TERIFLUNOMIDE VIATRIS 14 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Teriflunomide Viatris 14 mg film-coated tablets EFG

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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed 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.

Contents of the pack

1. What is Teriflunomide Viatris and what is it used for
2. What you need to know before you take Teriflunomide Viatris
3. How to take Teriflunomide Viatris
4. Possible side effects
5. Storage of Teriflunomide Viatris
6. Contents of the pack and other information

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

What is Teriflunomide Viatris

Teriflunomide Viatris contains the active substance teriflunomide, which is an immunomodulatory agent that adjusts the immune system to limit its attack on the nervous system.

What is Teriflunomide Viatris used for

Teriflunomide is used in adults and in children and adolescents (from 10 years of age) to treat relapsing-remitting multiple sclerosis (MS).

What is multiple sclerosis

MS is a long-term disease that affects the central nervous system (CNS). The CNS is made up of the brain and spinal cord. In multiple sclerosis, inflammation destroys the protective covering (myelin) that surrounds the nerves of the CNS. This loss of myelin is called demyelination. This makes the nerves stop working properly.

People with the relapsing form of multiple sclerosis will have repeated attacks (relapses) of physical symptoms caused by the poor functioning of the nerves. These symptoms vary from person to person but usually include:

• difficulty walking
• vision problems
• balance problems

Symptoms can disappear completely after a relapse, but over time, some problems may remain. This can cause physical disabilities that can interfere with daily activities.

How Teriflunomide Viatris works

Teriflunomide Viatris helps protect against attacks on the central nervous system by the immune system, limiting the growth of some white blood cells (lymphocytes). This limits the inflammation that causes 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 ingredients of this medicine (listed in section 6)
• if you have ever developed a severe skin rash, blistering, or peeling of the skin after taking teriflunomide or leflunomide
• if you have severe liver problems
• if you are pregnant, think you may be pregnant, or are breast-feeding
• if you have a serious condition that affects your immune system, for example, acquired immune deficiency syndrome (AIDS)
• if you have serious bone marrow problems or a low white blood cell, red blood cell, or platelet count
• if you have a serious infection
• if you have severe kidney problems that require dialysis
• if you have a low level of proteins in the blood (hypoproteinemia)

In case of doubt, ask your doctor or pharmacist before taking this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before starting Teriflunomide Viatris if:

• you have liver problems and/or if you drink large amounts of alcohol. Your doctor may perform blood tests to check your liver function before and during treatment. If the test results indicate a liver problem, your doctor may stop treatment with Teriflunomide Viatris. See section 4.
• you have high blood pressure, whether or not you are being treated for it.
• Teriflunomide Viatris may cause an increase in blood pressure. Your doctor will check your blood pressure before starting treatment and regularly during treatment. See section 4.
• you have an infection. Before you start taking Teriflunomide Viatris, your doctor will make sure you have enough white blood cells and platelets in your blood. Since Teriflunomide Viatris decreases the number of white blood cells in your blood, this may affect your ability to fight infection. Your doctor may perform blood tests to check your white blood cell count if they think you have an infection. See section 4.
• you have severe skin reactions
• you have respiratory symptoms
• you have weakness, numbness, and pain in hands and feet
• you are going to be vaccinated
• you are taking leflunomide with Teriflunomide Viatris
• you are switching from or to Teriflunomide Viatris
• a specific blood test (calcium level) is scheduled. A false decrease in calcium levels may be detected.

Respiratory reactions

Tell your doctor if you have unexplained cough and shortness of breath. Your doctor may perform additional tests.

Children and adolescents

Teriflunomide Viatris is not indicated for use 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 their caregivers:

• pancreatitis has been observed in patients receiving teriflunomide. Your child's doctor may perform blood tests if they suspect pancreatitis.

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 without a prescription.

