Teriflunomide Stada 14 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Teriflunomide Stada 14 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Package leaflet

1. What Teriflunomida Stada is and what it is used for
2. What you need to know before taking Teriflunomida Stada
3. How to take Teriflunomida Stada
4. Possible side effects
5. How to store Teriflunomida Stada
6. Contents of the pack and other information

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

What is Teriflunomida Stada

Teriflunomida Stada contains the active substance teriflunomide, which is an immunomodulatory agent that modulates the immune system to limit its attack on the nervous system.

What Teriflunomida Stada is used for

Teriflunomide is used in adults and in children and adolescents (10 years of age and older) for the treatment of 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 malfunction.

People with the relapsing form of multiple sclerosis will experience repeated episodes (relapses) of physical symptoms caused by improper nerve function. These symptoms vary from patient to patient but typically include:

• difficulty walking
• vision problems
• balance problems.

Symptoms may completely disappear after a relapse, but over time, some problems may persist. This can lead to physical disabilities that may interfere with daily activities.

How teriflunomide works

This medicine helps protect against immune system attacks on the central nervous system by limiting the growth of certain white blood cells (lymphocytes). This reduces the inflammation that causes nerve damage in MS.

2. What you need to know before starting to take Teriflunomida Stada

Do not take Teriflunomide Stada if:

• you are allergic to teriflunomide or any of the other ingredients of this medicine (listed in section 6),
• you have ever developed a severe skin rash, skin peeling, blisters and/or mouth ulcers after taking teriflunomide or leflunomide,
• you have severe liver problems,
• you are pregnant, think you might be pregnant, or are breastfeeding,
• you have a serious problem affecting the immune system, for example, acquired immunodeficiency syndrome (AIDS),
• you have serious bone marrow problems or have a low number of white or red blood cells in the blood or a reduced number of platelets,
• you have a serious infection,
• you have severe kidney problems requiring dialysis,
• you have very low levels of protein in the blood (hypoproteinemia).

If in doubt, ask your doctor or pharmacist before taking this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Teriflunomide Stada if:

• you have liver problems and/or drink large amounts of alcohol. Your doctor may carry out blood tests to check how your liver is working before and during treatment. If test results indicate a problem with your liver, your doctor may stop treatment with teriflunomide. See 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 monitor your blood pressure before starting treatment and regularly during treatment. See section 4.
• you have an infection. Before you start taking teriflunomide, your doctor will ensure you have sufficient white blood cells and platelets in your blood. Since teriflunomide reduces the number of white blood cells, this may affect your ability to fight infection. Your doctor may perform blood tests to monitor your white blood cells if they suspect you have an infection. Infections with herpes viruses, including oral herpes or herpes zoster (shingles), may occur during treatment with teriflunomide. In some cases, serious complications have occurred. Inform your doctor immediately if you suspect symptoms of a herpes virus infection. See section 4.
• you have severe skin reactions.
• you have respiratory symptoms.
• you have weakness, numbness, or pain in your hands and feet.
• you are due to be vaccinated.
• you are taking leflunomide together with teriflunomide.
• you are switching medication to or from teriflunomide.
• you are scheduled for a specific blood test (calcium levels). A falsely low calcium level may be detected.

Respiratory reactions

Inform your doctor if you develop unexplained cough or dyspnea (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 (inflammation of the pancreas) has been observed in patients receiving teriflunomide. Your child’s doctor may perform blood tests if pancreatitis is suspected.

Other medicines and Teriflunomide Stada

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This includes medicines without a prescription.

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

• leflunomide, methotrexate, and other medicines that affect the immune system (often called 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 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,
• indometacin, ketoprofen for pain or inflammation,
• furosemide for heart disease,
• cimetidine to reduce gastric acid,
• zidovudine for HIV infection,
• rosuvastatin, simvastatin, atorvastatin, pravastatin for hypercholesterolemia (high cholesterol),
• sulfasalazine for inflammatory bowel disease or rheumatoid arthritis,
• colestyramine for high cholesterol or relief of itching in liver disease,
• activated charcoal to reduce absorption of medicines or other substances.

Pregnancy and breastfeeding

Do not take teriflunomide if you are pregnant or think you might be pregnant. If you are pregnant or become pregnant while taking teriflunomide, there is an increased risk of having a baby with birth defects. Women of childbearing potential must not take this medicine unless they are using reliable contraceptive methods.

