days or discarded, even if it is subsequently returned to the refrigerator. You must record the date when the pre-filled syringe is first removed from the refrigerator and the date after which it must be discarded.

Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Hyrimoz contains

• The active substance is adalimumab. Each pre-filled syringe contains 20 mg of adalimumab in 0.4 mL of solution.
• The excipients are adipic acid, citric acid monohydrate, sodium chloride, mannitol (E 421), polysorbate 80 (E 433), hydrochloric acid (E 507), sodium hydroxide (E 524) and water for injections (see section 2 “Hyrimoz contains sodium”).

Description of the appearance of Hyrimoz and contents of the pack
Hyrimoz 20 mg solution for injection in pre-filled syringe for paediatric use is supplied as 0.4 mL of
solution ranging from clear to slightly opalescent, colourless or slightly yellowish.
Hyrimoz is supplied in a single-use, transparent type I glass syringe with a 29-gauge stainless steel needle, a needle safety device with finger grip, a needle rubber cap (thermoplastic elastomer) and a plastic plunger, containing 0.4 mL of solution.
The pack contains 2 pre-filled syringes of Hyrimoz.
Not all pack sizes may be marketed.
Hyrimoz is available in a pre-filled syringe and a pre-filled pen.

Marketing Authorisation Holder
Sandoz GmbH
Biochemiestr. 10
6250 Kundl
Austria

Manufacturer
Sandoz GmbH Schaftenau
Biochemiestr. 10
6336 Langkampfen
Austria
Novartis Pharmaceutical Manufacturing GmbH
Biochemiestrasse 10
6336 Langkampfen
Austria

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Sandoz nv/sa Sandoz Pharmaceuticals d.d filialas
Tél/Tel: +32 2 722 97 97 Tel: +370 5 2636 037

България Luxembourg/Luxemburg
Сандоз България КЧТ Sandoz nv/sa (Belgique/Belgien)
Тел.: +359 2 970 47 47 Tél/Tel.: +32 2 722 97 97

Česká republika Magyarország
Sandoz s.r.o. Sandoz Hungária Kft.
Tel: +420 225 775 111 Tel.: +36 1 430 2890

Danmark/Norge/Ísland/Sverige Malta
Sandoz A/S Sandoz Pharmaceuticals d.d.
Tlf./Sími/Tel: +45 63 95 10 00 Tel: +356 99644126

Deutschland Nederland
Hexal AG Sandoz B.V.
Tel: +49 8024 908 0 Tel: +31 36 52 41 600

Eesti Österreich
Sandoz d.d. Eesti filiaal Sandoz GmbH
Tel: +372 665 2400 Tel: +43 5338 2000

Ελλάδα Polska
SANDOZ HELLAS ΜΟΝΟΠΡΟΣΩΠΗ Α.Ε. Sandoz Polska Sp. z o.o.
Τηλ: +30 216 600 5000 Tel.: +48 22 209 70 00

España Portugal
Sandoz Farmacéutica, S.A. Sandoz Farmacêutica Lda.
Tel: +34 900 456 856 Tel: +351 21 000 86 00

France România
Sandoz SAS Sandoz Pharmaceuticals SRL
Tél: +33 1 49 64 48 00 Tel: +40 21 407 51 60

Hrvatska Slovenija
Sandoz d.o.o. Sandoz farmacevtska družba d.d.
Tel: +385 1 23 53 111 Tel: +386 1 580 29 02

Ireland Slovenská republika
Rowex Ltd. Sandoz d.d. - organizačná zložka
Tel: +353 27 50077 Tel: +421 2 48 200 600

Italia Suomi/Finland
Sandoz S.p.A. Sandoz A/S
Tel: +39 02 96541 Puh/Tel: +358 10 6133 400

Κύπρος United Kingdom (Northern Ireland)
SANDOZ HELLAS ΜΟΝΟΠΡΟΣΩΠΗ Α.Ε. Sandoz GmbH
(Greece) Tel: +43 5338 2000
Tel: +30 216 600 5000

Latvija
Sandoz d.d. Latvia filiāle
Tel: +371 67 892 006

Other sources of information
More detailed information on this medicinal product is available on the European Medicines Agency website: https://www.ema.europa.eu.

7. Instructions for use

To avoid possible infections and to ensure correct use of the medicine, it is important that
you follow these instructions.
Make sure you read, understand and follow these Instructions for Use before injecting Hyrimoz.
A healthcare professional must show you how to properly prepare and inject Hyrimoz using the
pre-filled syringe before you use the medicine for the first time. If you have any doubts, consult
your healthcare professional.
Single-use pre-filled syringe of Hyrimoz with needle safety device and additional
finger grip

Figure A: pre-filled syringe of Hyrimoz with needle safety device and additional
finger grip
It is important that you:

• do not open the outer carton until you are ready to use the syringe;
• do not use the syringe if the blister seals are broken, as use may not be safe;
• never leave the syringe unattended where it could be tampered with by others;
• do not use the syringe if it has been dropped and appears damaged or if it was dropped after removing the needle cap;
• do not remove the needle cap until the time of injection;
• take care not to touch the wings of the needle safety device before use. Doing so may activate the needle safety device too early. Do not remove the finger grip before injection;
• inject Hyrimoz 15–30 minutes after removing it from the refrigerator, for a more comfortable injection;
• dispose of the used syringe immediately after use. Do not reuse the syringe. See “4. Disposal of used syringes” at the end of these Instructions for Use.

How should you store Hyrimoz?

• Store the syringe carton in the refrigerator at a temperature between 2°C and 8°C.
• When necessary (e.g. when travelling), Hyrimoz may be stored at room temperature (up to 25°C) for a maximum of 21 days – ensure the medicine is protected from light. Once removed from the refrigerator for storage at room temperature, the pre-filled syringe must be used within 21 days or discarded, even if subsequently returned to the refrigerator. You must record the date when the pre-filled syringe was first removed from the refrigerator and the date after which it must be discarded.
• Store the syringes in their original packaging until ready to use, to protect the medicine from light.
• Do not store the syringes at extremely hot or cold temperatures.
• Do not freeze the syringes.

Keep Hyrimoz and all medicines out of the reach of children.
What is needed for the injection?
Place the following items on a clean, flat surface.
The package contains:

• Pre-filled syringe(s) of Hyrimoz (see Figure A). Each syringe contains 20 mg/0.4 mL of Hyrimoz.

The package does not contain (see Figure B):

• Alcohol swab.
• Cotton ball or gauze.
• Sharps disposal container.

Figure B: items not included in the package
See “4. Disposal of used syringes” at the end of these Instructions for Use.
Before injection

Figure C: needle safety device not activated – Figure D: needle safety device activated –
syringe ready for use do not use

• In this configuration, the needle safety device is NOT ACTIVATED.
  The syringe is ready for use (see Figure C).
• In this configuration, the needle safety device is ACTIVATED.
  DO NOT USE the syringe (see Figure D).

Preparing the syringe

• For a more comfortable injection, remove the blister containing the syringe from the refrigerator and leave it closed on the work surface for about 15–30 minutes to reach room temperature.
• Remove the syringe from the blister.
• Look through the viewing window. The solution should be colourless or slightly yellow and from clear to slightly opalescent. Do not use the syringe if you see particles and/or changes in colour. If you have any doubts about the appearance of the solution, consult your pharmacist for assistance.
• Do not use the syringe if it is broken or if the needle safety device is activated. Return the syringe and packaging to the pharmacy.
• Check the expiry date (Exp.) on the syringe. Do not use the syringe if the expiry date has passed.

Contact your pharmacist if the syringe fails any of the checks listed above.

1. Choosing the injection site:

• The recommended injection site is the front of the

thighs. You may also use the lower part of the stomach,
but not the area within 5 cm around the navel (see
Figure E).

• Choose a different site each time you give an injection.
• Do not inject the medicine into areas where the skin is tender, bruised, red, flaky, or hard. Avoid areas with scars or stretch marks. If you have psoriasis, DO NOT inject the medicine directly into areas with psoriasis plaques. Figure E: How to choose the injection site

2. Cleaning the injection site:

• Wash your hands thoroughly with water and soap.

• Using a circular motion, clean the injection site with an alcohol swab. Allow it to dry before administering the injection (see Figure F).
• Do not touch the cleaned area before the injection.

Figure F: How to clean the injection site

3. Administering the injection:

• Carefully pull off the needle cap from the

syringe (see Figure G).

• Dispose of the needle cap.
• You may see a drop of liquid at the tip of the needle. This is normal.

Figure G: How to remove the needle cap

• Gently create a skin fold at the injection site (see

Figure H).

• Insert the needle into the skin as shown.
• Push the entire needle under the skin to ensure the full dose of medicine is delivered.

Figure H: How to insert the needle

• Hold the syringe as shown (see Figure I).
• Slowly push the plunger all the way down until it stops, so that the plunger head moves completely between the safety wings of the needle safety device.
• While holding the syringe in place, keep the plunger fully depressed for 5 seconds.

Figure I: How to hold the syringe

• Keep the plunger fully depressed while

carefully withdrawing the needle from the injection site, then release the skin (see Figure J).
Figure J: How to withdraw the needle

• Slowly release the plunger and allow the needle safety device to automatically cover the exposed needle (see Figure K).
• You may notice a small amount of blood at the injection site. You may press a cotton ball or gauze pad against the injection site and hold it for 10 seconds. Do not rub the injection site. If needed, you may cover the injection site with a small adhesive bandage.
  Figure K: How to slowly release the plunger

4. Disposal of used syringes:

• Dispose of the used syringe in a sharps disposal container
  (puncture-resistant, closable container). For your safety,
  and the safety of others, used needles and syringes must
  never be reused.

• Do not dispose of any medicine via wastewater or household waste. Ask your doctor or pharmacist how to dispose of medicines you no longer use. This will help protect the environment. Unused medicine and waste materials derived from this medicine must be disposed of in accordance with local regulations.

If you have any doubts, consult a doctor, pharmacist, or nurse familiar with
Hyrimoz.

Package leaflet: information for the patient

Hyrimoz 20 mg solution for injection in pre-filled syringe

adalimumab
20 mg/0.2 mL
Please read this leaflet carefully before your child uses this medicine, as it contains important information.

• Keep this leaflet. You may need to read it again.
• Your doctor will provide you with a Patient Reminder Card containing important safety information you need to know before your child starts treatment with Hyrimoz and during treatment. Keep this Patient Reminder Card with you or your child during treatment and for 4 months after your child’s last injection of Hyrimoz.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for your child only. Do not give it to others, even if their symptoms are the same as your child’s, as it may be harmful.
• If your child experiences any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Hyrimoz is and what it is used for
2. What you need to know before your child uses Hyrimoz
3. How to use Hyrimoz
4. Possible side effects
5. How to store Hyrimoz
6. Contents of the pack and other information
7. Instructions for use

1. What Hyrimoz is and what it is used for

Hyrimoz contains the active substance adalimumab, a medicine that acts on the body's immune (defence) system.
Hyrimoz is indicated for the treatment of the following inflammatory diseases:

• polyarticular juvenile idiopathic arthritis,
• enthesitis-related arthritis,
• paediatric plaque psoriasis,
• paediatric Crohn’s disease,
• paediatric non-infectious uveitis.

The active substance in Hyrimoz, adalimumab, is a human monoclonal antibody. Monoclonal antibodies are proteins that bind to a specific target.
Adalimumab targets a protein called tumour necrosis factor (TNFα), which is involved in the immune (defence) system and is present at higher concentrations in the inflammatory diseases listed above. By binding to TNFα, Hyrimoz blocks its action and reduces the inflammatory process in these diseases.

Polyarticular juvenile idiopathic arthritis
Polyarticular juvenile idiopathic arthritis is an inflammatory disease of the joints.
Hyrimoz is used to treat polyarticular juvenile idiopathic arthritis in children and adolescents aged 2 to 17 years. At diagnosis, other disease-modifying drugs such as methotrexate may be given. If these medicines do not work satisfactorily, patients will be given Hyrimoz to treat polyarticular juvenile idiopathic arthritis.

Enthesitis-related arthritis
Enthesitis-related arthritis is an inflammatory disease of the joints and of the sites where tendons attach to bones.
Hyrimoz is used to treat enthesitis-related arthritis in children and adolescents aged 6 to 17 years.
Initially, other disease-modifying drugs such as methotrexate may be given to patients. If these medicines do not work well enough, patients will be given Hyrimoz to treat enthesitis-related arthritis.

Paediatric plaque psoriasis
Plaque psoriasis is an inflammatory skin condition causing reddish, scaly, and hardened patches of skin covered with silvery scales. Plaque psoriasis can also affect the nails, causing them to crack, thicken, or lift from the nail bed, which may be painful. Psoriasis is believed to be caused by a problem with the body’s immune system leading to increased production of skin cells.
Hyrimoz is used to treat severe plaque psoriasis in children and adolescents aged 4 to 17 years when skin-directed treatments and UV light therapy have not worked optimally or are not suitable.

Paediatric Crohn’s disease
Crohn’s disease is an inflammation of the intestine.
Hyrimoz is used to treat moderate to severe Crohn’s disease in children and adolescents aged 6 to 17 years.
Your child may first be given other medicines. If these medicines do not work satisfactorily, your child will be given Hyrimoz to reduce the typical symptoms of the disease.

Paediatric non-infectious uveitis
Non-infectious uveitis is an inflammatory disease affecting certain parts of the eye.
The inflammation leads to reduced vision and/or the presence of floaters in the eye (black spots or thin lines moving across the field of vision). Hyrimoz works by reducing this inflammation.
Hyrimoz is used to treat children from the age of 2 years with chronic non-infectious uveitis involving inflammation of the front part of the eye.
Your child may first be given other medicines. If these medicines do not work satisfactorily, your child will be given Hyrimoz to reduce the typical symptoms of the disease.

2. What you should know before your child uses Hyrimoz

Do not use Hyrimoz

• If your child is allergic to adalimumab or to any of the other ingredients of this medicine (listed in section 6).
• If your child has a serious infection, including tuberculosis, sepsis (blood poisoning), or other opportunistic infections (unusual infections associated with a weakened immune system). It is important to tell the doctor if your child has signs or symptoms of infection, such as fever, wounds, feeling tired, or dental problems (see "Warnings and precautions").
• If your child has moderate or severe heart failure. It is important to inform the doctor if there has been or currently is a serious heart condition (see "Warnings and precautions").

Warnings and precautions
Talk to your doctor or pharmacist before using Hyrimoz.

Allergic reaction

• In case of allergic reactions with symptoms such as chest tightness, wheezing, dizziness, swelling, or rash, do not administer Hyrimoz again and contact the doctor immediately, as in rare cases these reactions may be life-threatening.

Infections

• If your child has an infection, including long-term or localized infections (e.g., leg ulcers), consult the doctor before starting treatment with Hyrimoz. If you are unsure, contact the doctor.
• Your child may be more likely to get infections while being treated with Hyrimoz. This risk may increase if your child's lung function is reduced. These infections can be serious and may include tuberculosis, infections caused by viruses, fungi, parasites, or bacteria, or other unusual infectious organisms, and sepsis (septicaemia).
• In rare cases, these infections may be life-threatening. It is important to inform the doctor if your child has symptoms such as fever, wounds, feeling tired, or dental problems. The doctor may advise temporarily stopping Hyrimoz.

Tuberculosis (TB)

• Since cases of tuberculosis have occurred in patients treated with adalimumab, the doctor will check whether your child has signs or symptoms typical of tuberculosis before starting therapy with Hyrimoz. This will involve a detailed medical evaluation including your child’s medical history and clinical examinations (e.g., a chest X-ray and tuberculin skin test). The performance and results of these tests must be recorded in your child’s Patient Reminder Card. It is very important to inform the doctor if your child has ever had tuberculosis or has been in close contact with people who have tuberculosis. Tuberculosis may occur during treatment even if your child has received preventive treatment for tuberculosis. Contact the doctor immediately if symptoms of tuberculosis (persistent cough, weight loss, lack of energy, low-grade fever) or other infections appear during or after treatment.

Travel/recurrent infection

• Inform the doctor if your child has lived in or traveled to regions where fungal infections such as histoplasmosis, coccidioidomycosis, or blastomycosis are common.
• Inform the doctor if your child has had recurring infections or has conditions that increase the risk of infection.

Hepatitis B virus

• Inform the doctor if your child is a carrier of hepatitis B virus (HBV), has an active hepatitis B virus infection, or if you think your child may be at risk of contracting hepatitis B virus. The doctor must test your child for hepatitis B virus infection. Taking adalimumab may reactivate hepatitis B virus infection in people who are carriers of this virus. In rare cases, especially if your child is also taking other medicines that suppress the immune system, reactivation of hepatitis B virus infection may be life-threatening.

Surgery or dental procedures

• Before any surgery or dental procedures, inform the doctor that your child is taking Hyrimoz. The doctor may advise temporarily stopping Hyrimoz.

Demyelinating disease

• If your child has or develops demyelinating diseases (diseases affecting the protective covering of nerves), such as multiple sclerosis, the doctor will decide whether to start or continue treatment with Hyrimoz. Inform the doctor immediately if your child experiences symptoms such as changes in vision, weakness in arms or legs, or numbness or tingling in any part of the body.

Vaccination

• Certain vaccines contain live but weakened forms of bacteria or viruses that cause disease and must not be given during treatment with Hyrimoz, as they may cause infections. Consult the doctor before vaccinating your child. In children, it is recommended, if possible, to administer all age-appropriate vaccinations before starting Hyrimoz therapy.
• If your daughter takes Hyrimoz during pregnancy, the baby may have an increased risk of infection for up to about 5 months after the last dose your daughter received during pregnancy. It is important that you inform your daughter’s paediatrician or other healthcare provider about her use of Hyrimoz during pregnancy, so they can decide when the baby should receive any vaccinations.

Heart failure

• It is important to inform the doctor about any past or current heart problems. If your child has mild heart failure and is being treated with Hyrimoz, the doctor will need to carefully monitor heart function. If new symptoms of heart failure appear or existing symptoms worsen (e.g., shortness of breath or swelling of the feet), contact the doctor immediately.

Fever, bruising, bleeding, or paleness

• In some patients, the body may not be able to produce enough blood cells to fight infections or stop bleeding. If your child has persistent fever, bruising, easy bleeding, or paleness, contact the doctor immediately. The doctor may decide to stop treatment.

Tumours

• Very rare cases of certain types of tumours have been reported in children and adults treated with Hyrimoz or other anti-TNFα medicines. Patients with long-standing, severe rheumatoid arthritis may have a higher than average risk of developing lymphoma and leukaemia (cancers affecting blood cells and bone marrow). If your child takes Hyrimoz, the risk of developing lymphoma, leukaemia, or other tumours may increase. In rare cases, a specific and serious type of lymphoma has been observed in patients treated with adalimumab. Some of these patients were also taking the medicines azathioprine or mercaptopurine. Inform the doctor if your child is taking azathioprine or mercaptopurine with Hyrimoz.
• Cases of non-melanoma skin cancer have been observed in patients taking adalimumab. If areas of damaged skin appear during or after treatment, or if the appearance of moles or damaged areas changes, inform the doctor.
• Cases of tumours other than lymphoma have occurred in patients with a specific lung disease called chronic obstructive pulmonary disease (COPD) treated with another anti-TNFα medicine. If your child has COPD or smokes heavily, discuss with the doctor whether treatment with an anti-TNFα medicine is appropriate.

Autoimmune diseases

• Rarely, treatment with Hyrimoz may lead to the development of a lupus-like syndrome. Inform the doctor if symptoms such as unexplained persistent skin rash, fever, joint pain, or fatigue occur.

Other medicines and Hyrimoz
Inform the doctor or pharmacist if your child is taking, has recently taken, or might take any other medicines.
Hyrimoz may be taken together with methotrexate and other disease-modifying antirheumatic drugs (sulfasalazine, hydroxychloroquine, leflunomide, and parenteral gold salts), corticosteroids, or analgesics, including non-steroidal anti-inflammatory drugs (NSAIDs).
Hyrimoz must not be taken together with medicines containing the active substances anakinra or abatacept due to an increased risk of serious infections. The combination of adalimumab with other TNF inhibitors, anakinra, or abatacept is not recommended because of the possible increased risk of infections, including serious infections, and other potential drug interactions. If you have any doubts, consult the doctor.

Pregnancy and breastfeeding

• Your daughter should use an effective method of contraception to prevent pregnancy and continue using it for at least 5 months after the last dose of Hyrimoz.
• If your daughter is pregnant, suspects she may be pregnant, or is planning to become pregnant, consult her doctor about taking this medicine.
• Hyrimoz should be used during pregnancy only if necessary.
• According to a pregnancy study, no increased risk of birth defects was observed when mothers received adalimumab during pregnancy compared to mothers with the same condition who did not receive adalimumab.
• Hyrimoz may be used during breastfeeding with breast milk.
• If your daughter takes Hyrimoz during pregnancy, the baby may have an increased risk of infection.
• It is important that you inform your daughter’s paediatrician or other healthcare provider about her use of Hyrimoz during pregnancy, before the baby receives any vaccinations (for more information on vaccines, see section "Warnings and precautions").

Driving and using machines
Hyrimoz may have a minor influence on the ability to drive, ride a bicycle, or use machines. After taking Hyrimoz, vision disturbances or a sensation that the surroundings are spinning (dizziness) may occur.

Hyrimoz contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per 0.2 mL dose, i.e., essentially 'sodium-free'.

3. How to use Hyrimoz

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended doses of Hyrimoz for each approved indication are listed in the following
table. Your doctor may prescribe a different concentration of Hyrimoz if the child requires a different dose.

Method and route of administration
Hyrimoz is administered by subcutaneous injection (for subcutaneous injection).
Detailed instructions on how to inject Hyrimoz are provided in section 7, “Instructions for use”.

If you use more Hyrimoz than you should
If you accidentally inject Hyrimoz more frequently than you should, contact your doctor or pharmacist and explain that your child has received more medication than intended. Always keep the medicine carton, even if empty.

If you forget to use Hyrimoz
If you forget to give your child an injection, administer the next dose of Hyrimoz as soon as you remember. After that, resume your child's regular dosing schedule.

If you stop treatment with Hyrimoz
The decision to stop using Hyrimoz should be discussed with your child's doctor. Symptoms may return after stopping treatment.

If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Most side effects are mild to moderate in severity. However, some may be serious and require treatment.
Side effects may occur up to 4 months or more after the last injection of Hyrimoz.
Seek urgent medical advice if you notice any of the following signs of an allergic reaction or heart failure:

• severe rash, hives;
• swelling of the face, hands, or feet;
• difficulty breathing, difficulty swallowing;
• shortness of breath during physical activity or when lying down, or swollen feet.

Inform your doctor as soon as possible if you notice any of the following reactions:

• signs and symptoms of infection such as fever, feeling unwell, wounds, dental problems, burning when urinating, fatigue or weakness, or cough;
• symptoms of nerve problems such as tingling, numbness, double vision, or weakness in the arms or legs;
• signs of skin cancer such as a growing bump or open sore that does not heal;
• signs and symptoms suggesting disorders of the hematopoietic system, such as persistent fever, bruising, bleeding, or paleness.

The following side effects have been observed with Hyrimoz:
Very common (may affect more than 1 in 10 people)

• injection site reactions (including pain, swelling, redness, or itching);
• respiratory tract infections (including cold, runny nose, sinusitis, and pneumonia);
• headache;
• abdominal pain;
• nausea and vomiting;
• rash;
• muscle pain.

Common (may affect up to 1 in 10 people)

• serious infections (including sepsis and influenza);
• intestinal infections (including gastroenteritis);
• skin infections (including cellulitis and herpes zoster infection);
• ear infections;
• mouth infections (including dental infections and herpes simplex);
• reproductive tract infections;
• urinary tract infections;
• fungal infections;
• joint infections;
• benign tumors;
• skin cancer;
• allergic reactions (including seasonal allergies);
• dehydration;
• mood changes (including depression);
• anxiety;
• sleep disorders;
• sensory disturbances such as tingling, stabbing sensations, or numbness;
• migraine;
• symptoms of nerve root compression (including lower back pain and leg pain);
• visual disturbances;
• eye inflammation;
• eyelid inflammation and eye swelling;
• dizziness (sensation of spinning);
• awareness of heartbeat;
• high blood pressure;
• hot flushes;
• bruising (solid swelling with clotted blood);
• cough;
• asthma;
• shortness of breath;
• gastrointestinal bleeding;
• dyspepsia (indigestion, bloating, heartburn);
• acid reflux disorder;
• dry syndrome (including dry eyes and dry mouth);
• itching;
• itchy rash;
• contusion;
• skin inflammation (such as eczema);
• cracking or breaking of fingernails and toenails;
• increased sweating;
• hair loss;
• onset or worsening of psoriasis;
• muscle spasms;
• blood in the urine;
• kidney problems;
• chest pain;
• edema (fluid accumulation in the body, causing swelling of affected tissues);
• fever;
• reduced platelet count in the blood, increasing the risk of bleeding or bruising;
• poor wound healing.

Uncommon (may affect up to 1 in 100 people)

• unusual infections (including tuberculosis and other infections) that occur when immune defenses are reduced;
• neurological infections (including viral meningitis);
• eye infections;
• bacterial infections;
• diverticulitis (inflammation and infection of the large intestine);
• tumors, including tumors of the lymphatic system (lymphoma) and melanoma (a type of skin cancer);
• disorders of the immune system that may affect lungs, skin, and lymph nodes (most commonly a condition called sarcoidosis);
• vasculitis (inflammation of blood vessels);
• tremor (shaking);
• neuropathy (nerve damage);
• stroke;
• hearing loss, ringing in the ears;
• sensation of irregular heartbeat such as palpitations;
• heart problems that may cause shortness of breath or swelling of the ankles;
• acute myocardial infarction;
• formation of a sac in the wall of a major artery, vein inflammation and clot, blockage of a blood vessel;
• lung disease causing shortness of breath (including inflammation);
• pulmonary embolism (blockage of a pulmonary artery);
• pleural effusion (abnormal accumulation of fluid in the pleural space);
• inflammation of the pancreas causing severe abdominal and back pain;
• difficulty swallowing;
• facial edema (swelling);
• gallbladder inflammation, gallstones;
• fatty liver (accumulation of fat in liver cells);
• night sweats;
• scarring;
• abnormal muscle breakdown;
• systemic lupus erythematosus (immune system disorder, including inflammation of the skin, heart, lungs, joints, and other organs);
• interrupted sleep;
• impotence;
• inflammations.

Rare (may affect up to 1 in 1,000 people)

• leukemia (a cancer affecting blood and bone marrow);
• severe allergic reaction with shock;
• multiple sclerosis;
• neurological disorders (such as optic neuritis in the eye and Guillain-Barré syndrome, a condition that may cause muscle weakness, abnormal sensations, tingling in arms and upper body);
• cardiac arrest;
• pulmonary fibrosis (scarring of the lungs);
• intestinal perforation (a hole in the intestinal wall);
• hepatitis (inflammation of the liver);
• reactivation of hepatitis B infection;
• autoimmune hepatitis (liver inflammation caused by the body's own immune system);
• cutaneous vasculitis (inflammation of blood vessels in the skin);
• Stevens-Johnson syndrome (a life-threatening reaction with flu-like symptoms and a blistering rash);
• facial edema (swelling) associated with allergic reactions;
• erythema multiforme (inflammatory skin rash);
• lupus-like syndrome;
• angioedema (localized swelling of the skin);
• lichenoid skin reaction (pruritic red-purple rash).

Not known (frequency cannot be estimated from the available data)

• hepatosplenic T-cell lymphoma (a rare blood cancer that is often fatal);
• Merkel cell carcinoma (a type of skin cancer);
• Kaposi's sarcoma, a rare form of cancer associated with human herpesvirus 8 infection. Kaposi's sarcoma most commonly appears as purple lesions on the skin;
• liver failure;
• worsening of a condition called dermatomyositis (characterized by rash accompanied by muscle weakness);
• weight gain (in most patients, weight gain has been low).

Some of the side effects observed with adalimumab may be asymptomatic and can only be detected through blood tests. These include:
Very common (may affect more than 1 in 10 people)

• low white blood cell count;
• low red blood cell count;
• increased blood lipids;
• increased liver enzymes.

Common (may affect up to 1 in 10 people)

• increased white blood cell count;
• reduced platelet count;
• increased blood uric acid;
• altered blood sodium levels;
• reduced blood calcium;
• reduced blood phosphorus;
• increased blood sugar;
• increased blood lactate dehydrogenase;
• presence of autoantibodies in the blood;
• reduced blood potassium.

