Package leaflet: Information for the patient

Idacio 40 mg solution for injection in pre-filled syringe

adalimumab
Please read this leaflet carefully before you start using this medicine because 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 that you need to know before receiving Idacio and during treatment with Idacio. Keep this patient reminder card throughout your treatment and for 4 months after the last injection of Idacio (yours or your child's).
If you have any questions, ask 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 adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

What Idacio is and what it is used for
What you need to know before using Idacio
How to use Idacio
Possible side effects
How to store Idacio
Contents of the pack and other information

1. What Idacio is and what it is used for

Idacio contains the active substance adalimumab, a medicine that acts on your immune (defence) system.
Idacio 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 Idacio, adalimumab, is a monoclonal antibody. Monoclonal antibodies are proteins that bind to a specific target in the body.
The target of adalimumab is another protein called tumour necrosis factor (TNFα), which is present at higher concentrations in the inflammatory diseases listed above. By binding to TNFα, Idacio blocks its action and reduces inflammation in these diseases.

Rheumatoid arthritis
Rheumatoid arthritis is an inflammatory disease affecting the joints.
Idacio 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 Idacio to treat rheumatoid arthritis.
Idacio may also be used to treat severe, active and progressive rheumatoid arthritis that has not been previously treated with methotrexate.
Idacio can slow down the progression of joint cartilage and bone damage caused by the disease and improve physical function.
Idacio is generally used in combination with methotrexate. If your doctor considers methotrexate treatment inappropriate, Idacio may be given alone.

Polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis
Polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis are inflammatory diseases that usually occur during childhood.
Idacio 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. Patients may be given other disease-modifying drugs, such as methotrexate. If these drugs do not work satisfactorily, Idacio will be administered 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.
Idacio is used to treat these conditions in adults. 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 be given Idacio to reduce the signs and symptoms of the disease.

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

Plaque psoriasis in adults and children
Plaque psoriasis is an inflammatory condition causing red, scaly, thickened skin patches. 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 leading to increased production of skin cells.
Idacio is used to treat moderate to severe plaque psoriasis in adults. Idacio 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 or are not suitable.

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 lumps and abscesses (cysts) that may drain pus. It most commonly affects specific skin areas such as under the breasts, armpits, inner thighs, groin, and buttocks. Scarring may also develop in affected areas.
Idacio is used to treat hidradenitis suppurativa in adults and adolescents aged 12 years and older. Idacio can reduce the number of lumps and abscesses and the pain often associated with this disease.
You may initially receive other medicines. If these do not work satisfactorily, you will be given Idacio.

Crohn's disease in adults and children
Crohn's disease is an inflammation of the intestine.
Idacio 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 Idacio to reduce the typical signs and symptoms of Crohn's disease.

Ulcerative colitis in adults and children
Ulcerative colitis is an inflammatory disease of the large intestine (colon).
Idacio is used to treat ulcerative colitis in adults and children aged 6 to 17 years. If you have ulcerative colitis, you may initially take other medications. If these drugs do not work satisfactorily, you will be given Idacio 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 may lead to reduced vision and/or the presence of floaters in the eye (black spots or thin lines moving across the visual field). Idacio works by reducing this inflammation.
Idacio 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 Idacio

Do not use Idacio

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 infection), 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 Idacio.

Allergic reactions

If you experience allergic reactions with symptoms such as chest tightness, wheezing, dizziness, swelling, or skin rash, do not administer Idacio 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 Idacio. If you are unsure, contact your doctor.
You may be more likely to get infections while being treated with Idacio. This risk may increase if your lung function is reduced. These infections can be more severe and may include tuberculosis, viral, fungal, parasitic, or bacterial infections, or other unusual systemic infections and sepsis (blood infection). In rare cases, these infections may be life-threatening. It is important to inform your doctor if you experience symptoms such as fever, ulcers, feeling tired, or dental problems. Your doctor may recommend temporarily stopping Idacio.

