InfoCons Consumer Protection informs you – Teriflunomide Viatris – Package Leaflet

Before anything else

Read all of this leaflet carefully before you start 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 pharmacis t.
• This medicine has been prescrib ed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

ℹ️ 1. What Teriflunomide Viatris is and what it is used for

What Teriflunomide Viatris is Teriflunomide Viatris contains t he active substance teriflunomi de which is an immunomodulatory agent and adjusts the immune system to limit its attack on the nervou s system.

What Teriflunomide Viatris is used for Teriflunomide is used in adults and in children and adolescents (10 years of age and older) to treat relapsing remitting multiple sclerosis (MS).

What multiple sclerosis is MS is a long-term illness that affects the central nervous syst em (CNS). The CNS is made up of the brain and spinal cord. In multiple sclerosis, inflammation destroys t he protective sheath (called myelin) around the nerves in the CNS. This loss of myelin is called demyelinat ion. This stops nerves from working properly.

People with relapsing form of multiple sclerosis will have repe ated attacks (relapses) of physical symptoms caused by their nerves not working properly. These sym ptoms vary from patient to patient but usually involve:  difficulty walking  vision problems  balance problems.

Symptoms may disappear completel y after the relapse is over, bu t over time, some problems may remain between relapses. This can cau se physical disabilities that may interfere with your daily activities.

How Teriflunomide Viatris works

Teriflunomide Viatris helps to protect against attacks on the c entral nervous system by the immune system by limiting the increase of some white blood cells (lymphocytes ). This limits the inflammation that leads to nerve damage in MS.

⚠️ 2. What you need to know before you take Teriflunomide Viatris

Do not take Teriflunomide Viatris

• if you are allergic to teriflunomide or any of the other ingred ients of this medicine (listed in section 6)
• if you have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after taking teriflunomide or leflunomide
• if you have severe liver problems
• if you are pregnant, think you may be pregnant, or are breast-f eeding
• if you suffer from a serious pr oblem which affects your immune system e.g. acquired immunodeficiency syndrome (AIDS)
• if you have a serious problem w ith your bone marrow, or if you have low numbers of red or white cells in your blood or a reduced number of blood platelets
• if you are suffering from a serious infection
• if you have severe kidney problems which require dialysis
• if you have very low levels of proteins in your blood (hypoprot einaemia).

If you are not sure, talk to your doctor or pharmacist before t aking this medicine.

Warnings and precautions Talk to your doctor or pharmaci st before taking Teriflunomide V iatris if:

• you have liver problems, and/or if you drink large amounts of a lcohol. Your doctor will carry out blood tests before and during treatment to check how well your liver is working. If your test results show a problem with your liver, your doctor may stop your treat ment with Teriflunomide Viatris.

Please read section 4.

• you have high blood pr essure (hypertension) whether it is contr olled with medicines or not.

Teriflunomide Viatris can cause an increase in blood pressure. Your doctor will check your blood pressure before the start of treatment and regularly thereafter . Please read section 4.

• you have an infection. Before you take Teriflunomide Viatris, y our doctor will make sure you have enough white blood cells and platelets in your blood. As Terifl unomide Viatris decreases the number of white cells in the bl ood this may affect your ability to fight the infection. Your doctor may do blood tests to check your white blood cells if you think you have any infection. Herpes virus infections, including oral herpes or herpes zoster (shingles) m ay occur with teriflunomide treatment.

In some cases, serious complica tions have occurred. You should inform your doctor immediately if you suspect you have any symptoms of herpes virus infection. Pl ease read section 4.

• you have severe skin reactions
• you have respiratory symptoms
• you have weakness, numbness and pain in the hands and feet
• you are going to have a vaccination
• you take leflunomide with Teriflunomide Viatris
• you are switching to or from Teriflunomide Viatris
• you are due to have a specific blood test (calcium level). Fals ely low levels of calcium can be detected.

Respiratory reactions Tell your doctor if you have unexplained cough and dyspnoea (sh ortness of breath). Your doctor may perform additional tests.

Children and adolescents

Teriflunomide Viatris is not intended for use in children under 10 years of age, as it has not been studied in MS patients in this age group. The warnings and precautions liste d above also apply to childre n. The following information is important for children and their caregivers:

40 – inflammation of the pancreas has been observed in patients rece iving teriflunomide. Your child’s doctor may carry out blood tests if an inflammation to the panc reas is suspected.

Other medicines and Teriflunomide Viatris

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

This includes medicines obtained without a prescription.