Uncommon (may affect up to 1 in 100 people)

• elevated bilirubin levels in the blood (liver blood test).

Rare (may affect up to 1 in 1,000 people)

• low white blood cell, red blood cell, and platelet counts.

Reporting of side effects
If your child experiences any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Hyrimoz

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label/blister/pack after the word "Exp".
Store in a refrigerator (2°C – 8°C). Do not freeze.
Keep the pre-filled syringe in the outer packaging to protect the medicine from light.

Alternative storage conditions:
When necessary (e.g. when travelling), Hyrimoz may be stored at room temperature (up to 25°C) for a maximum period of 42 days – ensure the medicine is protected from light. Once removed from the refrigerator for storage at room temperature, the pre-filled syringe must be used within 42 days or discarded, even if it is later returned to the refrigerator. You must record the date when the pre-filled syringe is first removed from the refrigerator and the date after which the syringe must be discarded.

Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Hyrimoz contains

• The active substance is adalimumab. Each pre-filled syringe contains 20 mg of adalimumab in 0.2 mL of solution.
• The excipients are adipic acid, mannitol (E 421), polysorbate 80 (E 433), hydrochloric acid (E 507), sodium hydroxide (E 524) and water for injections (see section 2, “Hyrimoz contains sodium”).

Description of the appearance of Hyrimoz and contents of the pack
Hyrimoz 20 mg solution for injection in pre-filled syringe for paediatric use is supplied as 0.2 mL of solution, from clear to slightly opalescent, colourless or slightly yellowish.
Hyrimoz is supplied in a single-use, transparent type I glass syringe with a 29-gauge stainless steel needle, finger grip, needle rubber cap (thermoplastic elastomer) and plastic plunger, containing 0.2 mL of solution.
The multiple pack contains 2 (2 packs of 1) pre-filled syringes of Hyrimoz.
Not all pack sizes may be marketed.
Hyrimoz is available in a pre-filled syringe and in a pre-filled pen.

Marketing Authorisation Holder
Sandoz GmbH
Biochemiestr. 10
6250 Kundl
Austria

Manufacturer
Sandoz GmbH Schaftenau
Biochemiestr. 10
6336 Langkampfen
Austria
Novartis Pharmaceutical Manufacturing GmbH
Biochemiestrasse 10
6336 Langkampfen
Austria

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Sandoz nv/sa Sandoz Pharmaceuticals d.d filialas
Tél/Tel: +32 2 722 97 97 Tel: +370 5 2636 037

България Luxembourg/Luxemburg
Сандоз България КЧТ Sandoz nv/sa (Belgique/Belgien)
Тел.: +359 2 970 47 47 Tél/Tel.: +32 2 722 97 97

Česká republika Magyarország
Sandoz s.r.o. Sandoz Hungária Kft.
Tel: +420 225 775 111 Tel.: +36 1 430 2890

Danmark/Norge/Ísland/Sverige Malta
Sandoz A/S Sandoz Pharmaceuticals d.d.
Tlf./Sími/Tel: +45 63 95 10 00 Tel: +356 99644126

Deutschland Nederland
Hexal AG Sandoz B.V.
Tel: +49 8024 908 0 Tel: +31 36 52 41 600

Eesti Österreich
Sandoz d.d. Eesti filiaal Sandoz GmbH
Tel: +372 665 2400 Tel: +43 5338 2000

Ελλάδα Polska
SANDOZ HELLAS ΜΟΝΟΠΡΟΣΩΠΗ Α.Ε. Sandoz Polska Sp. z o.o.
Τηλ: +30 216 600 5000 Tel.: +48 22 209 70 00

España Portugal
Sandoz Farmacéutica, S.A. Sandoz Farmacêutica Lda.
Tel: +34 900 456 856 Tel: +351 21 000 86 00

France România
Sandoz SAS Sandoz Pharmaceuticals SRL
Tél: +33 1 49 64 48 00 Tel: +40 21 407 51 60

Hrvatska Slovenija
Sandoz farmacevtska družba d.d.
Sandoz d.o.o.
Tel: +386 1 580 29 02
Tel: +385 1 23 53 111

Ireland Slovenská republika
Rowex Ltd. Sandoz d.d. - organizačná zložka
Tel: +353 27 50077 Tel: +421 2 48 200 600

Italia Suomi/Finland
Sandoz S.p.A. Sandoz A/S
Tel: +39 02 96541 Puh/Tel: +358 10 6133 400

Κύπρος United Kingdom (Northern Ireland)
SANDOZ HELLAS ΜΟΝΟΠΡΟΣΩΠΗ Α.Ε. Sandoz GmbH
(Greece) Tel: +43 5338 2000
Τηλ: +30 216 600 5000

Latvija
Sandoz d.d. Latvia filiāle
Tel: +371 67 892 006

Other sources of information
More detailed information on this medicinal product is available on the European Medicines Agency website: https://www.ema.europa.eu .

7. Instructions for Use

To avoid possible infections and to ensure you use the medicine correctly, it is important that
you follow these instructions.
Make sure you read, understand, and follow these Instructions for Use before injecting Hyrimoz.
A healthcare professional must show you how to properly prepare and inject Hyrimoz using the
single-dose pre-filled syringe before you use the medicine for the first time. If you have any doubts, consult your
healthcare professional.
Single-use pre-filled syringe of Hyrimoz

Figure A: pre-filled syringe of Hyrimoz
It is important that you:

• do not use the pre-filled syringe if the seal on the outer carton is broken, as use may not be safe;
• do not open the inner carton until you are ready to use the pre-filled syringe of Hyrimoz;
• never leave the pre-filled syringe unattended where it could be tampered with by others;
• if you drop the syringe, do not use it if it appears damaged or if it was dropped after removing the needle cap;
• do not remove the needle cap until just before injection;
• inject Hyrimoz 15–30 minutes after removing it from the refrigerator, for a more comfortable injection;
• dispose of the used syringe immediately after use. Do not reuse the syringe. See “4. Disposal of Used Syringes” at the end of these Instructions for Use;
• consult your doctor or nurse for advice on the appropriate injection site and technique if you are underweight or administering the injection to a child.

How should you store the single-dose pre-filled syringe of Hyrimoz?

• Store the single-dose Hyrimoz syringe in its original packaging to protect the medicine from light.
• Store the pre-filled syringe carton in the refrigerator at a temperature between 2°C and 8°C.
• If necessary (e.g., when traveling), you may store the pre-filled syringe at room temperature up to 25°C for a maximum of 42 days.
• After 42 days, discard the pre-filled syringe stored at room temperature.
• You must record the date when the pre-filled syringe is first removed from the refrigerator and the date after which it must be discarded.
• Do not store the pre-filled syringe at extremely hot or cold temperatures.
• Do not freeze the pre-filled syringe.
• Do not use the pre-filled syringe after the expiry date stated on the outer carton or on the syringe label. If the expiry date has passed, return the entire pack to the pharmacy.

Keep Hyrimoz and all medicines out of the reach of children.
What is needed for the injection?
Place the following items on a clean, flat surface.
The pre-filled syringe pack contains:

• Pre-filled syringe of Hyrimoz (see Figure A). Each pre-filled syringe contains 20 mg/0.2 mL of adalimumab.

The pre-filled syringe pack of Hyrimoz does not contain (see Figure B ):

• Alcohol swab.
• Cotton ball or gauze.
• Sharps disposal container. See “4. Disposal of Used Syringes” at the end of these Instructions for Use.
• Adhesive bandage.

Figure B: items not included in the pack
Preparing the pre-filled syringe

• For a more comfortable injection, remove the carton containing the pre-filled syringe from the refrigerator and leave it closed on the work surface for about 15–30 minutes to reach room temperature.
• Remove the pre-filled syringe from the box and inspect it. The solution should be colorless or slightly yellowish and from clear to slightly opalescent. Do not use the syringe if you notice particles and/or changes in color. If you have any doubts about the appearance of the solution, consult your pharmacist for assistance.
• Do not use the pre-filled syringe if it is damaged. Return the entire product pack to the pharmacy.
• Check the expiry date (Exp.) of the pre-filled syringe. Do not use the pre-filled syringe if the expiry date has passed.

Consult your pharmacist if the pre-filled syringe fails any of the checks listed above.

1. Choosing the injection site:

The injection site is the location on the body where you will administer
the injection using the Hyrimoz pre-filled syringe.

• The recommended injection site is the front of the thighs. The lower abdominal area may also be used, except for a 5 cm area around the navel (see Figure C).
• Always choose a different site each time you give an injection.
• Do not inject the medicine into areas where the skin is tender, bruised, red, scaly, or hard. Avoid areas with scars or stretch marks. Figure C : how to choose the injection site If you have psoriasis, do not inject the medicine directly into areas affected by psoriatic plaques.

2. Cleaning the injection site:

• When you are ready to use the prefilled syringe, wash your hands thoroughly with water and soap.

• Using a circular motion, clean the injection site with an alcohol swab. Let it dry before administering the injection (see Figure D).

• Do not touch this area again before giving the injection. Let the skin dry completely before the injection. Do not fan or blow air onto the area.
  Figure D: How to clean the injection site.

3. Administering the injection:

• Carefully pull off the needle cap
  from the syringe (see Figure E ).

Figure E: How to remove the needle cap

• Discard (dispose of) the needle cap.

• You may see a drop of liquid at the tip of the needle. This is normal.

• Gently create a skin fold at the injection site
  (see Figure F ).

Figure F: How to insert the needle

• Insert the needle into the skin at a 45° angle, as shown (see Figure F).

• Hold the prefilled single-dose syringe as shown
  (see Figure G ).

Figure G: How to push the plunger

• Slowly push the plunger to the stop.
• While keeping the syringe in place, hold the plunger fully depressed for 5 seconds.
• Carefully withdraw the needle from the injection site, then release the skin. You may notice a small amount of blood at the injection site. You may press a cotton ball or gauze pad against the injection site and hold pressure for 10 seconds. Do not rub the injection site. If needed, you may cover the injection site with a small adhesive bandage.

4. Disposal of used pre-filled syringes:

• Dispose of the used syringe in a sharps disposal container
  
  (puncture-resistant, closable container). For your safety and health and that of others, needles and syringes must never be reused.

• Do not dispose of any medicine via wastewater or household waste. Ask your doctor or pharmacist how to dispose of medicines you no longer use. This will help protect the environment. Unused medicine and waste derived from this medicine must be disposed of in accordance with local regulations.

Figure H: how to dispose of the used
pre-filled syringe
If you have any questions, consult a doctor, pharmacist, or nurse familiar with
Hyrimoz.

Patient information leaflet

Hyrimoz 40 mg solution for injection in pre-filled syringe

adalimumab
40 mg/0.8 mL
Read this leaflet carefully before using this medicine because it contains important information for you

• Keep this leaflet. You may need to read it again.
• Your doctor will provide you with a Patient Reminder Card containing important safety information you need to know before receiving Hyrimoz and during treatment with Hyrimoz. Keep this Patient Reminder Card with you throughout treatment and for 4 months after the last injection (or the last injection given to your child) of Hyrimoz.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Hyrimoz is and what it is used for
2. What you need to know before using Hyrimoz
3. How to use Hyrimoz
4. Possible side effects
5. How to store Hyrimoz
6. Contents of the pack and other information
7. Instructions for use

1. What Hyrimoz is and what it is used for

Hyrimoz contains the active substance adalimumab, a medicine that acts on the body's immune (defence) system.
Hyrimoz is indicated for the treatment of the following inflammatory diseases:

• rheumatoid arthritis,
• polyarticular juvenile idiopathic arthritis,
• enthesitis-related arthritis,
• ankylosing spondylitis,
• non-radiographic axial spondyloarthritis (axial spondyloarthritis without radiographic evidence of ankylosing spondylitis),
• psoriatic arthritis,
• psoriasis,
• hidradenitis suppurativa,
• Crohn's disease,
• ulcerative colitis, and
• non-infectious uveitis.

The active substance in Hyrimoz, adalimumab, is a human monoclonal antibody. Monoclonal antibodies are proteins that bind to a specific target.
Adalimumab targets a protein called tumour necrosis factor (TNFα), which is involved in the immune (defence) system and is present at higher concentrations in the inflammatory diseases listed above. By binding to TNFα, Hyrimoz blocks its action and reduces the inflammatory process in these diseases.

Rheumatoid arthritis
Rheumatoid arthritis is an inflammatory disease affecting the joints.
Hyrimoz is used to treat rheumatoid arthritis in adults. If you have moderate to severe rheumatoid arthritis, you may initially be given other disease-modifying drugs, such as methotrexate. If these drugs do not work satisfactorily, you will be given Hyrimoz to treat rheumatoid arthritis.
Hyrimoz may also be used to treat severe, active and progressive rheumatoid arthritis without prior treatment with methotrexate.
Hyrimoz can slow down the progression of joint cartilage and bone damage caused by the disease and improve physical function.
Hyrimoz is generally used in combination with methotrexate. If your doctor considers methotrexate treatment inappropriate, Hyrimoz may be given alone.

Polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis
Polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis are inflammatory joint diseases that usually first appear during childhood.
Hyrimoz is used to treat polyarticular juvenile idiopathic arthritis in children and adolescents aged 2 to 17 years and enthesitis-related arthritis in children and adolescents aged 6 to 17 years. At diagnosis, other disease-modifying drugs such as methotrexate may be administered. If these drugs do not work satisfactorily, patients will be given Hyrimoz to treat polyarticular juvenile idiopathic arthritis or enthesitis-related arthritis.

Ankylosing spondylitis and non-radiographic axial spondyloarthritis
Ankylosing spondylitis and non-radiographic axial spondyloarthritis are inflammatory conditions of the spine.
Hyrimoz is used in adults to treat these conditions. If you have ankylosing spondylitis or non-radiographic axial spondyloarthritis, you will first be given other medications. If these drugs do not work satisfactorily, you will take Hyrimoz to reduce the signs and symptoms of the disease.

Plaque psoriasis in adults and children
Plaque psoriasis is an inflammatory skin condition causing red, scaly, thickened patches of skin covered with silvery scales. Plaque psoriasis can also affect the nails, causing them to break, thicken or lift from the nail bed, which can be painful. Psoriasis is believed to be caused by a problem with the body's immune system that leads to increased production of skin cells.
Hyrimoz is used to treat moderate to severe plaque psoriasis in adults. Hyrimoz is also used to treat severe plaque psoriasis in children and adolescents aged 4 to 17 years when topical medications and UV light therapy have not worked satisfactorily or are not suitable.

Psoriatic arthritis
Psoriatic arthritis is an inflammatory joint disease associated with psoriasis.
Hyrimoz is used to treat psoriatic arthritis in adults. Hyrimoz can slow down joint cartilage and bone damage caused by the disease and improve physical function.

Hidradenitis suppurativa in adults and adolescents
Hidradenitis suppurativa (sometimes called acne inversa) is a chronic, long-term inflammatory skin disease and is often painful. Symptoms may include painful lumps and abscesses (cysts) that may drain pus.
It most commonly affects specific skin areas such as the under-breast region, armpits, inner thighs, groin, and buttocks. Scarring may also develop in affected areas.
Hyrimoz is used to treat hidradenitis suppurativa in adults and adolescents aged 12 years and older. Hyrimoz can reduce the number of lumps and abscesses you have and the pain often associated with this disease. You may initially receive other medications. If these drugs do not work satisfactorily, you will be given Hyrimoz.

Crohn's disease in adults and children
Crohn's disease is an inflammation of the intestine.
Hyrimoz is used to treat Crohn's disease in adults and children aged 6 to 17 years. If you have Crohn's disease, you will first be given other medications. If you do not respond adequately to these drugs, you will be given Hyrimoz to reduce the typical symptoms of Crohn's disease.

Ulcerative colitis in adults and children
Ulcerative colitis is an inflammation of the large intestine (colon).
Hyrimoz is used to treat moderate to severe ulcerative colitis in adults and children aged 6 to 17 years. If you have ulcerative colitis, you may first take other medications. If these drugs do not work satisfactorily, you will take Hyrimoz to reduce the signs and symptoms of the disease.

Non-infectious uveitis in adults and children
Non-infectious uveitis is an inflammatory disease affecting certain parts of the eye.
The inflammation leads to reduced vision and/or the presence of floaters in the eye (black spots or thin lines moving across the visual field). Hyrimoz works by reducing this inflammation.
Hyrimoz is used for the treatment of:

• Adults with non-infectious uveitis with inflammation affecting the back of the eye
• Children from 2 years of age with chronic non-infectious uveitis with inflammation affecting the front part of the eye

2. What you should know before using Hyrimoz

Do not use Hyrimoz

• If you are allergic to adalimumab or to any of the other ingredients of this medicine (listed in section 6).
• If you have a serious infection, including tuberculosis, sepsis (blood poisoning), or other opportunistic infections (unusual infections associated with a weakened immune system). It is important to inform your doctor if you have signs or symptoms of infection, such as fever, wounds, feeling tired, or dental problems (see "Warnings and precautions").
• If you have moderate or severe heart failure. It is important to inform your doctor if you have had or currently have a serious heart condition (see "Warnings and precautions").

Warnings and precautions
Talk to your doctor or pharmacist before using Hyrimoz.

Allergic reaction

• If you experience allergic reactions with symptoms such as chest tightness, wheezing, dizziness, swelling, or skin rash, do not administer Hyrimoz again and contact your doctor immediately, as in rare cases these reactions may be life-threatening.

Infection

• If you have an infection, including long-term or localized infections (e.g., leg ulcers), consult your doctor before starting treatment with Hyrimoz. If you are unsure, contact your doctor.
• You may be more likely to get infections while being treated with Hyrimoz. This risk may increase if your lung function is reduced. These infections can be serious and may include tuberculosis, viral, fungal, parasitic, or bacterial infections, or other unusual infectious organisms, and sepsis (septicaemia).
• In rare cases, these infections may be life-threatening. It is important to inform your doctor if you have symptoms such as fever, wounds, feeling tired, or dental problems. Your doctor may advise temporarily stopping Hyrimoz.

Tuberculosis (TB)

• Since cases of tuberculosis have occurred in patients treated with adalimumab, your doctor will check for signs or symptoms of tuberculosis before starting therapy with Hyrimoz. This will involve a detailed medical evaluation including your medical history and clinical tests (e.g., a chest X-ray and tuberculin skin test). The performance and results of these tests must be recorded in the Patient Reminder Card. It is very important to inform your doctor if you have ever had tuberculosis or if you have had close contact with someone with tuberculosis. Tuberculosis may occur during treatment even if you have received preventive treatment for tuberculosis. Contact your doctor immediately if symptoms of tuberculosis (persistent cough, weight loss, lack of energy, low-grade fever) or other infections develop during or after treatment.

Travel/recurring infection

• Inform your doctor if you have lived in or traveled to regions where fungal infections such as histoplasmosis, coccidioidomycosis, or blastomycosis are common.
• Inform your doctor if you have had recurring infections or if you have conditions that increase your risk of infection.

Hepatitis B virus

• Inform your doctor if you are a carrier of hepatitis B virus (HBV), if you have an active hepatitis B virus infection, or if you think you may be at risk of contracting hepatitis B virus. Your doctor must test you for hepatitis B virus infection. Taking adalimumab may reactivate hepatitis B virus infection in people who are carriers of this virus. In rare cases, especially if the patient is also receiving treatment with other medicines that suppress the immune system, reactivation of hepatitis B virus infection may be life-threatening.

Age over 65 years

• If you are over 65 years of age, you may be more susceptible to infections while taking Hyrimoz. You and your doctor should pay particular attention to signs of infection while you are being treated with Hyrimoz. It is important to inform your doctor if symptoms of infection such as fever, wounds, feeling tired, or dental problems occur.

Surgery or dental procedures

• Before undergoing surgery or dental procedures, inform your doctor that you are taking Hyrimoz. Your doctor may advise temporarily stopping Hyrimoz.

Demyelinating disease

• If you have or develop demyelinating diseases (diseases affecting the insulating layer around nerves), such as multiple sclerosis, your doctor will decide whether to start or continue treatment with Hyrimoz. Inform your doctor immediately if you experience symptoms such as changes in vision, weakness in arms or legs, or numbness or tingling in any part of the body.

Vaccination

• Certain vaccines contain live but weakened forms of bacteria or viruses that cause disease and must not be administered during treatment with Hyrimoz, as they may cause infections. Consult your doctor before receiving any vaccinations. In children, it is recommended, if possible, to administer age-appropriate vaccinations before starting Hyrimoz therapy. If you take Hyrimoz during pregnancy, your baby may have an increased risk of infection for up to about 5 months after your last dose during pregnancy. It is important that you inform the paediatrician or other healthcare provider about your use of Hyrimoz during pregnancy so they can decide when the baby should receive any type of vaccination.

Heart failure

• It is important to inform your doctor about any past or present heart problems. If you have mild heart failure and are being treated with Hyrimoz, your doctor should carefully evaluate and monitor your heart condition. If new symptoms of heart failure appear or if existing symptoms worsen (e.g., shortness of breath or swelling of the feet), contact your doctor immediately.

Fever, bruising, bleeding, or paleness

• In some patients, the body may not be able to produce enough blood cells to fight infections or stop bleeding. If you have persistent fever, bruising, easy bleeding, or paleness, contact your doctor immediately. Your doctor may decide to stop treatment.

Tumours

• Very rarely, certain types of tumours have occurred in children and adults treated with Hyrimoz or other anti-TNFα medicines. Patients with long-standing, severe rheumatoid arthritis may have a higher than average risk of developing lymphoma and leukaemia (cancers affecting blood cells and bone marrow). If you are taking Hyrimoz, your risk of developing lymphomas, leukaemia, or other cancers may increase. In rare cases, a specific and serious type of lymphoma has been observed in patients treated with adalimumab. Some of these patients were also receiving treatment with azathioprine or mercaptopurine. Inform your doctor if you are taking azathioprine or mercaptopurine with Hyrimoz.
• Cases of non-melanoma skin cancer have been observed in patients taking adalimumab. If damaged skin areas appear during or after treatment, or if the appearance of existing marks or damaged areas changes, inform your doctor.
• Cases of cancers other than lymphoma have been reported in patients with a specific lung disease called chronic obstructive pulmonary disease (COPD) treated with another anti-TNFα medicine. If you have COPD or are a heavy smoker, you should discuss with your doctor whether treatment with an anti-TNFα medicine is appropriate.

Autoimmune diseases

• Rarely, treatment with Hyrimoz may lead to the development of a lupus-like syndrome. Inform your doctor if you develop symptoms such as unexplained persistent skin rash, fever, joint pain, or fatigue.

Children and adolescents

• Vaccinations: If possible, children should have received all age-appropriate vaccinations before using Hyrimoz.
• Do not give Hyrimoz to children under 2 years of age with polyarticular juvenile idiopathic arthritis.

Other medicines and Hyrimoz
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Hyrimoz can be taken with methotrexate and other disease-modifying antirheumatic drugs (sulfasalazine, hydroxychloroquine, leflunomide, and parenteral gold salts), corticosteroids, or analgesics, including non-steroidal anti-inflammatory drugs (NSAIDs).
Hyrimoz must not be taken together with medicines containing the active substances anakinra or abatacept due to an increased risk of serious infections. The combination of adalimumab with other anti-TNF medicines and anakinra or abatacept is not recommended due to a possible increased risk of infections, including serious infections, and other potential pharmacological interactions. If you have any doubts, consult your doctor.

Pregnancy and breastfeeding

• You should consider using an effective contraceptive method to prevent pregnancy and continue using it for at least 5 months after your last dose of Hyrimoz.
• If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, consult your doctor about taking this medicine.
• Hyrimoz should be used during pregnancy only if necessary.
• According to a pregnancy study, no increased risk of birth defects was observed when mothers received adalimumab during pregnancy compared to mothers with the same condition who did not receive adalimumab.
• Hyrimoz may be used during breastfeeding.
• If you take Hyrimoz during pregnancy, your baby may have an increased risk of infection.
• It is important that you inform the paediatrician or other healthcare provider about your use of Hyrimoz during pregnancy before the baby receives any type of vaccination (for more information on vaccines, see section "Warnings and precautions").

Driving and using machines
Hyrimoz may affect your ability to drive, ride a bicycle, or use machines, although only to a minor extent. After taking Hyrimoz, you may experience vision disturbances or a sensation that your surroundings are spinning (dizziness).

Hyrimoz contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per 0.8 mL dose, i.e., essentially 'sodium-free'.

3. How to use Hyrimoz

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Hyrimoz is available in 40 mg pens and 20 mg and 40 mg pre-filled syringes for
administration of a complete dose of 20 mg or 40 mg to patients.

Method and route of administration
Hyrimoz is administered by subcutaneous injection (for subcutaneous injection).
Detailed instructions on how to inject Hyrimoz are provided in section 7, “Instructions for use”.

If you use more Hyrimoz than you should
If you accidentally inject Hyrimoz more often than you should, contact your doctor or pharmacist and inform them that you have taken more medicine than required. Always keep the medicine packaging, even if empty.

If you forget to use Hyrimoz
If you forget to administer an injection, inject the next dose of Hyrimoz as soon as you remember. Then resume your regular dosing schedule as prescribed.

If you stop using Hyrimoz
The decision to stop using Hyrimoz should be discussed with your doctor. Symptoms may return after stopping treatment.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Most of the side effects are mild to moderate in severity. However, some may be serious and require treatment.
Side effects may occur up to 4 months or more after the last injection of Hyrimoz.

Seek urgent medical advice if you notice any of the following signs of an allergic reaction or heart failure:

• severe rash, hives;
• swelling of the face, hands, feet;
• difficulty breathing, difficulty swallowing;
• shortness of breath on exertion or when lying down, or swollen feet.

Inform your doctor as soon as possible if you notice any of the following reactions:

• signs and symptoms of infection such as fever, feeling unwell, wounds, dental problems, burning when urinating, fatigue or weakness, or cough;
• symptoms of nerve problems, such as tingling, numbness, double vision, or weakness in the arms or legs;
• signs of skin cancer such as a lump or open sore that does not heal;
• signs and symptoms suggesting the onset of disorders affecting the blood-forming system, such as persistent fever, bruising, bleeding, or paleness.

The following side effects have been observed with Hyrimoz:
Very common (may affect more than 1 in 10 people)

• injection site reactions (including pain, swelling, redness, or itching);
• respiratory tract infections (including cold, runny nose, sinusitis, and pneumonia);
• headache;
• abdominal pain (stomach pain);
• nausea and vomiting;
• rash;
• muscle pain.

Common (may affect up to 1 in 10 people)

• serious infections (including sepsis and influenza);
• intestinal infections (including gastroenteritis);
• skin infections (including cellulitis and herpes zoster infection);
• ear infections;
• mouth infections (including dental infections and herpes simplex);
• reproductive system infections;
• urinary tract infections;
• fungal infections;
• joint infections;
• benign tumours;
• skin cancer;
• allergic reactions (including seasonal allergies);
• dehydration;
• mood changes (including depression);
• anxiety;
• sleep disorders;
• sensory disturbances such as tingling, stabbing sensations, or numbness;
• migraine;
• symptoms of nerve root compression (including lower back pain and leg pain);
• visual disturbances;
• eye inflammation;
• eyelid inflammation and eye swelling;
• dizziness (sensation of the room spinning);
• sensation of rapid heartbeat;
• high blood pressure;
• hot flushes;
• haematoma (solid swelling with clotted blood);
• cough;
• asthma;
• shortness of breath;
• gastrointestinal bleeding;
• dyspepsia (indigestion, bloating, heartburn);
• acid reflux disorder;
• dry syndrome (including dry eyes and dry mouth);
• itching;
• itchy rash;
• bruising;
• skin inflammation (such as eczema);
• cracking or breaking of fingernails and toenails;
• increased sweating;
• hair loss;
• onset or worsening of psoriasis;
• muscle spasms;
• blood in the urine;
• kidney problems;
• chest pain;
• oedema (fluid accumulation in the body, causing swelling of affected tissues);
• fever;
• reduced platelet count in the blood, increasing the risk of bleeding or bruising;
• delayed wound healing.

