Prospecto:Information for the Patient

Teva Teriflunomida 14 mg Film-Coated Tablets

Read this prospectus carefully before starting to take this medication,because it contains important information for you.

• Keep this prospectus, as you may need to read it again.

- If you have any doubts, consult yourdoctor orpharmacist.

-This medication has been prescribedonlyto you, and you should not give it to other people even if they havethe same symptomsas you,as it may harm them.

• If you experience any adverse effects,consult your doctor or pharmacist,evenif they are not listed in this prospectus. See section 4.

1.What is Teva Teriflunomida and what is it used for

2.What you need to knowbeforestarting totake Teva Teriflunomida

3.How to take Teva Teriflunomida

4.Possible adverse effects

5Storage of Teva Teriflunomida

6. Contents of the package and additional information

Teva Teriflunomida 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 Teva Teriflunomida used for

Teva 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 CNS nerves. This loss of myelin is called demyelination. This makes the CNS 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 Teva Teriflunomida works

Teva 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 Teva

• 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 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 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 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 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 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 (lack of air) 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 medicines and Teriflunomida Teva

Inform your doctor or pharmacist if you are taking, have taken, recently taken, or may need to take any other medicine. This includes over-the-counter medicines.

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
• 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 kidney disease in diabetics
• 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, 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 medicines or other substances

Pregnancy and lactation

Do not take teriflunomida 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 medicine 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 medicine has been eliminated from your body before trying to become pregnant. The natural elimination of the active ingredient may take up to 2 years. This period of time can be reduced to a few weeks by taking certain medicines to accelerate the elimination of teriflunomida from your body.

In any case, you must confirm through a blood test that the active ingredient has been eliminated enough from your body and you need confirmation from your doctor that the level of teriflunomida in your 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 must interrupt teriflunomida and contact your doctor immediately to 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 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. Follow the instructions below:

• 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 your method

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 Teva contains lactose and sodium

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

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

A healthcare professional experienced in treating multiple sclerosis will oversee treatment with teriflunomida.

Follow exactly the administration instructions for this medication as indicated by your doctor. This medication indicadas by your doctor. En caso de duda, consulte de nuevo a su médico.

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: 14 mg once a day.
• Children with a body weight less than or equal to 40 kg: 7 mg once a day (Teriflunomida Teva is only available in 14 mg film-coated tablets, therefore, the doctor will refer these patients to a different medication containing teriflunomida).

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. Teriflunomida is taken once a day in a single 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 Teva 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).

If you think you have overdosed and are experiencing any of these symptoms, inform your doctor immediately. You can also call the Toxicological Information Service, Tel. 91 562 0420

If you forget to take Teriflunomida Teva

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

If you interrupt treatment with Teriflunomida Teva

Do not stop treatment or change the dose of teriflunomida without consulting your doctor first.

If you have any other questions about the use of this medicamento , 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 may include symptoms of rash, hives, swelling of lips, tongue, or face, or sudden difficulty breathing
• Severe skin reactions that may 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 may include symptoms such as high fever, chills, decreased urine flow, or confusion
• Pneumonia that may 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
• Finer 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
• Anxiety
• Needle-like sensations, 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)
• Urinating 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
• Psoriasis
• Inflammation of the mouth/lips
• Abnormal lipid levels in the blood
• Colitis (inflammation of the colon)

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

• 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 doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano: https//www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthe box and in the blisterafter “CAD” or “EXP”. 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. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. By doing so, you will help protect the environment.

Composition of Teriflunomida Teva

• The active ingredient is teriflunomida. Each film-coated tablet contains 14 mg of teriflunomida.
• The other components are lactose monohydrate, microcrystalline cellulose (E 460), cornstarch, sodium carboxymethylstarch from potato (type A), hydroxypropylcellulose (E 463), anhydrous colloidal silica (E 551), fumarate of stearic acid and sodium, hypromellose (E 464), titanium dioxide (E 171), talc (E 553b), macrogol (E 1521), aluminum lake of indigo carmine (E 132).

Appearance of the product and contents of the package

Teriflunomida Teva are blue film-coated, round tablets of approximately 6.6 mm in diameter and 4.1 mm in thickness, marked with “TV” on one face of the tablet and with “Y12” on the other face of the tablet.

Teriflunomida Teva is available in:

• Aluminum blister packs - OPA/Alu/PVC containing 10, 14, 28, 30, and 84 film-coated tablets or
• Single-dose perforated aluminum blister packs - OPA/Alu/PVC containing 10x1, 28x1, 30x1, and 84x1 film-coated tablets.

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Teva B.V.

Swensweg 5,

2031GA Haarlem,

Netherlands

Responsible for manufacturing

Teva Operations Poland Sp. z o.o.

Mogilska 80 Str.

31-546 Krakow

Poland

or

Balkanpharma Dupnitsa AD

3 Samokovsko Shosse Str.

2600 Dupnitsa

Bulgaria

You can request more information about this medication by contacting the local representative of the holder of the marketing authorization:

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1st floor,

Alcobendas, 28108 – Madrid

Spain

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

AustriaTeriflunomid ratiopharm 14 mg Filmtabletten

BelgiumTeriflunomide Teva 14 mg Filmomhulde tabletten/comprimés pelliculés/Filmtabletten

Czech RepublicTeriflunomide Teva

GermanyTeriflunomid-ratiopharm 14 mg Filmtabletten

DenmarkTeriflunomide Teva

EstoniaTeriflunomide Teva

SpainTeriflunomida Teva 14 mg comprimidos recubiertos con película EFG

FinlandTeriflunomide ratiopharm 14 mg tabletti, kalvopäällysteinen

FranceTériflunomide Teva 14 mg, comprimé pelliculé

CroatiaTeriflunomid Teva 14 mg filmom obložene tablete

HungaryTeriflunomide Teva 14 mg filmtabletta

IcelandTeriflunomide Teva

ItalyTeriflunomide Teva

LithuaniaTeriflunomide 14 mg plevele dengtos tabletes

LatviaTeriflunomide Teva 14 mg apvalkotas tabletes

NetherlandsTeriflunomide Teva 14 mg, filmomhulde tabletten

NorwayTeriflunomide Teva

PolandTeriflunomide Teva

PortugalTeriflunomida Teva

RomaniaTeriflunomida Teva 14 mg comprimate filmate

SwedenTeriflunomide Teva

SloveniaTeriflunomid Teva 14 mg filmsko oblozene tablete

SlovakiaTeriflunomid Teva 14 mg filmom obalené tablety

Last review date of thisleaflet:September 2024

Other sources of information

The detailed information about this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)} (http://www.aemps.gob.es/)

The latest approved information (patient information leaflet) about this medication is available by scanning the following QR code with a smartphone. The same information is also available on the following website (URL): https://cima.aemps.es/cima/DocsPub/16/3065