In particular, tell your doctor or pharmacist if you are taking any of the following:

• leflunomide, methotrexa te and other medicines that affect the i mmune system (often called immunosuppressants or immunomodulators)
• rifampicin (a medicine used to t reat tuberculosis and other inf ections)
• carbamazepine, phenobarbital , phenytoin for epilepsy
• St John’s wort (a herbal medicine for depression)
• repaglinide, pioglitazone, nateg linide, or rosiglitazone for di abetes
• daunorubicin, doxorubicin, paclitaxel, or topotecan for cancer
• duloxetine for depression, urina ry incontinence or in kidney di sease in diabetics
• alosetron for the management of severe diarrhoea
• theophylline for asthma
• tizanidine, a muscle relaxant
• warfarin, an anticoagulant used to make the blood thinner (i.e. more fluid) in order to avoid blood clots
• oral contraceptives (containing ethinylestradiol and levonorges trel)
• cefaclor, benzylpenicillin (peni cillin G), ciprofloxacin for in fections
• indometacin, ketoprofen for pain or inflammation
• furosemide for heart disease
• cimetidine for reducing gastric acid
• zidovudine for HIV infection
• rosuvastatin, simvastatin, atorv astatin, pravastatin for hyperc holesterolemia (high cholesterol)
• sulfasalazine for inflammatory bowel disease or rheumatoid arth ritis
• cholestyramine for high cholesterol or relief from itching in l iver disease
• activated charcoal to reduce ab sorption of medicines or other s ubstances.

Pregnancy and breast-feeding Do not take Teriflunomide Viatris if you are, or think you may be pregnant . If you are pregnant or become pregnant while taking Teriflunomide Viatris the risk of having a baby with birth defects is increased. Women of childbearing potential must not take this m edicine without using reliable contraceptive measures. If your child/adolescent daughter reaches menses while taking t eriflunomide, you should inform the doctor, who will provide specialis t counselling regarding contr aception and the potential risks in case of pregnancy.

Tell your doctor if you plan to become pregnant after stopping treatment with Teriflunomide Viatris as you need to ensure that most of this medicine has left your bod y before trying to become pregnant. The elimination of the active substa nce may take up to 2 years to o ccur naturally. The time can be reduced to a few weeks by taking certain medic ines which speed up removal of Teriflunomide Viatris from your body.

In either case it should be confirmed by a blood test that the active substance has been sufficiently removed from your body and you need confirmation from your trea ting physician that the blood level of Teriflunomide Viatris is low enough to allow you to become pregnant.

For further information on the laboratory testing please contac t your doctor.

If you suspect that you are pregnant while taking Teriflunomide Viatris or in the two years after you have stopped treatment, you must discontinue Teriflunomide Viatris a nd contact your doctor immediately for a pregnancy test. If the test confirms that you are pregnant, you r doctor may suggest treatment with certain medicines to remove Teriflunomide Viatris rapidly and sufficien tly from your body, as this may decrease the risk to your baby.

Contraception You must use an effective met hod of contraception during and af ter treatment with Teriflunomide Viatris.

Teriflunomide remains in your b lood for a long time after you s top taking it. Continue to use effective contraception after you stop treatment.  Do this until the levels of Teriflunomide Viatris in your blood are low enough – your doctor will check this.  Talk with your doctor about th e best method of contraception fo r you and any potential need for contraception change.

Do not take Teriflunomide Viatris when you are breast-feeding, as teriflunomide passes into the b reast milk.

Driving and using machines

Teriflunomide Viatris might make you feel dizzy which may impair your ability to conc entrate and react.

If you are affected, do not drive or use machines.

Teriflunomide Viatris contains lactose

Teriflunomide Viatris contains lactose (a type of sugar). If yo u have been told by your doctor that you have an intolerance to some s ugars, contact your doctor before taking this medicine.

Teriflunomide Viatris contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tabl et, that is to say essentially ‘sodium- free’.

💊 3. How to take Teriflunomide Viatris

Treatment with Teriflunomide Viatris will be overseen by a doct or who is experienced in the treatment of multiple sclerosis. Always take this medicine exac tly as your doctor has told you. Check with your doctor if you are not sure.

Adults The recommended dose is one 14 mg teriflunomide tablet daily.

Children and adolescents (10 years of age and above) The dose depends on body weight: – Children with body weight greater than 40 kg: one 14 mg tablet daily.