Uncommon (may affect up to 1 in 100 people)

• unusual infections (including tuberculosis and other infections) that occur when immune defences are reduced;
• neurological infections (including viral meningitis);
• eye infections;
• bacterial infections;
• diverticulitis (inflammation and infection of the large intestine);
• tumours, including tumours of the lymphatic system (lymphoma) and melanoma (a type of skin cancer);
• immune system disorders that may affect lungs, skin, and lymph nodes (most commonly a condition called sarcoidosis);
• vasculitis (inflammation of blood vessels);
• tremor;
• neuropathy (nerve damage);
• stroke;
• hearing loss, ringing in the ears;
• sensation of irregular heartbeat such as palpitations;
• heart problems that may cause shortness of breath or swelling of the ankles;
• acute myocardial infarction;
• formation of a sac in the wall of a major artery, inflammation and clot in a vein, blockage of a blood vessel;
• lung disease causing shortness of breath (including inflammation);
• pulmonary embolism (blockage of a pulmonary artery);
• pleural effusion (abnormal accumulation of fluid in the pleural space);
• inflammation of the pancreas causing severe abdominal and back pain;
• difficulty swallowing;
• facial oedema (swelling);
• gallbladder inflammation, gallstones;
• fatty liver (accumulation of fat in liver cells);
• night sweats;
• scar;
• abnormal muscle breakdown;
• systemic lupus erythematosus (an immune system disorder, including inflammation of the skin, heart, lungs, joints, and other organs);
• interrupted sleep;
• impotence;
• inflammations.

Rare (may affect up to 1 in 1,000 people)

• leukaemia (a cancer affecting blood and bone marrow);
• severe allergic reaction with shock;
• multiple sclerosis;
• neurological disorders (such as optic neuritis in the eye and Guillain-Barré syndrome, a condition that may cause muscle weakness, abnormal sensations, and tingling in the arms and upper body);
• cardiac arrest;
• pulmonary fibrosis (scarring of the lungs);
• intestinal perforation (a hole in the intestinal wall);
• hepatitis (inflammation of the liver);
• reactivation of hepatitis B infection;
• autoimmune hepatitis (liver inflammation caused by the body's own immune system);
• cutaneous vasculitis (inflammation of blood vessels in the skin);
• Stevens-Johnson syndrome (a life-threatening reaction with flu-like symptoms and a blistering skin rash);
• facial oedema (swelling) associated with allergic reactions;
• erythema multiforme (inflammatory skin rash);
• lupus-like syndrome;
• angioedema (localized swelling of the skin);
• lichenoid skin reaction (pruritic red-purple skin rash).

Not known (frequency cannot be estimated from the available data)

• hepatosplenic T-cell lymphoma (a rare and often fatal blood cancer);
• Merkel cell carcinoma (a type of skin cancer);
• Kaposi’s sarcoma, a rare form of cancer associated with human herpesvirus 8 infection. Kaposi’s sarcoma most commonly presents with purple lesions on the skin;
• liver failure;
• worsening of a condition called dermatomyositis (which presents as a skin rash accompanied by muscle weakness);
• weight gain (in most patients, weight gain was low).

Some of the side effects observed with adalimumab may be asymptomatic and detectable only through blood tests. These include:
Very common (may affect more than 1 in 10 people)

• low white blood cell count;
• low red blood cell count;
• increased blood lipids;
• increased liver enzymes.

Common (may affect up to 1 in 10 people)

• increased white blood cell count;
• decreased platelet count;
• increased uric acid in the blood;
• altered sodium levels in the blood;
• reduced calcium in the blood;
• reduced phosphorus in the blood;
• increased blood sugar;
• increased lactate dehydrogenase in the blood;
• presence of autoantibodies in the blood;
• reduced potassium in the blood.

Uncommon (may affect up to 1 in 100 people)

• elevated bilirubin levels in the blood (liver blood test).

Rare (may affect up to 1 in 1,000 people)

• low white blood cell, red blood cell, and platelet counts.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system listed in Annex V.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Hyrimoz

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label/blister/box after the word "Exp".
Store in a refrigerator (2°C – 8°C). Do not freeze.
Keep the pre-filled syringe in the outer packaging to protect the medicine from light.

Alternative storage conditions:
When necessary (for example, when travelling), Hyrimoz may be stored at room temperature (up to 25°C) for a maximum of 21 days – ensure the medicine is protected from light. Once removed from the refrigerator for storage at room temperature, the pre-filled syringe must be used within 21 days or discarded, even if subsequently placed back into the refrigerator. You must record the date on which the pre-filled syringe is first removed from the refrigerator and the date after which the syringe must be discarded.

Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Hyrimoz contains

• The active substance is adalimumab. Each pre-filled syringe contains 40 mg of adalimumab in 0.8 mL of solution.
• The excipients are adipic acid, citric acid monohydrate, sodium chloride, mannitol (E 421), polysorbate 80 (E 433), hydrochloric acid (E 507), sodium hydroxide (E 524) and water for injections (see section 2 “Hyrimoz contains sodium”).

Description of the appearance of Hyrimoz and contents of the pack
Hyrimoz 40 mg solution for injection in pre-filled syringe is supplied as a 0.8 mL solution, clear to slightly opalescent, colourless or slightly yellowish.
Hyrimoz is supplied in a single-use, transparent Type I glass syringe with a 29-gauge stainless steel needle, a needle safety device with finger grip, a rubber needle cap (thermoplastic elastomer) and a plastic plunger, containing 0.8 mL of solution.
Pack sizes contain 1 and 2 pre-filled syringes of Hyrimoz.
Multiple packs contain 6 (3 packs of 2) pre-filled syringes of Hyrimoz.
Not all pack sizes may be marketed.
Hyrimoz is available in pre-filled syringe and pre-filled pen.

Marketing Authorisation Holder
Sandoz GmbH
Biochemiestr. 10
6250 Kundl
Austria

Manufacturer
Sandoz GmbH Schaftenau
Biochemiestr. 10
6336 Langkampfen
Austria
Novartis Pharmaceutical Manufacturing GmbH
Biochemiestrasse 10
6336 Langkampfen
Austria

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Sandoz nv/sa Sandoz Pharmaceuticals d.d filialas
Tél/Tel: +32 2 722 97 97 Tel: +370 5 2636 037

България Luxembourg/Luxemburg
Сандоз България КЧТ Sandoz nv/sa (Belgique/Belgien)
Тел.: +359 2 970 47 47 Tél/Tel.: +32 2 722 97 97

Česká republika Magyarország
Sandoz s.r.o. Sandoz Hungária Kft.
Tel: +420 225 775 111 Tel.: +36 1 430 2890

Danmark/Norge/Ísland/Sverige Malta
Sandoz A/S Sandoz Pharmaceuticals d.d.
Tlf./Sími/Tel: +45 63 95 10 00 Tel: +356 99644126

Deutschland Nederland
Hexal AG Sandoz B.V.
Tel: +49 8024 908 0 Tel: +31 36 52 41 600

Eesti Österreich
Sandoz d.d. Eesti filiaal Sandoz GmbH
Tel: +372 665 2400 Tel: +43 5338 2000

Ελλάδα Polska
SANDOZ HELLAS ΜΟΝΟΠΡΟΣΩΠΗ Α.Ε. Sandoz Polska Sp. z o.o.
Τηλ: +30 216 600 5000 Tel.: +48 22 209 70 00

España Portugal
Sandoz Farmacéutica, S.A. Sandoz Farmacêutica Lda.
Tel: +34 900 456 856 Tel: +351 21 000 86 00

France România
Sandoz SAS Sandoz Pharmaceuticals SRL
Tél: +33 1 49 64 48 00 Tel: +40 21 407 51 60

Hrvatska Slovenija
Sandoz d.o.o. Sandoz farmacevtska družba d.d.
Tel: +385 1 23 53 111 Tel: +386 1 580 29 02

Ireland Slovenská republika
Rowex Ltd. Sandoz d.d. - organizačná zložka
Tel: +353 27 50077 Tel: +421 2 48 200 600

Italia Suomi/Finland
Sandoz S.p.A. Sandoz A/S
Tel: +39 02 96541 Puh/Tel: +358 10 6133 400

Κύπρος United Kingdom (Northern Ireland)
SANDOZ HELLAS ΜΟΝΟΠΡΟΣΩΠΗ Α.Ε. Sandoz GmbH
(Greece) Tel: +43 5338 2000
Tel: +30 216 600 5000

Latvija
Sandoz d.d. Latvia filiāle
Tel: +371 67 892 006

Other sources of information
More detailed information on this medicinal product is available on the European Medicines Agency website: https://www.ema.europa.eu.

7. Instructions for Use

To avoid possible infections and to ensure you use the medicine correctly, it is important that
you follow these instructions.
Make sure you read, understand, and follow these Instructions for Use before injecting Hyrimoz.
Your healthcare provider must show you how to properly prepare and inject Hyrimoz using the
pre-filled syringe before you use the medicine for the first time. If you have any doubts, consult
your healthcare provider.
Single-use pre-filled syringe of Hyrimoz with needle safety device and additional finger grip

Figure A: pre-filled syringe of Hyrimoz with needle safety device and additional finger grip
It is important that you:

• do not open the outer carton until you are ready to use the syringe;
• do not use the syringe if the blister seals are broken, as use may not be safe;
• never leave the syringe unattended where it could be tampered with by others;
• if you drop the syringe, do not use it if it appears damaged or if it was dropped after removing the needle cap;
• do not remove the needle cap until the time of injection;
• take care not to touch the wings of the needle safety device before use. Doing so may activate the needle safety device too early. Do not remove the finger grip before injection;
• inject Hyrimoz 15–30 minutes after removing it from the refrigerator for a more comfortable injection;
• dispose of the used syringe immediately after use. Do not reuse the syringe. See “4. Disposal of Used Syringes” at the end of these Instructions for Use.

How should you store Hyrimoz?

• Store the outer carton of syringes in the refrigerator at a temperature between 2°C and 8°C.
• When necessary (e.g., when traveling), Hyrimoz may be stored at room temperature (up to 25°C) for a maximum of 21 days—ensure the medicine is protected from light. Once removed from the refrigerator for storage at room temperature, the pre-filled syringe must be used within 21 days or discarded, even if subsequently returned to the refrigerator. You must record the date when the pre-filled syringe is first removed from the refrigerator and the date after which it must be discarded.
• Keep syringes in their original packaging until ready to use, to protect the medicine from light.
• Do not store syringes at extremely hot or cold temperatures.
• Do not freeze the syringes.

Keep Hyrimoz and all medicines out of the reach of children.
What is needed for the injection?
Place the following items on a clean, flat surface.
The package contains:

• Pre-filled syringe(s) of Hyrimoz (see Figure A). Each syringe contains 40 mg/0.8 mL of Hyrimoz.

The package does not contain (see Figure B):

• Alcohol swab.
• Cotton ball or gauze.
• Sharps disposal container.

Figure B: items not included in the package
See “4. Disposal of Used Syringes” at the end of these Instructions for Use.
Before the injection

Figure C: the needle safety device is not Figure D: the needle safety device
activated – the syringe is ready for use is activated – do not use
o In this configuration, the o In this configuration, the
needle safety device needle safety device
IS NOT ACTIVATED. is ACTIVATED.
o The syringe is ready for use (see o DO NOT USE the syringe (see
Figure C). Figure D).
Preparing the syringe

• For a more comfortable injection, remove the blister containing the syringe from the refrigerator and leave it closed on the work surface for about 15–30 minutes to reach room temperature.
• Remove the syringe from the blister.
• Look through the viewing window. The solution should be colourless or slightly yellowish and from clear to slightly opalescent. Do not use the syringe if you notice particles and/or changes in colour. If you have any doubts about the appearance of the solution, consult your pharmacist for assistance.
• Do not use the syringe if it is damaged or if the needle safety device is activated. Return the syringe and its packaging to the pharmacy.
• Check the syringe’s expiration date (Exp.). Do not use the syringe if the expiration date has passed.

Contact your pharmacist if the syringe fails any of the checks listed above.

1. Choosing the injection site:

• The recommended injection site is the front of the
  thighs. The lower part of the stomach may also be used,
  but not the area within 5 cm around the navel (see
  Figure E).

• Choose a different site each time you give an injection.

• Do not inject the medicine into areas where the skin is tender, bruised, red, scaly, or hard. Avoid areas with scars or stretch marks. If you have psoriasis, DO NOT inject the medicine directly into areas with psoriatic plaques.
  Figure E: How to choose the injection site

2. Cleaning the injection site:

• Wash your hands thoroughly with water and soap.

• Using a circular motion, clean the injection site with an alcohol swab. Let it dry before administering the injection (see Figure F).
• Do not touch the cleaned area before the injection.

Figure F: How to clean the injection site

3. Administering the injection:

• Carefully pull off the needle cap from the

syringe (see Figure G).

• Discard the needle cap.
• You may see a drop of liquid at the tip of the needle. This is normal.

Figure G: How to remove the needle cap

• Gently create a skin fold at the injection site

(see Figure H).

• Insert the needle into the skin as shown.
• Push the entire needle under the skin to ensure the full dose of medicine is delivered.

Figure H: How to insert the needle

• Hold the syringe as shown (see Figure I).
• Slowly push the plunger all the way down until it stops, making sure the plunger head moves completely between the wings of the needle safety device.
• While holding the syringe in place, keep the plunger fully depressed for 5 seconds.

Figure I: How to hold the syringe

• Keep the plunger fully depressed while

carefully withdrawing the needle from the injection site, then release the skin (see Figure J).
Figure J: How to withdraw the needle

• Slowly release the plunger and allow the needle safety device to automatically cover the exposed needle

(see Figure K).

• You may notice a small amount of blood at the injection site. You may press a cotton ball or gauze pad over the injection site and hold it for 10 seconds. Do not rub the injection site. If needed, you may cover the injection site with a small adhesive bandage.
  Figure K: How to slowly release the plunger

4. Disposal of used syringes:

• Dispose of the used syringe in a sharps waste container (a puncture-resistant, closable container) designed for the
  disposal of sharp materials.
  For your safety and the safety of others, used needles and syringes must never be reused.

• Do not dispose of any medication via wastewater or household waste. Ask your doctor or pharmacist how to properly discard medicines you no longer use. This will help protect the environment. Unused medicine and waste material from this medicine must be disposed of in accordance with local regulations.

If you have any questions, consult a doctor, pharmacist, or nurse familiar with
Hyrimoz.

Patient Information Leaflet

Hyrimoz 40 mg solution for injection in a pre-filled pen

adalimumab
40 mg/0.8 mL
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• Your doctor will give you a Patient Reminder Card containing important safety information you need to know before receiving Hyrimoz and during treatment with Hyrimoz. Keep this Patient Reminder Card with you during treatment and for 4 months after the last injection (or the last injection given to your child) of Hyrimoz.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Hyrimoz is and what it is used for
2. What you need to know before using Hyrimoz
3. How to use Hyrimoz
4. Possible side effects
5. How to store Hyrimoz
6. Contents of the pack and other information
7. Instructions for use

1. What Hyrimoz is and what it is used for

Hyrimoz contains the active substance adalimumab, a medicine that acts on the body’s immune (defence) system.
Hyrimoz is indicated for the treatment of the following inflammatory diseases:

• rheumatoid arthritis,
• polyarticular juvenile idiopathic arthritis,
• enthesitis-related arthritis,
• ankylosing spondylitis,
• non-radiographic axial spondyloarthritis (axial spondyloarthritis without radiographic evidence of ankylosing spondylitis),
• psoriatic arthritis,
• psoriasis,
• hidradenitis suppurativa,
• Crohn’s disease,
• ulcerative colitis, and
• non-infectious uveitis.

The active substance in Hyrimoz, adalimumab, is a human monoclonal antibody. Monoclonal antibodies are proteins that bind to a specific target.
The target of adalimumab is a protein called tumour necrosis factor (TNFα), which is involved in the immune (defence) system and is present at higher concentrations in the inflammatory diseases listed above. By binding to TNFα, Hyrimoz blocks its action and reduces the inflammatory process in these diseases.

Rheumatoid arthritis
Rheumatoid arthritis is an inflammatory disease affecting the joints.
Hyrimoz is used to treat rheumatoid arthritis in adults. If you have moderate to severe rheumatoid arthritis, other disease-modifying drugs such as methotrexate may be tried first. If these medicines do not work satisfactorily, you will be given Hyrimoz to treat your rheumatoid arthritis.
Hyrimoz may also be used for the treatment of severe, active and progressive rheumatoid arthritis without prior treatment with methotrexate.
Hyrimoz can slow down the progression of joint cartilage and bone damage caused by the disease and improve physical function.
Hyrimoz is generally used in combination with methotrexate. If your doctor considers that treatment with methotrexate is not appropriate, Hyrimoz may be given alone.

Polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis
Polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis are inflammatory joint diseases that usually first appear during childhood.
Hyrimoz is used to treat polyarticular juvenile idiopathic arthritis in children and adolescents aged 2 to 17 years and enthesitis-related arthritis in children and adolescents aged 6 to 17 years. At diagnosis, other disease-modifying drugs such as methotrexate may be administered. If these medicines do not work satisfactorily, patients will be given Hyrimoz to treat polyarticular juvenile idiopathic arthritis or enthesitis-related arthritis.

Ankylosing spondylitis and non-radiographic axial spondyloarthritis
Ankylosing spondylitis and non-radiographic axial spondyloarthritis are inflammatory conditions affecting the spine.
Hyrimoz is used in adults to treat these conditions. If you have ankylosing spondylitis or non-radiographic axial spondyloarthritis, you will usually be treated with other medicines first. If these medicines do not work satisfactorily, you will be given Hyrimoz to reduce the signs and symptoms of the disease.

Plaque psoriasis in adults and children
Plaque psoriasis is an inflammatory skin condition that causes red, scaly, thickened patches of skin covered with silvery scales. Plaque psoriasis can also affect the nails, causing them to break, thicken or lift from the nail bed, which can be painful. Psoriasis is thought to be caused by a problem with the body’s immune system that leads to an increased production of skin cells.
Hyrimoz is used to treat moderate to severe plaque psoriasis in adults. Hyrimoz is also used to treat severe plaque psoriasis in children and adolescents aged 4 to 17 years when topical medications and UV light therapy have not worked well enough or are not suitable.

Psoriatic arthritis
Psoriatic arthritis is an inflammatory joint disease associated with psoriasis.
Hyrimoz is used to treat psoriatic arthritis in adults. Hyrimoz can slow down the damage to joint cartilage and bones caused by the disease and improve physical function.

Hidradenitis suppurativa in adults and adolescents
Hidradenitis suppurativa (sometimes called acne inversa) is a chronic inflammatory skin disease that is often painful. Symptoms may include painful nodules and abscesses (cysts) that may drain pus. It most commonly affects specific areas of the skin such as the area under the breasts, armpits, inner thighs, groin, and buttocks. Scarring may also develop in affected areas.
Hyrimoz is used to treat hidradenitis suppurativa in adults and adolescents aged 12 years and older. Hyrimoz can reduce the number of nodules and abscesses you have and the pain often associated with this disease. You may first be given other medicines. If these do not work satisfactorily, you will be given Hyrimoz.

Crohn’s disease in adults and children
Crohn’s disease is an inflammation of the intestine.
Hyrimoz is used to treat Crohn’s disease in adults and children aged 6 to 17 years. If you have Crohn’s disease, you will first be given other medicines. If you do not respond adequately to these medicines, you will be given Hyrimoz to reduce the typical symptoms of Crohn’s disease.

Ulcerative colitis in adults and children
Ulcerative colitis is an inflammation of the large intestine (colon).
Hyrimoz is used to treat moderate to severe ulcerative colitis in adults and children aged 6 to 17 years. If you have ulcerative colitis, you may first be given other medicines. If these medicines do not work satisfactorily, you will be given Hyrimoz to reduce the signs and symptoms of the disease.

Non-infectious uveitis in adults and children
Non-infectious uveitis is an inflammatory disease affecting certain parts of the eye.
The inflammation leads to reduced vision and/or the presence of floaters in the eye (black spots or thin lines moving across the visual field). Hyrimoz works by reducing this inflammation.
Hyrimoz is used for the treatment of:

• Adults with non-infectious uveitis with inflammation affecting the back of the eye
• Children from 2 years of age with chronic non-infectious uveitis with inflammation affecting the front part of the eye

2. What you need to know before using Hyrimoz

Do not use Hyrimoz

• If you are allergic to adalimumab or to any of the other ingredients of this medicine (listed in section 6).
• If you have a serious infection, including tuberculosis, sepsis (blood poisoning), or other opportunistic infections (unusual infections associated with a weakened immune system). It is important to inform your doctor if you have signs or symptoms of infection, such as fever, wounds, feeling tired, or dental problems (see "Warnings and precautions").
• If you have moderate or severe heart failure. It is important to inform your doctor if you have had or currently have a serious heart condition (see "Warnings and precautions").

Warnings and precautions
Talk to your doctor or pharmacist before using Hyrimoz.
Allergic reaction

• If you experience allergic reactions with symptoms such as chest tightness, wheezing, dizziness, swelling, or rash, do not administer Hyrimoz again and contact your doctor immediately, as these reactions may, in rare cases, be life-threatening.

Infection

• If you have an infection, including long-term or localized infections (e.g., leg ulcers), consult your doctor before starting treatment with Hyrimoz. If you are in doubt, contact your doctor.
• You may be more likely to get infections while being treated with Hyrimoz. This risk may increase if your lung function is reduced. These infections can be serious and may include tuberculosis, infections caused by viruses, fungi, parasites, bacteria, or other unusual infectious organisms, and sepsis (septicemia).
• In rare cases, these infections may be life-threatening. It is important to inform your doctor if you have symptoms such as fever, wounds, feeling tired, or dental problems. Your doctor may advise temporarily stopping Hyrimoz.

Tuberculosis (TB)

• Since cases of tuberculosis have occurred in patients treated with adalimumab, your doctor will check for signs or symptoms of tuberculosis before starting treatment with Hyrimoz. This will include a detailed medical evaluation including your medical history and clinical examinations (e.g., a chest X-ray and tuberculin skin test). The performance and results of these tests must be recorded in the Patient Reminder Card. It is very important to inform your doctor if you have ever had tuberculosis or if you have been in close contact with people who have tuberculosis. Tuberculosis may occur during treatment even if you have received preventive treatment for tuberculosis. Contact your doctor immediately if you develop symptoms of tuberculosis (persistent cough, weight loss, fatigue, low-grade fever) or other infections during or after treatment.

Travel/recurring infection

• Inform your doctor if you have lived in or traveled to regions where fungal infections such as histoplasmosis, coccidioidomycosis, or blastomycosis are common.
• Inform your doctor if you have had recurring infections or if you have conditions that increase your risk of infection.

Hepatitis B virus

• Inform your doctor if you are a carrier of hepatitis B virus (HBV), if you have an active hepatitis B virus infection, or if you think you may be at risk of contracting hepatitis B virus.
  Your doctor must test you for hepatitis B virus infection. Taking adalimumab may reactivate hepatitis B virus infection in carriers of this virus. In some rare cases, especially if the patient is also receiving other medications that suppress the immune system, reactivation of hepatitis B virus infection may be life-threatening.

Age over 65 years

• If you are over 65 years of age, you may be more susceptible to infections while taking Hyrimoz. You and your doctor should pay particular attention to signs of infection while you are being treated with Hyrimoz. It is important to inform your doctor if you develop symptoms of infection such as fever, wounds, feeling tired, or dental problems.

Surgery or dental procedures

• Before undergoing surgery or dental procedures, inform your doctor that you are taking Hyrimoz. Your doctor may advise temporarily stopping Hyrimoz.

Demyelinating disease

• If you have or develop demyelinating diseases (diseases affecting the protective covering of nerves), such as multiple sclerosis, your doctor will decide whether you should start or continue treatment with Hyrimoz. Inform your doctor immediately if you experience symptoms such as changes in vision, weakness in arms or legs, or numbness or tingling in any part of your body.

Vaccination

• Certain vaccines contain live but weakened forms of bacteria or viruses that cause disease and must not be administered during treatment with Hyrimoz, as they may cause infections. Consult your doctor before receiving any vaccinations. In children, it is recommended, if possible, to complete age-appropriate vaccinations before starting Hyrimoz therapy. If you have taken Hyrimoz during pregnancy, your baby may have an increased risk of infection for up to approximately 5 months after your last dose during pregnancy. It is important that you inform the pediatrician or other healthcare provider about your use of Hyrimoz during pregnancy so they can determine when your baby should receive any vaccinations.

Heart failure

• It is important to inform your doctor about any past or current heart problems. If you have mild heart failure and are being treated with Hyrimoz, your doctor will need to carefully monitor your heart condition. If new symptoms of heart failure appear or if existing symptoms worsen (e.g., shortness of breath or swelling of the feet), contact your doctor immediately.

Fever, bruising, bleeding, or paleness

• In some patients, the body may not be able to produce enough blood cells to fight infections or stop bleeding. If you have persistent fever, bruising, easy bleeding, or paleness, contact your doctor immediately. Your doctor may decide to stop treatment.

Tumors

• Very rare cases of certain types of tumors have been observed in children and adults treated with adalimumab or other anti-TNFα medicines. Patients with long-standing, severe rheumatoid arthritis may have a higher than average risk of developing lymphoma and leukemia (cancers affecting blood cells and bone marrow). If you are taking Hyrimoz, your risk of developing lymphomas, leukemia, or other tumors may increase. In rare cases, a specific and serious type of lymphoma has been observed in patients treated with adalimumab. Some of these patients were also receiving azathioprine or mercaptopurine. Inform your doctor if you are taking azathioprine or mercaptopurine with Hyrimoz.

• In addition, cases of non-melanoma skin cancer have been observed in patients taking adalimumab. If you develop areas of damaged skin during or after treatment, or if the appearance of existing marks or damaged areas changes, inform your doctor.

• There have been cases of malignancies, other than lymphoma, in patients with a specific lung disease called chronic obstructive pulmonary disease (COPD) treated with another anti-TNFα. If you have COPD or are a heavy smoker, you should discuss with your doctor whether treatment with an anti-TNFα is appropriate.

Autoimmune diseases

• Rarely, treatment with Hyrimoz may lead to the development of a lupus-like syndrome. Inform your doctor if you develop symptoms such as persistent unexplained skin rash, fever, joint pain, or fatigue.

Children and adolescents

• Vaccinations: If possible, children should have completed all recommended vaccinations before starting Hyrimoz.
• Do not give Hyrimoz to children under 2 years of age with polyarticular juvenile idiopathic arthritis.

Other medicines and Hyrimoz
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Hyrimoz may be taken together with methotrexate and other disease-modifying antirheumatic drugs (sulfasalazine, hydroxychloroquine, leflunomide, and parenteral gold salts), corticosteroids, or analgesics, including non-steroidal anti-inflammatory drugs (NSAIDs).
Hyrimoz must not be taken together with medicines containing the active substances anakinra or abatacept due to an increased risk of serious infections. The combination of adalimumab and other anti-TNF agents with anakinra or abatacept is not recommended due to a possible increased risk of infections, including serious infections, and other potential pharmacological interactions. If you have any doubts, consult your doctor.

Pregnancy and breastfeeding

• You should use an effective method of contraception to prevent pregnancy and continue using it for at least 5 months after your last dose of Hyrimoz.
• If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, consult your doctor about taking this medicine.
• Hyrimoz should only be used during pregnancy if necessary.
• According to a pregnancy study, no increased risk of birth defects was observed in babies whose mothers received adalimumab during pregnancy compared to mothers with the same condition who did not receive adalimumab.
• Hyrimoz may be used during breastfeeding.
• If you take Hyrimoz during pregnancy, your baby may have an increased risk of infection.
• It is important that you inform the pediatrician or other healthcare provider about your use of Hyrimoz during pregnancy before your baby receives any vaccinations (for more information on vaccines, see section "Warnings and precautions").

Driving and using machines
Hyrimoz may affect your ability to drive, ride a bicycle, or use machines, although only to a minor extent. After taking Hyrimoz, you may experience visual disturbances or a sensation that your surroundings are spinning (dizziness).

Hyrimoz contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per 0.8 mL dose, i.e., essentially 'sodium-free'.

3. How to use Hyrimoz

Use this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Hyrimoz is available in 40 mg pens and 20 mg and 40 mg prefilled syringes for
administration of a complete dose of 20 mg or 40 mg to patients.

Method and route of administration
Hyrimoz is administered by subcutaneous injection (for injection under the skin).
Detailed instructions on how to inject Hyrimoz are provided in section 7, “Instructions for use”.

If you use more Hyrimoz than you should
If you accidentally inject Hyrimoz more frequently than you should, contact your doctor or pharmacist and inform them that you have taken more medicine than intended. Always keep the medicine carton, even if empty.

If you forget to use Hyrimoz
If you forget to give an injection, administer the next dose of Hyrimoz as soon as you remember. After that, continue with your regular dosing schedule as prescribed.

