Package Insert: Information for the Patient

Teriflunomida Glenmark 14 mg Film-Coated Tablets EFG

Read this package insert carefully before starting to take this medication, as 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 medication has been prescribed only for you 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 adverse effects, consult your doctor or pharmacist,even if they are not listed in this package insert. See section 4.

Teriflunomida Glenmark 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 Glenmark 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 Teriflunomida Glenmark works

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 Glenmark:

• 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 arepregnant, think you may be, 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 any infection. With teriflunomida treatment, you may experience viral infections, including oral herpes or shingles (herpes zoster). In some cases, serious complications have occurred. Inform your doctor immediately if you suspect that you have any symptoms of a viral herpes infection. 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 medication is being changed 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 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 Glenmark

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, 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 in liver disease
• activated charcoal to reduce the absorption of medications or other substances.

Pregnancy and Breastfeeding

Do nottake teriflunomida if you are pregnant or think you may bepregnant. 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, 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 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 should 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 teriflunomida 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 the blood for a long time 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 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 Glenmark contains lactose

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

Teriflunomida Glenmark contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablets; it is essentially “sodium-free”.

A healthcare professional experienced in treating multiple sclerosis will supervise 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 above)

The dose depends on body weight:

• children with a body weight greater than 40 kg: 14 mg once a day.
• children with a body weight less than or equal to 40 kg: 7 mg once a day.

The 7 mg dose of teriflunomida is not available. For this dose, other medications available on the market containing teriflunomida can be used.

Your doctor will instruct children and adolescents to change to a 14 mg tablet per day once they reach a stable body weight above 40 kg.

Form/via of administration

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

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

If you forgot to take Teriflunomida Glenmark

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 Glenmark

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, 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 like high fever, chills, decreased urine flow, or confusion
• Pneumonia that could include symptoms like 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 like yellowing of the skin or eyes, darker urine, unexplained nausea and vomiting, 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 discomfort (nausea)
• 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
• Herpes virus infections, including oral herpes and shingles (zoster) with symptoms like blisters, burning, itching, numbness, or pain in the skin, usually on one side of the upper body or face, and other symptoms, like 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
• 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 discomfort (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; problems in nerves of arms and legs (peripheral neuropathy)
• Alterations in nails, severe skin reactions
• Post-traumatic pain
• Poriasis
• Inflammation of the mouth/lips
• Anomalous 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

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 doctor or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use: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 blister after "CAD". The expiration date is the last day of the month indicated.

Aluminum/aluminum blister with desiccant: do not store at a temperature above 30°C.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and themedicines that you no longer need at the SIGREpoint of the pharmacy.Ask your pharmacist how to dispose of the containers and the medicines that you no longer need. This will help protect the environment.

Composition of Teriflunomida Glenmark

-The active ingredient is teriflunomida.

• Each tablet contains 14 mg of teriflunomida.

• The other components are: tablet core: lactose monohydrate, cornstarch, carboxymethylcellulose sodium (type A) (from potato), hydroxypropylcellulose (E-463), microcrystalline cellulose (E-460), magnesium stearate (E-470b), anhydrous colloidal silica; tablet coating: hypromellose 2910 (E-464), titanium dioxide (E-171), macrogol (E-1521), talc (E-553b) (see section 2 “Teriflunomida Glenmark contains lactose”).

Appearance of the product and contents of the package

The film-coated tablets are white to off-white, round, biconvex (approximately 7 mm in diameter), marked with “G” on one face and with “42” on the other face.

Teriflunomida Glenmark 14 mg film-coated tablets EFG is available in cartons with:

-pre-scored aluminum/aluminum blisters with desiccant that contain10x1, 14x1, 28x1, 84x1 and 98x1 film-coated tablets.

-aluminum/aluminum blisters with desiccant that contain10, 14, 28, 84 and 98 film-coated tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder

Glenmark Arzneimittel GmbH

Industriestr. 31

82194 Gröbenzell

Germany

Responsible for manufacturing

Glenmark Pharmaceuticals s.r.o.

Fibichova 143

566 17 Vysoke Myto

Czech Republic

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Viso Farmacéutica S.L.U.

c/ Retama 7, 7th floor

28045 Madrid

Spain

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

GermanyTeriflunomid Glenmark 14 mg Filmtabletten

DenmarkTeriflunomide Glenmark

SpainTeriflunomida Glenmark 14 mg film-coated tablets EFG

FinlandTeriflunomide Glenmark

NetherlandsTeriflunomide Glenmark 14 mg filmomhulde tabletten

ItalyTeriflunomide Glenmark

Last review date of this leaflet:July 2024.

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