TERIFLUNOMIDE VIVANTA 14 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Teriflunomide Vivanta 14 mg film-coated tablets EFGteriflunomide

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, 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 side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Teriflunomide Vivanta and what is it used for?
2. What you need to know before taking Teriflunomide Vivanta
3. How to take Teriflunomide Vivanta
4. Possible side effects
5. Storage of Teriflunomide Vivanta
6. Package contents and additional information

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

What is Teriflunomide Vivanta

Teriflunomide Vivanta 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 Vivanta used for

This medication is used in adults and 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 that affects the central nervous system (CNS). The CNS consists of the brain and spinal cord. In multiple sclerosis, inflammation destroys the protective sheath (myelin) that surrounds the nerves of the CNS. This loss of myelin is called demyelination. This causes the nerves to stop functioning properly.

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

• difficulty walking
• vision problems
• balance problems.

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

How Teriflunomide Vivanta works

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

2. What you need to know before taking Teriflunomide Vivanta

Do not takeTeriflunomide Vivanta:

• if you are allergic to teriflunomide 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 teriflunomide or leflunomide,
• if you have severe liver problems,
• if you are pregnant, think you may be pregnant, or are breastfeeding,
• if you have a serious immune system problem, such as acquired immune deficiency syndrome (AIDS),
• if you have serious bone marrow problems or a low white blood cell count or a low red blood cell count or a low platelet count in your blood,
• if you have a serious infection,
• if you have severe kidney problems that require dialysis,
• if you have a low protein level 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 teriflunomide 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. See section 4.
• you have high blood pressure (hypertension), whether or not you are being treated for it. Teriflunomide 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, your doctor will make sure you have enough white blood cells and platelets in your blood. Since teriflunomide 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 suspect you have an infection. With teriflunomide treatment, viral infections, including oral or genital herpes (shingles), may occur.In some cases, serious complications have occurred. You should inform your doctor immediately if you suspect you have any symptoms of a viral 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.
• you are being switched from or to Teriflunomide Vivanta.
• 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 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 medications and Teriflunomide Vivanta

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medications. This includes medications without a prescription.

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

• leflunomide, methotrexate, and other medications that affect the immune system (often referred to as immunosuppressants or immunomodulators)
• rifampicin (a medication 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 nephropathy
• 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 medications or other substances.

Pregnancy and breastfeeding

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

If your daughter has her first menstrual period while taking teriflunomide, she should 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, as you need to make sure that most of the medication 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 medications to accelerate the elimination of teriflunomide from the body.

In any case, you need your doctor to confirm, based on a blood test, that the level of the active substance 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 or in the 2 years following treatment, you should stop taking teriflunomide and contact your doctor immediatelyto have a pregnancy test. If the test confirms pregnancy, your doctor may suggest treatment with certain medications to eliminate teriflunomide from your body quickly, as this may reduce the risk to your baby.

Contraception

You should use an effective contraceptive method during and after treatment with teriflunomide. Teriflunomide remains in the blood for a long time after stopping treatment. Continue to take contraceptive measures after stopping treatment.

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

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

Driving and using machines

Teriflunomide Vivanta may cause dizziness, which may affect your ability to concentrate and react. If you are affected, do not drive or use machines.

Teriflunomide Vivanta contains lactose

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

Teriflunomide Vivanta contains sodium

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

3. How to take Teriflunomide Vivanta

A doctor with experience in treating multiple sclerosis will supervise treatment with teriflunomide.

Follow the instructions for taking this medication exactly as indicated by your doctor. If you are in doubt, consult your doctor again.

Adults

The recommended dose is one 14 mg 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.

This medication is not suitable for pediatric patients with a body weight of ≤40 kg; other medications are available in a lower concentration (such as 7 mg film-coated tablets).

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

Form/Route of Administration

Teriflunomide Vivanta is administered orally. Teriflunomide is taken once a day in a single daily dose at any time of day. The tablet should be swallowed whole with water.

Teriflunomide can be taken with or without food.

If you take more Teriflunomide Vivanta than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to takeTeriflunomide Vivanta

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

If you stop taking Teriflunomide Vivanta

Do not stop treatment or change the dose of teriflunomide without consulting your doctor first.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone gets them.

The following side effects may occur with this medication.

Serious side effects

Some side effects may be serious, and if you experience any of them, 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 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
• serious infections or sepsis (a type of infection that can be life-threatening) that may include symptoms such as high fever, chills, shaking, decreased urine flow, or confusion
• inflammation of the lungs that may include symptoms such as shortness of breath or persistent cough

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

• severe liver disease that may include symptoms such as yellowing of the skin or whites of the eyes, darker urine than normal, 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, dental infection, laryngitis, fungal infection of the foot
• viral infections, including oral or genital herpes (shingles), with symptoms such as blisters, burning, itching, numbness, or pain in the skin, usually on one side of the upper body or face, and other symptoms, such as fever and weaknessLaboratory values: a decrease in the number of red blood cells (anemia), changes in liver and white blood cells in blood tests (see section 2), as well as elevations in a muscle enzyme (creatine phosphokinase)
• mild allergic reactions
• feeling anxious
• tingling, feeling weak, numbness, 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 abdominal region
• 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 in the nerves of arms and legs (peripheral neuropathy)
• changes in nails, severe 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 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 side effects

If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Teriflunomida Vivanta

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 and blister after "EXP". The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Teriflunomida Vivanta

The active substance is teriflunomida.

• Each tablet contains 14 mg of teriflunomida.
  • The other ingredients are:

Tablet core: Lactose monohydrate (see section 2 "Teriflunomida Vivanta contains lactose"), maize starch, sodium carboxymethyl cellulose type A, hydroxypropyl cellulose, magnesium stearate, anhydrous colloidal silica,

Tablet coating: Hypromellose, titanium dioxide (E171), yellow iron oxide (E172), macrogol 6000, and indigo carmine (E132).

Appearance of Teriflunomida Vivanta and Package Contents

The film-coated tablets are biconvex, pentagonal in shape, blue in color, and engraved with "14" on one side and "T" on the other side.

Teriflunomida Vivanta 14 mg film-coated tablets EFG are available in cardboard boxes containing:

• 14, 28, 84, and 98 tablets in calendar blister packs;
• 10x1 tablet in unit-dose blisters,
• 28x1 tablet in unit-dose blisters.

Only some pack sizes may be marketed.

Marketing Authorization Holder:

Vivanta Generics s.r.o

Trtinova 260/1, Cakovice,

196 00, Prague 9

Czech Republic

Manufacturer:

Pharmadox Healthcare Limited,

KW20A Corradino Park, Paola, PLA3000

Malta

MSN Labs Europe Limited,

KW20A Corradino Park, Paola, PLA3000

Malta

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

Local Representative:

Vivanta Generics s.r.o. branch in Spain

C/Guzmán el Bueno 133, Britannia building

28003 Madrid

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

Date of the Last Revision of this Leaflet:August 2024

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