If you stop using Hyrimoz
The decision to stop using Hyrimoz should be discussed with your doctor. Symptoms may return after stopping treatment.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. Most side effects are mild to moderate in severity. However, some may be serious and require treatment. Side effects may occur up to 4 months or more after the last injection of Hyrimoz.
Contact a doctor urgently if you notice any of the following signs of an allergic reaction or heart failure:

• severe rash, hives;
• swelling of the face, hands, or feet;
• difficulty breathing, difficulty swallowing;
• shortness of breath during exertion or when lying down, or swollen feet.

Inform your doctor as soon as possible if you notice any of the following reactions:

• signs and symptoms of infection such as fever, feeling unwell, wounds, dental problems, burning sensation when urinating; fatigue or weakness, or cough;
• symptoms of nerve problems such as tingling, numbness, double vision, or weakness in the arms or legs;
• signs of skin cancer such as a swelling or open sore that does not heal;
• signs and symptoms suggesting the onset of disorders affecting the hematopoietic system, such as persistent fever, bruising, bleeding, or paleness.

The following side effects have been observed with Hyrimoz:
Very common (may affect more than 1 in 10 people)

• injection site reactions (including pain, swelling, redness, or itching);
• respiratory tract infections (including cold, runny nose, sinusitis, and pneumonia);
• headache;
• abdominal pain;
• nausea and vomiting;
• rash;
• muscle pain.

Common (may affect up to 1 in 10 people)

• serious infections (including sepsis and influenza);
• intestinal infections (including gastroenteritis);
• skin infections (including cellulitis and Herpes Zoster infection);
• ear infections;
• mouth infections (including dental infections and herpes simplex);
• reproductive system infections;
• urinary tract infections;
• fungal infections;
• joint infections;
• benign tumors;
• skin cancer;
• allergic reactions (including seasonal allergies);
• dehydration;
• mood changes (including depression);
• anxiety;
• sleep disorders;
• sensory disturbances such as tingling, stabbing sensations, or numbness;
• migraine;
• symptoms of nerve root compression (including lower back pain and leg pain);
• visual disturbances;
• eye inflammation;
• eyelid inflammation and eye swelling;
• dizziness (sensation of the room spinning);
• sensation of rapid heartbeat;
• high blood pressure;
• hot flushes;
• hematoma (solid swelling with coagulated blood);
• cough;
• asthma;
• shortness of breath;
• gastrointestinal bleeding;
• dyspepsia (indigestion, bloating, heartburn);
• acid reflux disorder;
• dry syndrome (including dry eyes and dry mouth);
• itching;
• itchy rash;
• bruising;
• skin inflammation (such as eczema);
• breaking of fingernails and toenails;
• increased sweating;
• hair loss;
• onset or worsening of psoriasis;
• muscle spasms;
• blood in the urine;
• kidney problems;
• chest pain;
• edema (fluid accumulation in the body, causing swelling of affected tissues);
• fever;
• reduction in platelets in the blood, increasing the risk of bleeding or bruising;
• impaired wound healing.

Uncommon (may affect up to 1 in 100 people)

• unusual infections (including tuberculosis and other infections) that occur when immune defenses are reduced;
• neurological infections (including viral meningitis);
• eye infections;
• bacterial infections;
• diverticulitis (inflammation and infection of the large intestine);
• tumors, including tumors of the lymphatic system (lymphoma) and melanoma (a type of skin cancer);
• immune system disorders that may affect the lungs, skin, and lymph nodes (most commonly a condition called sarcoidosis);
• vasculitis (inflammation of blood vessels);
• tremor;
• neuropathy (nerve damage);
• stroke;
• hearing loss, ringing in the ears;
• sensation of irregular heartbeat such as palpitations;
• heart problems that may cause shortness of breath or swelling in the ankles;
• acute myocardial infarction;
• formation of a sac in the wall of a major artery, inflammation and clot in a vein, blockage of a blood vessel;
• lung disease causing shortness of breath (including inflammation);
• pulmonary embolism (blockage of a pulmonary artery);
• pleural effusion (abnormal accumulation of fluid in the pleural space);
• inflammation of the pancreas causing severe abdominal and back pain;
• difficulty swallowing;
• facial edema (swelling);
• gallbladder inflammation, gallstones;
• fatty liver (accumulation of fat in liver cells);
• night sweats;
• scar;
• abnormal muscle breakdown;
• systemic lupus erythematosus (an immune system disorder, including inflammation of the skin, heart, lungs, joints, and other organs);
• interrupted sleep;
• impotence;
• inflammations.

Rare (may affect up to 1 in 1,000 people)

• leukemia (a cancer affecting blood and bone marrow);
• severe allergic reaction with shock;
• multiple sclerosis;
• neurological disorders (such as optic neuritis in the eye and Guillain-Barré syndrome, a condition that may cause muscle weakness, abnormal sensations, tingling in the arms and upper body);
• cardiac arrest;
• pulmonary fibrosis (scarring of the lungs);
• intestinal perforation (a hole in the intestinal wall);
• hepatitis (inflammation of the liver);
• reactivation of hepatitis B infection;
• autoimmune hepatitis (liver inflammation caused by the body's own immune system);
• cutaneous vasculitis (inflammation of blood vessels in the skin);
• Stevens-Johnson syndrome (a life-threatening reaction with flu-like symptoms and a blistering rash);
• facial edema (swelling) associated with allergic reactions;
• erythema multiforme (inflammatory skin rash);
• lupus-like syndrome;
• angioedema (localized swelling of the skin);
• lichenoid skin reaction (itchy red-purple rash).

Not known (frequency cannot be estimated from the available data)

• hepatosplenic T-cell lymphoma (a rare blood cancer that is often fatal);
• Merkel cell carcinoma (a type of skin cancer);
• Kaposi's sarcoma, a rare form of cancer associated with human herpesvirus 8 infection. Kaposi's sarcoma most commonly presents with purple lesions on the skin;
• liver failure;
• worsening of a condition called dermatomyositis (which manifests as a rash accompanied by muscle weakness);
• weight gain (in most patients, weight gain has been low).

Some of the side effects observed with adalimumab may be asymptomatic and can only be detected through blood tests. These include:
Very common (may affect more than 1 in 10 people)

• low white blood cell count;
• low red blood cell count;
• increased blood lipids;
• increased liver enzymes.

Common (may affect up to 1 in 10 people)

• increased white blood cell count;
• reduced platelet count;
• increased uric acid in the blood;
• altered sodium levels in the blood;
• reduced calcium in the blood;
• reduced phosphorus in the blood;
• increased blood sugar;
• increased lactate dehydrogenase in the blood;
• presence of autoantibodies in the blood;
• reduced potassium in the blood.

Uncommon (may affect up to 1 in 100 people)

• elevated bilirubin levels in the blood (liver blood test).

Rare (may affect up to 1 in 1,000 people)

• low white blood cell, red blood cell, and platelet counts.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Hyrimoz

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label/blister/box after the word "Exp".
Store in a refrigerator (2°C – 8°C). Do not freeze.
Keep the pre-filled pen in the outer packaging to protect the medicine from light.

Alternative storage conditions:
When necessary (e.g. when travelling), Hyrimoz may be stored at room temperature (up to 25°C) for a maximum of 21 days – ensure the medicine is protected from light. Once removed from the refrigerator for storage at room temperature, the pre-filled pen must be used within 21 days or discarded, even if it is subsequently returned to the refrigerator. You must record the date when the pre-filled pen is first removed from the refrigerator and the date after which the pen must be discarded.

Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Hyrimoz contains

• The active substance is adalimumab. Each pre-filled pen contains 40 mg of adalimumab in 0.8 mL of solution.
• The excipients are adipic acid, monohydrate citric acid, sodium chloride, mannitol (E 421), polysorbate 80 (E 433), hydrochloric acid (E 507), sodium hydroxide (E 524) and water for injections (see section 2 “Hyrimoz contains sodium”).

Description of the appearance of Hyrimoz and contents of the pack
Hyrimoz 40 mg solution for injection in pre-filled pen is supplied as 0.8 mL of solution, from clear to slightly opalescent, colourless to slightly yellowish.
Hyrimoz is supplied in a single-use pre-filled syringe assembled into a triangular-shaped pen with a transparent viewing window and label. The syringe inside the pen is made of Type I glass with a 29-gauge stainless steel needle, an internal rubber needle cap (thermoplastic elastomer), and a rubber stopper, containing 0.8 mL of solution.
Pack sizes contain 1 and 2 pre-filled pens of Hyrimoz.
Multiple packs contain 6 (3 packs of 2) pre-filled pens of Hyrimoz.
Not all pack sizes may be marketed.
Hyrimoz is available in pre-filled syringe and pre-filled pen.

Marketing Authorisation Holder
Sandoz GmbH
Biochemiestr. 10
6250 Kundl
Austria

Manufacturer
Sandoz GmbH Schaftenau
Biochemiestr. 10
6336 Langkampfen
Austria
Novartis Pharmaceutical Manufacturing GmbH
Biochemiestrasse 10
6336 Langkampfen
Austria

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Sandoz nv/sa Sandoz Pharmaceuticals d.d filialas
Tél/Tel: +32 2 722 97 97 Tel: +370 5 2636 037

България Luxembourg/Luxemburg
Сандоз България КЧТ Sandoz nv/sa (Belgique/Belgien)
Тел.: +359 2 970 47 47 Tél/Tel.: +32 2 722 97 97

Česká republika Magyarország
Sandoz s.r.o. Sandoz Hungária Kft.
Tel: +420 225 775 111 Tel.: +36 1 430 2890

Danmark/Norge/Ísland/Sverige Malta
Sandoz A/S Sandoz Pharmaceuticals d.d.
Tlf./Sími/Tel: +45 63 95 10 00 Tel: +356 99644126

Deutschland Nederland
Hexal AG Sandoz B.V.
Tel: +49 8024 908 0 Tel: +31 36 52 41 600

Eesti Österreich
Sandoz d.d. Eesti filiaal Sandoz GmbH
Tel: +372 665 2400 Tel: +43 5338 2000

Ελλάδα Polska
SANDOZ HELLAS ΜΟΝΟΠΡΟΣΩΠΗ Α.Ε. Sandoz Polska Sp. z o.o.
Τηλ: +30 216 600 5000 Tel.: +48 22 209 70 00

España Portugal
Sandoz Farmacéutica, S.A. Sandoz Farmacêutica Lda.
Tel: +34 900 456 856 Tel: +351 21 000 86 00

France România
Sandoz SAS Sandoz Pharmaceuticals SRL
Tél: +33 1 49 64 48 00 Tel: +40 21 407 51 60

Hrvatska Slovenija
Sandoz d.o.o. Sandoz farmacevtska družba d.d.
Tel: +385 1 23 53 111 Tel: +386 1 580 29 02

Ireland Slovenská republika
Rowex Ltd. Sandoz d.d. - organizačná zložka
Tel: +353 27 50077 Tel: +421 2 48 200 600

Italia Suomi/Finland
Sandoz S.p.A. Sandoz A/S
Tel: +39 02 96541 Puh/Tel: +358 10 6133 400

Κύπρος United Kingdom (Northern Ireland)
SANDOZ HELLAS ΜΟΝΟΠΡΟΣΩΠΗ Α.Ε. Sandoz GmbH
(Greece) Tel: +43 5338 2000
Τηλ: +30 216 600 5000

Latvija
Sandoz d.d. Latvia filiāle
Tel: +371 67 892 006

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu.

7. Instructions for Use

To avoid possible infections and to ensure you use the medicine correctly, it is important that
you follow these instructions.
Make sure you read, understand, and follow these Instructions for Use before injecting Hyrimoz.
A healthcare professional must show you how to properly prepare and inject Hyrimoz using the
pre-filled pen before you use the medicine for the first time. If you have any doubts, consult your
healthcare professional.
Hyrimoz Pre-filled Single-use Pen

Figure A: Parts of the Hyrimoz pen
In Figure A, the pen is shown without the cap. Do not remove the cap until you are ready to
administer the injection.
It is important that you:

• do not open the outer carton until you are ready to use the pen;
• do not use the pen if the outer packaging seal or the pen’s security seal is broken;
• never leave the pen unattended where it could be tampered with by others;
• if you drop the pen, do not use it if it appears damaged or if it was dropped after removing the cap;
• inject Hyrimoz 15–30 minutes after removing it from the refrigerator for a more comfortable injection;
• dispose of the used pen immediately after use. Do not reuse the pen. See “4. Disposal of Used Pens” at the end of these Instructions for Use.

How should you store the pen?

• Store the pen in its packaging in the refrigerator at a temperature between 2°C and 8°C.
• When necessary (e.g., when traveling), Hyrimoz may be stored at room temperature (up to 25°C) for a maximum of 21 days—ensure the medicine is protected from light. Once removed from the refrigerator for storage at room temperature, the pre-filled pen must be used within 21 days or discarded, even if subsequently returned to the refrigerator. You must record the date when the pre-filled pen was first removed from the refrigerator and the date after which it must be discarded.
• Keep the pen in its original packaging until ready to use, to protect the medicine from light.
• Do not store the pen at extremely hot or cold temperatures.
• Do not freeze the pen.

Keep Hyrimoz and all medicines out of the reach of children.
What is needed for the injection?
Place the following items on a clean, flat surface.
The package contains:

• Hyrimoz pre-filled pen(s) (see Figure A). Each pen contains 40 mg/0.8 mL of Hyrimoz. The package does not contain (see Figure B):
• Alcohol swab.
• Cotton ball or gauze.
• Sharps disposal container.

Figure B: Items not included in the package
See “4. Disposal of Used Pens” at the end of these Instructions for Use.
Before the injection
Preparing the pen

• For a more comfortable injection, remove the pen from the refrigerator approximately 15–30 minutes before the injection to allow it to reach room temperature.
• Look through the viewing window. The solution should be colourless or slightly yellowish and from clear to slightly opalescent. Do not use the pen if you see particles or any change in colour. If you have any doubts about the appearance of the solution, consult your pharmacist for assistance.

Figure C: Safety checks before injection

• Check the pen’s expiration date (Exp.). Do not use the pen if the expiration date has passed.
• Do not use the pen if the security seal is broken.

Contact your pharmacist if the pen fails any of the above checks.

1. Choosing the injection site:

• The recommended injection site is the front of the thighs.

The lower stomach area may also be used,
but avoid the area within 5 cm of the navel (see
Figure D).

• Select a different site each time you give an injection.
• Do not inject the medicine into areas where the skin is tender, bruised, red, scaly, or hard. Avoid areas with scars or stretch marks. If you have psoriasis, DO NOT inject the medicine directly into areas with psoriatic plaques. Figure D: How to choose the injection site

2. Cleaning the injection site:

• Wash your hands thoroughly with soap and water.

• Using a circular motion, clean the injection site with an alcohol swab. Allow it to dry before administering the injection (see Figure E).
• Do not touch the cleaned area before the injection.

Figure E: How to clean the injection site

3. Removing the pen cap:

• Remove the cap only when you are ready to use the pen.

• Rotate the cap in the direction of the arrows (see Figure F).
• After removing the cap, discard it. Never try to reattach the cap.
• Use the pen within 5 minutes after removing the cap.
• You may notice a few drops of liquid coming out of the needle. This is normal. Figure F: How to remove the cap

4. How to hold the pen:

• Hold the pen at a 90-degree angle to the injection site,
  clean (see Figure G).

Correct Incorrect
Figure G: How to hold the pen
Injection
Read before administering the injection
During the injection, you will hear 2 clicks:
o The first click indicates that the injection has started.
o A moment later, a second click indicates that the injection is almost complete.
You must keep the pen firmly pressed against the skin until you see a green indicator
fill the viewing window and stop moving.

5. Starting the injection:

• Press the pen firmly against the skin to start

the injection (see Figure H).

• The first click indicates that the injection has started.
• Keep pressing the pen firmly against the skin.
• The green indicator shows the progress of the injection.

Figure H: How to start the injection

6. Completing the injection:

• Pay attention to the second click, which indicates that the injection is almost complete.

• Check that the green indicator has filled the viewing window and has stopped moving (see Figure I).
• You may now remove the pen.

Figure I: How to complete
the injection
After the injection

7. Check that the green indicator fills the viewing window (see Figure J):
   • This means that the medicine has been delivered. Contact your doctor if the green indicator is not visible.

• You may notice a small amount of blood at the injection site. You may press a cotton ball or gauze pad over the injection site and hold it in place for 10 seconds. Do not rub the injection site. If needed, you may cover the injection site with a small adhesive bandage.
  Figure J: How to check
  the green indicator

8. Disposal of used pens:

• Dispose of the used pen in a sharps disposal container (puncture-resistant, closable container). For your safety and the safety of others, used pens must never be reused.

• Do not dispose of any medication via wastewater or household waste. Ask your doctor or pharmacist how to dispose of medications you no longer use. This will help protect the environment. Unused medicine and waste derived from this medicine must be disposed of in accordance with local regulations.

If you have any questions, consult a doctor, pharmacist, or nurse familiar with
Hyrimoz.

Patient information leaflet

Hyrimoz 40 mg solution for injection in a pre-filled syringe

adalimumab
40 mg/0.4 mL
Please read this leaflet carefully before using this medicine because it contains important information for you

• Keep this leaflet. You may need to read it again.
• Your doctor will provide you with a Patient Reminder Card containing important safety information you need to know before starting treatment with Hyrimoz and during treatment with Hyrimoz. Keep this Patient Reminder Card with you during treatment and for 4 months after the last injection (or the last injection given to your child) of Hyrimoz.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Hyrimoz is and what it is used for
2. What you need to know before using Hyrimoz
3. How to use Hyrimoz
4. Possible side effects
5. How to store Hyrimoz
6. Contents of the pack and other information
7. Instructions for use

1. What Hyrimoz is and what it is used for

Hyrimoz contains the active substance adalimumab, a medicine that acts on the body’s immune (defence) system.
Hyrimoz is indicated for the treatment of the following inflammatory diseases:

• rheumatoid arthritis,
• polyarticular juvenile idiopathic arthritis,
• enthesitis-related arthritis,
• ankylosing spondylitis,
• non-radiographic axial spondyloarthritis (axial spondyloarthritis without radiographic evidence of ankylosing spondylitis),
• psoriatic arthritis,
• plaque psoriasis,
• hidradenitis suppurativa,
• Crohn’s disease,
• ulcerative colitis,
• non-infectious uveitis.

The active substance in Hyrimoz, adalimumab, is a human monoclonal antibody. Monoclonal antibodies are proteins that bind to a specific target.
The target of adalimumab is a protein called tumour necrosis factor (TNFα), which is involved in the immune (defence) system and is present at higher concentrations in the inflammatory diseases listed above. By binding to TNFα, Hyrimoz blocks its action and reduces the inflammatory process in these diseases.

Rheumatoid arthritis
Rheumatoid arthritis is an inflammatory disease affecting the joints.
Hyrimoz is used to treat rheumatoid arthritis in adults. If you have moderate to severe rheumatoid arthritis, other disease-modifying drugs such as methotrexate may be prescribed first. If these medicines do not work satisfactorily, you will be given Hyrimoz to treat rheumatoid arthritis.
Hyrimoz may also be used to treat severe, active and progressive rheumatoid arthritis without prior treatment with methotrexate.
Hyrimoz can slow down the progression of joint cartilage and bone damage caused by the disease and improve physical function.
Hyrimoz is usually used in combination with methotrexate. If your doctor considers that treatment with methotrexate is not appropriate, Hyrimoz may be given alone.

Polyarticular juvenile idiopathic arthritis
Polyarticular juvenile idiopathic arthritis is an inflammatory joint disease.
Hyrimoz is used to treat polyarticular juvenile idiopathic arthritis in children and adolescents aged 2 to 17 years. At diagnosis, other disease-modifying drugs such as methotrexate may be given first. If these medicines do not work satisfactorily, patients will be given Hyrimoz.

Enthesitis-related arthritis
Enthesitis-related arthritis is an inflammatory disease affecting the joints and the sites where tendons attach to bones.
Hyrimoz is used to treat enthesitis-related arthritis in patients aged 6 years and older.
Initially, other disease-modifying drugs such as methotrexate may be used. If these medicines are not sufficiently effective, patients will be given Hyrimoz.

Ankylosing spondylitis and non-radiographic axial spondyloarthritis
Ankylosing spondylitis and non-radiographic axial spondyloarthritis are inflammatory conditions affecting the spine.
Hyrimoz is used in adults to treat these conditions. If you have ankylosing spondylitis or non-radiographic axial spondyloarthritis, you will first be treated with other medicines. If these medicines do not work satisfactorily, you will be given Hyrimoz to reduce the signs and symptoms of the disease.

Plaque psoriasis in adults and children
Plaque psoriasis is an inflammatory skin condition causing red, scaly, thickened patches of skin covered with silvery scales. Plaque psoriasis can also affect the nails, causing them to break, thicken or lift from the nail bed, which may be painful. Psoriasis is thought to be caused by a problem with the body’s immune system leading to an increased production of skin cells.
Hyrimoz is used to treat moderate to severe plaque psoriasis in adults. Hyrimoz is also used to treat severe plaque psoriasis in children and adolescents aged 4 to 17 years when topical medications and UV light therapy have not worked well enough or are not suitable.

Psoriatic arthritis
Psoriatic arthritis is an inflammatory joint disease associated with psoriasis.
Hyrimoz is used to treat psoriatic arthritis in adults. Hyrimoz can slow down the damage to joint cartilage and bones caused by the disease and improve physical function.

Hidradenitis suppurativa in adults and adolescents
Hidradenitis suppurativa (sometimes called acne inversa) is a long-term inflammatory skin disease that is often painful. Symptoms may include painful lumps and abscesses (cysts) that may drain pus.
It most commonly affects specific areas of the skin such as under the breasts, armpits, inner thighs, groin, and buttocks. Scarring may also develop in affected areas.
Hyrimoz is used to treat:

• moderate to severe hidradenitis suppurativa in adults, and
• moderate to severe hidradenitis suppurativa in adolescents aged 12 to 17 years.

Hyrimoz can reduce the number of lumps and abscesses you have and the pain often associated with this disease. You may first be given other medicines. If these do not work satisfactorily, you will be given Hyrimoz.

Crohn’s disease in adults and children
Crohn’s disease is an inflammation of the intestine.
Hyrimoz is used to treat:

• moderate to severe Crohn’s disease in adults, and
• moderate to severe Crohn’s disease in children and adolescents aged 6 to 17 years.

If you have Crohn’s disease, you will first be given other medicines. If you do not respond adequately to these medicines, you will be given Hyrimoz to reduce the typical symptoms of Crohn’s disease.

Ulcerative colitis in adults and children
Ulcerative colitis is an inflammation of the large intestine (colon).
Hyrimoz is used to treat:

• moderate to severe ulcerative colitis in adults, and
• moderate to severe ulcerative colitis in children and adolescents aged 6 to 17 years.

If you have ulcerative colitis, you may first be given other medicines. If these do not work satisfactorily, you will be given Hyrimoz to reduce the signs and symptoms of ulcerative colitis.

Non-infectious uveitis in adults and children
Non-infectious uveitis is an inflammatory disease affecting parts of the eye.
The inflammation leads to reduced vision and/or the presence of floaters (black spots or fine lines moving across the visual field). Hyrimoz works by reducing this inflammation.
Hyrimoz is used for the treatment of:

• adults with non-infectious uveitis with inflammation affecting the back of the eye,
• children from 2 years of age with chronic non-infectious uveitis with inflammation affecting the front part of the eye.

Other medicines may be used first. If the response to these medicines is not adequate, you will be given Hyrimoz.

2. What you need to know before using Hyrimoz

Do not use Hyrimoz

• If you are allergic to adalimumab or to any of the other ingredients of this medicine (listed in section 6).
• If you have a serious infection, including tuberculosis, sepsis (blood poisoning), or other opportunistic infections (unusual infections associated with a weakened immune system). It is important to tell your doctor if you have signs or symptoms of infection, such as fever, wounds, feeling tired, or dental problems (see "Warnings and precautions").
• If you have moderate or severe heart failure. It is important to inform your doctor if you have had or currently have a serious heart condition (see "Warnings and precautions").

Warnings and precautions
Talk to your doctor or pharmacist before using Hyrimoz.

Allergic reaction

• If you experience allergic reactions with symptoms such as chest tightness, wheezing, dizziness, swelling, or rash, do not administer Hyrimoz again and contact your doctor immediately, as these reactions may, in rare cases, be life-threatening.

Infections

• If you have an infection, including long-term or localized infections (e.g., leg ulcers), consult your doctor before starting treatment with Hyrimoz. If you are unsure, contact your doctor.
• You may be more likely to get infections while being treated with Hyrimoz. This risk may increase if your lung function is reduced. These infections can be serious and may include tuberculosis, infections caused by viruses, fungi, parasites, bacteria, or other unusual infectious organisms, and sepsis (septicaemia).
• In rare cases, these infections may be life-threatening. It is important to inform your doctor if you have symptoms such as fever, wounds, feeling tired, or dental problems. Your doctor may advise temporarily stopping Hyrimoz.

Tuberculosis (TB)

• Since cases of tuberculosis have occurred in patients treated with adalimumab, your doctor will check whether you have signs or symptoms typical of tuberculosis before starting treatment with Hyrimoz. This will involve a detailed medical assessment including your medical history and clinical examinations (e.g., a chest X-ray and tuberculin skin test). The performance and results of these tests must be recorded in the Patient Reminder Card. It is very important to inform your doctor if you have ever had tuberculosis or if you have been in close contact with someone who has tuberculosis. Tuberculosis may occur during treatment even if you have received preventive treatment for tuberculosis. Contact your doctor immediately if symptoms of tuberculosis (persistent cough, weight loss, lack of energy, low-grade fever) or other infections develop during or after treatment.

Travel/recurrent infection

• Inform your doctor if you have lived in or traveled to regions where fungal infections such as histoplasmosis, coccidioidomycosis, or blastomycosis are common.
• Inform your doctor if you have had recurrent infections or if you have conditions that increase your risk of infection.

Hepatitis B virus

• Inform your doctor if you are a carrier of the hepatitis B virus (HBV), if you have an active hepatitis B virus infection, or if you think you may be at risk of contracting hepatitis B virus. Your doctor must test you for hepatitis B virus infection. Taking adalimumab may reactivate hepatitis B virus infection in people who are carriers of the virus. In rare cases, especially if the patient is also being treated with other medicines that suppress the immune system, reactivation of hepatitis B virus infection may be life-threatening.

Age over 65 years

• If you are over 65 years of age, you may be more susceptible to infections while taking Hyrimoz. You and your doctor should pay particular attention to signs of infection while you are being treated with Hyrimoz. It is important to inform your doctor if symptoms of infection such as fever, wounds, feeling tired, or dental problems occur.

Surgery or dental procedures

• Before undergoing surgery or dental procedures, inform your doctor that you are taking Hyrimoz. Your doctor may advise temporarily stopping Hyrimoz.

Demyelinating disease

• If you have or develop demyelinating diseases (diseases affecting the insulating layer around nerves), such as multiple sclerosis, your doctor will decide whether to start or continue treatment with Hyrimoz. Inform your doctor immediately if you experience symptoms such as changes in vision, weakness in arms or legs, or numbness or tingling in any part of your body.

Vaccination

• Certain vaccines contain live but weakened forms of disease-causing bacteria or viruses and must not be given during treatment with Hyrimoz, as they may cause infections. Consult your doctor before receiving any vaccinations. In children, it is recommended, if possible, to complete age-appropriate vaccinations before starting Hyrimoz treatment. If you take Hyrimoz during pregnancy, the baby may have an increased risk of infection for up to approximately 5 months after your last dose during pregnancy. It is important that you inform the paediatrician or other healthcare provider about your use of Hyrimoz during pregnancy, so they can decide when the baby should receive any type of vaccination.

Heart failure

• It is important to inform your doctor about any past or current heart problems. If you have mild heart failure and are being treated with Hyrimoz, your doctor will need to carefully monitor your heart condition. If new symptoms of heart failure appear or existing symptoms worsen (e.g., shortness of breath or swelling of the feet), contact your doctor immediately.

Fever, bruising, bleeding, or paleness

• In some patients, the body may not be able to produce enough blood cells to fight infections or stop bleeding. If you have persistent fever, bruising, easy bleeding, or paleness, contact your doctor immediately. Your doctor may decide to stop treatment.

