Package Insert: Information for the Patient

Teriflunomida Vivanta 14 mg Film-Coated Tablets EFG
teriflunomida

Read this package insert carefully before you start taking this medicine, because it contains important information for you.

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

Table of Contents

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

What is Teriflunomida Vivanta

Teriflunomida Vivanta 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 Vivanta used for

This medication 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 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 episodes (recurrences) of 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 Vivanta works

Teriflunomida helps to protect against attacks in 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 takeTeriflunomida Vivanta:

• if you are allergic to teriflunomida or any of the other components 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 your 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 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 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 the treatment with teriflunomida. See section 4.
• you have high blood pressure (hypertension), whether or not you are being treated to control it. Teriflunomida 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, your doctor will ensure that you have enough white blood cells and platelets in your blood. Since teriflunomida 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.With teriflunomida treatment, you may experienceinfections caused by the herpes virus, including oral herpes or herpes zoster (shingles). In
  some cases, serious complications have occurred. You must 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 going to be vaccinated.
• you are taking leflunomida with teriflunomida.
• your medication is being changed from or to Teriflunomida Vivanta.
• 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 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:

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

Other medications and Teriflunomida Vivanta

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
• 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 breastfeeding

Do nottake teriflunomida if you are pregnant or think you may be pregnant. If you are pregnant or become pregnant while taking teriflunomida, 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 starts menstruating while taking teriflunomida, she must 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, 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 from your body.

In any case, your doctor needs to confirm, from a blood test, that the level of active ingredient 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 or in the 2 years following the end of treatment, you must interrupt teriflunomida 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 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. Teriflunomida remains in your blood for a long time after you stop taking it. Continue to use contraceptive methods after interrupting treatment.

• Continue to do so until your teriflunomida blood levels 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 during breastfeeding as teriflunomida passes into breast milk.

Driving and operating machinery

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

Teriflunomida Vivanta contains lactose

Teriflunomida Vivanta 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 Vivanta contains sodium

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

A healthcare professional experienced in treating multiple sclerosis will supervise the treatment with teriflunomida.

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 tablet per day.

Children and adolescents (10 years of age and above)

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.

This medication is not suitable for pediatric patients with a body weight ≤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/administration route

Teriflunomida Vivanta is administered orally. Teriflunomida 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 can be taken with or without food.

If you take more Teriflunomida Vivanta than you should

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

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

If you forget to takeTeriflunomida Vivanta

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

If you interrupt treatment with Teriflunomida Vivanta

Do not interrupt treatment or change the dose of teriflunomida 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.

This medicine may cause the following side effects.

Severe side effects

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

Frequent(may affect up to 1 in 10 people)

• Pancreatitis that may include symptoms of abdominal pain, nausea, or vomiting (frequent 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 ulcers in your mouth
• 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 with the available data)

• Severe 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

Frequent(may affect up to 1 in 10 people)

• Common cold, upper respiratory tract infection, urinary tract infection, bronchitis, sinusitis, sore throat, and difficulty swallowing, cystitis, viral gastroenteritis, dental infection, laryngitis, fungal infection of the foot
• Infections caused by herpes virus, including oral herpes and shingles (herpes zoster) 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 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
• Abnormal 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:

Frequent(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 that do not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on 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 and the blister pack after "CAD". The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Teriflunomida Vivanta

The active ingredient is teriflunomida.

-Each tablet contains 14 mg of teriflunomida.

• The other components are:

Tablet core: Lactose monohydrate (see section 2 “Teriflunomida Vivanta contains lactose”), cornstarch, carboxymethylcellulose sodium type A, hydroxypropylcellulose, magnesium stearate, anhydrous colloidal silica,

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

Appearance of Teriflunomida Vivanta and packaging contents

Coated tablets, biconvex, pentagonal in shape, blue in color, with “14” on one side and “T” on the other side.

Teriflunomida Vivanta 14 mg coated tablets EFG are available in carton boxes containing:

-14, 28, 84 and 98 tablets in blister packs with a calendar;

-10x1 tablet in single-dose blister packs,

-28x1 tablet in single-dose blister packs.

Only some packaging sizes may be marketed.

Marketing Authorization Holder:

Vivanta Generics s.r.o

Trtinova 260/1,Cakovice,

196 00, Praga 9

República Checa

Responsible for manufacturing:

Pharmadox Healthcare Limited,

KW20A Corradino Park, Paola, PLA3000

Malta

MSN Labs Europe Limited,

KW20A Corradino Park, Paola, PLA3000

Malta

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

Local Representative:

Vivanta Generics s.r.o. subsidiary in Spain

C/Guzmán el Bueno 133, edificio Britannia

28003 Madrid

This medication is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet:August 2024

More detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/