Tuberculosis

Cases of tuberculosis have occurred in patients treated with adalimumab. Your doctor must check for signs or symptoms of tuberculosis before starting treatment with Idacio. This will include a detailed medical evaluation, including your medical history and appropriate clinical tests (e.g., 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 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/infections endemic in certain areas

Consult your doctor if you have lived in or traveled to regions where fungal infections such as histoplasmosis, coccidioidomycosis, or blastomycosis are common.
Consult your doctor if you have recurrent infections or 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 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 cause reactivation of hepatitis B virus in carriers of this virus. In 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 Idacio. You and your doctor should pay particular attention to signs of infection during treatment. It is important to inform your doctor if you develop symptoms of infection such as fever, ulcers, feeling tired, or dental problems.

Surgery or dental procedures

If you are scheduled for surgery or dental procedures, inform your doctor that you are taking Idacio. Your doctor may recommend temporarily stopping the medication.

Demyelinating diseases

If you have or develop demyelinating diseases (a disease affecting the protective covering of nerves, such as multiple sclerosis), your doctor will decide whether to start or continue treatment with Idacio. 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.

Vaccines

Certain vaccines contain live viruses or weakened forms of bacteria that cause disease and therefore should not be given during treatment with Idacio, especially if you have an infection. Consult your doctor before receiving any vaccinations. In children, it is recommended, if possible, to complete the age-appropriate vaccination schedule before starting Idacio therapy. If you have taken Idacio 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 Idacio 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 Idacio, your doctor should carefully evaluate and monitor your 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 pale appearance

In some patients, the body may not be able to produce enough blood cells to help 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-TNF medicines. Patients with severe, long-standing rheumatoid arthritis may have a higher than average risk of developing lymphoma or leukemia (a tumor affecting blood cells and bone marrow). If you are taking Idacio, your 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 your doctor if you are taking azathioprine or mercaptopurine with Idacio.
In addition, cases of non-melanoma skin cancer have been observed in patients taking adalimumab. If new skin lesions appear during or after treatment, or if the appearance of existing lesions changes, inform your doctor.
Cases of tumors other than lymphoma have been reported in patients with a specific lung disease called chronic obstructive pulmonary disease (COPD) treated with another anti-TNF medicine. If you have COPD or are a heavy smoker, discuss with your doctor whether treatment with an anti-TNF medicine is appropriate.
Rarely, treatment with Idacio may cause 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 Idacio.
Do not administer Idacio to children with polyarticular juvenile idiopathic arthritis under 2 years of age.
Do not use the 40 mg pre-filled syringe or the 40 mg pre-filled pen if different doses from 40 mg are recommended.

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

Pregnancy and breastfeeding
If you suspect you are pregnant or are planning a pregnancy, consult your doctor or pharmacist before taking this medicine.
It is recommended to avoid pregnancy and to use adequate contraception during treatment with Idacio and for at least 5 months after the last injection of Idacio. If you become pregnant, contact your doctor.
Idacio should be used during pregnancy only if necessary.
According to a study conducted in pregnant women, 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.
Idacio may be used during breastfeeding.
If you take Idacio 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 Idacio during pregnancy before your baby receives any vaccinations (for more information on vaccinations, see the section on vaccinations).

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

Idacio 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 Idacio

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Idacio is injected under the skin (subcutaneous use). Patients who require a dose lower than
40 mg should use the Idacio vial presentation containing 40 mg.
The recommended dose of Idacio for each of the approved indications is shown in the following
table.

Rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or non-radiographic axial spondyloarthritis
Age or body weight	How much and how often should you take it?	Notes
Adults	40 mg every other week	In rheumatoid arthritis, methotrexate is continued during treatment with Idacio. If your doctor decides that methotrexate is not appropriate, Idacio may be given alone. If you have rheumatoid arthritis and are not receiving methotrexate in combination with Idacio, your doctor may decide to prescribe 40 mg of adalimumab weekly or 80 mg every other week.
Polyarticular juvenile idiopathic arthritis
Age or body weight	How much and how often should you take it?	Notes
Children, adolescents and adults aged 2 years and older with body weight equal to or greater than 30 kg	40 mg every other week	Not applicable
Children and adolescents aged 2 years and older with body weight between 10 kg and less than 30 kg	20 mg every other week	Not applicable
Enthesitis-related arthritis
Age or body weight	How much and how often should you take it?	Notes
Children, adolescents and adults aged 6 years and older with body weight equal to or greater than 30 kg	40 mg every other week	Not applicable
Children and adolescents aged 6 years and older with body weight between 15 kg and less than 30 kg	20 mg every other week	Not applicable
Plaque psoriasis
Age or body weight	How much and how often should you take it?	Notes
Adults	Initial dose of 80 mg (via two 40 mg injections on the same day), followed by 40 mg every other week starting the week after the initial dose.	If this dose does not work satisfactorily enough, your doctor may increase the dosage to 40 mg weekly or 80 mg every other week.
	You must continue treatment with Idacio for the duration prescribed by your doctor.
Children and adolescents aged 4 to 17 years with body weight equal to or greater than 30 kg	Initial dose of 40 mg, followed by 40 mg the following week. Subsequently, the usual dose is 40 mg every other week.	Not applicable
Children and adolescents aged 4 to 17 years with body weight between 15 kg and less than 30 kg	Initial dose of 20 mg, followed by 20 mg the following week. Subsequently, the usual dose is 20 mg every other week.	Not applicable
Suppurativa hidradenitis
Age or body weight	How much and how often should you take it?	Notes
Adults	Initial dose of 160 mg (via four 40 mg injections on the same day or two 40 mg injections per day for two consecutive days), followed by 80 mg (via two 40 mg injections on the same day) two weeks later. After another two weeks, continue with 40 mg weekly or 80 mg every other week, as prescribed by your doctor.	It is recommended to use an antiseptic wash solution daily on affected areas.
Adolescents aged 12 to 17 years with body weight equal to or greater than 30 kg	Initial dose of 80 mg (via two 40 mg injections on the same day), followed by 40 mg every other week starting one week after the initial dose.	If this dose does not work satisfactorily enough, your doctor may increase the dosage to 40 mg weekly or 80 mg every other week. It is recommended to use an antiseptic wash solution daily on affected areas.
Crohn’s disease
Age or body weight	How much and how often should you take it?	Notes
Children, adolescents and adults aged 6 years and older with body weight equal to or greater than 40 kg	Initial dose of 80 mg (via two 40 mg injections on the same day), followed by 40 mg after two weeks. If a more rapid response is needed, your doctor may prescribe an initial dose of 160 mg (via four 40 mg injections on the same day or two 40 mg injections per day for two consecutive days), followed by 80 mg (via two 40 mg injections on the same day) after two weeks. Subsequently, the usual dose is 40 mg every other week.	If this dose does not work satisfactorily enough, your doctor may increase the dosage to 40 mg weekly or 80 mg every other week.
Children and adolescents aged 6 to 17 years with body weight less than 40 kg	Initial dose of 40 mg followed by 20 mg after two weeks. If a more rapid response is needed, your doctor may prescribe an initial dose of 80 mg (via two 40 mg injections on the same day), followed by 40 mg after two weeks. Subsequently, the usual dose is 20 mg every other week.	If this dose does not work satisfactorily enough, your doctor may increase the frequency to 20 mg weekly.
Ulcerative colitis
Age or body weight	How much and how often should you take it?	Notes
Adults	Initial dose of 160 mg (via four 40 mg injections on the same day or two 40 mg injections per day for two consecutive days), followed by 80 mg (via two 40 mg injections on the same day) two weeks later. Subsequently, the usual dose is 40 mg every other week.	If this dose does not work satisfactorily enough, your doctor may increase the dosage to 40 mg weekly or 80 mg every other week.
Children and adolescents aged 6 to 17 years with body weight equal to or greater than 40 kg	An initial dose of 160 mg (via four 40 mg injections on the same day or two 40 mg injections per day for two consecutive days), followed by 80 mg (via two	Patients who turn 18 years old while receiving 80 mg every other week should continue the prescribed dose.
	injections of 40 mg on the same day) after two weeks. Subsequently, the usual dose is 80 mg every other week.
Children and adolescents aged 6 to 17 years with body weight less than 40 kg	An initial dose of 80 mg (via two 40 mg injections on the same day), followed by 40 mg (via one 40 mg injection) after two weeks. Subsequently, the usual dose is 40 mg every other week.	Patients who turn 18 years old while receiving 40 mg every other week should continue the prescribed dose.
Non-infectious uveitis
Age or body weight	How much and how often should you take it?	Notes
Adults	Initial dose of 80 mg (via two 40 mg injections), followed by 40 mg every other week starting one week after the initial dose. You must continue injecting Idacio for as long as your doctor prescribes.	Corticosteroids or other immunosuppressive medications may be continued during treatment with Idacio. Idacio may be administered as monotherapy.
Children and adolescents aged 2 years and older with body weight less than 30 kg	20 mg every other week	Your doctor may also prescribe an initial dose of 40 mg, which can be administered one week before starting the usual dose. Concomitant use of Idacio with methotrexate is recommended.
Children and adolescents aged 2 years and older with body weight equal to or greater than 30 kg	40 mg every other week	Your doctor may also prescribe an initial dose of 80 mg, which can be administered one week before starting the usual dose. Concomitant use of Idacio with methotrexate is recommended.