Tumours

• Very rarely, certain types of tumours have occurred in children and adults treated with Hyrimoz or other anti-TNFα medicines. Patients with long-standing, severe rheumatoid arthritis may have a higher than average risk of developing lymphoma and leukaemia (cancers affecting blood cells and bone marrow). If you are taking Hyrimoz, your risk of developing lymphomas, leukaemia, or other tumours may increase. In rare cases, a specific and serious type of lymphoma has been observed in patients treated with adalimumab. Some of these patients were also taking azathioprine or mercaptopurine. Inform your doctor if you are taking azathioprine or mercaptopurine with Hyrimoz.
• Cases of non-melanoma skin cancer have been observed in patients taking adalimumab. If damaged areas of skin appear during or after treatment, or if the appearance of existing marks or damaged areas changes, inform your doctor.
• Cases of tumours other than lymphoma have been reported in patients with a specific type of lung disease called chronic obstructive pulmonary disease (COPD) who were treated with another anti-TNFα medicine. If you have COPD or are a heavy smoker, you should discuss with your doctor whether treatment with an anti-TNFα medicine is appropriate.

Autoimmune diseases

• Rarely, treatment with Hyrimoz may lead to the development of a lupus-like syndrome. Inform your doctor if you develop symptoms such as a persistent unexplained skin rash, fever, joint pain, or fatigue.

Children and adolescents

• Vaccinations: If possible, children should have completed all recommended vaccinations before starting Hyrimoz.

Other medicines and Hyrimoz
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Hyrimoz may be taken with methotrexate and other disease-modifying antirheumatic drugs (sulfasalazine, hydroxychloroquine, leflunomide, and parenteral gold salts), corticosteroids, or analgesics, including non-steroidal anti-inflammatory drugs (NSAIDs).
Hyrimoz must not be taken together with medicines containing the active substances anakinra or abatacept due to an increased risk of serious infections. The combination of adalimumab with other anti-TNF medicines and anakinra or abatacept is not recommended because of the possible increased risk of infections, including serious infections, and other potential pharmacological interactions. If you have any doubts, consult your doctor.

Pregnancy and breastfeeding

• You should consider using an appropriate contraceptive method to prevent pregnancy and continue using it for at least 5 months after your last dose of Hyrimoz.
• If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor about taking this medicine.
• Hyrimoz should be used during pregnancy only if necessary.
• According to a pregnancy study, no increased risk of birth defects was observed when mothers received adalimumab during pregnancy compared to mothers with the same condition who did not receive adalimumab.
• Hyrimoz may be used during breastfeeding.
• If you take Hyrimoz during pregnancy, the baby may have an increased risk of infection.
• It is important that you inform the paediatrician or other healthcare provider about your use of Hyrimoz during pregnancy before the baby receives any type of vaccination (for more information on vaccines, see the section "Warnings and precautions").

Driving and using machines
Hyrimoz may affect your ability to drive, ride a bicycle, or use machines, although only to a minor extent. After taking Hyrimoz, you may experience vision disturbances or a sensation that your surroundings are spinning (dizziness).

Hyrimoz contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per 0.4 mL dose, i.e., essentially 'sodium-free'.

3. How to use Hyrimoz

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended doses of Hyrimoz for each approved indication are listed in the following
table. Your doctor may prescribe another concentration of Hyrimoz if a different dose is required.

Method and route of administration
Hyrimoz is administered by subcutaneous injection (by injection under the skin).
Detailed instructions on how to inject Hyrimoz are provided in section 7, “Instructions for use”.

If you use more Hyrimoz than you should
If you accidentally inject Hyrimoz more frequently than you should, contact your doctor or pharmacist and inform them that you have taken more medication than intended. Always keep the medicine package, even if empty.

If you forget to use Hyrimoz
If you forget to give an injection, administer the next dose of Hyrimoz as soon as you remember. After that, resume your regular dosing schedule as prescribed.

If you stop using Hyrimoz
The decision to stop using Hyrimoz should be discussed with your doctor. Symptoms may return after stopping treatment.

If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Most side effects are mild to moderate in severity. However, some may be serious and require treatment. Side effects may occur up to 4 months or more after the last injection of Hyrimoz.

Contact a doctor urgently if you notice any of the following signs of an allergic reaction or heart failure:

• severe rash, hives;
• swelling of the face, hands, feet;
• difficulty breathing, difficulty swallowing;
• shortness of breath during exertion or when lying down, or swollen feet.

Inform your doctor as soon as possible if you notice any of the following reactions:

• signs and symptoms of infection such as fever, feeling unwell, wounds, dental problems, burning sensation when urinating, fatigue or weakness, or cough;
• symptoms of nerve problems such as tingling, numbness, double vision, or weakness in arms or legs;
• signs of skin cancer such as a growing lump or an open sore that does not heal;
• signs and symptoms suggesting disorders of the blood-forming system, such as persistent fever, bruising, bleeding, or paleness.

The following side effects have been observed with adalimumab:

Very common (may affect more than 1 in 10 people)

• reactions at the injection site (including pain, swelling, redness, or itching);
• respiratory tract infections (including colds, runny nose, sinusitis, and pneumonia);
• headache;
• abdominal pain (stomach pain);
• nausea and vomiting;
• rash;
• muscle pain.

Common (may affect up to 1 in 10 people)

• serious infections (including sepsis and influenza);
• intestinal infections (including gastroenteritis);
• skin infections (including cellulitis and herpes zoster infection);
• ear infections;
• mouth infections (including dental infections and herpes simplex);
• reproductive system infections;
• urinary tract infections;
• fungal infections;
• joint infections;
• benign tumors;
• skin cancer;
• allergic reactions (including seasonal allergies);
• dehydration;
• mood changes (including depression);
• anxiety;
• sleep disturbances;
• sensory disturbances such as tingling, stabbing sensations, or numbness;
• migraine;
• symptoms of nerve root compression (including lower back pain and leg pain);
• visual disturbances;
• eye inflammation;
• eyelid inflammation and eye swelling;
• dizziness (sensation of the room spinning);
• sensation of rapid heartbeat;
• high blood pressure;
• hot flushes;
• hematoma (solid swelling with clotted blood);
• cough;
• asthma;
• shortness of breath;
• gastrointestinal bleeding;
• dyspepsia (indigestion, bloating, heartburn);
• acid reflux disorder;
• dry syndrome (including dry eyes and dry mouth);
• itching;
• itchy rash;
• bruising;
• skin inflammation (such as eczema);
• breaking of fingernails and toenails;
• increased sweating;
• hair loss;
• onset or worsening of psoriasis;
• muscle spasms;
• blood in the urine;
• kidney problems;
• chest pain;
• edema (fluid accumulation in the body, causing swelling of affected tissues);
• fever;
• reduced platelet count in the blood, increasing the risk of bleeding or bruising;
• poor wound healing.

Uncommon (may affect up to 1 in 100 people)

• unusual infections (including tuberculosis and other infections) that occur when immune defenses are reduced;
• neurological infections (including viral meningitis);
• eye infections;
• bacterial infections;
• diverticulitis (inflammation and infection of the large intestine);
• tumors, including tumors of the lymphatic system (lymphoma) and melanoma (a type of skin cancer);
• immune system disorders that may affect lungs, skin, and lymph nodes (most commonly a condition called sarcoidosis);
• vasculitis (inflammation of blood vessels);
• tremor (shaking);
• neuropathy (nerve damage);
• stroke;
• hearing loss, ringing in the ears;
• sensation of irregular heartbeat such as palpitations;
• heart problems that may cause shortness of breath or swelling in the ankles;
• acute myocardial infarction;
• formation of a sac in the wall of a major artery, vein inflammation and clot, or blockage of a blood vessel;
• lung disease causing shortness of breath (including inflammation);
• pulmonary embolism (blockage of a pulmonary artery);
• pleural effusion (abnormal accumulation of fluid in the pleural space);
• inflammation of the pancreas causing severe abdominal and back pain;
• difficulty swallowing;
• facial edema (swelling);
• gallbladder inflammation, gallstones;
• fatty liver (accumulation of fat in liver cells);
• night sweats;
• scarring;
• abnormal muscle breakdown;
• systemic lupus erythematosus (an immune system disorder, including inflammation of the skin, heart, lungs, joints, and other organs);
• interrupted sleep;
• impotence;
• inflammations.

Rare (may affect up to 1 in 1,000 people)

• leukemia (a cancer affecting blood and bone marrow);
• severe allergic reaction with shock;
• multiple sclerosis;
• neurological disorders (such as optic neuritis in the eye and Guillain-Barré syndrome, a condition that may cause muscle weakness, abnormal sensations, tingling in arms and upper body);
• cardiac arrest;
• pulmonary fibrosis (scarring of the lungs);
• intestinal perforation (a hole in the intestinal wall);
• hepatitis (liver inflammation);
• reactivation of hepatitis B infection;
• autoimmune hepatitis (liver inflammation caused by the body's own immune system);
• cutaneous vasculitis (inflammation of blood vessels in the skin);
• Stevens-Johnson syndrome (a life-threatening reaction with flu-like symptoms and a blistering skin rash);
• facial edema (swelling) associated with allergic reactions;
• erythema multiforme (inflammatory skin rash);
• lupus-like syndrome;
• angioedema (localized swelling of the skin);
• lichenoid skin reaction (pruritic red-purple skin rash).

Not known (frequency cannot be estimated from the available data)

• hepatosplenic T-cell lymphoma (a rare blood cancer that is often fatal);
• Merkel cell carcinoma (a type of skin cancer);
• Kaposi’s sarcoma, a rare form of cancer associated with human herpesvirus 8 infection. Kaposi’s sarcoma most commonly presents with purple lesions on the skin;
• liver failure;
• worsening of a condition called dermatomyositis (which presents as a skin rash accompanied by muscle weakness);
• weight gain (in most patients, weight gain has been low).

Some of the side effects observed with adalimumab may be asymptomatic and detectable only through blood tests. These include:

Very common (may affect more than 1 in 10 people)

• low white blood cell count;
• low red blood cell count;
• increased blood lipids;
• increased liver enzymes.

Common (may affect up to 1 in 10 people)

• increased white blood cell count;
• reduced platelet count;
• increased uric acid in the blood;
• changes in blood sodium levels;
• reduced blood calcium;
• reduced blood phosphorus;
• increased blood sugar;
• increased lactate dehydrogenase in the blood;
• presence of autoantibodies in the blood;
• reduced blood potassium.

Uncommon (may affect up to 1 in 100 people)

• elevated bilirubin levels in the blood (liver blood test).

Rare (may affect up to 1 in 1,000 people)

• low white blood cell, red blood cell, and platelet counts.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Hyrimoz

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label/blister/box following the word "Exp".
Store in a refrigerator (2°C – 8°C). Do not freeze.
Keep the pre-filled syringe in the outer packaging to protect the medicine from light.

Alternative storage conditions:
When necessary (e.g. when travelling), Hyrimoz may be stored at room temperature (up to 25°C) for a maximum period of 42 days – ensure the medicine is protected from light. Once removed from the refrigerator for storage at room temperature, the pre-filled syringe must be used within 42 days or discarded, even if it is subsequently returned to the refrigerator. You must record the date on which the pre-filled syringe was first removed from the refrigerator and the date after which it must be discarded.

Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Hyrimoz contains

• The active substance is adalimumab. Each pre-filled syringe contains 40 mg of adalimumab in 0.4 mL of solution.
• The excipients are adipic acid, mannitol (E 421), polysorbate 80 (E 433), hydrochloric acid (E 507), sodium hydroxide (E 524) and water for injections (see section 2 “Hyrimoz contains sodium”).

Description of the appearance of Hyrimoz and contents of the pack
Hyrimoz 40 mg solution for injection in pre-filled syringe is supplied as 0.4 mL of solution ranging from clear
to slightly opalescent, colourless or slightly yellowish.
Hyrimoz is supplied in a single-use, transparent type I glass syringe with a 29-gauge stainless steel needle,
a needle safety device with finger grip, a rubber needle cap (thermoplastic elastomer) and a plastic plunger,
containing 0.4 mL of solution.
Packs contain 1 and 2 pre-filled syringes of Hyrimoz.
Multiple packs contain 6 (3 packs of 2) pre-filled syringes of Hyrimoz.
Not all pack sizes may be marketed.
Hyrimoz is available in pre-filled syringe and pre-filled pen.

Marketing Authorization Holder
Sandoz GmbH
Biochemiestr. 10
6250 Kundl
Austria

Manufacturer
Sandoz GmbH Schaftenau
Biochemiestr. 10
6336 Langkampfen
Austria
Novartis Pharmaceutical Manufacturing GmbH
Biochemiestrasse 10
6336 Langkampfen
Austria

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
Sandoz nv/sa Sandoz Pharmaceuticals d.d filialas
Tél/Tel: +32 2 722 97 97 Tel: +370 5 2636 037

България Luxembourg/Luxemburg
Сандоз България КЧТ Sandoz nv/sa (Belgique/Belgien)
Тел.: +359 2 970 47 47 Tél/Tel.: +32 2 722 97 97

Česká republika Magyarország
Sandoz s.r.o. Sandoz Hungária Kft.
Tel: +420 225 775 111 Tel.: +36 1 430 2890

Danmark/Norge/Ísland/Sverige Malta
Sandoz A/S Sandoz Pharmaceuticals d.d.
Tlf./Sími/Tel: +45 63 95 10 00 Tel: +356 99644126

Deutschland Nederland
Hexal AG Sandoz B.V.
Tel: +49 8024 908 0 Tel: +31 36 52 41 600

Eesti Österreich
Sandoz d.d. Eesti filiaal Sandoz GmbH
Tel: +372 665 2400 Tel: +43 5338 2000

Ελλάδα Polska
SANDOZ HELLAS ΜΟΝΟΠΡΟΣΩΠΗ Α.Ε. Sandoz Polska Sp. z o.o.
Τηλ: +30 216 600 5000 Tel.: +48 22 209 70 00

España Portugal
Sandoz Farmacéutica, S.A. Sandoz Farmacêutica Lda.
Tel: +34 900 456 856 Tel: +351 21 000 86 00

France România
Sandoz SAS Sandoz Pharmaceuticals SRL
Tél: +33 1 49 64 48 00 Tel: +40 21 407 51 60

Hrvatska Slovenija
Sandoz farmacevtska družba d.d.
Sandoz d.o.o.
Tel: +386 1 580 29 02
Tel: +385 1 23 53 111

Ireland Slovenská republika
Rowex Ltd. Sandoz d.d. - organizačná zložka
Tel: +353 27 50077 Tel: +421 2 48 200 600

Italia Suomi/Finland
Sandoz S.p.A. Sandoz A/S
Tel: +39 02 96541 Puh/Tel: +358 10 6133 400

Κύπρος United Kingdom (Northern Ireland)
SANDOZ HELLAS ΜΟΝΟΠΡΟΣΩΠΗ Α.Ε. Sandoz GmbH
(Greece) Tel: +43 5338 2000
Tel: +30 216 600 5000

Latvija
Sandoz d.d. Latvia filiāle
Tel: +371 67 892 006

Other sources of information
More detailed information on this medicinal product is available on the European Medicines Agency website: https://www.ema.europa.eu .

7. Instructions for Use

To avoid possible infections and to ensure you use the medicine correctly, it is important that
you follow these instructions.
Make sure you read, understand, and follow these Instructions for Use before injecting Hyrimoz.
A healthcare professional must show you how to properly prepare and inject Hyrimoz using the
single-dose pre-filled syringe before you use the medicine for the first time. If you have any doubts, consult
your healthcare professional.
Single-dose pre-filled syringe of Hyrimoz with needle safety device and additional finger grip

Figure A: pre-filled syringe of Hyrimoz with needle safety device and finger grip
It is important that you:

• do not use the pre-filled syringe if the blister seals are broken, as use may not be safe;
• do not open the outer box until you are ready to use the pre-filled syringe;
• never leave the pre-filled syringe unattended where it could be tampered with by others;
• do not use the syringe if it has been dropped and appears damaged or if it was dropped after removing the needle cap;
• do not remove the needle cap until the time of injection;
• be careful not to touch the wings of the needle safety device before use. Doing so may activate the needle safety device prematurely.
• do not remove the finger grip before injection;
• inject Hyrimoz 15–30 minutes after removing it from the refrigerator, for a more comfortable injection;
• dispose of the used syringe immediately after use. Do not reuse the pre-filled syringe. See “4. Disposal of used pre-filled syringes” at the end of these Instructions for Use.

How should you store the single-dose pre-filled syringe of Hyrimoz?

• Store the outer packaging of the pre-filled syringes in the refrigerator at a temperature between 2°C and 8°C.
• When necessary (e.g., when traveling), Hyrimoz may be stored at room temperature (up to 25°C) for a maximum of 42 days – ensure the medicine is protected from light. Once removed from the refrigerator for storage at room temperature, the pre-filled syringe must be used within 42 days or discarded, even if subsequently placed back in the refrigerator. You must record the date when the pre-filled syringe was first removed from the refrigerator and the date after which it must be discarded.
• Keep the pre-filled syringes in their original packaging until you are ready to use them, to protect the medicine from light.
• Do not store the pre-filled syringes at extremely hot or cold temperatures.
• Do not freeze the pre-filled syringes.

Keep Hyrimoz and all medicines out of the reach of children.
What do you need for the injection?
Place the following items on a clean, flat surface.
The pre-filled syringe package contains:

• Pre-filled syringe(s) of Hyrimoz ( see Figure A ). Each pre-filled syringe contains 40 mg/0.4 mL of adalimumab.

The Hyrimoz pre-filled syringe package does not contain ( see Figure B ):

• Alcohol swab.
• Cotton ball or gauze.
• Sharps disposal container. See “4. Disposal of used syringes” at the end of these Instructions for Use.
• Adhesive bandage.

Figure B: items not included in the package
Before the injection

Figure C: the needle safety device is Figure D: the needle safety device is
not activated – the syringe is ready for use activated – do not use
o In this configuration, the needle safety o In this configuration, the needle safety
device is NOT ACTIVATED. device is ACTIVATED.
o The syringe is ready for use (see o DO NOT USE the syringe (see
Figure C ). Figure D ).
Preparing the syringe

• For a more comfortable injection, remove the syringe’s carton from the refrigerator and let it remain closed on the work surface for about 15–30 minutes to reach room temperature.
• Remove the pre-filled syringe from the blister.
• Look through the viewing window. The solution should be colourless or slightly yellowish and from clear to slightly opalescent. Do not use the syringe if you see particles or changes in colour. If you have any doubts about the appearance of the solution, consult your pharmacist for assistance.
• Do not use the pre-filled syringe if it is damaged or if the needle safety device is activated. Return the pre-filled syringe and its packaging to the pharmacy.
• Check the expiry date (Exp.) of the pre-filled syringe. Do not use the pre-filled syringe if the expiry date has passed.

Contact your pharmacist if the syringe fails any of the checks listed above.

1. Choosing the injection site:

• The recommended injection site is the front of the thighs. You may also use the lower part of the stomach, but not the area within 5 cm around the navel (see Figure E).

• Choose a different site each time you give an injection.

• Do not inject the medicine into areas where the skin is tender, bruised, red, flaky, or hard. Avoid areas with scars or stretch marks. If you have psoriasis, do not inject the medicine directly into areas affected by psoriasis plaques.

***Figure E***: How to choose the injection site

2. Cleaning the injection site:

• Wash your hands thoroughly with water and

soap.

• Using a circular motion, clean the injection site with an alcohol swab. Allow it to dry before administering the injection (see Figure F).
• Do not touch the cleaned area before injecting.

Figure F: How to clean the injection site

3. Administration of the injection:

• Carefully pull off the needle cap from the prefilled syringe (see Figure G).
• Discard the needle cap.
• You may see a drop of liquid at the tip of the needle. This is normal.

Figure G: How to remove the needle cap

• Gently create a skin fold at the injection site (see Figure H).
• Insert the needle into the skin as shown.
• Push the entire needle into the skin to ensure the full dose of medicine is delivered.
• Use the syringe within 5 minutes after removing the needle cap.

Figure H: How to insert the needle

• Hold the prefilled syringe as shown (see Figure I).
• Slowly push the plunger all the way down until it stops, so that the plunger head is completely between the safety device’s wings.
• While keeping the syringe in place, hold the plunger fully depressed for 5 seconds.

Figure I: How to hold the syringe

• Keep the plunger fully depressed while carefully withdrawing the needle from the injection site, then release the skin (see Figure J).

Figure J: How to withdraw the needle

• Slowly release the plunger and allow the needle safety device to automatically cover the exposed needle (see Figure K).
• You may notice a small amount of blood at the injection site. You can press a cotton ball or gauze pad against the injection site and hold pressure for 10 seconds. Do not rub the injection site. If needed, you may cover the injection site with a small adhesive bandage.
  Figure K: How to slowly release the plunger

4. Disposal of used syringes:

• Dispose of the used syringe in a sharps disposal container
  (see Figure L). The container should be closable,
  puncture-resistant, and leak-proof on the sides and bottom.
  For your safety and the safety of others, needles and
  syringes must never be reused.

• Do not dispose of any medicine via wastewater or household waste. Ask your doctor or pharmacist how to dispose of medicines no longer in use. This will help protect the environment. Unused medicine and waste material must be disposed of in accordance with local regulations.

Figure L: How to dispose of the used pre-filled syringe
If you have any questions, consult a doctor, pharmacist, or nurse familiar with
Hyrimoz.

Patient information leaflet

Hyrimoz 40 mg solution for injection in pre-filled pen

adalimumab
40 mg/0.4 mL
Please read this leaflet carefully before using this medicine because it contains important information for you

• Keep this leaflet. You may need to read it again.
• Your doctor will provide you with a Patient Reminder Card containing important safety information that you need to know before starting treatment with Hyrimoz and during treatment with Hyrimoz. Keep this Patient Reminder Card with you throughout treatment and for 4 months after the last injection (or the last injection given to your child) of Hyrimoz.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Hyrimoz is and what it is used for
2. What you should know before using Hyrimoz
3. How to use Hyrimoz
4. Possible side effects
5. How to store Hyrimoz
6. Contents of the pack and other information
7. Instructions for use

1. What Hyrimoz is and what it is used for

Hyrimoz contains the active substance adalimumab, a medicine that acts on the body's immune (defence) system.
Hyrimoz is indicated for the treatment of the following inflammatory diseases:

• rheumatoid arthritis,
• polyarticular juvenile idiopathic arthritis,
• enthesitis-related arthritis,
• ankylosing spondylitis,
• non-radiographic axial spondyloarthritis,
• psoriatic arthritis,
• plaque psoriasis,
• hidradenitis suppurativa,
• Crohn’s disease,
• ulcerative colitis,
• non-infectious uveitis.

The active substance in Hyrimoz, adalimumab, is a human monoclonal antibody. Monoclonal antibodies are proteins that bind to a specific target.
The target of adalimumab is a protein called tumour necrosis factor (TNFα), which is involved in the immune (defence) system and is present at higher concentrations in the inflammatory diseases listed above. By binding to TNFα, Hyrimoz blocks its action and reduces the inflammatory process in these diseases.

Rheumatoid arthritis
Rheumatoid arthritis is an inflammatory disease affecting the joints.
Hyrimoz is used to treat rheumatoid arthritis in adults. If you have moderate to severe rheumatoid arthritis, other disease-modifying drugs such as methotrexate may initially be prescribed. If these drugs do not work satisfactorily, you will be given Hyrimoz to treat rheumatoid arthritis.
Hyrimoz may also be used for the treatment of severe, active and progressive rheumatoid arthritis without prior treatment with methotrexate.
Hyrimoz can slow down the progression of joint cartilage and bone damage caused by the disease and improve physical function.
Hyrimoz is generally used in combination with methotrexate. If your doctor considers that treatment with methotrexate is not appropriate, Hyrimoz may be given alone.

Polyarticular juvenile idiopathic arthritis
Polyarticular juvenile idiopathic arthritis is an inflammatory joint disease that usually first appears during childhood.
Hyrimoz is used to treat polyarticular juvenile idiopathic arthritis in children and adolescents aged 2 to 17 years. At diagnosis, other disease-modifying drugs such as methotrexate may be administered. If these drugs do not work satisfactorily, patients will be given Hyrimoz.

Enthesitis-related arthritis
Enthesitis-related arthritis is an inflammatory disease affecting the joints and the sites where tendons attach to bones. Hyrimoz is used to treat enthesitis-related arthritis in patients aged 6 years and older.
Other disease-modifying drugs such as methotrexate may be used initially. If these medicines do not work well enough, patients will be given Hyrimoz.

Ankylosing spondylitis and non-radiographic axial spondyloarthritis
Ankylosing spondylitis and non-radiographic axial spondyloarthritis are inflammatory conditions affecting the spine.
Hyrimoz is used in adults to treat these conditions. If you have ankylosing spondylitis or non-radiographic axial spondyloarthritis, you will first be given other medicines. If these medicines do not work satisfactorily, you will be given Hyrimoz to reduce the signs and symptoms of the disease.

Plaque psoriasis in adults and children
Plaque psoriasis is an inflammatory skin condition that causes red, scaly, thickened patches of skin covered with silvery scales. Plaque psoriasis can also affect the nails, causing them to crack, thicken or lift from the nail bed, which can be painful. Psoriasis is thought to be caused by a problem with the body's immune system leading to increased production of skin cells.
Hyrimoz is used to treat moderate to severe plaque psoriasis in adults. Hyrimoz is also used to treat severe plaque psoriasis in children and adolescents aged 4 to 17 years when topical medications and UV light therapy have not worked adequately or are not suitable.

Psoriatic arthritis
Psoriatic arthritis is an inflammatory joint disease associated with psoriasis.
Hyrimoz is used to treat psoriatic arthritis in adults. Hyrimoz can slow down joint cartilage and bone damage caused by the disease and improve physical function.

Hidradenitis suppurativa in adults and adolescents
Hidradenitis suppurativa (sometimes called acne inversa) is a long-term inflammatory skin disease that is often painful. Symptoms may include painful lumps and abscesses (cysts) that may drain pus. It most commonly affects specific areas of the skin such as under the breasts, armpits, inner thighs, groin, and buttocks. Scarring may also develop in the affected areas.
Hyrimoz is used to treat:

• moderate to severe hidradenitis suppurativa in adults, and
• moderate to severe hidradenitis suppurativa in adolescents aged 12 to 17 years.

Hyrimoz can reduce the number of lumps and abscesses you have and the pain often associated with this disease. You may first be given other medicines. If these medicines do not work satisfactorily, you will be given Hyrimoz.

Crohn’s disease in adults and children
Crohn’s disease is an inflammation of the intestine.
Hyrimoz is used to treat:

• moderate to severe Crohn’s disease in adults, and
• moderate to severe Crohn’s disease in children and adolescents aged 6 to 17 years.

If you have Crohn’s disease, you will first be given other medicines. If you do not respond adequately to these medicines, you will be given Hyrimoz to reduce the typical symptoms of Crohn’s disease.

Ulcerative colitis in adults and children
Ulcerative colitis is an inflammation of the large intestine (colon).
Hyrimoz is used to treat:

• moderate to severe ulcerative colitis in adults, and
• moderate to severe ulcerative colitis in children and adolescents aged 6 to 17 years.

If you have ulcerative colitis, you may first take other medicines. If these medicines do not work satisfactorily, you will take Hyrimoz to reduce the signs and symptoms of ulcerative colitis.

Non-infectious uveitis in adults and children
Non-infectious uveitis is an inflammatory disease affecting certain parts of the eye.
The inflammation leads to reduced vision and/or the presence of floaters (black spots or thin lines moving across the visual field). Hyrimoz works by reducing this inflammation.
Hyrimoz is used for the treatment of:

• adults with non-infectious uveitis with inflammation affecting the back of the eye,
• children from 2 years of age with chronic non-infectious uveitis with inflammation affecting the front of the eye.

Other medicines may be used initially. If the response to these medicines is not adequate, you will be given Hyrimoz.

2. What you should know before using Hyrimoz

Do not use Hyrimoz

• If you are allergic to adalimumab or to any of the other ingredients of this medicine (listed in section 6).
• If you have a serious infection, including tuberculosis, sepsis (blood poisoning), or other opportunistic infections (unusual infections associated with a weakened immune system). It is important to inform your doctor if you have signs or symptoms of infection, such as fever, wounds, feeling tired, or dental problems (see "Warnings and precautions").
• If you have moderate or severe heart failure. It is important to inform your doctor if you have had or currently have a serious heart condition (see "Warnings and precautions").

Warnings and precautions
Talk to your doctor or pharmacist before using Hyrimoz.
Allergic reaction

• If you experience allergic reactions with symptoms such as chest tightness, wheezing, dizziness, swelling, or skin rash, do not administer Hyrimoz again and contact your doctor immediately, as these reactions may, in rare cases, be life-threatening.

