Teriflunomide Viatris: detailed information

Package leaflet: Information for the patient

Teriflunomide Viatris 14 mg film-coated tablets

teriflunomide
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 questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

What Teriflunomide Viatris is and what it is used for
What you need to know before taking Teriflunomide Viatris
How to take Teriflunomide Viatris
Possible side effects
How to store Teriflunomide Viatris
Contents of the pack and other information

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

What Teriflunomide Viatris is
Teriflunomide Viatris contains the active substance teriflunomide, which is an immunomodulator and
modulates the immune system to limit its attacks on the nervous system.
What Teriflunomide Viatris is used for
Teriflunomide is used in adults, children, and adolescents (aged 10 years and older)
for the treatment of relapsing-remitting multiple sclerosis (MS).
What is multiple sclerosis
MS is a long-term disease that affects the central nervous system (CNS), which consists of the
brain and spinal cord. In multiple sclerosis, inflammation destroys the protective covering
(called myelin) that surrounds the nerves of the CNS. This loss of myelin is called
demyelination and prevents nerves from functioning properly.
People with relapsing forms of multiple sclerosis experience repeated attacks (relapses) of physical symptoms caused by improper nerve function. These symptoms vary from
patient to patient but generally include:

difficulty walking
vision problems
balance problems.

Symptoms may completely disappear at the end of a relapse, but over time some
problems may persist between relapses. This can lead to physical disability that
may interfere with daily activities.
How Teriflunomide Viatris works
Teriflunomide Viatris helps protect the central nervous system from attacks by the immune
system by limiting the proliferation of certain white blood cells (lymphocytes). This reduces the inflammation that causes nerve damage characteristic of MS.

2. What you should know before taking Teriflunomide Viatris

Do not take Teriflunomide Viatris:

if you are allergic to teriflunomide or to any of the other ingredients of this medicine (listed in section 6)
if you have developed a severe skin rash, skin peeling, blistering, and/or mouth ulcers after taking teriflunomide or leflunomide
if you have severe liver problems
if you are pregnant, suspect you may be pregnant, or are breastfeeding
if you have any serious condition affecting the immune system (e.g. acquired immunodeficiency syndrome (AIDS))
if you have any severe bone marrow disorder or if you have low levels of red blood cells, white blood cells, or platelets in your blood
if you have a serious infection
if you have severe kidney problems requiring dialysis
if you have very low levels of proteins in your blood (hypoproteinemia).

If you have any doubts, consult your doctor or pharmacist before taking this medicine.
Warnings and precautions
Talk to your doctor or pharmacist before taking Teriflunomide Viatris if:

you have liver problems and/or consume large amounts of alcohol. Your doctor will request blood tests before and during treatment to monitor liver function. If blood test results indicate liver problems, your doctor may ask you to stop treatment with Teriflunomide Viatris. See section 4.
you have high blood pressure (hypertension), whether or not it is controlled with medication. Teriflunomide Viatris may cause an increase in blood pressure. Your doctor will check your blood pressure before starting treatment and regularly thereafter. See section 4.
you have an infection. Before starting Teriflunomide Viatris, your doctor will check that your white blood cell and platelet counts are adequate. Since Teriflunomide Viatris reduces the number of white blood cells in the blood, this may affect your ability to fight infections. If you suspect you have an infection, your doctor may perform blood tests to monitor white blood cells. Infections with herpes viruses, including oral herpes or herpes zoster (shingles), may occur during treatment with teriflunomide. In some cases, serious complications may arise. You must inform your doctor immediately if you suspect any symptoms of a herpes virus infection. See section 4.
you have severe skin reactions.
you have respiratory symptoms.
you experience weakness, numbness, or pain in your hands or feet.
you need to receive a vaccination.
you are taking leflunomide together with Teriflunomide Viatris.
you are switching to or from treatment with Teriflunomide Viatris.
you need to undergo a specific blood test (calcium level). Falsely low calcium levels may be observed.