If your daughter starts menstruating while taking teriflunomide, inform the doctor, who will provide specific advice on contraception and the potential risks in case of pregnancy.

Inform your doctor if you plan to become pregnant after stopping treatment with teriflunomide, as you must ensure that most of the medicine has been eliminated from your body before attempting pregnancy. Natural elimination of the active substance 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, your doctor must confirm through a blood test that the level of active substance in the blood is low enough to allow pregnancy.

For more information about laboratory tests, contact your doctor.

If you suspect you are pregnant while taking teriflunomide or within two years after stopping treatment, you must stop teriflunomide and contact your doctor immediately for a pregnancy test. If the test confirms pregnancy, your doctor may recommend treatment with certain medicines to rapidly and sufficiently eliminate teriflunomide from your body, as this may reduce the risk to your baby.

Contraception

You must use an effective method of contraception during and after treatment with teriflunomide. Teriflunomide remains in the blood for a long time after stopping treatment. Continue using contraception after stopping treatment.

• Continue until teriflunomide blood levels are sufficiently low—your doctor will confirm this.
• Consult your doctor about the best contraceptive method for you and if you need to change methods.

Do not take teriflunomide during breastfeeding, as teriflunomide passes into breast milk.

Driving and use of machines

Teriflunomide may cause dizziness, which can affect concentration and reaction ability. If affected, do not drive or operate machinery.

Teriflunomide Stada contains lactose and sodium

This medicine contains lactose (a type of sugar). If your doctor has informed you that you have an intolerance to certain sugars, consult them before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially “sodium-free”.

3. How to take Teriflunomida Stada

A doctor experienced in the treatment of multiple sclerosis will supervise treatment with teriflunomide.

Always follow exactly your doctor's instructions for taking this medicine. If in 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 body weight greater than 40 kg: one 14 mg tablet once daily.
• children with body weight less than or equal to 40 kg: 7 mg of teriflunomide once daily.

Teriflunomide is only available in 14 mg tablets. If your doctor has instructed you to take 7 mg of teriflunomide daily, you must split your teriflunomide tablet into two equal halves along the break line and take one half, corresponding to 7 mg. Consult your doctor if you are unsure.

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

Method/route of administration

Teriflunomide is administered orally. It is taken once daily at any time of day, as a single daily dose.

The tablet may be divided into equal doses.

The tablet should be swallowed with water.

This medicine may be taken with or without food.

If you take more Teriflunomida Stada than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you have taken too much teriflunomide, contact your doctor immediately. You may experience adverse effects similar to those described in section 4 (below).

If you forget to take Teriflunomida Stada

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

If you stop taking Teriflunomida Stada

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

If you have any further questions about 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 everyone experiences them.

The following adverse effects may occur with this medicine.

Serious adverse effects

Some adverse effects may be or may become serious. If you experience any of these, inform your doctor immediately.

Frequent (may affect up to 1 in 10 people):

• inflammation of the pancreas, which may include symptoms such as abdominal pain, nausea, or vomiting (frequent in pediatric patients and uncommon in adult patients).

Uncommon (may affect up to 1 in 100 people):

• allergic reactions that could include symptoms such as rash, hives, swelling of lips, tongue, or face, or sudden difficulty breathing.
• severe skin reactions that could include symptoms such as skin rash, blisters, fever, or mouth ulcers.
• serious infections or sepsis (a type of infection that may be potentially life-threatening), which could include symptoms such as high fever, shaking, chills, reduced urine output, or confusion.
• lung inflammation that could include symptoms such as shortness of breath or persistent cough.

Not known (frequency cannot be estimated from available data):

• severe liver disease that may include symptoms such as yellowing of the skin or whites of the eyes, abnormally dark urine, unexplained nausea and vomiting, or abdominal pain.

Other adverse effects may occur with the following frequencies:

Very frequent (may affect more than 1 in 10 people):

• headache.
• diarrhea, feeling unwell.
• increased ALT (elevated levels of certain liver enzymes in blood tests) shown in laboratory analyses.
• thinner hair.