Infections

• If you have an infection, including long-term or localized infections (e.g., leg ulcers), consult your doctor before starting treatment with Hyrimoz. If you are unsure, contact your doctor.
• You may be more likely to get infections while being treated with Hyrimoz. This risk may increase if your lung function is reduced. These infections can be serious and may include tuberculosis, infections caused by viruses, fungi, parasites, bacteria, or other unusual infectious organisms, and sepsis (septicaemia).
• In rare cases, these infections may be life-threatening. It is important to inform your doctor if you have symptoms such as fever, wounds, feeling tired, or dental problems. Your doctor may advise temporarily stopping Hyrimoz.

Tuberculosis (TB)

• Since cases of tuberculosis have occurred in patients treated with adalimumab, your doctor will need to check for signs or symptoms of tuberculosis before starting therapy with Hyrimoz. This will involve a detailed medical assessment including your medical history and clinical examinations (e.g., a chest X-ray and tuberculin test). The performance and results of these tests must be recorded in the Patient Reminder Card. It is very important to inform your doctor if you have ever had tuberculosis or if you have been in close contact with someone who has tuberculosis. Tuberculosis may occur during treatment even if you have received preventive treatment for tuberculosis. Contact your doctor immediately if you develop symptoms of tuberculosis (persistent cough, weight loss, lack of energy, low-grade fever) or other infections during or after treatment.

Travel/recurrent infection

• Inform your doctor if you have lived in or traveled to regions where fungal infections such as histoplasmosis, coccidioidomycosis, or blastomycosis are common.
• Inform your doctor if you have had recurrent infections or if you have conditions that increase your risk of infection.

Hepatitis B virus

• Inform your doctor if you are a carrier of the hepatitis B virus (HBV), if you have an active hepatitis B virus infection, or if you think you may be at risk of contracting hepatitis B virus. Your doctor must test you for hepatitis B virus infection. Taking adalimumab may reactivate hepatitis B virus infection in people who are carriers of this virus. In some rare cases, especially if the patient is also being treated with other medicines that suppress the immune system, reactivation of hepatitis B virus infection may be life-threatening.

Age over 65 years

• If you are over 65 years of age, you may be more susceptible to infections while taking Hyrimoz. You and your doctor should pay particular attention to signs of infection while you are being treated with Hyrimoz. It is important to inform your doctor if you develop symptoms of infection such as fever, wounds, feeling tired, or dental problems.

Surgery or dental procedures

• Before undergoing surgery or dental procedures, inform your doctor that you are taking Hyrimoz. Your doctor may advise temporarily stopping Hyrimoz.

Demyelinating disease

• If you have or develop demyelinating diseases (diseases affecting the insulating layer around nerves), such as multiple sclerosis, your doctor will decide whether to start or continue treatment with Hyrimoz. Inform your doctor immediately if you experience symptoms such as changes in vision, weakness in arms or legs, or numbness or tingling in any part of the body.

Vaccination

• Certain vaccines contain live but weakened forms of bacteria or viruses that cause disease and must not be given during treatment with Hyrimoz, as they may cause infections. Consult your doctor before receiving any vaccinations. In children, it is recommended, if possible, to administer age-appropriate vaccinations before starting Hyrimoz therapy.
  If you have taken Hyrimoz during pregnancy, the baby may have an increased risk of infection for up to approximately 5 months after your last dose during pregnancy. It is important that you inform the paediatrician or other healthcare provider about your use of Hyrimoz during pregnancy, so they can decide when the baby should receive any vaccinations.

Heart failure

• It is important to inform your doctor about any past or current heart problems. If you have mild heart failure and are being treated with Hyrimoz, your doctor should carefully monitor your heart condition. If new symptoms of heart failure appear or if existing symptoms worsen (e.g., shortness of breath or swelling of the feet), contact your doctor immediately.

Fever, bruising, bleeding, or paleness

• In some patients, the body may not be able to produce enough blood cells to fight infections or stop bleeding. If you have persistent fever, bruising, easy bleeding, or paleness, contact your doctor immediately. Your doctor may decide to stop treatment.

Tumours

• Very rare cases of certain types of tumours have been observed in children and adults treated with adalimumab or other anti-TNFα medicines. Patients with long-standing, severe rheumatoid arthritis may have a higher than average risk of developing lymphoma and leukaemia (cancers affecting blood cells and bone marrow). If you are taking Hyrimoz, your risk of developing lymphomas, leukaemia, or other tumours may increase. In rare cases, a specific and serious type of lymphoma has been observed in patients treated with adalimumab. Some of these patients were also taking azathioprine or mercaptopurine. Inform your doctor if you are taking azathioprine or mercaptopurine with Hyrimoz.
• In addition, cases of non-melanoma skin cancer have been observed in patients taking adalimumab. If you develop damaged skin areas during or after treatment, or if the appearance of existing marks or damaged areas changes, inform your doctor.
• Cases of malignancies other than lymphoma have been reported in patients with a specific lung disease called chronic obstructive pulmonary disease (COPD) treated with another anti-TNFα medicine. If you have COPD or are a heavy smoker, you should discuss with your doctor whether treatment with an anti-TNFα medicine is appropriate.

Autoimmune diseases

• Rarely, treatment with Hyrimoz may lead to the development of a lupus-like syndrome. Inform your doctor if you develop symptoms such as unexplained persistent skin rash, fever, joint pain, or fatigue.

Children and adolescents

• Vaccinations: If possible, children should have completed all age-appropriate vaccinations before starting Hyrimoz.

Other medicines and Hyrimoz
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Hyrimoz may be taken with methotrexate and other disease-modifying antirheumatic drugs (sulfasalazine, hydroxychloroquine, leflunomide, and parenteral gold salts), corticosteroids, or analgesics, including non-steroidal anti-inflammatory drugs (NSAIDs).
Hyrimoz must not be taken together with medicines containing the active substances anakinra or abatacept due to an increased risk of serious infections. The combination of adalimumab with other anti-TNF medicines, anakinra, or abatacept is not recommended due to a possible increased risk of infections, including serious infections, and other potential pharmacological interactions. If you have any doubts, consult your doctor.

Pregnancy and breastfeeding

• You should consider using adequate contraception to prevent pregnancy and continue using it for at least 5 months after your last dose of Hyrimoz.
• If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor about taking this medicine.
• Hyrimoz should be used during pregnancy only if necessary.
• According to a pregnancy study, no increased risk of birth defects was observed when mothers received adalimumab during pregnancy compared to mothers with the same condition who did not receive adalimumab.
• Hyrimoz may be used during breastfeeding.
• If you take Hyrimoz during pregnancy, the baby may have an increased risk of infection.
• It is important that you inform the paediatrician or other healthcare provider about your use of Hyrimoz during pregnancy before the baby receives any vaccinations (for more information on vaccines, see section "Warnings and precautions").

Driving and using machines
Hyrimoz may affect, although only to a minor extent, your ability to drive, ride a bicycle, or use machines. After taking Hyrimoz, you may experience vision disturbances or a sensation that your surroundings are spinning (dizziness).

Hyrimoz contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per 0.4 mL dose, i.e., essentially 'sodium-free'.

3. How to use Hyrimoz

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended doses of Hyrimoz for each approved indication are listed in the following
table. Your doctor may prescribe a different concentration of Hyrimoz if a different dose is required.

Method and route of administration
Hyrimoz is administered by subcutaneous injection (by injection under the skin).
Detailed instructions on how to inject Hyrimoz are provided in section 7, “Instructions for use”.

If you use more Hyrimoz than you should
If you accidentally inject Hyrimoz more frequently than you should, contact your doctor or pharmacist and inform them that you have taken more medicine than prescribed. Always keep the medicine packaging, even if empty.

If you forget to use Hyrimoz
If you forget to administer an injection, inject the next dose of Hyrimoz as soon as you remember. Then continue with your regular dosing schedule.

If you stop using Hyrimoz
The decision to stop using Hyrimoz should be discussed with your doctor. Symptoms may return after stopping treatment.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them. Most side effects are mild to moderate in severity. However, some may be serious and require treatment. Side effects may occur up to 4 months or more after the last injection of Hyrimoz.
Seek immediate medical attention if you notice any of the following signs of an allergic reaction or heart failure:

• severe rash, hives;
• swelling of the face, hands, or feet;
• difficulty breathing, difficulty swallowing;
• shortness of breath during exertion or when lying down, or swollen feet.

Inform your doctor as soon as possible if you notice any of the following reactions:

• signs and symptoms of infection such as fever, feeling unwell, wounds, dental problems, burning during urination; fatigue or weakness, or cough;
• symptoms of nerve problems such as tingling, numbness, double vision, or weakness in the arms or legs;
• signs of skin cancer such as a lump or open sore that does not heal;
• signs and symptoms suggesting disorders of the hematopoietic system, such as persistent fever, bruising, bleeding, or paleness.

The following side effects have been observed with Hyrimoz:
Very common (may affect more than 1 in 10 people)

• injection site reactions (including pain, swelling, redness, or itching);
• respiratory tract infections (including cold, runny nose, sinusitis, and pneumonia);
• headache;
• abdominal pain;
• nausea and vomiting;
• rash;
• muscle pain.

Common (may affect up to 1 in 10 people)

• serious infections (including sepsis and influenza);
• intestinal infections (including gastroenteritis);
• skin infections (including cellulitis and herpes zoster infection);
• ear infections;
• mouth infections (including dental infections and herpes simplex);
• reproductive system infections;
• urinary tract infections;
• fungal infections;
• joint infections;
• benign tumors;
• skin cancer;
• allergic reactions (including seasonal allergies);
• dehydration;
• mood changes (including depression);
• anxiety;
• sleep disorders;
• sensory disturbances such as tingling, prickling sensations, or numbness;
• migraine;
• symptoms of nerve root compression (including lower back pain and leg pain);
• visual disturbances;
• eye inflammation;
• eyelid inflammation and eye swelling;
• dizziness (sensation of spinning room);
• sensation of rapid heartbeat;
• high blood pressure;
• hot flushes;
• hematoma (solid swelling with clotted blood);
• cough;
• asthma;
• shortness of breath;
• gastrointestinal bleeding;
• dyspepsia (indigestion, bloating, heartburn);
• acid reflux disorder;
• dry syndrome (including dry eyes and dry mouth);
• itching;
• itchy rash;
• bruising;
• skin inflammation (such as eczema);
• nail breakage in fingers and toes;
• increased sweating;
• hair loss;
• onset or worsening of psoriasis;
• muscle spasms;
• blood in urine;
• kidney problems;
• chest pain;
• edema (fluid accumulation in the body causing swelling of affected tissues);
• fever;
• reduced platelet count in blood, increasing the risk of bleeding or bruising;
• delayed wound healing.

Uncommon (may affect up to 1 in 100 people)

• unusual infections (including tuberculosis and other infections) occurring when immune defenses are reduced;
• neurological infections (including viral meningitis);
• eye infections;
• bacterial infections;
• diverticulitis (inflammation and infection of the large intestine);
• tumors, including tumors of the lymphatic system (lymphoma) and melanoma (a type of skin cancer);
• disorders of the immune system that may affect lungs, skin, and lymph nodes (most commonly a condition called sarcoidosis);
• vasculitis (inflammation of blood vessels);
• tremor (shaking);
• neuropathy (nerve damage);
• stroke;
• hearing loss, ringing in the ears;
• sensation of irregular heartbeat such as palpitations;
• heart problems that may cause shortness of breath or swelling in the ankles;
• acute myocardial infarction;
• formation of a sac in the wall of a major artery, vein inflammation and clot, blockage of a blood vessel;
• lung disease causing shortness of breath (including inflammation);
• pulmonary embolism (blockage of a pulmonary artery);
• pleural effusion (abnormal fluid accumulation in the pleural space);
• pancreatitis causing severe abdominal and back pain;
• difficulty swallowing;
• facial edema (swelling);
• gallbladder inflammation, gallstones;
• fatty liver (accumulation of fat in liver cells);
• night sweats;
• scar;
• abnormal muscle breakdown;
• systemic lupus erythematosus (immune system disorder, including inflammation of the skin, heart, lungs, joints, and other organs);
• interrupted sleep;
• impotence;
• inflammations.

Rare (may affect up to 1 in 1,000 people)

• leukemia (a cancer affecting blood and bone marrow);
• severe allergic reaction with shock;
• multiple sclerosis;
• neurological disorders (such as optic neuritis in the eye and Guillain-Barré syndrome, a condition that may cause muscle weakness, abnormal sensations, tingling in arms and upper body);
• cardiac arrest;
• pulmonary fibrosis (scarring of the lungs);
• intestinal perforation (a hole in the intestinal wall);
• hepatitis (liver inflammation);
• reactivation of hepatitis B infection;
• autoimmune hepatitis (liver inflammation caused by the body's own immune system);
• cutaneous vasculitis (inflammation of blood vessels in the skin);
• Stevens-Johnson syndrome (a life-threatening reaction with flu-like symptoms and blistering rash);
• facial edema (swelling) associated with allergic reactions;
• erythema multiforme (inflammatory skin rash);
• lupus-like syndrome;
• angioedema (localized swelling of the skin);
• lichenoid skin reaction (itchy red-purple rash).

Not known (frequency cannot be estimated from available data)

• hepatosplenic T-cell lymphoma (a rare and often fatal blood cancer);
• Merkel cell carcinoma (a type of skin cancer);
• Kaposi’s sarcoma, a rare form of cancer associated with human herpesvirus 8 infection. Kaposi’s sarcoma most commonly presents with purple lesions on the skin;
• liver failure;
• worsening of a condition called dermatomyositis (which presents as a rash accompanied by muscle weakness);
• weight gain (in most patients, weight gain has been minimal).

Some of the side effects observed with adalimumab may be asymptomatic and detectable only through blood tests. These include:
Very common (may affect more than 1 in 10 people)

• low white blood cell count;
• low red blood cell count;
• increased blood lipids;
• increased liver enzymes.

Common (may affect up to 1 in 10 people)

• increased white blood cell count;
• decreased platelet count;
• increased uric acid in blood;
• altered sodium levels in blood;
• decreased calcium levels in blood;
• decreased phosphorus levels in blood;
• increased blood glucose;
• increased lactate dehydrogenase in blood;
• presence of autoantibodies in blood;
• decreased potassium levels in blood.

Uncommon (may affect up to 1 in 100 people)

• elevated bilirubin levels in blood (liver blood test).

Rare (may affect up to 1 in 1,000 people)

• low white blood cell, red blood cell, and platelet counts.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Hyrimoz

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label/blister/box following the word "Exp".
Store in a refrigerator (2°C – 8°C). Do not freeze.
Keep the pre-filled pen in the outer packaging to protect the medicine from light.

Alternative storage conditions:
When necessary (e.g. when travelling), Hyrimoz may be stored at room temperature (up to 25°C) for a maximum of 42 days – ensure the medicine is protected from light. Once removed from the refrigerator for storage at room temperature, the pre-filled pen must be used within 42 days or discarded, even if subsequently returned to the refrigerator. You must record the date on which the pre-filled pen is first removed from the refrigerator and the date after which the pen must be discarded.

Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Hyrimoz contains

• The active substance is adalimumab. Each pre-filled pen contains 40 mg of adalimumab in 0.4 mL of solution.
• The excipients are adipic acid, mannitol (E 421), polysorbate 80 (E 433), hydrochloric acid (E 507), sodium hydroxide (E 524), and water for injections (see section 2 “Hyrimoz contains sodium”).

Description of the appearance of Hyrimoz and contents of the pack
Hyrimoz 40 mg solution for injection in pre-filled pen is supplied as 0.4 mL of a solution from clear to slightly opalescent, colourless or slightly yellowish.
Hyrimoz is supplied in a single-use pre-filled syringe assembled into a triangular-shaped pen with a transparent viewing window and label. The syringe inside the pen is made of Type I glass with a 29-gauge stainless steel needle, an inner needle rubber cap (thermoplastic elastomer), and a rubber stopper, containing 0.4 mL of solution.
Packs contain 1, 2 and 4 pre-filled pens of Hyrimoz.
Multiple packs contain 6 (3 packs of 2) pre-filled pens of Hyrimoz.
Not all pack sizes may be marketed.
Hyrimoz is available in pre-filled syringe and pre-filled pen presentations.

Marketing Authorisation Holder
Sandoz GmbH
Biochemiestr. 10
6250 Kundl
Austria

Manufacturer
Sandoz GmbH Schaftenau
Biochemiestr. 10
6336 Langkampfen
Austria
Novartis Pharmaceutical Manufacturing GmbH
Biochemiestrasse 10
6336 Langkampfen
Austria

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Sandoz nv/sa Sandoz Pharmaceuticals d.d filialas
Tél/Tel: +32 2 722 97 97 Tel: +370 5 2636 037

България Luxembourg/Luxemburg
Сандоз България КЧТ Sandoz nv/sa (Belgique/Belgien)
Тел.: +359 2 970 47 47 Tél/Tel.: +32 2 722 97 97

Česká republika Magyarország
Sandoz s.r.o. Sandoz Hungária Kft.
Tel: +420 225 775 111 Tel.: +36 1 430 2890

Danmark/Norge/Ísland/Sverige Malta
Sandoz A/S Sandoz Pharmaceuticals d.d.
Tlf./Sími/Tel: +45 63 95 10 00 Tel: +356 99644126

Deutschland Nederland
Hexal AG Sandoz B.V.
Tel: +49 8024 908 0 Tel: +31 36 52 41 600

Eesti Österreich
Sandoz d.d. Eesti filiaal Sandoz GmbH
Tel: +372 665 2400 Tel: +43 5338 2000

Ελλάδα Polska
SANDOZ HELLAS ΜΟΝΟΠΡΟΣΩΠΗ Α.Ε. Sandoz Polska Sp. z o.o.
Τηλ: +30 216 600 5000 Tel.: +48 22 209 70 00

España Portugal
Sandoz Farmacéutica, S.A. Sandoz Farmacêutica Lda.
Tel: +34 900 456 856 Tel: +351 21 000 86 00

France România
Sandoz SAS Sandoz Pharmaceuticals SRL
Tél: +33 1 49 64 48 00 Tel: +40 21 407 51 60

Hrvatska Slovenija
Sandoz farmacevtska družba d.d.
Sandoz d.o.o.
Tel: +386 1 580 29 02
Tel: +385 1 23 53 111

Ireland Slovenská republika
Rowex Ltd. Sandoz d.d. - organizačná zložka
Tel: +353 27 50077 Tel: +421 2 48 200 600

Italia Suomi/Finland
Sandoz S.p.A. Sandoz A/S
Tel: +39 02 96541 Puh/Tel: +358 10 6133 400

Κύπρος United Kingdom (Northern Ireland)
SANDOZ HELLAS ΜΟΝΟΠΡΟΣΩΠΗ Α.Ε. Sandoz GmbH
(Greece) Tel: +43 5338 2000
Τηλ: +30 216 600 5000

Latvija
Sandoz d.d. Latvia filiāle
Tel: +371 67 892 006

Other sources of information
More detailed information on this medicinal product is available on the European Medicines Agency website: https://www.ema.europa.eu .

7. Instructions for Use

To avoid possible infections and to ensure that you use Hyrimoz correctly, it is important that you
follow these instructions.
Be sure to read, understand, and follow these Instructions for Use before injecting Hyrimoz.
Your healthcare provider must show you how to properly prepare and inject Hyrimoz using the
Hyrimoz single-dose pre-filled pen before you use the medicine for the first time. If you have
any doubts, consult your healthcare provider.
Hyrimoz Single-Use Pre-filled Pen

Figure A: Parts of the Hyrimoz pen
In Figure A, the pen is shown without the cap. Do not remove the cap until you are ready to administer
the injection.
It is important that you:

• do not use the pen if the outer packaging seal or the pen’s security seal is broken;
• keep the pen in its sealed outer packaging until you are ready to use it;
• never leave the pen unattended where it could be tampered with by others;
• do not use the pen if it has been dropped, appears damaged, or has been dropped after removing the cap;
• inject Hyrimoz 15–30 minutes after removing it from the refrigerator, for a more comfortable injection;
• dispose of the used pen immediately after use. Do not reuse the pen. See “4. Disposal of Used Pens” at the end of these Instructions for Use.

How should you store the pen?

• Store the pen’s packaging in the refrigerator at a temperature between 2°C and 8°C.
• When necessary, for example when traveling, Hyrimoz may be stored at room temperature (up to 25°C) for a maximum of 42 days—ensure the medicine is protected from light. Once removed from the refrigerator for storage at room temperature, the pre-filled pen must be used within 42 days or discarded, even if subsequently returned to the refrigerator.
• You must record the date when the pre-filled pen is first removed from the refrigerator and the date after which it must be discarded.
• Keep the pen in its original packaging until you are ready to use it, to protect the medicine from light.
• Do not store the pen at extremely hot or cold temperatures.
• Do not freeze the pen.

Keep Hyrimoz and all medicines out of the reach of children.
What do you need for the injection?
Place the following items on a clean, flat surface.
The package contains:

• Hyrimoz pre-filled pen(s) (see Figure A). Each pen contains 40 mg/0.4 mL of adalimumab.

The pen package does not contain (see Figure B ):

• Alcohol swab.
• Cotton ball or gauze.
• Sharps disposal container. See “8. Disposal of Used Pens” at the end of these Instructions for Use.
• Adhesive bandage.

Figure B: Items not included in the package
Preparing the Pen
Before Injection

• For a more comfortable injection, remove the pen from the refrigerator approximately 15–30 minutes

before the injection so it can reach
room temperature.

• Look through the viewing window. The solution should be colorless or slightly yellowish and from clear to slightly opalescent. Do not use the pen if you notice particles and/or changes in color. You may see small air bubbles. This is normal. If you have doubts about the appearance of the solution shown in Figure C, consult your pharmacist for assistance.
• Check the expiration date (Exp.) of the pen (see Figure C). Do not use the pen if the expiration date has passed.
• Do not use the pen if the security seal is broken.

Consult your pharmacist if the pen fails any of the checks listed above.

1. Choosing the injection site:

• The recommended injection site is the
  front of the thighs.

The lower area of the stomach may also be used, but not within 5 cm of the navel (see Figure D).

• Always choose a different site each time you give an injection.
• Do not inject the medicine into areas where the skin is tender, bruised, red, scaly, or hard. Avoid areas with scars or stretch marks. If you have psoriasis, DO NOT inject the medicine directly into areas affected by psoriatic plaques. See Figure D: How to choose the injection site.

2. Cleaning the injection site:

• Wash your hands thoroughly with water and

soap.

• Using a circular motion, clean the injection site with an alcohol swab. Allow it to dry before administering the injection (see Figure E).
• Do not touch the cleaned area before the injection. Figure E: How to clean the injection site

3. Removing the cap from your pen:

• Remove the cap only when you are ready to use the pen.

• Twist the cap in the direction of the arrows (see Figure F).
• Once the cap is removed, discard it. Never attempt to reattach the cap.
• Use the pen within 5 minutes after removing the cap.
• You may notice some drops of liquid coming out of the needle—this is normal. Figure F: How to remove the cap

4. How to hold the pen:

• Hold the pen at a 90-degree angle to the clean injection site (see Figure G).

Correct Incorrect
Figure G: How to hold the pen
Injection
Read before administering the injection
During the injection, you will hear 2 clicks:
o The first click indicates that the injection has started.
o A moment later, a second click indicates that the injection is almost complete.
You must keep the pen firmly pressed against the skin until you see a green indicator
fill the viewing window and stop moving.

5. Starting the injection:

• Press the pen firmly against the

skin to start the injection (see
Figure H).

• The first click indicates that the injection has started.
• Keep pressing the pen firmly against the skin.
• The green indicator shows the progress of the injection. Figure H: how to start the injection

6. Completing the injection:

• Pay attention to the second click, which

indicates that the injection is almost complete.

• Check that the green indicator has completely filled the viewing window and has stopped moving (see Figure I).
• You may now remove the pen.

Figure I: How to complete the injection
After the injection

7. Check that the green indicator

fills the viewing window (see Figure J ):

• This means that the medicine has been

administered. Contact your doctor if
the green indicator is not visible.

• You may notice a small amount of blood at the injection site. You can press a cotton ball or gauze pad against the injection site and hold it in place for 10 seconds. Do not rub the injection site. If needed, you may cover the Figure J: how to check the green indicator injection site with a small adhesive bandage.

8. Disposal of used pens:

• Dispose of the used pen in a sharps disposal container (puncture-resistant, closable container, see Figure K). For your safety and the safety of others, used pens must never be reused.

• Do not dispose of any medication via wastewater or household waste. Ask your doctor or pharmacist how to dispose of medicines you no longer use. This will help protect the environment. Unused medicine and waste derived from this medicine must be disposed of in accordance with local regulations.

Figure K: how to dispose of the used pen
If you have any doubts, consult a doctor, pharmacist, or nurse familiar with
Hyrimoz.

Patient information leaflet

Hyrimoz 80 mg solution for injection in pre-filled syringe

adalimumab
Please read this leaflet carefully before using this medicine because it contains important information for you

• Keep this leaflet. You may need to read it again.
• Your doctor will provide you with a Patient Reminder Card containing important safety information you need to know before administration of Hyrimoz and during treatment with Hyrimoz. Keep this Patient Reminder Card with you during treatment and for 4 months after the last injection (or the last injection given to your child) of Hyrimoz.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Hyrimoz is and what it is used for
2. What you need to know before using Hyrimoz
3. How to use Hyrimoz
4. Possible side effects
5. How to store Hyrimoz
6. Contents of the pack and other information
7. Instructions for use

1. What Hyrimoz is and what it is used for

Hyrimoz contains the active substance adalimumab, a medicine that acts on the body's immune (defence) system.
Hyrimoz is indicated for the treatment of the following inflammatory diseases:

• rheumatoid arthritis,
• plaque psoriasis,
• hidradenitis suppurativa,
• Crohn’s disease,
• ulcerative colitis,
• non-infectious uveitis.

The active substance in Hyrimoz, adalimumab, is a human monoclonal antibody. Monoclonal antibodies are proteins that bind to a specific target.
Adalimumab targets a protein called tumour necrosis factor (TNFα), which is involved in the immune (defence) system and is present at higher concentrations in the inflammatory diseases listed above. By binding to TNFα, Hyrimoz blocks its action and reduces the inflammatory process in these diseases.

Rheumatoid arthritis
Rheumatoid arthritis is an inflammatory disease affecting the joints.
Hyrimoz is used to treat rheumatoid arthritis in adults. If you have moderate to severe rheumatoid arthritis, other disease-modifying drugs such as methotrexate may initially be prescribed. If these medicines do not work satisfactorily, you will be given Hyrimoz to treat rheumatoid arthritis.
Hyrimoz may also be used to treat severe, active and progressive rheumatoid arthritis without prior treatment with methotrexate.
Hyrimoz can slow down the progression of joint cartilage and bone damage caused by the disease and improve physical function.
Hyrimoz is generally used in combination with methotrexate. If your doctor considers that treatment with methotrexate is not appropriate, Hyrimoz may be given alone.

Plaque psoriasis
Plaque psoriasis is an inflammatory skin condition that causes red, scaly, hardened patches of skin covered with silvery scales. Plaque psoriasis can also affect the nails, causing them to break, thicken or lift from the nail bed, which can be painful. Psoriasis is thought to be caused by a problem with the body’s immune system leading to an increased production of skin cells.
Hyrimoz is used to treat moderate to severe plaque psoriasis in adults.

Hidradenitis suppurativa in adults and adolescents
Hidradenitis suppurativa (sometimes called inverse acne) is a long-term inflammatory skin disease that is often painful. Symptoms may include painful nodules and abscesses (cysts) that may drain pus.
It most commonly affects specific areas of the skin, such as the area under the breasts, armpits, inner thighs, groin, and buttocks. Scarring may also develop in the affected areas.
Hyrimoz is used to treat:

• moderate to severe hidradenitis suppurativa in adults, and
• moderate to severe hidradenitis suppurativa in adolescents aged 12 to 17 years.

Hyrimoz can reduce the number of nodules and abscesses you have, as well as the pain often associated with this disease. You may initially be given other medicines. If these do not work satisfactorily, you will receive Hyrimoz.

Crohn’s disease in adults and children
Crohn’s disease is an inflammation of the intestine.
Hyrimoz is used to treat:

• moderate to severe Crohn’s disease in adults, and
• Crohn’s disease in children and adolescents aged 6 to 17 years.

If you have Crohn’s disease, you will first be given other medicines. If you do not respond adequately to these medicines, Hyrimoz will be administered to reduce the typical symptoms of Crohn’s disease.

Ulcerative colitis in adults and children
Ulcerative colitis is an inflammation of the large intestine.
Hyrimoz is used to treat:

• moderate to severe ulcerative colitis in adults, and
• moderate to severe ulcerative colitis in children aged 6 to 17 years.

