Label: information for the patient

Teriflunomida Viatris 14 mg film-coated tablets EFG

teriflunomida

Read this label carefully before starting to take this medicine, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

What is Teriflunomida Viatris

Teriflunomida Viatris contains the active ingredient teriflunomida, which is an immunomodulator agent that adjusts the immune system to limit its attack on the nervous system.

What is Teriflunomida Viatris used for

Teriflunomida 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 MS, 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 functioning properly.

People with relapsing-remitting MS will have repeated attacks (recurrences) of the physical symptoms caused by the improper functioning of the nerves. These symptoms vary from patient to patient, but usually include:

• difficulty walking
• vision problems
• balance problems

The symptoms may disappear completely after the recurrence but, over time, some problems may remain. This can cause physical disabilities that can interfere with daily activities.

How Teriflunomida Viatris works

Teriflunomida Viatris helps to 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.

Do not take Teriflunomida Viatris

• if you are allergic to teriflunomida or any of the other ingredients of this medication (listed in section 6)
• if you have ever developed a severe skin rash or skin peeling, blisters, and/or mouth ulcers after taking teriflunomida or leflunomida
• if you have severe liver problems
• if you are pregnant, think you may be pregnant, or are breastfeeding
• if you have a severe condition that affects the immune system, for example, acquired immunodeficiency syndrome (AIDS)
• if you have severe bone marrow problems or if you have a low number of white blood cells, red blood cells, or platelets in your blood or a reduced number of platelets
• if you have a severe infection
• if you have severe kidney problems that require dialysis
• if you have a very low level of proteins in your blood (hypoproteinemia)

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Teriflunomida 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 treatment and during treatment. If the test results indicate a liver problem, your doctor may interrupt treatment with Teriflunomida Viatris. See section 4.
• you have high blood pressure (hypertension), whether or not you are being treated to control it.
• Teriflunomida 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 Teriflunomida Viatris, your doctor will ensure that you have enough white blood cells and platelets in your blood. Since Teriflunomida Viatris reduces the number of white blood cells in your blood, this may affect your ability to fight the infection. Your doctor may perform blood tests to check your white blood cells if they suspect you have an infection. See section 4.
• you have severe skin reactions
• you have respiratory symptoms
• you have weakness, numbness, and pain in your hands and feet
• you are planning to be vaccinated
• you are taking leflunomida with Teriflunomida Viatris
• you are changing medication from or to Teriflunomida Viatris
• you are scheduled to have a specific blood test (calcium level). A false decrease in calcium levels may be detected.

Respiratory reactions

Inform your doctor if you have cough and shortness of breath without explanation. Your doctor may perform additional tests.

Children and adolescents

Teriflunomida Viatris is not indicated for use in children under 10 years of age, as it has not been studied in patients with EM in this age group.

The warnings and precautions listed above also apply to children. The following information is important for children and their caregivers:

Other medications and Teriflunomida Viatris

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. This includes over-the-counter medications.

Especially, inform your doctor or pharmacist if you are taking any of the following medications:

• leflunomida, methotrexate, and other medications that affect the immune system (often referred to as immunodepressants or immunomodulators)
• rifampicin (a medication used to treat tuberculosis and other infections)
• carbamazepine, phenobarbital, phenytoin for epilepsy
• hypericum (a plant-based medication for depression)
• repaglinide, pioglitazone, nateglinide, or rosiglitazone for diabetes
• daunorubicin, doxorubicin, paclitaxel, or topotecan for cancer
• duloxetine for depression, incontinence, or kidney disease in diabetics
• 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 (high cholesterol)
• sulfasalazine for inflammatory bowel disease or rheumatoid arthritis
• cholestyramine for high cholesterol or itching in liver disease
• activated charcoal to reduce the absorption of medications or other substances

Pregnancy and lactation

Do nottake Teriflunomida Viatris if you arepregnantor think you may bepregnant. If you are pregnant or become pregnant while taking Teriflunomida Viatris, you will have an increased risk of having a baby with birth defects. Women of childbearing age should not take this medication unless they are using reliable contraceptive methods.

If your daughter in puberty/adolescence has her first menstruation while taking teriflunomida, she should inform her doctor, who will give her specialized advice on contraceptive methods and the possible risks in case of pregnancy.

Inform your doctor if you plan to become pregnant after interrupting treatment with Teriflunomida Viatris, as you need to ensure that most of this medication has been eliminated from your body before attempting to become pregnant. The natural elimination of the active ingredient may take up to 2 years. This time period can be reduced to a few weeks by taking certain medications to accelerate the elimination of Teriflunomida Viatris from your body.