Frequent (may affect up to 1 in 10 people):

• flu, upper respiratory tract infection, urinary tract infection, bronchitis, sinusitis, sore throat and difficulty swallowing, cystitis (bladder inflammation), viral gastroenteritis (stomach flu), dental infection, laryngitis, fungal foot infection.
• herpes virus infections, including oral herpes and herpes zoster (shingles), with symptoms such as blisters, burning, itching, numbness, or pain on the skin, usually on one side of the upper body or face, and other symptoms such as fever and weakness.
• laboratory findings: a decrease in red blood cell count (anemia), changes in liver function and white blood cells observed in blood tests (see section 2), as well as elevations in a muscle enzyme (creatine phosphokinase).
• mild allergic reactions.
• feeling anxious.
• muscle soreness, feeling of weakness, numbness, tingling, or pain in the lower back or leg (sciatica); sensation of numbness, burning, tingling, or pain in hands and fingers (carpal tunnel syndrome).
• palpitations.
• increased blood pressure.
• feeling unwell (vomiting), toothache, upper abdominal pain.
• rash, acne.
• tendon, joint, or bone pain, muscle pain (musculoskeletal pain).
• need to urinate more often than usual.
• heavy menstrual periods.
• pain.
• lack of energy or weakness (asthenia).
• weight loss.

Uncommon (may affect up to 1 in 100 people):

• decrease in platelet count (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).
• nail disorders, severe skin reactions.
• post-traumatic pain.
• psoriasis (a skin disease).
• inflammation of 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.

Frequency not known (frequency cannot be estimated from available data):

• pulmonary hypertension (high blood pressure affecting the arteries in the lungs).

Adverse effects in children (aged 10 years 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 of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Teriflunomide Stada

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

Do not use this medicine after the expiry date stated on the carton after "EXP". The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Teriflunomide Stada

• The active substance is teriflunomide. Each tablet contains 14 mg of teriflunomide.

• The other components are:

• Tablet core: lactose monohydrate (see section 2 “Teriflunomide Stada contains lactose and sodium”), maize starch, microcrystalline cellulose, hydroxypropylcellulose, sodium carboxymethylstarch (type A) (from potato), talc and calcium stearate.

• Tablet coating: hypromellose, titanium dioxide (E171), macrogol 8000 and indigo carmine aluminium lake (E132).

Appearance of the product and contents of the pack

Teriflunomide Stada are film-coated, round, light blue tablets with a score line and a diameter of approximately 7 mm. The tablet can be divided into equal doses.

Teriflunomide Stada 14 mg film-coated tablets are available in cardboard boxes containing Alu/PVC/Alu/OPA blisters with 14 tablets each.

Pack sizes of 14, 28, 84 or 98 tablets.

Only some pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

Pharmadox Healthcare Limited

KW20A Kordin Industrial Park,

Paola, PLA 3000,

Malta

or

Adalvo Limited

Malta Life Science Park, Building 1 Level 4,

Sir Temi Zamit Buildings,

San Gwan Industrial Estate,

San Gwan, SGN 3000,

Malta

or

KeVaro GROUP Ltd

9 Tzaritza Elenora STr., office 23

1618 Sofia,

Bulgaria

or

STADA Arzneimittel AG

Stadastrasse 2 – 18,

Bad Vilbel, 61118,

Germany

o

STADA Arzneimittel GmbH

Muthgasse 36/2,

Wien, 1190,

Austria

o

Centrafarm Services B.V.

Van de Reijtstraat 31 E,

Breda, 4814NE,

Netherlands

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Iceland Teriflunomide STADA 14 mg film-coated tablets

Austria Teriflunomid STADA 14 mg Filmtabletten

Belgium Teriflunomide EG 14 mg filmomhulde tabletten

Germany Teriflunomid AL 14 mg Filmtabletten

Denmark Teriflunomide STADA STADA Arzneimittel AG

Spain Teriflunomida STADA 14 mg film-coated tablets EFG

Finland Teriflunomide STADA 14 mg kalvopäällysteiset tabletit

France TERIFLUNOMIDE EG 14 mg, comprimé pelliculé sécable

Hungary Teriflunomide Stada 14 mg filmtabletta STADA Arzneimittel AG

Italy Teriflunomide EG EG S.p.A.

Luxembourg Teriflunomide EG 14 mg comprimés pelliculés

Netherlands Teriflunomide CF 14 mg, filmomhulde tabletten

Norway Teriflunomide STADA 14 mg filmdrasjerte tabletter

Romania Teriflunomida Stada 14 mg comprimate filmate

Sweden Teriflunomide STADA 14 mg filmdragerade tabletter

Slovakia Teriflunomide Stada 14 mg filmom obalené tablety

Date of the most recent review of this leaflet: September 2022

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