Teriflunomide Aurovitas 14 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Teriflunomide Aurovitas 14 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet as 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 you should not give it to other people even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of this leaflet

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

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

What Teriflunomide Aurovitas is

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

What Teriflunomide Aurovitas is used for

Teriflunomide is used in adults and in children and adolescents (aged 10 years 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 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 Aurovitas 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 starting Teriflunomide Aurovitas

Do not take Teriflunomide Aurovitas

• 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 may be pregnant, or are breastfeeding.
• if you have a serious disorder affecting the immune system, for example, acquired immunodeficiency syndrome (AIDS).
• if you have severe bone marrow problems or if you have low levels of white blood cells or red blood cells in your blood or a low platelet count.
• 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 teriflunomide if:

• you have liver problems and/or drink large amounts of alcohol. Your doctor may carry out blood tests to check your liver function before and during treatment. If test results indicate a problem with your liver, your doctor may stop treatment with teriflunomide. See section 4.
• you have high blood pressure (hypertension), whether or not you are being treated to control it. Teriflunomide may cause an increase in blood pressure. Your doctor will monitor your blood pressure before starting treatment and regularly during treatment. See section 4.
• you have an infection. Before starting teriflunomide, your doctor will ensure you have adequate levels of 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 infections. Your doctor may perform blood tests to check your white blood cell count 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 have occurred. You must inform your doctor immediately if you suspect any symptoms of a herpes virus infection. See section 4.
• you have severe skin reactions.
• you have respiratory symptoms.
• you experience weakness, numbness, and pain in hands and feet.
• you are due to be vaccinated.
• you are taking leflunomide together with teriflunomide.
• you are switching from or to teriflunomide.
• you are scheduled to have a specific blood test (calcium level). A falsely low calcium level may be detected.

Respiratory reactions

Inform your doctor if you have unexplained cough or dyspnea (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 (inflammation of the pancreas) has been observed in patients receiving teriflunomide. Your child’s doctor may perform blood tests if pancreatitis is suspected.

Other medicines and Teriflunomide Aurovitas

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This includes medicines 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 (Hypericum perforatum), 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 kidney disease in diabetics.
• alosetron for the treatment of severe diarrhea.
• theophylline for asthma.
• tizanidine, a muscle relaxant.
• warfarin, an anticoagulant to thin the blood (i.e., make it less likely to clot) to prevent clots.
• oral contraceptives (containing ethinylestradiol and levonorgestrel).
• cefaclor, benzylpenicillin (penicillin G), ciprofloxacin for infections.
• indometacin, ketoprofen for pain or inflammation.
• furosemide for heart disease.
• cimetidine to reduce gastric acid.
• zidovudine for HIV infection.
• rosuvastatin, simvastatin, atorvastatin, pravastatin for hypercholesterolemia (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 absorption of medicines or other substances.

Pregnancy and breastfeeding

Do not take teriflunomide if you are pregnant or think you may be pregnant. If you are pregnant or become pregnant while taking teriflunomide, there is an increased risk of birth defects in your baby. Women of childbearing potential must not take this medicine unless they are using reliable contraceptive methods.

If your daughter starts menstruation while taking teriflunomide, inform the doctor, who will provide specialized advice on 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 this medicine has been eliminated from your body before attempting pregnancy. Elimination of the active substance naturally 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 from the body.

In any case, blood testing must confirm that the active substance has been sufficiently eliminated from your body, and you need confirmation from your doctor that the blood level of teriflunomide is low enough to allow pregnancy.

For further information on 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 and sufficiently eliminate teriflunomide from your body, as this may reduce the risk to your baby.

Contraception

You must use an effective method of contraception during and after treatment with teriflunomide. Teriflunomide remains in the blood for a long time after you stop taking it. Continue using effective contraceptive measures after stopping treatment.

• Continue until blood levels of teriflunomide 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 during breastfeeding, as teriflunomide passes into breast milk.

Driving and using machines

Teriflunomide may cause dizziness, which may affect concentration and reaction ability. If affected, do not drive or operate machinery.

Teriflunomide Aurovitas contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.

Teriflunomide Aurovitas contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; hence, it is essentially “sodium-free”.

3. How to take Teriflunomide Aurovitas

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

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor again.

Adults

The recommended dose is one 14 mg tablet per day.

Children and adolescents (aged 10 years and older)

The dose depends on body weight:

• Children with body weight greater than 40 kg: one 14 mg tablet per day.
• Children with body weight less than or equal to 40 kg: one 7 mg tablet per day.