Respiratory reactions
Inform your doctor if you develop unexplained cough or shortness of breath (dyspnea). Your doctor may perform further evaluations.
Children and adolescents
Teriflunomide Viatris is not indicated in children under 10 years of age, as it has not been studied in patients with MS in this age group.
The warnings and precautions listed above also apply to children. The following information is important for children and those caring for them:

inflammation of the pancreas has been observed in patients taking teriflunomide. Your child’s doctor may perform blood tests if pancreatitis is suspected.

Other medicines and Teriflunomide Viatris
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

leflunomide, methotrexate, and other medicines that affect the immune system (commonly called immunosuppressants or immunomodulators)
rifampicin (a medicine used to treat tuberculosis and other infections)
carbamazepine, phenobarbital, phenytoin (for epilepsy)
St. John’s wort (a herbal medicine for depression)
repaglinide, pioglitazone, nateglinide, or rosiglitazone (for diabetes)
daunorubicin, doxorubicin, paclitaxel, or topotecan (for cancer)
duloxetine (for depression, urinary incontinence, or kidney problems in diabetics)
alosetron (for management of severe diarrhea)
theophylline (for asthma)
tizanidine (a muscle relaxant)
warfarin (an anticoagulant used to thin the blood to prevent clotting)
oral contraceptives (containing ethinylestradiol and levonorgestrel)
cefaclor, benzylpenicillin (penicillin G), ciprofloxacin (for infections)
indomethacin, ketoprofen (for pain or inflammation)
furosemide (for heart conditions)
cimetidine (for reducing gastric acid)
zidovudine (for HIV infection)
rosuvastatin, simvastatin, atorvastatin, pravastatin (for hypercholesterolemia (high cholesterol))
sulfasalazine (for inflammatory bowel disease or rheumatoid arthritis)
cholestyramine (for high cholesterol or relief of itching in liver diseases)
activated charcoal (to reduce absorption of medicines or other substances).

Pregnancy and breastfeeding
Do not take Teriflunomide Viatris if you are pregnant or suspect you are pregnant. If you become pregnant while taking Teriflunomide Viatris, the risk of birth defects in the baby increases. Women of childbearing potential must not take this medicine without using reliable contraceptive measures.
If your daughter/adolescent daughter begins menstruation while taking teriflunomide, you must inform the doctor, who will provide specialist advice regarding contraception and potential risks in case of pregnancy.
Inform your doctor if you plan to become pregnant after stopping treatment with Teriflunomide Viatris, because you must ensure that most of the medicine has been eliminated from your body before planning a pregnancy. Elimination of the active substance may take up to 2 years to occur naturally. This period can be reduced to a few weeks by taking certain medicines that accelerate the elimination of Teriflunomide Viatris from the body.
In any case, a blood test must confirm that the active substance has been sufficiently eliminated from your body, and you must wait for confirmation from your doctor that the level of Teriflunomide Viatris in the blood is low enough to allow pregnancy.
For further information on laboratory tests, consult your doctor.
If you suspect pregnancy while taking Teriflunomide Viatris or within two years after stopping treatment, you must stop Teriflunomide Viatris and contact your doctor immediately to perform a pregnancy test. If the test confirms pregnancy, your doctor may recommend treatment with certain medicines to rapidly and sufficiently eliminate Teriflunomide Viatris from the body, as this may reduce the risk to the fetus.
Contraception
You must use an effective method of contraception during and after treatment with Teriflunomide Viatris.
Teriflunomide remains in the blood for a long time after stopping treatment. Continue using effective contraception after stopping treatment.

Continue until Teriflunomide Viatris blood levels are sufficiently low. Your doctor will monitor them.
Discuss with your doctor the most suitable contraceptive method for you and if any change in contraception is needed.

