Teriflunomide adamed

Package leaflet: Information for the patient

Teriflunomid Adamed, 14 mg, film-coated tablets
Teriflunomidum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Teriflunomid Adamed is and what it is used for
2. Important information before taking Teriflunomid Adamed
3. How to take Teriflunomid Adamed
4. Possible side effects
5. How to store Teriflunomid Adamed
6. Contents of the pack and other information

1. What Teriflunomid Adamed is and what it is used for
What Teriflunomid Adamed is
Teriflunomid Adamed contains the active substance teriflunomide, which is an immunomodulatory and immune-regulating agent that helps reduce the immune system's attack on the nervous system.
What Teriflunomid Adamed is used for
Teriflunomid Adamed is used to treat relapsing-remitting multiple sclerosis (MS) in adults and children and adolescents (aged 10 years and older).
What is multiple sclerosis
Multiple sclerosis is a chronic disease that attacks the central nervous system. The central nervous system consists of the brain and spinal cord. In multiple sclerosis, inflammation damages the protective covering (called myelin) around the nerves in the central nervous system. This process is called demyelination. It prevents nerves from functioning properly.
In relapsing-remitting multiple sclerosis, patients experience repeated attacks (relapses) of physical symptoms caused by improper nerve function. Symptoms vary between individuals but usually include:

• difficulty walking,
• vision problems,
• balance problems.

These symptoms may completely disappear after a relapse ends, but over time some problems may persist between relapses. This may lead to physical disability, making it difficult to perform daily activities.
How Teriflunomid Adamed works
Teriflunomid Adamed helps protect the central nervous system from the immune system by reducing the increase in certain white blood cells (lymphocytes). This reduces inflammation, which leads to nerve damage in multiple sclerosis.

2. Important information before taking Teriflunomid Adamed

Do not take Teriflunomid Adamed:

• if you are allergic to teriflunomide or any of the other ingredients of this medicine (listed in section 6);
• if you have ever had a severe skin rash, skin peeling, blisters, and/or mouth ulcers after taking teriflunomide or leflunomide;
• if you have severe liver function disorders;
• if you are pregnant, think you may be pregnant, or are breastfeeding;
• if you have a severe disease affecting the immune system, e.g. acquired immunodeficiency syndrome (AIDS);
• if you have any severe bone marrow disorders or have low numbers of red or white blood cells or low platelet count;
• if you have a severe infection;
• if you have severe kidney function disorders requiring dialysis;
• if you have very low levels of proteins in the blood (hypoproteinemia). If in doubt, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions
Before starting Teriflunomid Adamed, talk to your doctor or pharmacist if:

• you have liver function disorders and/or drink large amounts of alcohol; your doctor will order blood tests before and during treatment to check liver function. If your test results show liver function abnormalities, your doctor may discontinue Teriflunomid Adamed. See section 4.
• you have high blood pressure (hypertension), whether controlled with medication or not. Teriflunomid Adamed may increase blood pressure. Your doctor will check your blood pressure before starting treatment and will monitor it regularly thereafter. See section 4.
• you have an infection. Before you take Teriflunomid Adamed, your doctor will ensure you have adequate levels of white blood cells and platelets in your blood. Since Teriflunomid Adamed reduces the number of white blood cells, it may affect your ability to fight infections. Your doctor may perform a blood test to check your white blood cell count if an infection is suspected. During treatment with teriflunomide, herpes virus infections may occur, including cold sores or shingles. In some cases, serious complications have occurred. Immediately inform your doctor if you suspect any symptoms of a herpes virus infection. See section 4;
• you have severe skin reactions;
• you have respiratory symptoms;
• you have weakness, numbness, or pain in your hands and feet;
• you plan to receive a vaccination;
• you are taking leflunomide in combination with Teriflunomid Adamed;
• you are switching from another medicine to Teriflunomid Adamed or from Teriflunomid Adamed to another medicine;
• you are due to have a specific blood test (calcium level measurement). Results may be falsely low.

Respiratory reactions
Inform your doctor if you develop a cough of unknown origin or shortness of breath (dyspnea). Your doctor may order additional tests.
Children and adolescents
Teriflunomid Adamed is not intended for use in children under 10 years of age, as it has not been studied in patients with multiple sclerosis in this age group. The above warnings and precautions also apply to children. The following information is important for children and their caregivers:

• cases of pancreatitis have been observed in patients receiving teriflunomide. The doctor treating the child may order blood tests if pancreatitis is suspected.