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

If you use more Idacio than you should
If you accidentally inject Idacio more frequently than prescribed by your doctor or pharmacist, contact your doctor or pharmacist and inform them that you have taken more medicine than required.
Always keep the medicine carton, even if it is empty.

If you forget to use Idacio
If you forget to give an injection, administer the next dose of Idacio as soon as you remember.
After that, resume your regular dosing schedule according to the prescribed regimen, as if you had not missed a dose.

If you stop using Idacio
The decision to stop using Idacio 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 side effects are mild to moderate in severity. However, some may be serious and require treatment.
Side effects may occur up to 4 months after the last injection of Idacio.

Contact your doctor immediately if you notice any symptoms of an allergic reaction or heart failure such as:

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, ulcers, dental problems, burning during urination, fatigue, weakness, or cough;
symptoms of nerve problems such as tingling, double vision, weakness in the arms or legs;
signs of skin tumours such as lumps or sores that do not heal;
signs and symptoms suggesting disorders of the haematopoietic 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)

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 tumours;
skin tumours;
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;
haematoma (a 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 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 occurring when immune defences are reduced);
neurological infections (including viral meningitis);
eye infections;
bacterial infections;
diverticulitis (inflammation and infection of the large intestine);
tumours, including those affecting 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;
double vision;
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, blood vessel blockage;
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);
pancreatitis (inflammation of the pancreas) causing severe abdominal and back pain;
difficulty swallowing;
facial oedema (swelling);
gallbladder inflammation, gallstones;
fatty liver (fat accumulation in liver cells);
night sweats;
scarring;
abnormal muscle breakdown;
systemic lupus erythematosus (an autoimmune disease including inflammation of the skin, heart, lungs, joints, and other organs);
interrupted sleep;
impotence;
inflammation.

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 and Guillain-Barré syndrome, a condition that may cause muscle weakness, abnormal sensations, tingling in arms and upper body);
cardiac arrest;
pulmonary fibrosis (lung scarring);
intestinal perforation (a hole in the intestinal wall);
hepatitis (liver inflammation);
reactivation of hepatitis B;
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 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 blood uric acid;
altered blood sodium;
decreased blood calcium;
decreased blood phosphorus;
increased blood glucose;
increased lactate dehydrogenase in blood;
presence of autoantibodies in blood;
decreased blood potassium.

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, 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 Idacio

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label/box after the word
Exp. The expiry date refers to the last day of that month.
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), a single pre-filled syringe of Idacio may be
stored at room temperature (up to 25°C) for a maximum of 28 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 28 days or discarded, even
if it is returned to the refrigerator.
You must record the date when the 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 doctor or pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Idacio contains

The active substance is adalimumab. Each pre-filled syringe contains 40 mg of adalimumab in 0.8 ml of solution.
The other components are monobasic sodium phosphate dihydrate, dibasic sodium phosphate dihydrate, mannitol, sodium chloride, citric acid monohydrate, sodium citrate, polysorbate 80, sodium hydroxide and water for injections.

Description of the appearance of Idacio and contents of the pack
Idacio 40 mg solution for injection (injection) in pre-filled syringe is supplied as 0.8 ml of sterile, clear, colourless solution containing 40 mg of adalimumab.
The Idacio pre-filled syringe contains a glass pre-filled syringe with needle and finger guard protection. Each pack contains 2 or 6 pre-filled syringes and 2 or 6 alcohol swabs.
Idacio is available in vial, pre-filled syringe, and pre-filled pen.
Marketing Authorisation Holder
Fresenius Kabi Deutschland GmbH
Else-Kröner-Straße 1
61352 Bad Homburg v.d.Höhe
Germany
Manufacturer
Fresenius Kabi Austria GmbH
Hafnerstraße 36,
8055 Graz
Austria
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

Make sure to read, understand and follow these instructions for use before injecting Idacio. Your
doctor should show you how to properly prepare and inject Idacio using the pre-filled
syringe before using it for the first time. Contact your doctor if you have any questions.

