Teriflunomide Viatris Pharmaceuticals 14 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Package Leaflet: Information for the patient

Teriflunomide Viatris Pharmaceuticals 14 mg film-coated tablets EFG

Read the entire 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 and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

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

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

What Teriflunomide Viatris Pharmaceuticals is

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

What Teriflunomide Viatris Pharmaceuticals 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 is multiple sclerosis

MS is a long-term disease affecting the central nervous system (CNS). The CNS consists of the brain and spinal cord. In multiple sclerosis, inflammation destroys the protective sheath (called myelin) that surrounds the nerves of the CNS. This loss of myelin is known as demyelination. This causes the nerves to malfunction.

People with the relapsing form of multiple sclerosis will experience repeated attacks (relapses) of physical symptoms caused by improper nerve function. These symptoms vary from patient to patient but typically include:

• difficulty walking
• vision problems
• balance problems

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

How Teriflunomide Viatris Pharmaceuticals works

Teriflunomide helps protect against immune system attacks on the central nervous system by limiting the growth of certain white blood cells (lymphocytes). This reduces the inflammation that causes nerve damage in MS.

2. What you need to know before taking Teriflunomide Viatris Pharmaceuticals

Do not take Teriflunomide Viatris Pharmaceuticals:

• if you are allergic to teriflunomide or to any of the other ingredients of this medicine (listed in Section 6);

• if you have ever developed a severe skin rash, skin peeling, blisters and/or mouth ulcers after taking teriflunomide or leflunomide;

• if you have severe liver problems;

• if you are pregnant, think you might be pregnant, or are breastfeeding;

• if you have a serious condition affecting your immune system, for example, acquired immunodeficiency syndrome (AIDS);

• if you have severe bone marrow problems, or if you have low levels of red or white blood cells or a low platelet count in your blood;

• if you have a serious infection;

• if you have severe kidney problems requiring dialysis;

• if you have very low levels of protein in your blood (hypoproteinemia).

If in doubt, ask your doctor or pharmacist before taking this medicine.

Warnings and precautions

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

• you have liver problems and/or drink large amounts of alcohol. Your doctor may carry out blood tests before and during treatment to check how well your liver is working. If your test results show any liver problems, your doctor may stop treatment with teriflunomide. See section 4.
• you have high blood pressure (hypertension), whether or not you are being treated for it. The medicine 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 the medicine, your doctor will ensure you have sufficient white blood cells and platelets in your blood. Since teriflunomide reduces the number of white blood cells in the blood, this may affect your ability to fight any infection you may have. Your doctor may perform blood tests to monitor your white blood cells if they suspect you have an infection. Viral herpes infections, including oral herpes or herpes zoster (shingles), may occur during treatment with teriflunomide. In some cases, serious complications may arise. You should inform your doctor immediately if you suspect you have any symptoms of a herpes virus 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 due to be vaccinated.
• you are taking leflunomide with teriflunomide.
• you are switching medication to or from teriflunomide.
• you are scheduled for a specific blood test (calcium level). A falsely low calcium level may be detected.

Respiratory reactions

Inform your doctor if you have cough and dyspnea (difficulty breathing) without an apparent cause. Your doctor may perform additional tests.

Children and adolescents

Teriflunomide 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:

• Pancreatic inflammation has been observed in patients receiving teriflunomide. Your child’s doctor may perform blood tests if they suspect pancreatic inflammation.

Other medicines and Teriflunomide Viatris Pharmaceuticals

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. 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 that affect the immune system (often 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 remedy for depression)
• repaglinide, pioglitazone, nateglinide, or rosiglitazone for diabetes
• daunorubicin, doxorubicin, paclitaxel, or topotecan for cancer
• duloxetine for depression, urinary incontinence, or kidney disease in diabetics
• alosetron for the treatment of severe diarrhea
• theophylline for asthma
• tizanidine, a muscle relaxant
• warfarin, an anticoagulant used to thin the blood (i.e., make it more fluid) to prevent blood clots
• oral contraceptives (containing ethinylestradiol and levonorgestrel)
• cefaclor, benzylpenicillin (penicillin G), ciprofloxacin for infections
• indometacin, ketoprofen for pain or inflammation
• furosemide for heart conditions
• cimetidine for reducing gastric acid
• zidovudine for AIDS
• rosuvastatin, simvastatin, atorvastatin, pravastatin for hypercholesterolemia (high cholesterol)
• sulfasalazine for inflammatory bowel disease or rheumatoid arthritis
• colestyramine 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 this medicine if you are pregnant or think you may be pregnant. If you become pregnant while taking teriflunomide, there is an increased risk of having a baby with birth defects. Women of childbearing potential must not take this medicine unless they are using reliable contraceptive methods.