Teriflunomid Adamed and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any you plan to take. This includes medicines obtained without a prescription.
In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

• leflunomide, methotrexate, and other medicines affecting the immune system (often called immunosuppressants or immunomodulators);
• rifampicin (a medicine used to treat tuberculosis and other infections);
• carbamazepine, phenobarbital, phenytoin, used to treat epilepsy;
• St. John’s wort (a herbal remedy for depression);
• repaglinide, pioglitazone, nateglinide, or rosiglitazone, medicines used to treat diabetes;
• daunorubicin, doxorubicin, paclitaxel, or topotecan, used to treat cancer;
• duloxetine, used to treat depression, urinary incontinence, or kidney disease in patients with diabetes;
• alosetron, used to treat severe diarrhoea;
• theophylline, used to treat asthma;
• tizanidine, a muscle relaxant;
• warfarin, an anticoagulant used to thin the blood (i.e. increase blood fluidity) to prevent clots;
• oral contraceptives (containing ethinylestradiol and levonorgestrel);
• cefaclor, benzylpenicillin (penicillin G), ciprofloxacin, used to treat infections;
• indometacin, ketoprofen used to treat inflammation or pain;
• furosemide, used to treat heart conditions;
• cimetidine, used to reduce gastric acid secretion;
• zidovudine, used to treat HIV infection;
• rosuvastatin, simvastatin, atorvastatin, pravastatin used to treat hypercholesterolemia (high blood cholesterol);
• sulfasalazine, used to treat inflammatory bowel disease and rheumatoid arthritis;
• cholestyramine, used in cases of high blood cholesterol or to relieve itching in liver disease;
• activated charcoal, used to reduce absorption of medicines or other substances.

Pregnancy and breastfeeding
Do not take Teriflunomid Adamed if you are pregnant or think you may be pregnant. In women who are pregnant or who become pregnant while taking Teriflunomid Adamed, there is an increased risk of congenital malformations in the child. Women of childbearing potential should not take this medicine without using effective contraceptive methods.
If a girl starts menstruating while taking Teriflunomid Adamed, inform the doctor, who will provide specialist advice on contraception and the potential risks in case of pregnancy.
If you plan to become pregnant after stopping Teriflunomid Adamed, inform your doctor, because before attempting pregnancy, it is essential to ensure that significant levels of this medicine are no longer present in the body. Elimination of the active substance may take up to 2 years. This period can be shortened to several weeks by taking appropriate medicines that accelerate the elimination of Teriflunomid Adamed from the body.
In both cases, blood testing must confirm that the active substance has been sufficiently removed from the body. Your doctor should confirm that the blood level of Teriflunomid Adamed is low enough to allow pregnancy.
Further information about laboratory tests can be obtained from your doctor.
If you suspect you became pregnant while taking Teriflunomid Adamed or within two years after stopping treatment, stop taking Teriflunomid Adamed and immediately contact your doctor to have a pregnancy test performed.
If the test confirms pregnancy, your doctor may recommend taking appropriate medicines to rapidly and adequately eliminate Teriflunomid Adamed from the body to reduce the risk to the child.
Contraception
Effective contraception must be used during and after treatment with Teriflunomid Adamed. Teriflunomide remains in the blood for a long time after stopping treatment. Effective contraception must continue after stopping treatment.

• This should be continued until the blood level of Teriflunomid Adamed is sufficiently low – as confirmed by your doctor.
• The choice of the most appropriate contraceptive method or the need to change it should be discussed with your doctor.

Do not take Teriflunomid Adamed while breastfeeding, as teriflunomide passes into human milk.
Driving and operating machinery
Teriflunomid Adamed may cause dizziness, which may impair concentration and reaction ability. In such cases, do not drive or operate machinery.
Teriflunomid Adamed contains lactose
Teriflunomid Adamed contains lactose (a type of sugar). If you have been previously diagnosed with intolerance to certain sugars, consult your doctor before taking this medicine.
Teriflunomid Adamed contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Teriflunomid Adamed

Treatment with Teriflunomid Adamed should be supervised by a physician experienced in the management of multiple sclerosis.
This medicine should always be used exactly as recommended by the physician. In case of doubt, consult your doctor.
Adults
The recommended dose is one 14 mg tablet per day.
Children and adolescents (aged 10 years and older)
The dose depends on body weight:

• Children with body weight greater than 40 kg: one 14 mg tablet per day.
• Children with body weight less than or equal to 40 kg: one 7 mg tablet per day. For these patients, other teriflunomide-containing medicines with a lower dose are available (7 mg tablets).

Children and adolescents who reach a stable body weight above 40 kg will be informed by the physician about changing the dose to one 14 mg tablet per day.
Route and method of administration
Teriflunomid Adamed is intended for oral use. Teriflunomid Adamed should be taken daily as a single dose at any time of the day. The tablet should be swallowed whole with water.
Teriflunomid Adamed may be taken with food or independently of meals.
Taking more Teriflunomid Adamed than recommended
If more Teriflunomid Adamed has been taken than recommended, contact your doctor immediately. Adverse effects similar to those described in section 4 below may occur.
Missing a dose of Teriflunomid Adamed
Do not take a double dose to make up for a missed dose. Take the next dose according to the prescribed schedule.
Stopping Teriflunomid Adamed treatment
Do not stop taking Teriflunomid Adamed or change the dose without first consulting your doctor.
If you have any further 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.
The following side effects may occur after taking this medicine.
Serious side effects
Some side effects may be serious or may become serious. If any of the following symptoms occur, contact your doctor immediately.
Common (may affect up to 1 in 10 patients):

• inflammation of the pancreas, which may cause symptoms such as abdominal pain, nausea or vomiting (frequency is common in children and adolescents and uncommon in adult patients).