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

• leflunomide, methotrexate, and other medicines that affect the immune system (often referred to as 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 diabetic neuropathy
• alosetron for severe diarrhea
• theophylline for asthma
• tizanidine, a muscle relaxant
• warfarin, an anticoagulant to thin the blood (make it more fluid) and prevent clots
• oral contraceptives (ethinylestradiol, levonorgestrel)
• cefaclor, benzylpenicillin (penicillin G), ciprofloxacin for infections
• indomethacin, ketoprofen for pain or inflammation
• furosemide for heart disease
• cimetidine to reduce stomach acid
• zidovudine for AIDS
• rosuvastatin, simvastatin, atorvastatin, pravastatin for high cholesterol
• sulfasalazine for inflammatory bowel disease or rheumatoid arthritis
• cholestyramine for high cholesterol or relief of itching in liver disease
• activated charcoal to reduce the absorption of medicines or other substances

Pregnancy and breast-feeding

Do nottake Teriflunomide Viatris if you are pregnantor think you may be pregnant. If you are pregnant or become pregnant while taking Teriflunomide Viatris, you will increase the risk of having a baby with birth defects. Women of childbearing age must not take this medicine if they are not using reliable contraceptive methods.

If your daughter has her first menstrual period while taking teriflunomide, she must inform her doctor, who will provide specialized advice on contraceptive methods and 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 make sure that most of this medicine has been eliminated from your body before trying to become pregnant. The natural elimination of the active substance may take up to 2 years. This period can be reduced to a few weeks by taking certain medicines to accelerate the elimination of Teriflunomide Viatris from the body.

In any case, you need your doctor to confirm, based on a blood test, that the level of Teriflunomide Viatris in your blood is low enough for you to become pregnant.

For more information on laboratory tests, contact your doctor.

If you suspect you are pregnant while taking Teriflunomide Viatris or in the 2 years following the end of treatment, you must stop taking Teriflunomide Viatris and contact your doctor immediatelyto have a pregnancy test. If the test confirms pregnancy, your doctor may suggest treatment with certain medicines to eliminate Teriflunomide Viatris from your body quickly enough, as this may reduce the risk to your baby.

Contraception

You must use a reliable contraceptive method during and after treatment with Teriflunomide Viatris. Teriflunomide remains in the blood for a long time after stopping it. Continue to take contraceptive measures after stopping treatment.

• Continue to do so until the levels of Teriflunomide Viatris in your blood are low enough (your doctor will check this).
• Ask your doctor about the best contraceptive method for you and in case you need to change the method.

Do not take Teriflunomide Viatris during breast-feeding, as teriflunomide passes into breast milk.

Driving and using machines

Teriflunomide Viatris may cause dizziness, which may affect your ability to concentrate 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 your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Teriflunomide Viatris contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially "sodium-free".

3. How to take Teriflunomide Viatris

Treatment with Teriflunomide Viatris will be supervised by a doctor with experience in the treatment of multiple sclerosis.

Follow the instructions for administration of this medicine exactly as told by your doctor. If you are unsure, consult your doctor again.

Adults

The recommended dose is one 14 mg teriflunomide tablet per day.

Children and adolescents (10 years of age and older)

The dose depends on body weight:

• children with a body weight over 40 kg: 14 mg once a day.
• children with a body weight of 40 kg or less: 7 mg once a day.

Viatris Pharmaceuticals Limited does not market the 7 mg teriflunomide concentration, but it may be available from other marketing authorization holders.

Your doctor will instruct children and adolescents who reach a stable body weight over 40 kg to switch to a 14 mg tablet per day.

Form/Route of Administration

Teriflunomide Viatris is administered orally. Teriflunomide Viatris is taken once daily at any time of day.

The tablet should be swallowed whole with water.

Teriflunomide Viatris can be taken with or without food.

If you take more Teriflunomide Viatris than you should

If you have taken too much Teriflunomide Viatris, call your doctor immediately. 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 forgotten doses. Take the dose at the scheduled time.

If you stop taking Teriflunomide Viatris

Do not stop treatment or change the dose of Teriflunomide Viatris without consulting 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, although not everybody gets them.

The following side effects may occur with this medicine.