Single-use syringe with needle and protective cap positioned diagonally on a neutral gray background


® Single-use prefilled syringe (adalimumab) for subcutaneous injection 40mg

Note: Images for illustrative purposes only
Read all instructions carefully before using Idacio in prefilled syringe.
Important information

Use Idacio in prefilled syringe only if a healthcare professional has properly trained you on how to use the prefilled syringe.
Idacio is a single-use prefilled syringe.
Idacio prefilled syringe has a transparent needle shield that covers the needle after the injection is completed.
Children under 12 years of age must not self-inject; the injection must be administered by a trained adult.
Keep Idacio prefilled syringe and the sharps disposal container out of reach and sight of children.
Do not shake. Shaking may damage the prefilled syringe and the medicine.
Do not use the Idacio prefilled syringe if the solution appears cloudy, has changed color, or contains particles or floccules. The solution must be clear and colorless.
Do not attempt to activate the transparent needle shield before injection.
Do not insert fingers into the opening of the transparent needle shield.
Do not use an Idacio prefilled syringe that has been frozen or left in direct light.
Do not use the Idacio prefilled syringe if it has been dropped or damaged, as the syringe may be broken even if the damage is not visible. Instead, use a new prefilled syringe.

Storage information

Store the prefilled syringe in its original packaging to protect it from light.
Store the prefilled syringe in the refrigerator between 2 °C and 8 °C.
If necessary, for example when travelling, a single prefilled syringe may be stored at room temperature for up to 28 days.

Become familiar with Idacio prefilled syringe
Before use
Transparent needle shield Plunger

Horizontal prefilled syringe of Idacio 40 mg with white label and transparent body with gray plunger on white background

Front view
Needle cap Syringe barrel filled with
liquid (inside)

Horizontal medical syringe with label showing EXP 10/2035 and Lot 123456 and gray plunger on white background

Back view
After use
Transparent needle shield Plunger

Transparent prefilled syringe with Idacio 40 mg mark and internal screw mechanism for the

Covered needle Needle shield spring
Step 1 Prepare for injection
Each Idacio prefilled syringe pack contains two or six syringes.
1.1 Prepare a clean surface, such as a table or flat surface, in a well-lit area.
1.2 You will also need (Figure A):

an alcohol swab (included in the pack)
a cotton ball or gauze, and
a sharps disposal container. Open the sharps disposal container so it is ready for use.

Gray container with white lid, three white balls, and a folded sheet of paper on neutral background

Figure A
1.3 Remove the pack from the refrigerator (Figure B).
1.4 Check the expiry date on the side of the pack (Figure B).
Warning: Do not use beyond the expiry date.

A hand moves a white box toward an open refrigerator with a gray arrow indicating movement toward the

Figure B
1.5 Caution: Do not grasp the syringe by the plunger or the needle cap. Doing so may damage the syringe or prematurely activate the transparent needle shield.
Remove the syringe from its original packaging:

place two fingers in the middle of the transparent needle shield
pull the syringe upward and out of the packaging (Figure C). Place it on a clean surface.

A hand lifts a prefilled syringe Idacio from a white plastic tray

Figure C
1.6 Return any remaining syringe(s) to their original packaging and store in the refrigerator (Figure D).
Refer to storage information for instructions on how to store unused syringe(s).

A hand holds a white box and an arrow indicates the positioning of the package into the

Figure D
1.7 Allow the syringe to warm to room temperature for 30 minutes to let the medicine warm up. Injecting cold medicine may be painful. (Figure E).

Circular clock with black graduated scale and the text '30 minutes' in the center on white and gray background indicating a time interval

Figure E
Warning: Do not warm the syringe in any other way, such as in a microwave, warm water, or direct sunlight.
Warning: Do not remove the needle cap to allow the syringe to reach room temperature.
Step 2 Wash your hands
2.1 Wash your hands thoroughly with soap and water (Figure F) and dry them.
Warning: Gloves do not replace the need to wash hands.