If you have ulcerative colitis, you may first take other medicines. If these medicines do not work satisfactorily, you will take Hyrimoz to reduce the signs and symptoms of ulcerative colitis.

Non-infectious uveitis in adults and children
Non-infectious uveitis is an inflammatory disease affecting certain parts of the eye.
The inflammation leads to reduced vision and/or the presence of floating spots in the eye (dark spots or fine lines moving across the visual field). Hyrimoz works by reducing this inflammation.
Hyrimoz is used for the treatment of:

• adults with non-infectious uveitis with inflammation affecting the back of the eye, and
• children from 2 years of age with chronic non-infectious uveitis with inflammation affecting the front part of the eye.

You may first be given other medicines. If you do not respond satisfactorily to these medicines, Hyrimoz will be administered.

2. What you should know before using Hyrimoz

Do not use Hyrimoz

• If you are allergic to adalimumab or to any of the other ingredients of this medicine (listed in section 6).
• If you have a serious infection, including tuberculosis, sepsis (blood poisoning), or other opportunistic infections (unusual infections associated with a weakened immune system). It is important to inform your doctor if you have signs or symptoms of infection, such as fever, wounds, feeling tired, or dental problems (see "Warnings and precautions").
• If you have moderate or severe heart failure. It is important to inform your doctor if you have had or currently have a serious heart condition (see "Warnings and precautions").

Warnings and precautions
Talk to your doctor or pharmacist before using Hyrimoz.
Allergic reaction

• If you experience allergic reactions with symptoms such as chest tightness, wheezing, dizziness, swelling, or rash, do not administer Hyrimoz again and contact your doctor immediately, as these reactions may, in rare cases, be life-threatening.

Infections

• If you have an infection, including long-term or localized infections (e.g., leg ulcers), consult your doctor before starting treatment with Hyrimoz. If you are unsure, contact your doctor.
• You may be more likely to get infections while being treated with Hyrimoz. This risk may increase if your lung function is reduced. These infections can be serious and may include tuberculosis, infections caused by viruses, fungi, parasites, or bacteria, or other unusual infectious organisms, and sepsis (septicemia).
• In rare cases, these infections may be life-threatening. It is important to inform your doctor if you have symptoms such as fever, wounds, feeling tired, or dental problems. Your doctor may advise you to temporarily stop using Hyrimoz.

Tuberculosis (TB)

• Since cases of tuberculosis have occurred in patients treated with adalimumab, your doctor will check for signs or symptoms of tuberculosis before starting treatment with Hyrimoz. This will involve a detailed medical evaluation including your medical history and clinical examinations (e.g., a chest X-ray and tuberculin test). The performance and results of these tests must be recorded in the Patient Reminder Card. It is very important to inform your doctor if you have ever had tuberculosis or have been in close contact with someone who has tuberculosis. Tuberculosis may occur during treatment even if you have received preventive treatment for tuberculosis. Contact your doctor immediately if you develop symptoms of tuberculosis (persistent cough, weight loss, lack of energy, low-grade fever) or other infections during or after treatment.

Travel/recurrent infection

• Inform your doctor if you have lived in or traveled to areas where fungal infections such as histoplasmosis, coccidioidomycosis, or blastomycosis are common.
• Inform your doctor if you have had recurrent infections or if you have conditions that increase your risk of infection.

Hepatitis B virus (HBV)

• Inform your doctor if you are a carrier of hepatitis B virus (HBV), if you have an active hepatitis B infection, or if you think you may be at risk of contracting hepatitis B virus. Your doctor should test you for hepatitis B infection. Taking adalimumab may reactivate hepatitis B virus infection in people who are carriers of this virus. In rare cases, especially if the patient is also being treated with other medicines that suppress the immune system, reactivation of hepatitis B virus infection may be life-threatening.

Age over 65 years

• If you are over 65 years of age, you may be more susceptible to infections while taking Hyrimoz. You and your doctor should pay particular attention to signs of infection while you are being treated with Hyrimoz. It is important to inform your doctor if you develop symptoms of infections such as fever, wounds, feeling tired, or dental problems.

Surgery or dental procedures

• Before undergoing surgery or dental procedures, inform your doctor that you are taking Hyrimoz. Your doctor may advise you to temporarily stop using Hyrimoz.

Demyelinating disease

• If you have or develop demyelinating diseases (diseases affecting the insulating layer around nerves), such as multiple sclerosis, your doctor will decide whether to start or continue treatment with Hyrimoz. Inform your doctor immediately if you experience symptoms such as changes in vision, weakness in arms or legs, or numbness or tingling in any part of your body.

Vaccination

• Certain vaccines contain live but weakened forms of bacteria or viruses that cause disease and should not be administered during treatment with Hyrimoz, as they may cause infections. Consult your doctor before receiving any vaccinations. In children, it is recommended, if possible, to administer age-appropriate vaccinations before starting Hyrimoz therapy. If you take Hyrimoz during pregnancy, your baby may have an increased risk of infection for up to about 5 months after your last dose during pregnancy. It is important that you inform the pediatrician or other healthcare provider about your use of Hyrimoz during pregnancy so they can determine when your baby should receive any vaccinations.

Heart failure

• It is important to inform your doctor about any past or current heart problems. If you have mild heart failure and are being treated with Hyrimoz, your doctor should carefully monitor your heart condition. If new symptoms of heart failure appear or existing symptoms worsen (e.g., shortness of breath or swelling of the feet), contact your doctor immediately.

Fever, bruising, bleeding, or paleness

• In some patients, the body may not be able to produce enough blood cells to fight infections or stop bleeding. If you have persistent fever, bruising, easy bleeding, or paleness, contact your doctor immediately. Your doctor may decide to stop treatment.

Tumors

• Very rarely, certain types of tumors have occurred in children and adults treated with Hyrimoz or other anti-TNFα medicines. Patients with long-standing, severe rheumatoid arthritis may have a higher-than-average risk of developing lymphoma and leukemia (cancers affecting blood cells and bone marrow). If you are taking Hyrimoz, your risk of developing lymphomas, leukemia, or other tumors may increase. In rare cases, a specific and serious type of lymphoma has been observed in patients treated with adalimumab. Some of these patients were also taking azathioprine or mercaptopurine. Inform your doctor if you are taking azathioprine or mercaptopurine with Hyrimoz.
• Cases of non-melanoma skin cancer have been observed in patients taking adalimumab. If you notice damaged skin areas during or after treatment, or if the appearance of moles or damaged areas changes, inform your doctor.
• Cases of malignancies other than lymphoma have been reported in patients with a specific lung disease called chronic obstructive pulmonary disease (COPD) treated with another anti-TNFα medicine. If you have COPD or are a heavy smoker, you should discuss with your doctor whether treatment with an anti-TNFα medicine is appropriate.

Autoimmune diseases

• Rarely, treatment with Hyrimoz may lead to the development of a lupus-like syndrome. Inform your doctor if you develop symptoms such as unexplained persistent skin rash, fever, joint pain, or fatigue.

Children and adolescents

• Vaccinations: If possible, children should have completed all age-appropriate vaccinations before starting Hyrimoz.

Other medicines and Hyrimoz
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Hyrimoz may be taken with methotrexate and other disease-modifying antirheumatic drugs (such as sulfasalazine, hydroxychloroquine, leflunomide, and parenteral gold salts), corticosteroids, or analgesics, including non-steroidal anti-inflammatory drugs (NSAIDs).
Hyrimoz must not be taken together with medicines containing the active substances anakinra or abatacept due to an increased risk of serious infections. The combination of adalimumab with other anti-TNF medicines, anakinra, or abatacept is not recommended due to the possible increased risk of infections, including serious infections, and other potential drug interactions. If you have any doubts, consult your doctor.

Pregnancy and breastfeeding

• You should use an effective method of contraception to prevent pregnancy and continue using it for at least 5 months after your last dose of Hyrimoz.
• If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor before taking this medicine.
• Hyrimoz should be used during pregnancy only if necessary.
• According to a pregnancy study, no increased risk of birth defects was observed in babies whose mothers received adalimumab during pregnancy compared to mothers with the same condition who did not receive adalimumab.
• Hyrimoz may be used during breastfeeding.
• If you take Hyrimoz during pregnancy, your baby may have an increased risk of infection.
• It is important that you inform the pediatrician or other healthcare provider about your use of Hyrimoz during pregnancy before your baby receives any vaccinations (for more information on vaccines, see the section "Warnings and precautions").

Driving and using machines
Hyrimoz may affect your ability to drive, ride a bicycle, or use machines, although only to a minor extent. After taking Hyrimoz, you may experience vision disturbances or a sensation that your surroundings are spinning (dizziness).

Hyrimoz contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per 0.8 mL dose, i.e., essentially 'sodium-free'.

3. How to use Hyrimoz

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended doses of Hyrimoz for each approved indication are listed in the following
table. Your doctor may prescribe a different concentration of Hyrimoz if the child requires
a different dose.

Method and route of administration
Hyrimoz is administered by subcutaneous injection (for injection under the skin).
Detailed instructions on how to inject Hyrimoz are provided in section 7, "Instructions for use".
If you use more Hyrimoz than you should
If you accidentally inject Hyrimoz more frequently than you should, contact your doctor or pharmacist and inform them that you have taken more medicine than required. Always keep the medicine packaging, even if empty.
If you forget to use Hyrimoz
If you forget to give an injection, administer the next dose of Hyrimoz as soon as you remember. After that, resume your regular dosing schedule as prescribed.
If you stop using Hyrimoz
The decision to stop using Hyrimoz should be discussed with your doctor. Symptoms may return after stopping treatment.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Most of the side effects are mild to moderate in severity. However, some may be serious and require treatment. Side effects may occur up to 4 months or more after the last injection of Hyrimoz.

Seek urgent medical attention if you notice any of the following signs of an allergic reaction or heart failure:

• severe rash, hives;
• swelling of the face, hands, or feet;
• difficulty breathing, difficulty swallowing;
• shortness of breath during physical activity or when lying down, or swollen feet.

Inform your doctor as soon as possible if you notice any of the following reactions:

• signs and symptoms of infection such as fever, feeling unwell, wounds, dental problems, burning during urination, fatigue or weakness, or cough;
• symptoms of nerve problems such as tingling, numbness, double vision, or weakness in the arms or legs;
• signs of skin cancer such as a lump or open sore that does not heal;
• signs and symptoms suggesting disorders of the hematopoietic system, such as persistent fever, bruising, bleeding, or paleness.

The following side effects have been observed with Hyrimoz:

Very common (may affect more than 1 in 10 people)

• injection site reactions (including pain, swelling, redness, or itching);
• respiratory tract infections (including cold, runny nose, sinusitis, and pneumonia);
• headache;
• abdominal pain (stomach pain);
• nausea and vomiting;
• rash;
• muscle pain.

Common (may affect up to 1 in 10 people)

• serious infections (including sepsis and influenza);
• intestinal infections (including gastroenteritis);
• skin infections (including cellulitis and herpes zoster infection);
• ear infections;
• mouth infections (including dental infections and herpes simplex);
• reproductive system infections;
• urinary tract infections;
• fungal infections;
• joint infections;
• benign tumors;
• skin cancer;
• allergic reactions (including seasonal allergies);
• dehydration;
• mood changes (including depression);
• anxiety;
• sleep disorders;
• sensory disturbances such as tingling, stabbing sensations, or numbness;
• migraine;
• symptoms of nerve root compression (including lower back pain and leg pain);
• visual disturbances;
• eye inflammation;
• eyelid inflammation and eye swelling;
• dizziness (sensation of room spinning);
• sensation of rapid heartbeat;
• high blood pressure;
• hot flushes;
• hematoma (solid swelling with clotted blood);
• cough;
• asthma;
• shortness of breath;
• gastrointestinal bleeding;
• dyspepsia (indigestion, bloating, heartburn);
• acid reflux disorder;
• sicca syndrome (including dry eyes and dry mouth);
• itching;
• itchy rash;
• bruising;
• skin inflammation (such as eczema);
• cracking of fingernails and toenails;
• increased sweating;
• hair loss;
• onset or worsening of psoriasis;
• muscle spasms;
• blood in urine;
• kidney problems;
• chest pain;
• edema (fluid accumulation in the body, causing swelling of affected tissues);
• fever;
• reduced platelet count in the blood, increasing the risk of bleeding or bruising;
• delayed wound healing.

Uncommon (may affect up to 1 in 100 people)

• unusual infections (including tuberculosis and other infections) that occur when immune defenses are reduced;
• neurological infections (including viral meningitis);
• eye infections;
• bacterial infections;
• diverticulitis (inflammation and infection of the large intestine);
• tumors, including tumors of the lymphatic system (lymphoma) and melanoma (a type of skin cancer);
• disorders of the immune system that may affect lungs, skin, and lymph nodes (most commonly a condition called sarcoidosis);
• vasculitis (inflammation of blood vessels);
• tremor (shaking);
• neuropathy (nerve damage);
• stroke;
• hearing loss, ringing in the ears;
• sensation of irregular heartbeat such as palpitations;
• heart problems that may cause shortness of breath or swelling in the ankles;
• acute myocardial infarction;
• formation of a sac in the wall of a major artery, inflammation and clot in a vein, blockage of a blood vessel;
• lung disease causing shortness of breath (including inflammation);
• pulmonary embolism (blockage of a lung artery);
• pleural effusion (abnormal accumulation of fluid in the pleural space);
• inflammation of the pancreas causing severe abdominal and back pain;
• difficulty swallowing;
• facial edema (swelling);
• gallbladder inflammation, gallstones;
• fatty liver (accumulation of fat in liver cells);
• night sweats;
• scarring;
• abnormal muscle breakdown;
• systemic lupus erythematosus (immune system disorder, including inflammation of the skin, heart, lungs, joints, and other organs);
• interrupted sleep;
• impotence;
• inflammations.

Rare (may affect up to 1 in 1,000 people)

• leukemia (a cancer affecting blood and bone marrow);
• severe allergic reaction with shock;
• multiple sclerosis;
• neurological disorders (such as optic neuritis in the eye and Guillain-Barré syndrome, a condition that may cause muscle weakness, abnormal sensations, tingling in arms and upper body);
• cardiac arrest;
• pulmonary fibrosis (scarring of the lungs);
• intestinal perforation (hole in the intestinal wall);
• hepatitis (liver inflammation);
• reactivation of hepatitis B infection;
• autoimmune hepatitis (liver inflammation caused by the body's own immune system);
• cutaneous vasculitis (inflammation of blood vessels in the skin);
• Stevens-Johnson syndrome (life-threatening reaction with flu-like symptoms and rash with blisters);
• facial edema (swelling) associated with allergic reactions;
• erythema multiforme (inflammatory skin rash);
• lupus-like syndrome;
• angioedema (localized swelling of the skin);
• lichenoid skin reaction (pruritic red-purple rash).

Not known (frequency cannot be estimated from the available data)

• hepatosplenic T-cell lymphoma (a rare blood cancer that is often fatal);
• Merkel cell carcinoma (a type of skin cancer);
• Kaposi’s sarcoma, a rare form of cancer associated with human herpesvirus 8 infection. Kaposi’s sarcoma most commonly appears as purple lesions on the skin;
• liver failure;
• worsening of a condition called dermatomyositis (which presents as a rash accompanied by muscle weakness);
• weight gain (in most patients, weight gain has been low).

Some of the side effects observed with adalimumab may be asymptomatic and may only be detected through blood tests. These include:

Very common (may affect more than 1 in 10 people)

• low white blood cell count;
• low red blood cell count;
• increased blood lipids;
• increased liver enzymes.

Common (may affect up to 1 in 10 people)

• increased white blood cell count;
• decreased platelet count;
• increased uric acid in blood;
• altered sodium levels in blood;
• decreased calcium in blood;
• decreased phosphorus in blood;
• increased blood sugar;
• increased lactate dehydrogenase in blood;
• presence of autoantibodies in blood;
• decreased potassium in blood.

Uncommon (may affect up to 1 in 100 people)

• elevated bilirubin levels in blood (liver blood test).

Rare (may affect up to 1 in 1,000 people)

• low white blood cell, red blood cell, and platelet counts.

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, speak to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Hyrimoz

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label/blister/box following the word "Exp".
Store in a refrigerator (2°C – 8°C). Do not freeze.
Keep the pre-filled syringe in its outer packaging to protect the medicine from light.

Alternative storage conditions:
When necessary (for example, when travelling), Hyrimoz may be stored at room temperature (up to 25°C) for a maximum of 42 days – ensure the medicine is protected from light. Once removed from the refrigerator for storage at room temperature, the pre-filled syringe must be used within 42 days or discarded, even if it is subsequently returned to the refrigerator. You must record the date when the pre-filled syringe is first removed from the refrigerator and the date by which it must be discarded.

Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Hyrimoz contains

• The active substance is adalimumab. Each pre-filled syringe contains 80 mg of adalimumab in 0.8 mL of solution.
• The excipients are adipic acid, mannitol (E 421), polysorbate 80 (E 433), hydrochloric acid (E 507), sodium hydroxide (E 524) and water for injections (see section 2 “Hyrimoz contains sodium”).

Description of the appearance of Hyrimoz and contents of the pack
Hyrimoz 80 mg solution for injection in pre-filled syringe is supplied as 0.8 mL of solution from clear
to slightly opalescent, colourless or slightly yellowish.
Hyrimoz is supplied in a single-use, transparent type I glass syringe with a 29-gauge stainless steel needle,
a needle safety device with finger grip, a needle rubber cap (thermoplastic elastomer), and a plastic plunger,
containing 0.8 mL of solution.
The packs contain 1 and 2 pre-filled syringes of Hyrimoz.
Not all pack sizes may be marketed.
Hyrimoz is available in pre-filled syringe and pre-filled pen.

Marketing Authorisation Holder
Sandoz GmbH
Biochemiestr. 10
6250 Kundl
Austria

Manufacturer
Sandoz GmbH Schaftenau
Biochemiestr. 10
6336 Langkampfen
Austria
Novartis Pharmaceutical Manufacturing GmbH
Biochemiestrasse 10
6336 Langkampfen
Austria

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Sandoz nv/sa Sandoz Pharmaceuticals d.d filialas
Tél/Tel: +32 2 722 97 97 Tel: +370 5 2636 037

България Luxembourg/Luxemburg
Сандоз България КЧТ Sandoz nv/sa (Belgique/Belgien)
Тел.: +359 2 970 47 47 Tél/Tel.: +32 2 722 97 97

Česká republika Magyarország
Sandoz s.r.o. Sandoz Hungária Kft.
Tel: +420 225 775 111 Tel.: +36 1 430 2890

Danmark/Norge/Ísland/Sverige Malta
Sandoz A/S Sandoz Pharmaceuticals d.d.
Tlf./Sími/Tel: +45 63 95 10 00 Tel: +356 99644126

Deutschland Nederland
Hexal AG Sandoz B.V.
Tel: +49 8024 908 0 Tel: +31 36 52 41 600

Eesti Österreich
Sandoz d.d. Eesti filiaal Sandoz GmbH
Tel: +372 665 2400 Tel: +43 5338 2000

Ελλάδα Polska
SANDOZ HELLAS ΜΟΝΟΠΡΟΣΩΠΗ Α.Ε. Sandoz Polska Sp. z o.o.
Τηλ: +30 216 600 5000 Tel.: +48 22 209 70 00

España Portugal
Sandoz Farmacéutica, S.A. Sandoz Farmacêutica Lda.
Tel: +34 900 456 856 Tel: +351 21 000 86 00

France România
Sandoz SAS Sandoz Pharmaceuticals SRL
Tél: +33 1 49 64 48 00 Tel: +40 21 407 51 60

Hrvatska Slovenija
Sandoz farmacevtska družba d.d. Sandoz d.o.o.
Tel: +385 1 23 53 111 Tel: +386 1 580 29 02

Ireland Slovenská republika
Rowex Ltd. Sandoz d.d. - organizačná zložka
Tel: +353 27 50077 Tel: +421 2 48 200 600

Italia Suomi/Finland
Sandoz S.p.A. Sandoz A/S
Tel: +39 02 96541 Puh/Tel: +358 10 6133 400

Κύπρος United Kingdom (Northern Ireland)
SANDOZ HELLAS ΜΟΝΟΠΡΟΣΩΠΗ Α.Ε. Sandoz GmbH
(Ελλάδα) Tel: +43 5338 2000
Τηλ: +30 216 600 5000

Latvija
Sandoz d.d. Latvia filiāle
Tel: +371 67 892 006

Other sources of information
More detailed information on this medicinal product is available on the European Medicines Agency website: https://www.ema.europa.eu .

7. Instructions for Use

To avoid possible infections and to ensure you use the medicine correctly, it is important that
you follow these instructions.
Make sure you read, understand, and follow these Instructions for Use before injecting Hyrimoz.
A healthcare professional must show you how to properly prepare and inject Hyrimoz using the
single-use pre-filled syringe before you use the medicine for the first time. If you have any doubts, consult
your healthcare professional.
Single-use pre-filled syringe of Hyrimoz with needle safety device and additional finger grip

Figure A: pre-filled syringe of Hyrimoz with needle safety device and finger grip
It is important that you:

• do not use the syringe if the blister pack seals are broken, as use may not be safe;
• do not open the outer carton until you are ready to use the pre-filled syringe;
• never leave the pre-filled syringe unattended where it could be tampered with by others;
• if you drop the syringe, do not use it if it appears damaged or if it was dropped after removing the needle cap;
• do not remove the needle cap until immediately before injection;
• be careful not to touch the wings of the needle safety device before use. Doing so may activate the needle safety device too early;
• do not remove the finger grip before injection;
• inject Hyrimoz 15–30 minutes after removing it from the refrigerator for a more comfortable injection;
• dispose of the used syringe immediately after use. Do not reuse the pre-filled syringe. See “4. Disposal of used pre-filled syringes” at the end of these Instructions for Use.

How should you store the single-dose pre-filled syringe of Hyrimoz?

• Store the outer packaging of the pre-filled syringes in the refrigerator, at a temperature between 2°C and 8°C.
• When necessary (e.g., when traveling), Hyrimoz may be stored at room temperature (up to 25°C) for a maximum of 42 days—ensure the medicine is protected from light. Once removed from the refrigerator for storage at room temperature, the pre-filled syringe must be used within 42 days or discarded, even if subsequently returned to the refrigerator. You must record the date when the pre-filled syringe is first removed from the refrigerator and the date after which it must be discarded.
• Store pre-filled syringes in their original packaging until you are ready to use them, to protect the medicine from light.
• Do not store pre-filled syringes at extremely hot or cold temperatures.
• Do not freeze pre-filled syringes.

Keep Hyrimoz and all medicines out of the reach of children.
What is needed for the injection?
Place the following items on a clean, flat surface.
The pre-filled syringe packaging contains:

• Pre-filled syringe(s) of Hyrimoz (see Figure A). Each pre-filled syringe contains 80 mg/0.8 mL of adalimumab.

The Hyrimoz pre-filled syringe packaging does not contain (see Figure B ):

• Alcohol swab.
• Cotton ball or gauze.
• Sharps disposal container. See “4. Disposal of used syringes” at the end of these Instructions for Use.
• Adhesive bandage.

Figure B: items not included in the package
Before the injection

Figure C: needle safety device is not activated – the single-use pre-filled syringe is ready for use
Figure D: needle safety device is activated – do not use

• In this configuration, the needle safety device is not activated.

• The syringe is ready for use (see Figure C).

• In this configuration, the needle safety device of the pre-filled syringe is activated.

• Do not use the syringe (see Figure D).

Preparing the syringe

• For a more comfortable injection, remove the carton containing the pre-filled syringe from the refrigerator and let it sit closed on the work surface for about 15–30 minutes to reach room temperature.
• Remove the pre-filled syringe from the blister pack.
• Look through the viewing window. The solution should be colorless or slightly yellowish and from clear to slightly opalescent. Do not use the syringe if you see particles or any changes in color. If you have any doubts about the appearance of the solution, consult your pharmacist for assistance.
• Do not use the pre-filled syringe if it is damaged or if the needle safety device is activated. Return the pre-filled syringe and its packaging to the pharmacy.
• Check the expiry date (Exp.) of the pre-filled syringe. Do not use the pre-filled syringe if the expiry date has passed.

Contact your pharmacist if the syringe fails any of the checks listed above.

1. Choosing the injection site:

• The recommended injection site is the front of the

thighs. The lower abdomen may also be used,
but not the area within 5 cm around the navel (see
Figure E ).

• Choose a different site each time you give an injection.
• Do not inject the medicine into areas where the skin is tender, bruised, red, flaky, or hard. Avoid areas with scars or stretch marks. If you have psoriasis, DO NOT inject the medicine directly into areas with psoriatic plaques. Figure E : How to choose the injection site

2. Cleaning the injection site:

• Wash your hands thoroughly with water and soap.

• Using a circular motion, clean the injection site with an alcohol swab. Allow it to dry before administering the injection (see Figure F).
• Do not touch the cleaned area before the injection.

Figure F: How to clean the injection site

3. Administration of the injection:

• Carefully pull off the needle cap from the pre-filled syringe (see Figure G).
• Discard the needle cap.
• You may see a drop of liquid at the tip of the needle. This is normal.

Figure G: How to remove the needle cap

• Gently create a skin fold at the injection site (see Figure H).
• Insert the needle into the skin as shown.
• Push the entire needle under the skin to ensure the full dose of medicine is delivered.
• Use the syringe within 5 minutes after removing the needle cap.

Figure H: How to insert the needle

• Hold the pre-filled syringe as shown (see Figure I).
• Slowly push the plunger all the way down until it stops, so that the plunger head is completely between the safety device’s wings.
• While keeping the syringe in place, press the plunger fully for 5 seconds.

Figure I: How to hold the syringe

• Keep the plunger fully pressed while carefully withdrawing the needle from the injection site, then release the skin (see Figure J).

Figure J: How to withdraw the needle

• Slowly release the plunger and allow the needle safety device to automatically cover the exposed needle (see Figure K).
• You may notice a small amount of blood at the injection site. You may press a cotton ball or gauze pad against the injection site and hold pressure for 10 seconds. Do not rub the injection site. If needed, you may cover the injection site with a small adhesive bandage.
  Figure K: How to slowly release the plunger

4. Disposal of used syringes:

• Dispose of the used syringe in a sharps disposal container
  (puncture-resistant, closable container, see Figure L).
  
  For your safety and health and that of others,
  needles and syringes must never be reused.

• Do not dispose of any medicine via wastewater or household waste. Ask your doctor or pharmacist how to properly dispose of medicines you no longer use. This will help protect the environment. Unused medicine and waste derived from this medicine must be disposed of in accordance with local regulations.

Figure L: how to dispose of the used pre-filled syringe
If you have any questions, consult a doctor, pharmacist, or nurse familiar with
Hyrimoz.

Patient information leaflet

Hyrimoz 80 mg solution for injection in pre-filled pen

adalimumab
Please read this leaflet carefully before using this medicine because it contains important information for you

• Keep this leaflet. You may need to read it again.
• Your doctor will provide you with a Patient Reminder Card containing important safety information you need to know before receiving Hyrimoz and during treatment with Hyrimoz. Keep this Patient Reminder Card with you throughout treatment and for 4 months after the last injection (or the last injection given to your child) of Hyrimoz.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Hyrimoz is and what it is used for
2. What you need to know before using Hyrimoz
3. How to use Hyrimoz
4. Possible side effects
5. How to store Hyrimoz
6. Contents of the pack and other information
7. Instructions for use

1. What Hyrimoz is and what it is used for

Hyrimoz contains the active substance adalimumab, a medicine that acts on the body's immune (defence) system.
Hyrimoz is indicated for the treatment of the following inflammatory diseases:

• rheumatoid arthritis,
• plaque psoriasis,
• hidradenitis suppurativa,
• Crohn’s disease,
• ulcerative colitis,
• non-infectious uveitis.

The active substance in Hyrimoz, adalimumab, is a human monoclonal antibody. Monoclonal antibodies are proteins that bind to a specific target.
The target of adalimumab is a protein called tumour necrosis factor (TNFα), which is involved in the immune (defence) system and is present at higher concentrations in the inflammatory diseases listed above. By binding to TNFα, Hyrimoz blocks its action and reduces the inflammatory process in these diseases.

Rheumatoid arthritis
Rheumatoid arthritis is an inflammatory disease affecting the joints.
Hyrimoz is used to treat rheumatoid arthritis in adults. If you have moderate to severe rheumatoid arthritis, you may initially be given other disease-modifying drugs, such as methotrexate. If these medicines do not work satisfactorily, you will be given Hyrimoz to treat rheumatoid arthritis.
Hyrimoz may also be used to treat severe, active and progressive rheumatoid arthritis without prior treatment with methotrexate.
Hyrimoz can slow down the progression of joint damage to cartilage and bone caused by the disease and improve physical function.
Hyrimoz is generally used in combination with methotrexate. If your doctor considers that treatment with methotrexate is not appropriate, Hyrimoz may be given alone.

