Package Insert: Information for the Patient

Teriflunomida Sandoz 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 you should not give it 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.

What isTeriflunomida Sandoz

Teriflunomida Sandozcontains the active ingredient teriflunomida, which is an immunomodulator agent that adjusts the immune system to limit its attack on the nervous system.

What is it used forTeriflunomida Sandoz

Teriflunomidais 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 formed by 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 correctly.

People who suffer from the relapsing form of MS will have repeated attacks (recurrences) of the physical symptoms caused by the inadequate functioning of the nerves. These symptoms vary from patient to patient, but usually include:

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 Sandoz works

Teriflunomidahelps 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 Sandoz:

• if you are allergic to teriflunomida 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 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 the immune system, for example, acquired immunodeficiency syndrome (AIDS),
• if you have severe problems with the bone marrow or if you have a low number of white blood cells, red blood cells or platelets in the 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 very low level of protein in the blood (hypoproteinemia).

Ask your doctor or pharmacist for advice before taking this medicine.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Teriflunomida if:

• you have liver problems and/or if you drink large quantities of alcohol. Your doctor may perform blood tests to check the function of your liver before and during treatment. If the test results indicate a liver problem, your doctor may interrupt treatment with teriflunomida. Please 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. Please 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 the blood. Since teriflunomida reduces the number of white blood cells in the blood, this may affect your ability to fight off the infection. Your doctor may perform blood tests to check your white blood cells if they suspect that you have any infection. With teriflunomida treatment, you may experience viral infections, including oral herpes or shingles (herpes zoster). In some cases, serious complications have occurred. You should inform your doctor immediately if you suspect that you have any symptoms of a viral herpes infection. Please 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 doctor is changing your medication from or to teriflunomida,
• you are due to have a specific blood test (calcium level). False low levels of calcium may be detected.

Respiratory reactions

Inform your doctor if you have cough and shortness of breath (lack of air) without explanation. Your doctor may perform additional tests.

Children and adolescents

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

Other medicines and Teriflunomida Sandoz

Inform your doctor or pharmacist if you are taking, have taken recently or may need to takeany other medicine. This includes medicines without a prescription.

Especially, inform your doctor or pharmacist if you are taking any of the following medicines:

• leflunomida, methotrexate and other medicines that affect the immune system (often referred to as immunodepressants or immunomodulators),
• rifampicin (a medicine used to treat tuberculosis and other infections),
• carbamazepine, phenobarbital, phenytoin for epilepsy,
• hypericum (a plant-based medicine 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 (containing ethinylestradiol and levonorgestrel),
• cefaclor, benzylpenicillin (penicillin G), ciprofloxacin for infections,
• indometacin, 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 (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 breastfeeding

Do nottake teriflunomida if you are, 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 medicine unless they are using reliable contraceptive methods.

If your daughter starts menstruating while takingteriflunomida, she should 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 medicine has been eliminated from your body before trying to become pregnant. The elimination of the active ingredient naturally may take up to 2 years. This period of time may be reduced to a few weeks by taking certain medicines to accelerate the elimination of teriflunomida from your body.

In any case, you should confirm from a blood test that the active ingredient has been sufficiently eliminated from your body and you need confirmation from your doctor that the level of teriflunomida in the blood is low enough to become pregnant.

For more information on laboratory tests, contact your doctor.

If you suspect that you are pregnant while taking teriflunomida or in the two years following the end of treatment, you should interrupt teriflunomida and contact your doctorimmediatelyto perform a pregnancy test. If the test confirms pregnancy, your doctor may suggest a treatment with certain medicines to eliminate teriflunomida 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 withteriflunomida. Teriflunomida remains in the blood for a long time after stopping it. Continue to take contraceptive measures after interrupting treatment.

Do not taketeriflunomidaduring breastfeeding as it passes into breast milk.

Driving and operating machines

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

Teriflunomida Sandoz contains lactose

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

Teriflunomida Sandoz contains Red Allura AC (E129)

It may cause allergic reactions.

Teriflunomida Sandoz contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per coated tablet; it 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 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 older)

The dose depends on body weight:

• Children with a body weight greater than 40 kg: one 14 mg tablet per day.
• Children with a body weight less than or equal to 40 kg: one 7 mg tablet per day. Teriflunomida Sandoz is only available in 14 mg tablets, therefore, your doctor will refer these patients to another medication available.

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

Form/administration route

Teriflunomidais administered orally.Teriflunomidais taken once a day in a single daily dose at any time of the day.

The tablet should be swallowed whole with water.

Teriflunomidacan be taken with or without food.

If you takemore Teriflunomida Sandoz 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.

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

If you forget to takeTeriflunomida Sandoz

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

If you interrupt the treatment with Teriflunomida Sandoz

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 or may become 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 could include symptoms of rash, urticaria, 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 your mouth,
• Severe infections or sepsis (a type of infection that can be potentially fatal) that could include symptoms such as high fever, chills, decreased urine flow, or confusion,
• Lung inflammation that could 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 than normal urine, nausea, and vomiting without explanation, or abdominal pain.

Other side effectsmay occur with the following frequencies:

Very frequent(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)

• Flu, upper respiratory tract infection, urinary tract infection, bronchitis, sinusitis, sore throat, and swallowing difficulties, cystitis, viral gastroenteritis, dental infection, laryngitis, fungal infection of the foot,
• Herpes virus infections, including oral herpes and shingles (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,
• Shooting pains, 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,
• Poriasis,
• Swelling of the mouth/lips,
• Anomalous 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 any type of side effect, consult your doctororpharmacist, even if it is a possible side effect that does 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 blister pack and on the box after CAD/EXP. 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.Deposit the containers and medications you no longer need at the SIGRE collection point of the pharmacy.Ask your pharmacist if you are unsure how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition ofTeriflunomida Sandoz

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

• The other components are:

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

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

Appearance of the product and contents of the package

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

The tablets are packaged in OPA/Aluminium/PVC – Aluminium blisters, in cardboard boxes.

Package sizes:

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

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

Single-dose perforated blisters of 10 x 1 and 28 x 1 film-coated tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible 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

Last review date of this leaflet:September 2024.

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (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 Medical Devices (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 smartphone. You can also access this information at the following internet address:https://cima.aemps.es/info/88466