Do not take Teriflunomide Viatris if you are breastfeeding, as teriflunomide passes into breast milk.
Driving and using machines
Teriflunomide Viatris may cause dizziness, which could impair your ability to concentrate and react. Do not drive or operate machinery if you experience this symptom.
Teriflunomide Viatris contains lactose
Teriflunomide Viatris contains lactose (a type of sugar). If you have been told by your doctor that you have an intolerance to certain sugars, contact your doctor before taking this medicine.
Teriflunomide Viatris contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take Teriflunomide Viatris

Treatment with Teriflunomide Viatris must be supervised by a physician experienced in the
treatment of multiple sclerosis.
Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your
doctor.
Adults
The recommended dose is one 14 mg teriflunomide tablet daily.
Children and adolescents (aged 10 years and older)
The dose depends on body weight:

Children with body weight above 40 kg: one 14 mg tablet daily.
Children with body weight less than or equal to 40 kg: one 7 mg tablet daily.

The 7 mg dose of teriflunomide is not marketed by Viatris Limited but may be available from other marketing authorization holders.
Children and adolescents who reach a stable body weight above 40 kg will be instructed by their physician 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 daily dose at any time of the day.
The tablet should be swallowed whole with a little water.
Teriflunomide Viatris may be taken with or without food.
If you take more Teriflunomide Viatris than you should
If you have taken too much Teriflunomide Viatris, contact your doctor immediately. You may experience adverse 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 the missed tablet. Take the next dose at the scheduled time.
If you stop taking Teriflunomide Viatris
Do not stop using Teriflunomide Viatris or change the dose without first discussing it with your
doctor.
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.
The following side effects may occur with this medicine.
Serious side effects
Some side effects may be serious or may become serious. Contact your doctor immediately if you notice any of the following serious side effects.
Common (may affect up to 1 in 10 people)

Inflammation of the pancreas which may include symptoms of abdominal pain, nausea or vomiting (frequency is common in paediatric patients and uncommon in adult patients).

Uncommon (may affect up to 1 in 100 people)

Allergic reactions which may include symptoms such as rash, hives, swelling of the lips, tongue or face, or sudden breathing difficulties
Serious skin reactions which may include symptoms such as rash, blisters, fever, or mouth ulcers
Severe infections or sepsis (a type of infection that may be life-threatening) which may include symptoms such as high fever, shaking, chills, reduced urine output, or confusion
Inflammation of the lungs which may include symptoms such as shortness of breath or persistent cough

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

Severe liver diseases which may include symptoms such as yellowing of the skin or whites of the eyes, darker than normal urine, unexplained nausea and vomiting, or abdominal pain

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

Headache
Diarrhoea, nausea
Increased ALT (increase in levels of certain liver enzymes in the blood) detected by blood tests
Hair thinning

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

Influenza, upper respiratory tract infection, urinary tract infection, bronchitis, sinusitis, sore throat and discomfort when swallowing, cystitis, viral gastroenteritis, dental infection, laryngitis, fungal foot infection
Herpes virus infections, including oral herpes and herpes zoster (shingles), with symptoms such as blisters, burning, itching, numbness or pain of the skin, usually on one side of the upper body or face, and other symptoms such as fever and weakness
Laboratory tests: decreased number of red blood cells (anaemia) has been observed, changes in liver and white blood cell test results (see section 2), as well as increases in a muscle enzyme (creatine phosphokinase)
Mild allergic reactions
Feeling anxious
Tingling, weakness, numbness, tingling or pain in the lower back or legs (sciatica); numbness, burning, tingling or pain in the hands and fingers (carpal tunnel syndrome)
Awareness of your heartbeat
Increased blood pressure
Vomiting, toothache, upper abdominal pain
Rash, acne
Tendon, joint, bone pain, muscle pain (musculoskeletal pain)
Need to urinate more often than usual
Heavy menstrual bleeding
Pain
Lack of energy or feeling weak (asthenia)
Weight loss

Uncommon (may affect up to 1 in 100 people)