Plaque psoriasis
Plaque psoriasis is an inflammatory skin condition that causes red, scaly, thickened patches of skin covered with silvery scales. Plaque psoriasis can also affect the nails, causing them to crack, thicken or separate from the nail bed, which can be painful. Psoriasis is thought to be caused by a problem with the body's immune system leading to increased production of skin cells.
Hyrimoz is used to treat moderate to severe plaque psoriasis in adults.

Hidradenitis suppurativa in adults and adolescents
Hidradenitis suppurativa (sometimes called inverse acne) is a long-term inflammatory skin disease and is often painful. Symptoms may include painful nodules and abscesses (cysts) that can drain pus.
It most commonly affects specific areas of the skin, such as the under-breast area, armpits, inner thighs, groin, and buttocks. Scarring may also develop in the affected areas.
Hyrimoz is used to treat:

• moderate to severe hidradenitis suppurativa in adults, and
• moderate to severe hidradenitis suppurativa in adolescents aged 12 to 17 years.

Hyrimoz can reduce the number of nodules and abscesses you have, as well as the pain often associated with this disease. You may initially be given other medicines. If these medicines do not work satisfactorily, you will be given Hyrimoz.

Crohn’s disease in adults and children
Crohn’s disease is an inflammation of the intestine.
Hyrimoz is used to treat:

• moderate to severe Crohn’s disease in adults, and
• moderate to severe Crohn’s disease in children and adolescents aged 6 to 17 years.

If you have Crohn’s disease, you will first be given other medicines. If you do not respond adequately to these medicines, you will be given Hyrimoz to reduce the typical symptoms of Crohn’s disease.

Ulcerative colitis in adults and children
Ulcerative colitis is an inflammation of the large intestine (colon).
Hyrimoz is used to treat:

• moderate to severe ulcerative colitis in adults, and
• moderate to severe ulcerative colitis in children and adolescents aged 6 to 17 years.

If you have ulcerative colitis, you may first take other medicines. If these medicines do not work satisfactorily, you will take Hyrimoz to reduce the signs and symptoms of the disease.

Non-infectious uveitis in adults and children
Non-infectious uveitis is an inflammatory disease affecting certain parts of the eye.
The inflammation leads to reduced vision and/or the presence of floaters in the eye (black spots or thin lines moving across the visual field). Hyrimoz works by reducing this inflammation.
Hyrimoz is used for the treatment of:

• adults with non-infectious uveitis with inflammation affecting the back of the eye,
• children from 2 years of age with chronic non-infectious uveitis with inflammation affecting the front part of the eye.

You may first be given other medicines. If you do not respond satisfactorily to these medicines, you will be given Hyrimoz.

2. What you need to know before using Hyrimoz

Do not use Hyrimoz

• If you are allergic to adalimumab or to any of the other ingredients of this medicine (listed in section 6).
• If you have a serious infection, including tuberculosis, sepsis (blood poisoning), or other opportunistic infections (unusual infections associated with a weakened immune system). It is important to inform your doctor if you have signs or symptoms of infection, such as fever, wounds, feeling tired, or dental problems (see "Warnings and precautions").
• If you have moderate or severe heart failure. It is important to inform your doctor if you have had or currently have a serious heart condition (see "Warnings and precautions").

Warnings and precautions
Talk to your doctor or pharmacist before using Hyrimoz.
Allergic reaction

• If you experience allergic reactions with symptoms such as chest tightness, wheezing, dizziness, swelling, or rash, do not administer Hyrimoz again and contact your doctor immediately, as in rare cases these reactions may be life-threatening.

Infections

• If you have an infection, including long-term or localized infections (e.g., leg ulcers), consult your doctor before starting treatment with Hyrimoz. If you are unsure, contact your doctor.
• You may be more likely to get infections while being treated with Hyrimoz. This risk may increase if your lung function is reduced. These infections can be serious and may include tuberculosis, infections caused by viruses, fungi, parasites, or bacteria, or other unusual infectious organisms, and sepsis (septicaemia).
• In rare cases, these infections may be life-threatening. It is important to inform your doctor if you have symptoms such as fever, wounds, feeling tired, or dental problems. Your doctor may advise temporarily stopping Hyrimoz.

Tuberculosis (TB)

• Since cases of tuberculosis have occurred in patients treated with adalimumab, your doctor will check for signs or symptoms of tuberculosis before starting treatment with Hyrimoz. This will involve a detailed medical evaluation including your medical history and clinical examinations (e.g., a chest X-ray and tuberculin skin test). The performance and results of these tests must be recorded in the Patient Reminder Card. It is very important to inform your doctor if you have ever had tuberculosis or if you have been in close contact with someone who has tuberculosis. Tuberculosis may develop during treatment even if you have received preventive treatment for tuberculosis. Contact your doctor immediately if you develop symptoms of tuberculosis (persistent cough, weight loss, lack of energy, low-grade fever) or other infections during or after treatment.

Travel/recurrent infection

• Inform your doctor if you have lived in or traveled to areas where fungal infections such as histoplasmosis, coccidioidomycosis, or blastomycosis are common.
• Inform your doctor if you have had recurrent infections or if you have conditions that increase your risk of infection.

Hepatitis B virus (HBV)

• Inform your doctor if you are a carrier of hepatitis B virus (HBV), if you have an active hepatitis B infection, or if you think you may be at risk of contracting hepatitis B virus. Your doctor must test you for hepatitis B infection. Taking adalimumab may reactivate hepatitis B virus infection in people who are carriers of this virus. In rare cases, especially if the patient is also taking other medicines that suppress the immune system, reactivation of hepatitis B virus infection may be life-threatening.

Age over 65 years

• If you are over 65 years of age, you may be more susceptible to infections while taking Hyrimoz. You and your doctor should pay particular attention to signs of infection while you are being treated with Hyrimoz. It is important to inform your doctor if you develop symptoms of infection such as fever, wounds, feeling tired, or dental problems.

Surgery or dental procedures

• Before undergoing surgery or dental procedures, inform your doctor that you are taking Hyrimoz. Your doctor may advise temporarily stopping Hyrimoz.

Demyelinating disease

• If you have or develop demyelinating diseases (diseases affecting the protective covering around nerves), such as multiple sclerosis, your doctor will decide whether to start or continue treatment with Hyrimoz. Inform your doctor immediately if you experience symptoms such as changes in vision, weakness in arms or legs, or numbness or tingling in any part of your body.

Vaccination

• Certain vaccines contain live but weakened forms of bacteria or viruses that cause disease and must not be given during treatment with Hyrimoz, as they may cause infections. Consult your doctor before receiving any vaccinations. In children, it is recommended, if possible, to complete all age-appropriate vaccinations before starting treatment with Hyrimoz. If you have taken Hyrimoz during pregnancy, your baby may have an increased risk of infection for up to about 5 months after your last dose during pregnancy. It is important that you inform the paediatrician or other healthcare provider about your use of Hyrimoz during pregnancy so that they can determine when your baby should receive any vaccinations.

Heart failure

• It is important to inform your doctor about any past or current heart problems. If you have mild heart failure and are being treated with Hyrimoz, your doctor should carefully monitor your heart condition. If new symptoms of heart failure appear or existing symptoms worsen (e.g., shortness of breath or swelling of the feet), contact your doctor immediately.

Fever, bruising, bleeding, or paleness

• In some patients, the body may not be able to produce enough blood cells to fight infections or stop bleeding. If you have persistent fever, bruising, easy bleeding, or paleness, contact your doctor immediately. Your doctor may decide to stop treatment.

Tumours

• Very rare cases of certain types of tumours have been reported in children and adults treated with adalimumab or other anti-TNFα medicines. Patients with long-standing, severe rheumatoid arthritis may have a higher than average risk of developing lymphoma and leukaemia (cancers affecting blood cells and bone marrow). If you are taking Hyrimoz, your risk of developing lymphoma, leukaemia, or other tumours may increase. In rare cases, a specific and serious type of lymphoma has been observed in patients treated with adalimumab. Some of these patients were also taking azathioprine or mercaptopurine. Inform your doctor if you are taking azathioprine or mercaptopurine with Hyrimoz.
• In addition, cases of non-melanoma skin cancer have been observed in patients taking adalimumab. If you develop areas of damaged skin during or after treatment, or if the appearance of existing marks or damaged areas changes, inform your doctor.
• Cases of malignancies other than lymphoma have been reported in patients with a specific lung disease called chronic obstructive pulmonary disease (COPD) treated with another anti-TNFα medicine. If you have COPD or are a heavy smoker, you should discuss with your doctor whether treatment with an anti-TNFα medicine is appropriate.

Autoimmune diseases

• Rarely, treatment with Hyrimoz may lead to the development of a lupus-like syndrome. Inform your doctor if you develop symptoms such as an unexplained persistent rash, fever, joint pain, or fatigue.

Children and adolescents

• Vaccinations: if possible, children should have completed all recommended vaccinations before starting Hyrimoz.

Other medicines and Hyrimoz
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Hyrimoz may be taken with methotrexate and other disease-modifying antirheumatic drugs (sulfasalazine, hydroxychloroquine, leflunomide, and parenteral gold salts), corticosteroids, or analgesics, including non-steroidal anti-inflammatory drugs (NSAIDs).
Hyrimoz must not be taken together with medicines containing the active substances anakinra or abatacept due to an increased risk of serious infections. The combination of adalimumab with other anti-TNF medicines and anakinra or abatacept is not recommended due to the possible increased risk of infections, including serious infections, and other potential pharmacological interactions. If you have any doubts, consult your doctor.

Pregnancy and breastfeeding

• You should use an appropriate contraceptive method to prevent pregnancy and continue using it for at least 5 months after your last dose of Hyrimoz.
• If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, consult your doctor about taking this medicine.
• Hyrimoz should be used during pregnancy only if necessary.
• According to a pregnancy study, no increased risk of birth defects was observed in babies whose mothers received adalimumab during pregnancy compared to mothers with the same condition who did not receive adalimumab.
• Hyrimoz may be used during breastfeeding.
• If you take Hyrimoz during pregnancy, your baby may have an increased risk of infection.
• It is important that you inform the paediatrician or other healthcare provider about your use of Hyrimoz during pregnancy before your baby receives any vaccinations (for more information on vaccines, see section "Warnings and precautions").

Driving and using machines
Hyrimoz may have a minor influence on your ability to drive, ride a bicycle, or use machines. After taking Hyrimoz, you may experience vision disturbances or a sensation that your surroundings are spinning (dizziness).

Hyrimoz contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per 0.8 mL dose, i.e., essentially 'sodium-free'.

3. How to use Hyrimoz

Use this medicine exactly as instructed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
The recommended doses of Hyrimoz for each approved indication are listed in the following
table. Your doctor may prescribe a different concentration of Hyrimoz if the child requires a different dose.

Method and route of administration
Hyrimoz is administered by subcutaneous injection (by injection under the skin).
Detailed instructions on how to inject Hyrimoz are provided in section 7, “Instructions for use”.

If you use more Hyrimoz than you should
If you accidentally inject Hyrimoz more frequently than you should, contact your doctor or pharmacist and inform them that you have taken more medicine than intended. Always keep the medicine carton, even if empty.

If you forget to use Hyrimoz
If you forget to give an injection, administer the next dose of Hyrimoz as soon as you remember. After that, resume your regular dosing schedule as prescribed.

If you stop using Hyrimoz
The decision to stop using Hyrimoz should be discussed with your doctor. Symptoms may return after stopping treatment.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Most side effects are mild to moderate in severity. However, some may be serious and require treatment. Side effects may occur up to 4 months or more after the last injection of Hyrimoz.

Seek immediate medical advice if you notice any of the following signs of an allergic reaction or heart failure:

• severe rash, hives;
• swelling of the face, hands, or feet;
• difficulty breathing, difficulty swallowing;
• shortness of breath during physical activity or when lying down, or swollen feet.

Inform your doctor as soon as possible if you notice any of the following reactions:

• signs and symptoms of infection such as fever, feeling unwell, wounds, dental problems, burning when urinating; fatigue or weakness; or cough;
• symptoms of nerve problems such as tingling, numbness, double vision, or weakness in the arms or legs;
• signs of skin cancer such as a swelling or open sore that does not heal;
• signs and symptoms suggesting disorders of the blood-forming system, such as persistent fever, bruising, bleeding, or paleness.

The following side effects have been observed with Hyrimoz:

Very common (may affect more than 1 in 10 people)

• injection site reactions (including pain, swelling, redness, or itching);
• respiratory tract infections (including cold, runny nose, sinusitis, and pneumonia);
• headache;
• abdominal pain (stomach pain);
• nausea and vomiting;
• rash;
• muscle pain.

Common (may affect up to 1 in 10 people)

• serious infections (including sepsis and influenza);
• intestinal infections (including gastroenteritis);
• skin infections (including cellulitis and herpes zoster infection);
• ear infections;
• mouth infections (including dental infections and herpes simplex);
• reproductive system infections;
• urinary tract infections;
• fungal infections;
• joint infections;
• benign tumours;
• skin cancer;
• allergic reactions (including seasonal allergies);
• dehydration;
• mood changes (including depression);
• anxiety;
• sleep disorders;
• sensory disturbances such as tingling, stabbing sensations, or numbness;
• migraine;
• symptoms of nerve root compression (including lower back pain and leg pain);
• visual disturbances;
• eye inflammation;
• eyelid inflammation and eye swelling;
• dizziness (sensation of spinning);
• sensation of rapid heartbeat;
• high blood pressure;
• hot flushes;
• haematoma (solid swelling with clotted blood);
• cough;
• asthma;
• shortness of breath;
• gastrointestinal bleeding;
• dyspepsia (indigestion, bloating, heartburn);
• acid reflux disorder;
• dry syndrome (including dry eyes and dry mouth);
• itching;
• itchy rash;
• bruising;
• skin inflammation (such as eczema);
• breaking of fingernails and toenails;
• increased sweating;
• hair loss;
• onset or worsening of psoriasis;
• muscle spasms;
• blood in the urine;
• kidney problems;
• chest pain;
• oedema (fluid accumulation in the body, causing swelling of affected tissues);
• fever;
• reduced platelet count in the blood, increasing the risk of bleeding or bruising;
• poor wound healing.

Uncommon (may affect up to 1 in 100 people)

• unusual infections (including tuberculosis and other infections) that occur when immune defences are reduced;
• neurological infections (including viral meningitis);
• eye infections;
• bacterial infections;
• diverticulitis (inflammation and infection of the large intestine);
• tumours, including tumours of the lymphatic system (lymphoma) and melanoma (a type of skin cancer);
• immune system disorders that may affect lungs, skin, and lymph nodes (most commonly a condition called sarcoidosis);
• vasculitis (inflammation of blood vessels);
• tremor (shakiness);
• neuropathy (nerve damage);
• stroke;
• hearing loss, ringing in the ears;
• sensation of irregular heartbeat such as palpitations;
• heart problems that may cause shortness of breath or swelling of the ankles;
• acute myocardial infarction;
• formation of a sac in the wall of a major artery, blood clot in a vein, blockage of a blood vessel;
• lung disease causing shortness of breath (including inflammation);
• pulmonary embolism (blockage of a pulmonary artery);
• pleural effusion (abnormal accumulation of fluid in the pleural space);
• inflammation of the pancreas causing severe abdominal and back pain;
• difficulty swallowing;
• facial oedema (swelling);
• gallbladder inflammation, gallstones;
• fatty liver (accumulation of fat in liver cells);
• night sweats;
• scarring;
• abnormal muscle breakdown;
• systemic lupus erythematosus (an immune system disorder, including inflammation of the skin, heart, lungs, joints, and other organs);
• interrupted sleep;
• impotence;
• inflammations.

Rare (may affect up to 1 in 1,000 people)

• leukaemia (a cancer affecting blood and bone marrow);
• severe allergic reaction with shock;
• multiple sclerosis;
• neurological disorders (such as optic neuritis in the eye and Guillain-Barré syndrome, a condition that may cause muscle weakness, unusual sensations, tingling in arms and upper body);
• cardiac arrest;
• pulmonary fibrosis (scarring of the lungs);
• intestinal perforation (a hole in the intestinal wall);
• hepatitis (inflammation of the liver);
• reactivation of hepatitis B infection;
• autoimmune hepatitis (liver inflammation caused by the body’s own immune system);
• cutaneous vasculitis (inflammation of blood vessels in the skin);
• Stevens-Johnson syndrome (a life-threatening reaction with flu-like symptoms and blistering rash);
• facial oedema (swelling) associated with allergic reactions;
• erythema multiforme (inflammatory skin rash);
• lupus-like syndrome;
• angioedema (localized swelling of the skin);
• lichenoid skin reaction (itchy, red-purple rash).

Not known (frequency cannot be estimated from the available data)

• hepatosplenic T-cell lymphoma (a rare and often fatal blood cancer);
• Merkel cell carcinoma (a type of skin cancer);
• Kaposi’s sarcoma, a rare form of cancer associated with human herpesvirus 8 infection. Kaposi’s sarcoma most commonly presents with purple lesions on the skin;
• liver failure;
• worsening of a condition called dermatomyositis (characterized by skin rash accompanied by muscle weakness);
• weight gain (in most patients, weight gain has been low).

Some of the side effects observed with adalimumab may be asymptomatic and may only be detected through blood tests. These include:

Very common (may affect more than 1 in 10 people)

• low white blood cell count;
• low red blood cell count;
• increased blood lipids;
• increased liver enzymes.

Common (may affect up to 1 in 10 people)

• increased white blood cell count;
• reduced platelet count;
• increased uric acid in the blood;
• changes in blood sodium levels;
• reduced blood calcium;
• reduced blood phosphorus;
• increased blood sugar;
• increased lactate dehydrogenase in the blood;
• presence of autoantibodies in the blood;
• reduced blood potassium.

Uncommon (may affect up to 1 in 100 people)

• elevated bilirubin levels in the blood (liver blood test).

Rare (may affect up to 1 in 1,000 people)

• low white blood cell, red blood cell, and platelet counts.

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Hyrimoz

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label/blister/box following the word "Exp".
Store in a refrigerator (2°C – 8°C). Do not freeze.
Keep the pre-filled pen in the outer packaging to protect the medicine from light.

Alternative storage conditions:
When necessary (e.g. when travelling), Hyrimoz may be stored at room temperature (up to 25°C) for a maximum of 42 days – ensure the medicine is protected from light. Once removed from the refrigerator for storage at room temperature, the pre-filled pen must be used within 42 days or discarded, even if it is subsequently returned to the refrigerator. You must record the date on which the pre-filled pen was first removed from the refrigerator and the date after which the pen must be discarded.

Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Hyrimoz contains

• The active substance is adalimumab. Each pre-filled pen contains 80 mg of adalimumab in 0.8 mL of solution.
• The excipients are adipic acid, mannitol (E 421), polysorbate 80 (E 433), hydrochloric acid (E 507), sodium hydroxide (E 524) and water for injections (see section 2 “Hyrimoz contains sodium”).

Description of the appearance of Hyrimoz and contents of the pack
Hyrimoz 80 mg solution for injection in pre-filled pen is supplied as 0.8 mL of solution, from clear to slightly opalescent, colourless or slightly yellowish.
Hyrimoz is supplied in a single-use pre-filled syringe assembled into a triangular-shaped pen with a transparent window and label. The syringe inside the pen is made of Type I glass with a 29-gauge stainless steel needle, an inner needle rubber cap (thermoplastic elastomer), and a rubber stopper, containing 0.8 mL of solution.
Pack sizes contain 1, 2 and 3 pre-filled pens of Hyrimoz.
Not all pack sizes may be marketed.
Hyrimoz is available in pre-filled syringe and pre-filled pen.

Marketing Authorisation Holder
Sandoz GmbH
Biochemiestr. 10
6250 Kundl
Austria

Manufacturer
Sandoz GmbH Schaftenau
Biochemiestr. 10
6336 Langkampfen
Austria
Novartis Pharmaceutical Manufacturing GmbH
Biochemiestrasse 10
6336 Langkampfen
Austria

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Sandoz nv/sa Sandoz Pharmaceuticals d.d filialas
Tél/Tel: +32 2 722 97 97 Tel: +370 5 2636 037

България Luxembourg/Luxemburg
Сандоз България КЧТ Sandoz nv/sa (Belgique/Belgien)
Тел.: +359 2 970 47 47 Tél/Tel.: +32 2 722 97 97

Česká republika Magyarország
Sandoz s.r.o. Sandoz Hungária Kft.
Tel: +420 225 775 111 Tel.: +36 1 430 2890

Danmark/Norge/Ísland/Sverige Malta
Sandoz A/S Sandoz Pharmaceuticals d.d.
Tlf./Sími/Tel: +45 63 95 10 00 Tel: +356 99644126

Deutschland Nederland
Hexal AG Sandoz B.V.
Tel: +49 8024 908 0 Tel: +31 36 52 41 600

Eesti Österreich
Sandoz d.d. Eesti filiaal Sandoz GmbH
Tel: +372 665 2400 Tel: +43 5338 2000

Ελλάδα Polska
SANDOZ HELLAS ΜΟΝΟΠΡΟΣΩΠΗ Α.Ε. Sandoz Polska Sp. z o.o.
Τηλ: +30 216 600 5000 Tel.: +48 22 209 70 00

España Portugal
Sandoz Farmacéutica, S.A. Sandoz Farmacêutica Lda.
Tel: +34 900 456 856 Tel: +351 21 000 86 00

France România
Sandoz SAS Sandoz Pharmaceuticals SRL
Tél: +33 1 49 64 48 00 Tel: +40 21 407 51 60

Hrvatska Slovenija
Sandoz farmacevtska družba d.d.
Sandoz d.o.o.
Tel: +386 1 580 29 02
Tel: +385 1 23 53 111

Ireland Slovenská republika
Rowex Ltd. Sandoz d.d. - organizačná zložka
Tel: +353 27 50077 Tel: +421 2 48 200 600

Italia Suomi/Finland
Sandoz S.p.A. Sandoz A/S
Tel: +39 02 96541 Puh/Tel: +358 10 6133 400

Κύπρος United Kingdom (Northern Ireland)
SANDOZ HELLAS ΜΟΝΟΠΡΟΣΩΠΗ Α.Ε. Sandoz GmbH
(Ελλάδα) Tel: +43 5338 2000
Τηλ: +30 216 600 5000

Latvija
Sandoz d.d. Latvia filiāle
Tel: +371 67 892 006

Other sources of information
More detailed information on this medicinal product is available on the European Medicines Agency website: https://www.ema.europa.eu .

7. Instructions for Use

To avoid possible infections and to ensure that you use Hyrimoz correctly, it is important that you
follow these instructions.
Make sure you read, understand, and follow these Instructions for Use before injecting Hyrimoz.
Your healthcare provider must show you how to properly prepare and inject Hyrimoz using the
Hyrimoz single-dose pre-filled pen before you use the medicine for the first time. If you have
any doubts, consult your healthcare provider.
Hyrimoz single-use pre-filled pen

Figure A: parts of the Hyrimoz pen
In Figure A, the pen is shown without the cap. Do not remove the cap until you are ready to
administer the injection.
It is important that you:

• do not use the pen if the outer packaging seal or the pen safety seal is broken;
• keep the pen in its sealed outer packaging until you are ready to use it;
• never leave the pen unattended where it could be tampered with by others;
• do not use the pen if it has been dropped, appears damaged, or has been dropped after removing the cap;
• inject Hyrimoz 15–30 minutes after removing it from the refrigerator for a more comfortable injection;
• dispose of the used pen immediately after use. Do not reuse the pen. See “4. Disposal of Used Pens” at the end of these Instructions for Use.

How should you store the pen?

• Store the pen in its packaging in the refrigerator at a temperature between 2°C and 8°C.
• When necessary, for example when traveling, Hyrimoz may be stored at room temperature (up to 25°C) for a maximum of 42 days—ensure the medicine is protected from light. Once removed from the refrigerator for storage at room temperature, the pre-filled pen must be used within 42 days or discarded, even if later returned to the refrigerator.
• You must record the date when the pre-filled pen is first removed from the refrigerator and the date after which it must be discarded.
• Keep the pen in its original packaging until you are ready to use it, to protect the medicine from light.
• Do not store the pen at extremely hot or cold temperatures.
• Do not freeze the pen.

Keep Hyrimoz and all medicines out of the reach of children.
What do you need for the injection?
Place the following items on a clean, flat surface.
The package contains:

• Hyrimoz pre-filled pen(s) (see Figure B). Each pen contains 80 mg/0.8 mL of adalimumab.

The pen package does not contain (see Figure B ):

• Alcohol swab.
• Cotton ball or gauze.
• Sharps disposal container. See “8. Disposal of Used Pens” at the end of these Instructions for Use.
• Adhesive bandage.

Figure B: items not included in the package
Before the injection
Preparing the pen

• For a more comfortable injection, remove the pen from the refrigerator approximately 15–30 minutes before

the injection so it can reach room temperature.

• Look through the viewing window. The solution should be colorless or slightly yellowish and from clear to slightly opalescent. Do not use the pen if you notice particles and/or changes in color. You may see small air bubbles. This is normal. If you have any doubts about the appearance of the solution, consult your pharmacist for assistance.
• Check the expiration date (Exp.) of the pen (see Figure C). Do not use the pen if the expiration date has passed.
• Do not use the pen if the safety seal is broken.

Consult your pharmacist if the pen fails
any of the checks listed above.

Figure C: safety checks before injection

1. Choosing the injection site:

• The recommended injection site is the
  front of the thighs.

You may also use the lower abdominal area,
but not within 5 cm around the navel (see Figure D).

• Always choose a different site each time you administer an injection.
• Do not inject the medicine into areas where the skin is tender, bruised, red, scaly, or hard. Avoid areas with scars or stretch marks. If you have psoriasis, Figure D: how to choose the injection site – DO NOT inject the medicine directly into areas with psoriasis plaques.

2. Cleaning the injection site:

• Wash your hands thoroughly with water and

soap.

• Using a circular motion, clean the injection site with an alcohol swab. Allow it to dry before administering the injection (see Figure E).
• Do not touch the cleaned area before the injection.

Figure E: How to clean the injection site

3. Removing the pen cap:

• Remove the cap only when you are ready to use the

pen.

• Twist the cap in the direction of the arrows (see Figure F).
• Once the cap is removed, discard it. Never attempt to reattach the cap.
• Use the pen within 5 minutes after removing the cap.
• You may notice a few drops of liquid coming out—this is normal. Figure F: How to remove the needle cap.

4. How to hold the pen:

• Hold the pen at a 90-degree angle to the injection site,
  clean (see Figure G ).

Correct Incorrect
Figure G: how to hold the pen
Injection
Read before administering the injection
During the injection, you will hear 2 clicks:
o The first click indicates that the injection has started.
o A moment later, a second click indicates that the injection is almost complete.
You must keep the pen firmly pressed against the skin until you see a green indicator fill the viewing window and stop moving.

5. Starting the injection:

• Press the pen firmly against the skin to

start the injection (see Figure H).

• The first click indicates that the injection has started.
• Keep pressing the pen firmly against the skin.
• The green indicator shows the progress of the injection.

Figure H: How to start the injection

6. Completing the injection:

• Pay attention to the second click, which indicates

that the injection is almost complete.

• Check that the green indicator has filled the viewing window and has stopped moving (see Figure I).
• You can now remove the pen.

Figure I: How to complete the injection
After the injection

7. Check that the green indicator

fills the viewing window (see Figure J ):

• This means that the medicine has been

administered. Contact your doctor if
the green indicator is not visible.

• You may notice a small amount of blood at the injection site. You may press a cotton ball or gauze pad against the injection site and hold it in place for 10 seconds. Do not rub the injection site. If needed, you may cover the injection site Figure J: how to check the green indicator with a small adhesive dressing.

8. Disposal of used pens:

• Dispose of the used pen in a sharps disposal
  
  container (puncture-resistant, closable container, see Figure K). For your safety and the safety of others, used pens must never be reused.

• Do not dispose of medicines via wastewater or household waste. Ask your doctor or pharmacist how to dispose of medicines you no longer use. This will help protect the environment. Unused medicine and waste derived from this medicine must be disposed of in accordance with local regulations.

Figure K: How to dispose of the used pen

If you have any questions, consult a doctor, pharmacist, or nurse familiar with
Hyrimoz.