Figure F
Step 3 Check the prefilled syringe
3.1 Check the syringe to ensure that:

the syringe, transparent needle shield, and needle cap are not cracked or damaged (Figure G).

Schematic drawing of a prefilled syringe Idacio with a stylized eye above indicating the field of view via dashed lines

Figure G

the needle cap is securely attached (Figure H).

Horizontal prefilled syringe of Idacio 40 mg with white label indicating dosage of 40 mg in 0.8 ml on neutral background

Figure H

the needle shield spring is not extended (Figure I).

Comparison between two medical devices with a cross above the one on the left and a checkmark above the one on the right with widened base

Figure I
Warning: Do not use the syringe if any damage is observed.
If so, dispose of the syringe in a sharps disposal container and contact your healthcare professional or pharmacist.
3.2 Check the solution to ensure that:

the solution is clear, colorless, and free from particles (Figure J). Warning: Do not use the syringe if the solution contains particles, is cloudy, discolored, or contains floccules.

Close-up of an Idacio 40 mg injection pen with an eye symbol highlighting the lot number 123456 printed on the body

Figure J
3.3 Check the label to ensure that:

the name on the syringe reads Idacio (Figure K).
the expiry date on the syringe has not passed (Figure K).

Close-up detail of a single-use syringe of Idacio 40 mg in 0.8 ml with white label and black text on light background

Figure K
Warning: Do not use the syringe if:

the name on the syringe is not Idacio.
the expiry date on the syringe has passed.
If so, dispose of the syringe in a sharps disposal container and contact your healthcare professional or pharmacist.

Step 4 Choose the injection site
4.1 Choose an injection site (Figure L):

on the upper thigh.
on the abdomen (inject at least 5 cm away from the navel)

Stylized human body with circular gray areas on the

Figure L
4.2 Choose a different site (at least 2.5 cm away from the previous injection site) each time to reduce redness, irritation, or other skin problems.
Warning: Do not inject into areas that are tender, bruised, red, hard, scarred, or have stretch marks.
Warning: If you have psoriasis, do not inject into scaly, red, thick, raised lesions.
Step 5 Clean the injection site
Step 5 Clean the injection site
5.1 Clean the skin at the injection site by wiping with an alcohol swab (Figure M).
Warning: Do not blow on or touch the injection site after cleaning.

A hand gently applies an adhesive patch onto a smooth, light-colored skin surface

Figure M
Step 6 Administer the injection
Step 6 Administer the injection
6.1 Remove the needle cap

Always hold the syringe by the transparent needle shield.
Hold the syringe upright and pull the needle cap straight off (Figure N).

Two hands separating a protective cap from a syringe with needle and liquid, with an arrow indicating movement away from the

Figure N
You may see drops of liquid at the tip of the needle.

Discard the needle cap. Warning: Do not touch the needle.

6.2 Pinch the skin

Hold the syringe like a pen.
With the other hand, gently pinch the skin (without squeezing) to avoid injecting into muscle (Figure O).

Figure O
6.3 Insert the needle

With a quick, short motion, insert the needle fully into the skin at an angle of 45°–90° (Figure P).

A hand holding a syringe ready to inject into the skin with a

Figure P

After inserting the needle, keep the skin pinched.

6.4 Inject

Use your thumb to gently push the plunger all the way down (Figure Q).

A hand holding a prefilled syringe labeled Idacio for a

Figure Q

Give the plunger a final push to ensure the full dose has been injected (Figure R).
Hold the syringe firmly in place without moving it, maintaining the same angle (Figure R).

A hand holding a syringe-like medical device with a circular magnification showing the detail of the upper part of the device

Figure R
Do not remove the needle from the skin when the plunger reaches the end.
Slowly release your thumb upward.
This will allow the needle to move into its transparent shield, which will fully cover it (Figure S).

A hand holding a prefilled syringe of Idacio with a magnification showing the detail of the vial with 40 mg and 0.8 ml

Figure S
Warning: Contact your healthcare professional or pharmacist if:

you did not inject the full dose, or
the transparent needle shield does not activate after injection.
Warning: Do not reuse a syringe if the injection was partial. Do not attempt to recap the needle, as you may get pricked.