In any case, you need your doctor to confirm, from a blood test, that the level of Teriflunomida 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 Teriflunomida Viatris or in the two years following the end of treatment, you should interrupt Teriflunomida Viatris and contact your doctorimmediatelyto perform a pregnancy test. If the test confirms pregnancy, your doctor may suggest a treatment with certain medications to eliminate Teriflunomida Viatris from your body quickly and effectively, as this may reduce the risk to your baby.

Contraception

You must use an effective contraceptive method during and after treatment with Teriflunomida Viatris. Teriflunomida remains in the blood for a long time after stopping treatment. Continue to take contraceptive measures after interrupting treatment.

• Continue to do so until the levels of Teriflunomida Viatris in your blood are low enough (your doctor will check).
• Consult your doctor about the best contraceptive method for you and if you need to change methods.

Do not take Teriflunomida Viatris during lactation as teriflunomida passes into breast milk.

Driving and operating machines

Teriflunomida Viatris may cause dizziness, which may affect your ability to concentrate and react. If you are affected, do not drive or operate machines.

Teriflunomida Viatris contains lactose

Teriflunomida Viatris contains lactose (a type of sugar). If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Teriflunomida Viatris contains sodium

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

A healthcare professional experienced in treating multiple sclerosis will supervise treatment with Teriflunomida Viatris.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor again.

Adults

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

Children and adolescents (10 years of age and older)

The dose depends on body weight:

• children with a body weight greater than 40 kg: 14 mg once a day.
• children with a body weight less than or equal to 40 kg: 7 mg once a day.

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

Your doctor will instruct children and adolescents to switch to a 14 mg tablet per day once they reach a stable body weight greater than 40 kg.

Form/administration route

Teriflunomida Viatris is administered orally. Teriflunomida Viatris is taken once a day in a single daily dose at any time of the day.

The tablet should be swallowed whole with water.

Teriflunomida Viatris can be taken with or without food.

If you take more Teriflunomida Viatris than you should

If you have taken too much Teriflunomida Viatris, call your doctor immediately. You may experience adverse effects similar to those described in section 4 (below).

If you forget to take Teriflunomida Viatris

Do not take a double dose to make up for missed doses. Take the dose at the scheduled time.

If you interrupt treatment with Teriflunomida Viatris

Do not interrupt treatment or change the dose of Teriflunomida Viatris without consulting your doctor first.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

The following side effects may occur with this medicine.

Severe side effects

Some side effects may be severe, if you experience any of the following, inform your doctor immediately:report them to 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 rare in adult patients).

Uncommon(may affect up to 1 in 100 people)

• Allergic reactions that may include symptoms of rash, hives, swelling of lips, tongue, or face, or sudden difficulty breathing.
• Severe skin reactions that may include symptoms of skin rash, blisters, fever, or mouth ulcers.
• Severe infections or sepsis (a type of infection that can be potentially fatal) that may include symptoms such as high fever, chills, decreased urine flow, or confusion.
• Pneumonia that may include symptoms such as shortness of breath or persistent cough.

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

• Liver disease that may include symptoms such as yellowing of the skin or eyes, darker urine, nausea, and vomiting without explanation, or abdominal pain.

Other side effectsmay occur with the following frequencies:

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

• Headache
• Diarrhea, feeling of illness
• Increased ALT (increase in certain liver enzymes in the blood) in tests
• Thinner hair

Common(may affect up to 1 in 10 people)

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

Uncommon(may affect up to 1 in 100 people)

• Decrease in the number of platelets (mild thrombocytopenia)
• Increased sensitivity, especially in the skin; stabbing or pulsating pain in one or more nerves; nerve problems in arms and legs (peripheral neuropathy)
• Changes in nails, severe skin reactions
• Post-traumatic pain
• Psoriasis
• Inflammation of the mouth/lips
• Anomalous levels of fats (lipids) in the blood
• Colitis (inflammation of the colon)

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

• Liver inflammation or damage

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

• Pulmonary hypertension

Children (10 years of age and older) and adolescents

The previously listed side effects 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 side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through thenational notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box after “CAD”. The expiration date is the last day of the month indicated.

Store below 25 °C.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. In this way, you will help protect the environment.

Teriflunomida Viatris Composition

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

Tablet Core: lactose monohydrate, cornstarch, 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), aluminium lake carmine indigo (E132).

Product Appearance and Packaging Contents

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

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

Only some packaging sizes may be commercially available.

Marketing Authorization Holder

Viatris Limited

Damastown Industrial Park

Mulhuddart

Dublin15

Irlanda

Responsible Person

Mylan Hungary Kft

Mylan utca 1

Komárom

H-2900

Hungría

Mylan Germany GmbH

Zweigniederlassung Bad

Homburg Benzstrasse 1

Bad Homburg v. d. Höhe

61352

Alemania

For more information about this medication, please contact the local representative of the marketing authorization holder:

Last review date of this leaflet:November 2022.

Other sources of information

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