Serious side effects

Some side effects may be serious, if you experience any of these, tell your doctor immediately:

Common(may affect up to 1 in 10 people)

• Pancreatitis that may include symptoms of abdominal pain, nausea, or vomiting (common in pediatric patients and uncommon in adult patients).

Uncommon(may affect up to 1 in 100 people)

• Allergic reactions that could include symptoms of rash, hives, swelling of lips, tongue, or face, or sudden difficulty breathing.
• Severe skin reactions that could include symptoms of skin rash, blisters, fever, or ulcers in your mouth.
• Severe or life-threatening infections that could include symptoms such as high fever, chills, decreased urine flow, or confusion.
• Lung inflammation that could include symptoms such as shortness of breath or persistent cough.

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

• Liver disease that may include symptoms such as yellowing of the skin or the whites of the eyes, darker than normal urine, unexplained nausea and vomiting, or abdominal pain.

Other side effectsmay occur with the following frequencies:

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

• Headache
• Diarrhea, feeling sick
• Increased ALT (increase in certain liver enzymes in the blood) in blood tests
• Thinning hair

Common(may affect up to 1 in 10 people)

• Flu, upper respiratory tract infection, urinary tract infection, bronchitis, sinusitis, sore throat and discomfort when swallowing, cystitis, viral gastroenteritis, oral herpes, dental infection, laryngitis, fungal infection of the foot
• Laboratory values: a decrease in red blood cell count (anemia), changes in liver and white blood cell counts in blood tests (see section 2), as well as elevations in a muscle enzyme (creatine phosphokinase)
• Mild allergic reactions
• Feeling anxious
• Pins and needles, feeling weak, numbness, tingling, or pain in the lower back or leg (sciatica); feeling numb, burning, tingling, or pain in hands and fingers (carpal tunnel syndrome)
• Palpitations
• Increased blood pressure
• Feeling sick (vomiting), toothache, pain in the upper abdomen
• Rash, acne
• Pain in tendons, joints, bones, muscle pain (musculoskeletal pain)
• Need to urinate more often than usual
• Heavy periods
• Pain
• Lack of energy or weakness (asthenia)
• Weight loss

Uncommon(may affect up to 1 in 100 people)

• Mild decrease in platelet count (thrombocytopenia)
• Increased sensitivity, especially in the skin; stabbing or pulsating pain in one or more nerves; problems with the nerves in the arms and legs (peripheral neuropathy)
• Abnormalities in the nails, severe skin reactions
• Post-traumatic pain
• Psoriasis
• Mouth/lip inflammation
• Abnormal levels of fats (lipids) in the blood
• Colon inflammation (colitis)

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

• Liver inflammation or damage

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

• Pulmonary hypertension

Children (10 years of age 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 people)

• Pancreatitis

Reporting of side effects

If you experience 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 directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Teriflunomide Viatris

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 carton after "EXP". The expiry date refers to the last day of the month stated.

Store below 25°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Container contents and additional information

Composition of Teriflunomida Viatris

• The active ingredient is teriflunomida. Each tablet contains 14 mg of teriflunomida.
• The other components are:

Core of the tablet: lactose monohydrate, corn starch, microcrystalline cellulose (E460i), sodium glycolate starch (type A), hydroxypropylcellulose (E463), magnesium stearate (E470b), anhydrous colloidal silica.

Coating of the tablet: hypromellose (E464), titanium dioxide (E171), talc (E553b), macrogol 6000 (E1521), aluminum lake carmine indigo (E132).

Appearance of the product and container contents

Round, biconvex (curved surface on both sides) and pale blue to blue pastel in color, engraved with "T" on one side and "1" on the other and with a diameter of approximately 7.6 mm.

Teriflunomida Viatris is available in blister packs of 28 or 84 tablets, single-dose precut blisters of 28 x 1, 84 x 1 or 98 x 1 tablets and bottles of 84 or 98 tablets.

Only some pack sizes may be marketed.

Marketing authorization holder

Viatris Limited

Damastown Industrial Park

Mulhuddart

Dublin 15

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

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Date of the last revision of this prospectus:November 2022.

Other sources of information

Detailed information about this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.