If your daughter starts menstruating while taking this medicine, you must inform the doctor, who will provide specific advice regarding contraception and the potential risks in case of pregnancy.

Inform your doctor if you plan to become pregnant after stopping treatment with teriflunomide, as you must ensure that most of the medicine has been eliminated from your body before attempting pregnancy. 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 that accelerate the elimination of teriflunomide from the body. In any case, your doctor must confirm, through a blood test, that the level of active substance in your blood is low enough to allow pregnancy.

For further information about laboratory tests, contact your doctor.

If you suspect you are pregnant while taking teriflunomide or within two years after stopping treatment, you must stop taking teriflunomide and contact your doctor immediately for a pregnancy test. If the test confirms pregnancy, your doctor may recommend treatment with certain medicines to rapidly reduce teriflunomide levels in your body, as this may reduce the risk to your baby.

Contraception

You must use an effective contraceptive method during and after treatment with this medicine. Teriflunomide remains in the blood for a long time after stopping treatment. Continue using an effective contraceptive method after stopping treatment.

• Continue until teriflunomide blood levels are sufficiently low (your doctor will check this).
• Consult your doctor about the best contraceptive method for you and if you need to change methods.

Do not take Teriflunomide Viatris Pharmaceuticals during breastfeeding, as teriflunomide passes into breast milk.

Driving and using machines

This medicine may cause dizziness, which could affect your concentration and reaction ability. If affected, do not drive or operate machinery.

Teriflunomide Viatris Pharmaceuticals contains lactose

This medicine 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 medicine.

Teriflunomide Viatris Pharmaceuticals contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially "sodium-free".

3. How to take Teriflunomida Viatris Pharmaceuticals

Treatment with teriflunomide will be supervised by a physician experienced in the treatment of multiple sclerosis.

Always follow your doctor's instructions for taking this medicine exactly. If in doubt, consult your doctor again.

Adults

The recommended dose is one 14 mg tablet per day.

Children and adolescents (from 10 years of age)

The dose depends on body weight:

• Children with body weight above 40 kg: one 14 mg tablet per day.
• Children with body weight equal to or below 40 kg: one 7 mg tablet per day.

Teriflunomida Viatris Pharmaceuticals 14 mg film-coated tablets EFG are not suitable for pediatric patients with a body weight ≤40 kg. Other medicinal products containing teriflunomide at a lower dose (7 mg film-coated tablets) are available.

The physician will instruct children and adolescents who reach a stable body weight above 40 kg to switch to one 14 mg tablet per day.

Method of administration

Teriflunomida Viatris Pharmaceuticals is administered orally. It is taken once daily, at any time of day. The tablets must be swallowed whole with water.

It may be taken with or without food.

If you take more Teriflunomida Viatris Pharmaceuticals than you should

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

In case of overdose or accidental ingestion, contact your doctor or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Teriflunomida Viatris Pharmaceuticals

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

If you stop taking Teriflunomida Viatris Pharmaceuticals

Do not stop taking this medicine or change the dose without first consulting your doctor.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The following adverse effects may occur with this medicine.

Serious adverse effects

Some adverse effects could be or become serious. If you experience any of these effects, inform your doctor immediately.

Frequent (may affect up to 1 in 10 people)

• Inflammation of the pancreas which may include symptoms of abdominal pain, nausea or vomiting (frequent in pediatric 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 lips, tongue or face, or sudden difficulty breathing
• Serious skin reactions which may include symptoms such as skin rash, blisters, fever or mouth ulcers
• Severe infections or sepsis (a potentially life-threatening type of infection) which may include symptoms such as high fever, trembling, chills, reduced urine output or confusion
• Inflammation of the lungs which may include symptoms such as shortness of breath or persistent cough

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

• Serious liver disease 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 adverse effects that may occur with the following frequencies:

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

• Headache
• Diarrhea, feeling unwell
• Increased ALT (elevation in levels of certain liver enzymes in blood) in laboratory tests
• Thinner hair

Frequent (may affect up to 1 in 10 people)

• Flu, upper respiratory tract infection, urinary tract infection, bronchitis, sinusitis, sore throat and difficulty swallowing, cystitis, viral gastroenteritis, oral herpes, dental infection, laryngitis, fungal infection of the feet
• Infections with herpes viruses, including oral herpes and herpes zoster (shingles), with symptoms such as blisters, burning, itching, numbness or pain on the skin, usually on one side of the upper body or face, and other symptoms such as fever and weakness
• Laboratory findings: a decrease in red blood cells (anemia), changes in liver function tests and white blood cell counts (see section 2), as well as elevations in a muscle enzyme (creatine phosphokinase)
• Mild allergic reactions
• Feeling of anxiety
• Muscle soreness, feeling of weakness, numbness, tingling or pain in the lower back or leg (sciatica); sensation of numbness, burning, tingling or pain in the hands and fingers (carpal tunnel syndrome)
• Palpitations
• Increased blood pressure
• Feeling unwell (vomiting), toothache, pain in the upper abdomen
• Rash, acne
• Tendon, joint or bone pain, muscle pain (musculoskeletal pain)
• Need to urinate more frequently than usual
• Heavy menstrual 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 platelets in the blood (mild thrombocytopenia)
• Increased sensation or sensitivity, especially in the skin; stabbing or pulsating pain in one or more nerves, nerve problems in arms or legs (peripheral neuropathy)
• Nail disorders, serious 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)

• Liver inflammation or liver damage

Frequency not known (cannot be estimated from available data)

• Pulmonary hypertension

Children (from age 10) and adolescents

The adverse effects listed above also apply to children and adolescents. The following additional information is important for children, adolescents and their caregivers:

Frequent (may affect up to 1 in 10 people)

• Inflammation of the pancreas

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Teriflunomida Viatris Pharmaceuticals

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

Do not use this medicine after the expiry date stated on the carton after "EXP". The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Teriflunomide Viatris Pharmaceuticals

The active substance is teriflunomide.

Teriflunomide Viatris Pharmaceuticals 14 mg film-coated tablets EFG

• Each tablet contains 14 mg of teriflunomide.
• The other components are:

Tablet core: lactose monohydrate, corn starch, hydroxypropylcellulose, microcrystalline cellulose, sodium carboxymethylstarch type A, colloidal anhydrous silica, magnesium stearate.

Film coating: hypromellose, titanium dioxide (E171), colloidal anhydrous silica, macrogol (E1521), indigo carmine, FD&C Blue No. 2 (E132).

(See Section 2 "Teriflunomide Viatris Pharmaceuticals contains lactose").

Appearance of the product and contents of the pack

Teriflunomide Viatris Pharmaceuticals 14 mg film-coated tablets EFG are blue, round (8.0 mm), biconvex film-coated tablets, smooth on both sides.

Teriflunomide Viatris Pharmaceuticals 14 mg film-coated tablets EFG are packed in:

• Aluminium-aluminium blisters containing 28 and 84 film-coated tablets.
• BUD aluminium-aluminium blisters containing 28 film-coated tablets.
• Calendar blisters composed of aluminium-aluminium containing 98 film-coated tablets.

Only some pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorization Holder

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

Manufacturer

Laboratorios Liconsa, S.A.

Avda. Miralcampo, No. 7,

Pol. Ind. Miralcampo,

19200 Azuqueca de Henares,

Guadalajara, Spain

or

Pharmadox Healthcare Ltd

KW20A Kordin Industrial Park,

Paola, PLA 3000,

Malta

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Iceland: Teriflunomida Medical Valley 14 mg film-coated tablets

Germany: Teriflunomid AXiromed 14 mg Filmtabletten

France: TERIFLUNOMIDE LICONSA 14 mg, comprimé pelliculé

Spain: Teriflunomida Viatris Pharmaceuticals 14 mg film-coated tablets EFG

Portugal: Teriflunomida Liconsa 14 mg film-coated tablets

Italy: Teriflunomida Xiromed

Norway: Teriflunomida Medical Valley

Poland: Teriflunomida Medical Valley

Date of latest review of this leaflet: July 2025

Other sources of information

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/