Decreased number of platelets (mild thrombocytopenia)
Increased sensitivity, particularly of the skin; stabbing or throbbing pain in one or more nerves, nerve problems in the arms or legs (peripheral neuropathy)
Nail disorders, serious skin reactions
Post-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 people)

Inflammation or damage to the liver

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

Increased blood pressure in the lungs (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 those caring for them:
Common (may affect up to 1 in 10 people)

Inflammation of the pancreas

Reporting of side effects
If you experience any side effects, 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 referred to in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Teriflunomide Viatris

Keep this medicine out of the 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 that month.
Store below 25 °C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Teriflunomide Viatris contains

The active substance is teriflunomide. Each tablet contains 14 mg of teriflunomide.
The other components are: Tablet core: lactose monohydrate, maize starch, microcrystalline cellulose (E460i), sodium starch glycolate (type A), hydroxypropylcellulose (E463), magnesium stearate (E470b), anhydrous colloidal silica; Tablet coating: hypromellose (E464), titanium dioxide (E171), talc (E553b), macrogol 6000 (E1521), indigo carmine – aluminium lake (E132).

Description of the appearance of Teriflunomide Viatris and contents of the pack
Round, biconvex (curved outward on both sides), light blue to pastel blue tablets, imprinted with “T” on one side and “1” on the other side, approximately 7.6 mm in diameter.
Teriflunomide Viatris is available in blister packs containing 14, 28 or 84 tablets, perforated unit-dose blisters containing 14 x 1, 28 x 1, 84 x 1 or 98 x 1 tablets, calendar blister packs containing 14, 28, 84 or 98 tablets, and 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
Germany

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

België/Belgique/Belgien Lietuva
Viatris Viatris UAB
Tél/Tel: 32 (0)2 658 61 00 Tel: +370 5 205 1288

България Luxembourg/Luxemburg
Майлан ЕООД Viatris
Тел.: +359 2 44 55 400 Tél/Tel: +32 (0)2 658 61 00
(Belgique/Belgien)

Česká republika Magyarország
Viatris CZ s.r.o. Viatris Healthcare Kft.
Tel: +420 222 004 400 Tel.: +36 1 465 2100

Danmark Malta
Viatris ApS V.J. Salomone Pharma Ltd
Tlf: +45 28 11 69 32 Tel: +356 21 22 01 74

Deutschland Nederland
Viatris Healthcare GmbH Mylan BV
Tel: +49 800 0700 800 Tel: +31 (0)20 426 3300

Eesti Norge
Viatris OÜ Viatris AS
Tel: +372 6363 052 Tlf: +47 66 75 33 00

Ελλάδα Österreich
Viatris Hellas Ltd Viatris Austria GmbH
Τηλ: +30 2100 100 002 Tel: +43 1 86390

España Polska
Viatris Pharmaceuticals, S.L. Viatris Healthcare Sp. z o.o.
Tel: +34 900 102 712 Tel.: +48 22 546 64 00

France Portugal
Viatris Santé Mylan, Lda.
Tél: +33 4 37 25 75 00 Tel: +351 214 127 200

Hrvatska România
Viatris Hrvatska d.o.o. BGP Products SRL
Tel: +385 1 23 50 599 Tel: +40 372 579 000

Irland Slovenija
Mylan Ireland Limited Viatris d.o.o.
Tel: +353 1 8711600 Tel: +386 1 23 63 180

Ísland Slovenská republika
Icepharma hf. Viatris Slovakia s.r.o.
Sími: +354 540 8000 Tel: +421 2 32 199 100

Italia Suomi/Finland
Viatris Italia S.r.l. Viatris Oy
Tel: +39 (0)2 612 46921 Puh/Tel: +358 20 720 9555

Κύπρος Sverige
GPA Pharmaceuticals Ltd Viatris AB
Τηλ: +357 22863100 Tel: +46 (0)8 630 19 00

Latvija
Viatris SIA
Tel: +371 676 055 80

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