TERIFLUNOMIDE AUROVITAS 14 mg FILM-COATED TABLETS

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, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

What is Teriflunomide Aurovitas

Teriflunomide Aurovitas 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 Aurovitas 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 that affects the central nervous system (CNS). The CNS consists of the brain and spinal cord. In multiple sclerosis, inflammation destroys the protective covering (myelin) that surrounds the nerves of the CNS. This loss of myelin is called demyelination. This disrupts the normal functioning of the nerves.

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 can 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 Aurovitas works

Teriflunomide helps protect against attacks on the central nervous system by the immune system, by 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 you take Teriflunomide Aurovitas

Do not take Teriflunomide Aurovitas

• if you are allergic to teriflunomide or any of the other ingredients of this medicine (listed in section 6).
• if you have ever developed a severe skin rash or peeling of the skin, blisters and/or ulcers in the mouth after taking teriflunomide or leflunomide.
• if you have severe liver problems.
• if you are pregnant, think you may be pregnant or are breast-feeding.
• if you have a serious condition that affects your immune system, such as acquired immune deficiency syndrome (AIDS).
• if you have serious bone marrow problems or if you have a low number of white blood cells or red blood cells 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 medicine.

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 cells if they think you have any infection. During treatment with teriflunomide, viral infections such as oral or genital herpes (shingles) may occur. In some cases, serious complications have occurred. You should immediately inform your doctor 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.
• 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 medicines and Teriflunomide Aurovitas

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

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

• leflunomide, methotrexate, and other medicines that affect the immune system (often referred to as immunosuppressants or immunomodulators).
• rifampicin (a medicine 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 the treatment of severe diarrhea.
• theophylline for asthma.
• tizanidine, a muscle relaxant.
• warfarin, an anticoagulant to thin the blood (i.e., make it more fluid) to prevent clots.
• oral contraceptives (containing ethinylestradiol and 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 HIV infection.
• 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 medicines or other substances.

Pregnancy and breast-feeding

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 having a baby with birth defects. Women of childbearing age must not take this medicine if they are not using reliable contraceptive methods.

If your daughter has her first period while taking teriflunomide, she must 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 this medicine has been eliminated from your body before trying to become pregnant. The natural elimination of the active substance can 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, it must be confirmed by a blood test 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 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 the end of treatment, stop taking teriflunomide and contact your doctor immediately for a pregnancy test. If the test confirms pregnancy, your doctor may suggest treatment with certain medicines to eliminate teriflunomide from your body quickly, as this can reduce the risk to your baby.

Contraception

You must 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 effective 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 breast-feeding, as teriflunomide passes into breast milk.

Driving and using machines

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

Teriflunomide Aurovitas contains lactose

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

Teriflunomide Aurovitas contains sodium

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

3. How to take Teriflunomide Aurovitas

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

Follow the instructions for administration of this medicine exactly as prescribed by your doctor. If you are unsure, 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: one 14 mg tablet per day.
• Children with a body weight of 40 kg or less: 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 have a 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.

Form/Route of administration

Teriflunomide is administered orally. This medicine is taken once daily in a single 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 Aurovitas than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 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 forgotten 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 consulting your doctor first.

If you have any further questions on 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 all people suffer from them.

The following adverse effects may occur with this medicine.

Severe Adverse Effects

Some adverse effects can be or may become severe; 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 infrequent in adult patients).

Infrequent (may affect up to 1 in 100 people)

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

Unknown Frequency (frequency cannot be estimated from 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 Adverse Effectsmay occur with the following frequencies:

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

• Headache.
• Diarrhea, feeling sick.
• Increased ALT (increase in certain liver enzymes in the blood) in 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 swallowing difficulties, cystitis, viral gastroenteritis, tooth infection, laryngitis, fungal infection of the foot.
• Herpes virus infections, 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 weakness.
• 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.
• Muscle spasms, 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 discomfort (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 normal.
• Heavy periods.
• Pain.
• Lack of energy or weakness (asthenia).
• Weight loss.

Infrequent (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 the arms and legs (peripheral neuropathy).
• Nail disorders, severe skin reactions.
• Post-traumatic pain.
• Psoriasis.
• Mouth/lip inflammation.
• Abnormal levels of fats (lipids) in the blood.
• Colon inflammation (colitis).

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

• Liver inflammation or damage.

Unknown Frequency (frequency cannot be estimated from available data)

• Respiratory hypertension.

Children (10 years of age 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)

• Pancreatitis.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this leaflet. You can also report them directly through the Spanish Medicines Surveillance System for Human Use: www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Teriflunomida Aurovitas

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

Do not use this medicine after the expiration date that appears on the box and on the blister after CAD. The expiration date is the last day of the month indicated.

Cold-formed triple-layer blister (Al-Al):

This medicine does not require special storage conditions.

White opaque PVC/PVdC-Aluminum blister:

Store below 25°C.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines that you no longer need at the SIGRE Point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition ofTeriflunomidaAurovitas

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

Core of the tablet:lactose monohydrate, cornstarch, sodium carboxymethylcellulose type A (from potato), low-viscosity hydroxypropylcellulose, microcrystalline cellulose (grade 102), anhydrous colloidal silica, and magnesium stearate.

Coating of the tablet:hypromellose 2910 (E464),titanium dioxide (E171), talc (E553b), macrogol 6000 (E1521), indigo carmine (E132).

Appearance of the Product and Package Contents

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

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

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

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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

O

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

O

Arrow Génériques

26 Avenue Tony Garnier

69007 Lyon

France

This medicine is authorized in the Member States of the European Economic Area 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 last revision of this leaflet: August 2024

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