• Children with body weight less th an or equal to 40 kg: one 7 mg tablet daily.

Teriflunomide 7 mg strength is not marketed by Viatris Limited but may be available from other Marketing Authorisation Holders.

Children and adolescents who reach a stable body weight above 4 0 kg will be instructe d by their doctor to switch to one 14 mg tablet daily. Route/method of administration Teriflunomide Viatris is for oral use. Teriflunomide Viatris is taken every day as a single dose at any time of the day.

You should swallow the tablet whole with some water.

Teriflunomide Viatris may be taken with or without food.

If you take more Teriflunomide Viatris than you should

42 If you have taken too much Teriflunomide Viatris, call your doc tor straight away. You may experience side effects similar to those described in section 4 below. If you forget to take Teriflunomide Viatris Do not take a double dose to make up for a forgotten tablet. Ta ke your next dose at the scheduled time.

If you stop taking Teriflunomide Viatris

Do not stop taking Teriflunomide Viatris or change your dose without talking to your doctor first.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

❗ 4. Possible side effects

Like all medicines, this medicine can cause side effects, altho ugh not everybody gets them.

The following side effects may happen with this medicine.

Serious side effects Some side effects could be or could become serious, if you expe rience any of these, tell your doctor immediately:

Common (may affect up to 1 in 10 people)

• Inflammation of the pancreas which might include symptoms of pa in in the abdominal area, nausea, or vomiting (the frequency is co mmon in paediatric patients and uncommon in adult patients).

Uncommon (may affect up to 1 in 100 people)

• Allergic reactions which might include symptoms of rash, hives, swelling of lips, tongue or face or sudden difficulty breathing.
• Severe skin reactions which might include symptoms of skin rash , blistering, fever or ulcers in your mouth.
• Severe infections or sepsis (a potentially life-threatening typ e of infection) which might include symptoms of high fever, shaking , chills, reduced urine flow, or confusion.
• Inflammation of the lungs which m ight include symptoms of short ness of breath or persistent cough.

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

• Serious liver disease which might include symptoms of yellowing of your skin or the whites of your eyes, darker urine than normal , unexplained nausea and vomiting , or abdominal pain.

Other side effects can occur with the following frequencies

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

• Headache
• Diarrhoea, feeling sick
• Increase in ALT (increase in blood levels of certain hepatic en zymes) shown in tests
• Hair thinning.

Common (may affect up to 1 in 10 people)

• Influenza, upper respiratory tract infection, urinary tract inf ection, bronchitis, sinusitis, sore throat and discomfort when swallowing, cystitis, gastroenteritis viral , tooth infection, laryngitis, fungal infection of the foot 43 ‐ Herpes virus infections, including oral herpes and herpes zoste r (shingles) with symptoms such as blisters, burning, itc hing, numbness or pain of the skin, typic ally on one side of the upper body or face, and other symptoms, like fever and weakness
• Laboratory values: a decrease in the number of red blood cells (anaemia), changes in liver and white blood cell test results (see section 2), as well as elevations in a muscle enzyme (creatine phosphokinase) have been observed
• Mild allergic reactions
• Feeling anxious
• Pins and needles, feeling weak, numb, tingling or pain in the l ower back or leg (sciatica); feeling numb, burning, tingling or pain in the hands and fingers (carpa l tunnel syndrome)
• Feeling your heartbeat
• Increase in blood pressure
• Being sick (vomiting), toothache, upper abdominal pain
• Rash, acne
• Pain of the tendons, joints, bones, muscle pain (musculoskeleta l pain)
• Needing to urinate more often than usual
• Heavy periods
• Pain
• Lack of energy or feeling weak (asthenia)
• Weight loss.

Uncommon (may affect up to 1 in 100 people)

• Decrease in the number of blood platelets (mild thrombocytopeni a)
• Increased feeling or sensitivity , especially in the skin; stabb ing or throbbing pain along one or more nerves, problems in the nerves of the arms or legs (peripheral neuropathy)
• Nail disorders, severe skin reactions
• Post-traumatic pain
• Psoriasis
• Inflammation of mouth/lips
• Abnormal levels of fats (lipids) in the blood
• Inflammation of the colon (colitis).

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

• Inflammation or injury of the liver.

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

• Respiratory hypertension.

Children (10 years of age and above) and adolescents The side effects listed above als o apply to children and adoles cents. The following additional information is important for children, adolescents, and their caregivers:

Common (may affect up to 1 in 10 people)

• Inflammation of the pancreas.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects direct ly via the national reporting system listed in Appendix V . By reporting side effects you can help provide more informati on on the safety of this medicine.