Uncommon (may affect up to 1 in 100 patients):

• allergic reactions, which may include symptoms such as rash, hives, swelling of the lips, tongue or face, or sudden breathing difficulties;
• severe skin reactions, which may include symptoms such as skin rash, formation of blisters on the skin, fever or mouth ulcers;
• severe infections or sepsis (a potentially life-threatening type of infection), which may cause symptoms such as high fever, seizures, chills, reduced urine output or confusion;
• inflammation of the lungs, which may cause symptoms such as shortness of breath or persistent cough.

Frequency not known (frequency cannot be estimated from the available data):

• severe liver disease, which may cause yellowing of the skin or whites of the eyes, urine darker than usual, unexplained nausea, vomiting or abdominal pain.

Other side effects may occur with the following frequencies:
Very common (may affect more than 1 in 10 patients):

• headache;
• diarrhoea, nausea;
• increased AlAT activity observed in laboratory tests (increased activity of certain liver enzymes in blood);
• hair thinning.

Common (may affect up to 1 in 10 patients):

• flu, upper respiratory tract infection, urinary tract infection, bronchitis, sinusitis, sore throat and discomfort when swallowing, bladder inflammation, viral gastroenteritis, dental inflammation, laryngitis, fungal foot infection;
• herpes virus infections, including cold sores and shingles, with symptoms such as blisters, burning, itching, numbness or pain in the skin, usually on one side of the upper body or face, and other symptoms such as fever and fatigue;
• laboratory test results: decreased number of red blood cells (anaemia), changes in liver and white blood cell test results (see section 2), and increased activity of muscle enzyme (creatine phosphokinase);
• mild allergic reactions;
• feeling of anxiety;
• sensation of pricking, weakness, tingling, numbness or pain in the lower back or leg (sciatica); numbness, burning, tingling or pain in the hands and fingers (carpal tunnel syndrome);
• palpitations;
• increased blood pressure;
• nausea (vomiting), toothache, upper abdominal pain;
• rash, acne;
• tendon, joint, bone pain, muscle pain (musculoskeletal pain);
• need to urinate more often than usual;
• heavy menstrual periods;
• pain;
• lack of energy or feeling of weakness (asthenia);
• weight loss.

Uncommon (may affect up to 1 in 100 patients):

• decreased number of platelets (mild thrombocytopenia);
• increased sensation or sensitivity, especially of the skin; stabbing or pulsating pain along one or more nerves, nerve disorders of hands or feet (peripheral neuropathy);
• nail disorders, severe skin reactions;
• traumatic pain;
• psoriasis;
• inflammation of the mouth/lips;
• abnormal levels of fats (lipids) in the blood;
• inflammation of the colon (colitis).

Rare (may affect up to 1 in 1,000 patients):

• inflammation or damage to the liver.

Frequency not known (frequency cannot be estimated from the available data):

• pulmonary hypertension.

Children (aged 10 years and older) and adolescents
The side effects listed above also apply to children and adolescents. The following additional information is important for children, adolescents and their caregivers:
Common (may affect up to 1 in 10 patients):

• inflammation of the pancreas.

Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorisation holder.
By reporting side effects, you help provide more information on the safety of this medicine.

5. How to store Teriflunomid Adamed

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after: EXP.
The expiry date refers to the last day of the stated month.
No special storage conditions apply for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Teriflunomid Adamed contains

• The active substance is teriflunomide. Each coated tablet contains 14 mg of teriflunomide.
• Other ingredients are:
  Core: lactose monohydrate, corn starch, hydroxypropylcellulose, sodium hydroxide, microcrystalline cellulose, sodium carboxymethylstarch, colloidal anhydrous silica, magnesium stearate.
  Coating: hypromellose 2910, titanium dioxide (E 171), triacetin, talc, indigo carmine, aluminium lake (E 132).

What Teriflunomid Adamed looks like and contents of the pack
Teriflunomid Adamed coated tablets are pale blue, biconvex, pentagonal in shape, approximately 7.4 mm in length, with the imprint "14" on one side and smooth on the other side.
Teriflunomid Adamed is available in PVC/PCTFE/Aluminium blisters or Aluminium/PVC/OPA/Aluminium blisters, packed in a cardboard box containing 14, 28, 84 or 98 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
tel.: +48 22 732 77 00

Manufacturer
Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice
Pharmacare Premium Ltd.
HHF003 Hal Far Industrial Estate
Birzebbugia, BBG 3000
Malta
Genepharm S.A.
18th km Marathonos Ave
153 51 Pallini Attiki
Greece