Package Insert: Information for the User

Teriflunomida Tarbis 7 mg Film-Coated Tablets

Teriflunomida Tarbis 14 mg Film-Coated Tablets

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.

What is Teriflunomida Tarbis

Teriflunomida Tarbis 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 Tarbis used for

Teriflunomida 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 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:

• 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 does Teriflunomida Tarbis work

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 take Teriflunomida Tarbis:

• 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 the 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 very 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 that you have an infection. Infections caused by the herpes virus, including oral herpes or shingles (herpes zoster), may occur with teriflunomida treatment. In some cases, serious complications have occurred. Inform your doctor immediately if you suspect that you have any symptoms of herpes virus infections. 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 planning to be vaccinated.
• you are taking leflunomida with Teriflunomida.
• you are changing medication from or to Teriflunomida.
• 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 Tarbis 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:

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

Other medications and Teriflunomida Tarbis

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, urinary 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 (high cholesterol)
• sulfasalazine for inflammatory bowel disease or rheumatoid arthritis
• cholestyramine for high cholesterol or itching relief in liver disease
• activated charcoal to reduce the absorption of medications or other substances.

Pregnancy and breastfeeding

Do nottake Teriflunomida Tarbis 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, inform your doctor, who will give you 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, you need your doctor 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 that 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 this medication 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 period after stopping treatment. Continue to use contraceptive methods after interrupting treatment.

• Continue to do so until the levels of Teriflunomida in your blood 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

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

Teriflunomida Tarbis contains lactose

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

Teriflunomida Tarbis contains sodium

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

A doctor with experience 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 older)

The dose depends on body weight:

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

Teriflunomida is administered orally. This medication 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 Tarbis can be taken with or without food.

If you take more Teriflunomida Tarbis 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, contact your doctor or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Teriflunomida Tarbis

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

If you interrupt treatment with Teriflunomida Tarbis

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 can cause side effects, although not everyone will experience them.

This medicine may cause the following side effects.

Severe side effects

Some side effects can be 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 rare in adult patients).

Uncommon(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 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
• Pneumonia that could include symptoms such as shortness of breath or persistent cough

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

• Severe liver disease that may include symptoms such as yellowing of the skin or eyes, darker urine than normal, 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
• 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
• 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
• Herpes virus infections, including oral herpes and shingles (zoster), with symptoms such as blisters, burning, itching, numbness, or pain in the skin, typically on one side of the upper body or face, and other symptoms such as fever and weakness.

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
• Anomalous lipid levels in blood
• Colitis (inflammation of the colon)

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

• Liver inflammation or damage

Frequency not known(frequency cannot be estimated with 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 doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products 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 packaging and in the blister pack after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

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

Composition of Teriflunomida Tarbis

The active ingredient is teriflunomida.

Teriflunomida Tarbis 7 mg film-coated tablets EFG

Each tablet contains 7 mg of teriflunomida.

Teriflunomida Tarbis 14 mg film-coated tablets EFG

Each tablet contains 14 mg of teriflunomida.

The other ingredients are:

Tablet core:Lactose monohydrate, cornstarch, Carboxymethylstarch sodium of potato type A, hydroxypropylcellulose, microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate

Tablet coating:Hydroxypropylmethylcellulose, titanium dioxide (E171), macrogol 400, talc, yellow iron oxide (E172) (for 7 mg)

Appearance of the product and contents of the package

Teriflunomida Tarbis 7 mg film-coated tablets EFG

Film-coated tablets, biconvex, round, pale yellow to yellow, approximately 5.2 mm in diameter, engraved with “H” on one side and “T19” on the other.

Teriflunomida Tarbis 14 mg film-coated tablets EFG

Film-coated tablets, biconvex, round, white to off-white, approximately 7.3 mm in diameter, engraved with "H" on one side and "T41" on the other.

Packages containing 28 and 84 film-coated tablets.

Unit dose packages containing 28 and 84 film-coated tablets.

Only some package sizes may be commercially available.

Marketing Authorization Holder

Tarbis Farma S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Responsible for manufacturing

Amarox Pharma B.V.

Rouboslaan 32

Voorschoten, 2252TR

Netherlands

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

Germany:Teriflunomid Amarox 7 mg/14 mg Filmtabletten

Spain:Teriflunomida Tarbis 7 mg/14 mg film-coated tablets EFG

Netherlands:Teriflunomid Amarox 7 mg/14 mg, filmomhulde tabletten

Last review date of this leaflet: 08/2024

Further information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/