🌡️ 5. How to store Teriflunomide Viatris

44 Keep this medicine out of th e sight and reach of children.

Do not use this medicine after th e expiry date which is stated on the carton after ‘EXP’. The expiry date refers to the last day of that month.

Store below 25 C.

Do not throw away any medicines via wastewater or household was te. Ask your pharmacist how to throw away medicines you no longer use . These measures will help prot ect the environment.

📦 6. Contents of the pack and other information What Teriflunomide Viatris contains – The active substance is terifl unomide. Each tablet contains 14 mg of teriflunomide.

• The other ingredients are:

Tablet core: lactose monohydrate , maize starc h, microcrystalline cellulose (E460i), sodium starch glycolate (Type A) , hydroxypropylcellulose (E463), magnesium s tearate (E470b), colloidal anhydrous silica; Tablet coat: hypromellose (E464), titanium di oxide (E171), talc (E553b), mac rogol 6000 (E1521), indigo carmine aluminium lake (E132).

What Teriflunomide Viatris looks like and contents of the pack Pale blue to pastel blue, round, biconvex (surface curved outwa rds on both sides) with ‘T’ on one side and ‘1’ on the other side, approximately 7.6 mm diameter.

Teriflunomide Viatris is available in blister packs of 14, 28 or 84 tablets, perforat ed unit dose blisters of 14 x 1, 28 x 1, 84 x1 or 98 x 1 tablets, calendar packs of 14, 28, 84 or 98 tablets and in bottles containing 84 or 98 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Viatris Limited Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland Manufacturer Mylan Hungary Kft Mylan utca 1 Komárom H-2900 Hungary Mylan Germany GmbH Zweigniederlassung Bad Homburg Benzstrasse 1 Bad Homburg v. d. Höhe 61352 Germany 45 For any information about this medicine, please contact the loc al representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Viatris Tél/Tel: + 32 (0)2 658 61 00 Lietuva Viatris UAB Tel: +370 5 205 1288 България Майлан ЕООД Тел: +359 2 44 55 400 Luxembourg/Luxemburg Viatris Tél/Tel: + 32 (0)2 658 61 00 (Belgique/Belgien) Česká republika Viatris CZ s.r.o.

Tel: + 420 222 004 400 Magyarország Viatris Healthcare Kft. Tel: + 36 1 465 2100 Danmark Viatris ApS Tlf: +45 28 11 69 32 Malta V.J. Salomone Pharma Ltd Tel: + 356 21 22 01 74 Deutschland Viatris Healthcare GmbH Tel: +49 800 0700 800 Nederland Mylan BV Tel: +31 (0)20 426 3300 Eesti Viatris OÜ Tel: + 372 6363 052 Norge Viatris AS Tlf: + 47 66 75 33 00 Ελλάδα Viatris Hellas Ltd Τηλ: +30 2100 100 002 Österreich Viatris Austria GmbH Tel: +43 1 86390 España Viatris Pharmaceuticals, S.L. Tel: + 34 900 102 712 Polska Viatris Healthcare Sp. z o.o. Tel: + 48 22 546 64 00 France Viatris Santé Tél: +33 4 37 25 75 00 Portugal Mylan, Lda. Tel: + 351 214 127 2 00 Hrvatska Viatris Hrvatska d.o.o.

Tel: +385 1 23 50 599 Ireland Mylan Ireland Limited Tel: +353 1 8711600 România BGP Products SRL Tel: +40 372 579 000 Slovenija Viatris d.o.o. Tel: + 386 1 23 63 180 Ísland Icepharma hf Símí: +354 540 8000 Slovenská republika Viatris Slovakia s.r.o. Tel: +421 2 32 199 100 Italia Viatris Italia S.r.l. Tel: + 39 (0) 2 612 46921 Suomi/Finland Viatris Oy Puh/Tel: +358 20 720 9555 46 Κύπρος GPA Pharmaceuticals Ltd Τηλ: +357 22863100 Sverige Viatris AB Tel: + 46 (0)8 630 19 00 Latvija Viatris SIA Tel: +371 676 055 80

This leaflet was last revised in

Other sources of information Detailed information on this med icine is available on the Europ ean Medicines Agency web site: http://www.ema.europa.eu

📄 Package Leaflet – official source

This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Teriflunomide Viatris (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/22/1698).

⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.