6.5 If there is blood or solution at the injection site, gently press a cotton ball or gauze (Figure T).

A hand holds a white cotton pad and gently presses it against a light, smooth skin surface

Figure T
Step 7 Dispose of the syringe
Step 7 Dispose of the syringe
7.1 After use, dispose of the used syringe in a sharps disposal container (Figure U).

A hand holds a medical device above a disposal container with a downward-pointing arrow indicating disposal

Figure U
Warning: Keep the sharps disposal container out of sight and reach of children.
Warning: Do not dispose of the syringe in household waste.
If you do not have a sharps disposal container, you may use a household waste container that:

is made of strong plastic;
can be closed with a tight-fitting, puncture-resistant lid; this will prevent needles from sticking out;
is upright and stable during use;
is leak-resistant;
is appropriately labeled to indicate the presence of hazardous waste inside the container.
7.2 When the sharps disposal container is nearly full, follow local guidelines for proper disposal of sharps disposal containers. Do not recycle the sharps disposal container.

Step 8 Record your injection
8.1 To help you remember when and where to give your next injection, keep a diary with injection dates and the injection site used (Figure V).

A hand holding a black pen above a white lined paper sheet on neutral background

Figure V

Patient Information Leaflet: Information for the patient

Idacio 40 mg solution for injection in pre-filled pen

adalimumab
Please read this leaflet carefully before starting to use this medicine because 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 receiving Idacio and during treatment with Idacio. Keep this patient reminder card throughout your treatment and for 4 months after your (or your child’s) last injection of Idacio.
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 adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet

What Idacio is and what it is used for
What you need to know before using Idacio
How to use Idacio
Possible side effects
How to store Idacio
Contents of the pack and other information

1. What Idacio is and what it is used for

Idacio contains the active substance adalimumab, a medicine that acts on your immune (defence) system.
Idacio 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.

Rheumatoid arthritis
Rheumatoid arthritis is an inflammatory disease affecting the joints.
Idacio 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 Idacio to treat rheumatoid arthritis.
Idacio may also be used for the treatment of severe, active and progressive rheumatoid arthritis without prior treatment with methotrexate.
Idacio can slow down the progression of joint cartilage and bone damage caused by the disease and improve physical function.
Idacio is generally used in combination with methotrexate. If your doctor considers methotrexate treatment inappropriate, Idacio may be given alone.

Polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis
Polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis are inflammatory diseases that typically occur during childhood.
Idacio 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. Patients may be given other disease-modifying drugs, such as methotrexate. If these medicines do not work satisfactorily, Idacio will be administered 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.
Idacio is used to treat these conditions in adults. If you have ankylosing spondylitis or non-radiographic axial spondyloarthritis, you will first be given other medicines. If these treatments do not work satisfactorily, Idacio will be administered to reduce the signs and symptoms of the disease.

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

Plaque psoriasis in adults and children
Plaque psoriasis is an inflammatory skin condition causing reddish, scaly and 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 believed to be caused by a problem with the body’s immune system leading to an increased production of skin cells.
Idacio is used to treat moderate to severe plaque psoriasis in adults. Idacio is also used to treat severe plaque psoriasis in children and adolescents aged 4 to 17 years when topical medicines and UV light therapy have not worked adequately or are not suitable.

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

Crohn’s disease in adults and children
Crohn’s disease is an inflammatory condition of the intestine.
Idacio 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 treatments, Idacio will be administered to reduce the typical signs and symptoms of Crohn’s disease.

Ulcerative colitis in adults and children
Ulcerative colitis is an inflammatory bowel disease affecting the large intestine (colon).
Idacio 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 initially be given other medicines. If these do not work satisfactorily, Idacio will be administered 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.
Inflammation may lead to reduced vision and/or the presence of floaters in the eye (black spots or fine lines moving across the visual field). Idacio works by reducing this inflammation.
Idacio 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 Idacio

Do not use Idacio

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 infection), 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, ulcers,
feeling of tiredness, 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 Idacio
Allergic reactions

If you experience allergic reactions with symptoms such as chest tightness, wheezing, dizziness, swelling, or skin rash, do not administer Idacio 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 Idacio. If you are in doubt, contact your doctor.
You may be more likely to get infections while being treated with Idacio. This risk may increase if your lung function is reduced. These infections can be more severe and may include tuberculosis, viral, fungal, parasitic, or bacterial infections, or other unusual systemic infections, as well as sepsis (blood infection). 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 of tiredness, or dental problems. Your doctor may advise temporarily stopping Idacio.