The 14 mg film-coated tablets of teriflunomide are not suitable for pediatric patients with a body weight ≤40 kg.

This brand does not provide the 7 mg dose. Other teriflunomide medicines with a lower dose (such as 7 mg film-coated tablets) are available on the market.

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

Method/route of administration

Teriflunomide is administered orally. This medicine is taken daily as a single dose at any time of the day.

The tablet must be swallowed whole with water.

Teriflunomide may be taken with or without food.

If you take more Teriflunomide Aurovitas than you should

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

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

If you forget to take Teriflunomide Aurovitas

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

If you stop taking Teriflunomide Aurovitas

Do not stop treatment or change the dose of teriflunomide 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 may be or may become serious. If you experience any of these, inform your doctor immediately.

Frequent (may affect up to 1 in 10 people)

• inflammation of the pancreas, which may include symptoms such as 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 that could include symptoms such as rash, hives, swelling of the lips, tongue, or face, or sudden difficulty breathing.
• severe skin reactions that could include symptoms such as skin rash, blisters, fever, or mouth ulcers.
• severe infections or sepsis (a type of infection that may be potentially life-threatening), which could include symptoms such as high fever, shaking, chills, reduced urine output, or confusion.
• inflammation of the lungs that could include symptoms such as shortness of breath or persistent cough.

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

• severe liver disease, which may include symptoms such as yellowing of the skin or whites of the eyes, unusually dark urine, unexplained nausea and vomiting, or abdominal pain.

Other adverse effects may occur with the following frequencies:

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

• headache.
• diarrhea, feeling unwell.
• increased ALT (elevation of certain liver enzymes in blood 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, dental infection, laryngitis, fungal foot infection.
• herpes virus infections, 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 cell count (anemia), changes in liver function 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.
• muscle soreness, feeling of weakness, numbness, tingling, or pain in the lower back or leg (sciatica); sensation of numbness, burning, tingling, or pain in hands and fingers (carpal tunnel syndrome).
• palpitations.
• increased blood pressure.
• feeling unwell (nausea), toothache, upper abdominal pain.
• rash, acne.
• tendon, joint, or bone pain, muscle pain (musculoskeletal pain).
• need to urinate more often than usual.
• heavy menstrual periods.
• pain.
• lack of energy or weakness (asthenia).
• weight loss.

Uncommon (may affect up to 1 in 100 people)

• decreased platelet count (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).
• nail disorders, 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 people)

• liver inflammation or damage.

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

• pulmonary hypertension.

Children (aged 10 years and older) 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 type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Teriflunomide Aurovitas

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 on the blister after EXP. The expiry date refers to the last day of the month indicated.

Cold-forming triple-layered blister (Al-Al):

This medicine does not require any special storage conditions.

White opaque PVC/PVdC-Aluminum blister:

Store below 25 °C.

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

6. Contents of the pack and other information

Composition of Teriflunomide Aurovitas

• The active substance is teriflunomide. Each film-coated tablet contains 14 mg of teriflunomide.
• The other components (excipients) are:

Tablet core: lactose monohydrate, corn starch, sodium carboxymethyl starch type A (from potato), hydroxypropylcellulose (low viscosity grade), microcrystalline cellulose (grade 102), colloidal anhydrous silica, and magnesium stearate.

Tablet coating: hypromellose 2910 (E464), titanium dioxide (E171), talc (E553b), macrogol 6000 (E1521), indigo carmine blue FD&C 2 (E132).

Nature and contents of the container

Film-coated tablets, light blue to blue, round (approximately 7.2 mm in diameter), marked with "N" on one side and "14" on the other.

Teriflunomide Aurovitas film-coated tablets are available in blister packs.

Pack sizes: 14, 28, 30, 56, 60, 70, 84, 90, 98, 100, 120 and 200 film-coated tablets.

Only some pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

Or

Arrow Génériques

26 Avenue Tony Garnier

69007 Lyon

France

This medicinal product is authorised in the European Economic Area member states under the following names:

Germany: Teriflunomid PUREN 14 mg Filmtabletten
Belgium: Teriflunomide AB 14 mg filmomhulde tabletten / comprimés pelliculés / Filmtabletten
Spain: Teriflunomida Aurovitas 14 mg comprimidos recubiertos con película EFG
France: Teriflunomide Arrow 14 mg comprimé pelliculé
Netherlands: Teriflunomide Aurobindo 14 mg, filmomhulde tabletten
Poland: Teriflunomide Aurovitas
Portugal: Teriflunomida Generis

Date of the most recent revision of this leaflet: August 2024

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/).