TERIFLUNOMIDE SANDOZ 14 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Teriflunomide Sandoz 14 mg film-coated tablets EFG

teriflunomide

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

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

What isTeriflunomide Sandoz

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

WhatTeriflunomide Sandozis 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 sheath (myelin) that surrounds the nerves of the CNS. This loss of myelin is called demyelination. This causes the nerves to stop working properly.

People with the relapsing form of multiple sclerosis will have repeated attacks (relapses) of physical symptoms caused by the poor functioning 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 remain. This can cause physical disabilities that can interfere with daily activities.

HowTeriflunomide Sandozworks

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 Sandoz

Do not takeTeriflunomide Sandoz:

• 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 and/or sores 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 white blood cell count or low red blood cell count or low platelet count,
• if you have a serious infection,
• if you have severe kidney problems that require dialysis,
• if you have a low level of proteins in the 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 blood test results indicate a liver problem, your doctor may stop treatment with teriflunomide. Please read 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. Please read 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 the 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 any infection. With teriflunomide treatment, 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. Please read 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,
• your medication is being switched from or to teriflunomide,
• a specific blood test (calcium level) is scheduled. False low 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 taking teriflunomide. Your child's doctor may perform blood tests if they suspect pancreatitis.

Other medicines and Teriflunomide Sandoz

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 severe diarrhea,
• theophylline for asthma,
• tizanidine, a muscle relaxant,
• warfarin, an anticoagulant to thin the blood (make it more fluid) and prevent blood 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 nottake teriflunomide if you are, 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 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 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, 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 teriflunomide level 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 must stop taking teriflunomide and immediatelycontact your doctor to perform a pregnancy test. If the test confirms pregnancy, your doctor may suggest treatment with certain medicines to eliminate teriflunomide from your body quickly enough, as this may 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 contraceptive measures after stopping treatment.

• Continue to do so until the teriflunomide levels 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 it passes into breast milk.

Driving and using machines

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

Teriflunomide Sandoz contains lactose

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

Teriflunomide Sandoz contains redallura AC (E129)

It may cause allergic reactions.

Teriflunomide Sandoz contains sodium

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

3. How to take Teriflunomide Sandoz

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. Teriflunomide Sandoz is only available in 14 mg tablets; therefore, your doctor will switch this category of patients to a different medicine.

For children and adolescents who reach a stable body weight of over 40 kg, your doctor will instruct them to switch to a 14 mg tablet per day.

Form/Route of administration

Teriflunomide is administered orally. Teriflunomide is taken once daily 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 takemore Teriflunomide Sandoz 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, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to takeTeriflunomide Sandoz

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 Sandoz

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)

• inflammation of the pancreas 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 life-threatening) that could include symptoms such as high fever, chills, shivering, decreased urine flow, or confusion,
• inflammation of the lungs that could include symptoms such as shortness of breath or persistent cough.

Unknown Frequency (frequency cannot be estimated with available data)

• severe liver disease that 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 Effectsmay occur with the following frequencies:

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

• headache,
• diarrhea, feeling of illness,
• increase in 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 herpes zoster (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 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 illness (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.

Infrequent(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; problems in the nerves of the arms and legs (peripheral neuropathy),
• changes in the 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)

• inflammation or liver damage.

Unknown Frequency(frequency cannot be estimated with 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)

• inflammation of the pancreas.

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 prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Teriflunomida Sandoz

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

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

This medicine does not require special storage conditions.

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. In case of doubt, 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 ofTeriflunomida Sandoz

• The active ingredient is teriflunomide. Each film-coated tablet contains 14 mg of teriflunomide.

• The other components are:

Tablet core: lactose monohydrate, cornstarch, microcrystalline cellulose, hydroxypropylcellulose, sodium glycolate starch (type A), colloidal anhydrous silica, magnesium stearate.

Tablet coating: hypromellose, titanium dioxide (E171), carmine indigo aluminum lake (E132), glycerol, talc, brilliant blue FCF aluminum lake (E133), and allura red AC aluminum lake (E129).

Product Appearance and Package Contents

Teriflunomida Sandoz are film-coated tablets of blue color, round biconvex shape (approximately 7 mm in diameter), marked with "14" on one face.

The tablets are packaged in OPA/Aluminum/PVC - Aluminum blisters, in cardboard boxes.

Package sizes:

Blisters of 14, 28, 84, or 98 film-coated tablets.

Integrated blisters of 14 (1 pack of 14), 28 (1 pack of 28), 84 (3 packs of 28), 98 (7 packs of 14) film-coated tablets.

Perforated unit-dose blisters of 10 x 1 and 28 x 1 film-coated tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1

39179 Barleben

Germany

or

Combino Pharm (Malta) Ltd.

HF60, Hal Far Industrial Estate,

Hal Far, BBG3000

Malta

or

HBMP Pharma s.r.o.

Sklabinská 30

SK-036 80 Martin

Slovakia

Date of the Last Revision of this Prospectus:September 2024.

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

Other Sources of Information

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

You can access detailed and updated information on how to administer this medicine by scanning the QR code included in the packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/info/88466.