Tuberculosis

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 Idacio. This will involve a detailed medical evaluation including your medical history and appropriate 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 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/infections endemic in certain areas

Talk to your doctor if you have lived in or traveled to regions where fungal infections such as histoplasmosis, coccidioidomycosis, or blastomycosis are common.
Talk to 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 should test you for hepatitis B virus infection. Taking adalimumab

may cause reactivation of hepatitis B virus in individuals who are carriers of this
virus. In some rare cases, especially if the patient is also receiving treatment with 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 Idacio. You and your doctor should pay particular attention to signs of infection while you are being treated with Idacio. It is important to inform your doctor if you develop symptoms of infection such as fever, ulcers, feeling of tiredness, or dental problems.

Surgery or dental procedures

If you are scheduled for surgery or dental procedures, inform your doctor that you are taking Idacio. Your doctor may recommend temporarily stopping the medication.

Demyelinating diseases

If you have or develop demyelinating diseases (a disease affecting the insulating layer around nerves, such as multiple sclerosis), your doctor will decide whether or not to start or continue treatment with Idacio. Inform your doctor immediately if you experience symptoms such as vision changes, weakness in arms or legs, or numbness and tingling affecting any part of the body.

Vaccines

Certain vaccines contain live but weakened viruses or bacteria that cause disease and must not be administered during treatment with Idacio in case of infections. Consult your doctor before receiving any vaccinations. In children, it is recommended, if possible, to complete the age-appropriate vaccination schedule before starting Idacio therapy. If you have taken Idacio 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 pediatrician or other healthcare provider about your use of Idacio during pregnancy, so they can determine when the baby should receive any vaccinations.

Heart failure

It is important to inform your doctor about any past or current heart problems. In case of mild heart failure and concomitant treatment with Idacio, your doctor must carefully evaluate and monitor your heart function. 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 help fight infections or stop bleeding. If you have persistent fever, bruising, easy bleeding, or paleness, contact your doctor immediately. Your doctor may decide to discontinue the treatment.

Tumors

In children and adults treated with adalimumab or other anti-TNF medicines, certain types of cancer have very rarely occurred. Patients with long-standing, severe rheumatoid arthritis may have a higher than average risk of developing lymphoma or leukemia (a cancer affecting blood cells and bone marrow). If you are taking Idacio, your risk of developing lymphoma, leukemia, or other cancers may increase. In rare instances, 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 Idacio.
In addition, cases of skin cancer other than melanoma have been reported in patients taking adalimumab. If new skin lesions appear during or after treatment, or if the appearance of existing lesions changes, inform your doctor.
There have been reports of cancers other than lymphoma in patients with a specific type of lung disease called chronic obstructive pulmonary disease (COPD) treated with another anti-TNF medicine. If you have COPD or are a heavy smoker, you should discuss with your doctor whether treatment with an anti-TNF medicine is appropriate.
Rarely, treatment with Idacio 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 recommended vaccinations before starting Idacio.
Do not give Idacio to children under 2 years of age with polyarticular juvenile idiopathic arthritis.
Do not use the 40 mg pre-filled syringe or the 40 mg pre-filled pen if different dosages from 40 mg are recommended.

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

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.
You are advised to avoid pregnancy and must use an effective method of contraception during treatment with Idacio and for at least 5 months after the last injection of Idacio. If you become pregnant, contact your doctor.
Idacio should be used during pregnancy only if necessary.
According to a study conducted in pregnant women, no increased risk of birth defects was observed when the mother received adalimumab during pregnancy compared to mothers with the same condition who did not receive adalimumab.
Idacio may be used during breastfeeding.
If you take Idacio during pregnancy, the baby may have an increased risk of infection. It is important that you inform the pediatrician or other healthcare provider about your use of Idacio during pregnancy before the baby receives any vaccinations (for further information on vaccinations, see the section on vaccinations).

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

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