TERIFLUNOMIDE STADA 14 mg FILM-COATED TABLETS

Introduction

Patient Information Leaflet

Teriflunomida Stada 14 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Teriflunomida Stada and what is it used for
2. What you need to know before you take Teriflunomida Stada
3. How to take Teriflunomida Stada
4. Possible side effects
5. Storage of 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 adjusts the immune system to limit its attack on the nervous system.

What is Teriflunomida Stada used for

Teriflunomide is used in adults and in children and adolescents (from 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 made up 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 makes the nerves stop working properly.

People with the relapsing form of multiple sclerosis will have repeated attacks (relapses) of physical symptoms caused by the poor functioning of the nerves. These symptoms vary from person to person, but usually include:

• difficulty walking
• vision problems
• balance problems.

The symptoms may disappear completely after the relapse, but over time, some problems may remain. This can cause physical disabilities that can interfere with daily activities.

How teriflunomide works

This medicine helps protect against attacks on 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.

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

Do not take Teriflunomida 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, and/or mouth ulcers after taking teriflunomide or leflunomide,
• you have severe liver problems,
• you are pregnant, think you may be pregnant or are breast-feeding,
• you have a serious immune system problem, such as acquired immune deficiency syndrome (AIDS),
• you have a serious bone marrow problem or a low white blood cell count or a low red blood cell count or a low platelet count,
• you have a serious infection,
• you have severe kidney problems that require dialysis,
• you have a low level of proteins in the blood (hypoproteinemia),

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

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with Teriflunomida Stada 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 and during treatment. If the test results indicate a liver problem, 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 check 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 make sure you have enough white blood cells and platelets in your blood. Since teriflunomide decreases the number of white blood cells in the blood, this may affect your ability to fight infection. Your doctor may perform blood tests to check your white blood cell count if you suspect you have any infection. With teriflunomide treatment, viral infections such as oral or genital herpes (shingles) may occur. In some cases, serious complications have occurred. You should immediately inform your doctor if you suspect you have any symptoms of a viral infection. See section 4.
• you have severe skin reactions.
• you have respiratory symptoms.
• you have weakness, numbness, and pain in hands and feet.
• you are going to be vaccinated.
• you are taking leflunomide with teriflunomide.
• you are being switched from or to teriflunomida.
• a specific blood test (calcium level) is scheduled. A false decrease in calcium levels may be detected.

Respiratory reactions

Tell your doctor if you have unexplained cough and shortness of breath. 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 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 has been observed in patients receiving teriflunomide. Your child's doctor may perform blood tests if pancreatitis is suspected.

Other medicines and Teriflunomida Stada

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

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

• leflunomide, 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 diabetic nephropathy
• 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 infection,
• rosuvastatin, simvastatin, atorvastatin, pravastatin for high cholesterol (hypercholesterolemia),
• 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 breast-feeding

Do not taketeriflunomide if you are pregnant or think you may be pregnant. If you are pregnant or become pregnant while taking teriflunomide, you will increase the risk of having a baby with birth defects. Women of childbearing age must not take this medicine if they are not using reliable contraceptive methods.

If your daughter has her first period while taking teriflunomide, she must inform her doctor, who will provide specialized advice on contraceptive methods and potential risks in case of pregnancy.

Tell your doctor if you plan to become pregnant after stopping treatment with teriflunomida, as you need to make sure that most of this medicine has been eliminated from your body before trying to become pregnant. The elimination of the active substance naturally 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, you need your doctor to confirm, based on a blood test, that the level of active substance in the blood is low enough to become pregnant.

For more information on laboratory tests, contact your doctor.

If you suspect you are pregnant while taking teriflunomida or in the two years following the end of treatment, you must stop taking teriflunomida and contact your doctor immediatelyto perform a pregnancy test. If the test confirms pregnancy, your doctor may suggest treatment with certain medicines to eliminate teriflunomida from the body quickly enough, 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 take contraceptive measures after stopping treatment.

• Continue to do so until the levels of teriflunomida in the blood are low enough - your doctor will check this.
• Consult your doctor about the best contraceptive method for you and in case you need to change the method.

Do not take teriflunomida during breast-feeding, as teriflunomida passes into breast milk.

Driving and using machines

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

Teriflunomida Stada contains lactose and sodium

This medicine contains lactose (a type of sugar). If your doctor has told you that you have an intolerance to some 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".

3. How to take Teriflunomida Stada

A doctor with experience in treating multiple sclerosis will supervise treatment with teriflunomide.

Follow the instructions for administration of this medicine exactly as indicated by your doctor. 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 older)

The dose depends on body weight:

• children with a body weight over 40 kg: one 14 mg tablet once a day.
• children with a body weight of 40 kg or less: 7 mg of teriflunomide once a day.

Teriflunomida is only available in 14 mg doses. If your doctor has told you to take 7 mg of teriflunomida per day, you must divide your teriflunomida tablet in half along the break line and take half of the tablet, corresponding to 7 mg. Consult your doctor if you are unsure.

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

Form/Route of administration

Teriflunomida is administered orally. It is taken once a day in a single daily dose at any time of day.

The tablet can be divided into equal doses.

The tablet should be swallowed with water.

This medicine can be taken with or without food.

If you take more Teriflunomida Stada than you should

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

If you have taken too much teriflunomida, call your doctor immediately. You may experience side 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 forgotten doses. Take your next dose at the scheduled time.

If you stop taking Teriflunomida Stada

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

If you have any further questions on 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 all people suffer from them.

The following adverse effects may occur with this medicine.

Severe Adverse Effects

Some adverse effects can be or may become severe; if you experience any of these, inform your doctor immediately.

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

• inflammation of the pancreas that may include symptoms of abdominal pain, nausea, or vomiting (frequent in pediatric patients and infrequent in adult patients).

Infrequent(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 the mouth.
• severe infections or sepsis (a type of infection that can be potentially life-threatening) that could include symptoms such as high fever, chills, shivering, decreased urine flow, or confusion.
• inflammation of the lungs that could include symptoms such as shortness of breath or persistent cough.

Unknown(frequency cannot be estimated from the available data):

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

Other Adverse Effectsmay occur with the following frequencies:

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

• headache.
• diarrhea, feeling sick.
• increase in ALT (increase in levels of certain liver enzymes in the blood) shown 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 (inflammation of the bladder), viral gastroenteritis (stomach flu), tooth infection, laryngitis, fungal infection of the foot.
• herpes virus infections, including oral herpes and shingles (herpes 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 (creatinine phosphokinase).
• mild allergic reactions.
• feeling of anxiety.
• muscle aches, 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.
• increase in blood pressure.
• feeling sick (vomiting), toothache, pain in the upper abdominal region.
• rash, acne.
• pain in tendons, joints, bones, muscle pain (musculoskeletal pain).
• need to urinate more often than usual.
• heavy periods.
• pain.
• lack of energy or weakness (asthenia).
• weight loss.

Infrequent(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 the nerves of the arms and legs (peripheral neuropathy).
• changes in the nails, severe skin reactions.
• post-traumatic pain.
• psoriasis (a skin disease).
• inflammation of the 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 the available data):

• pulmonary hypertension (high blood pressure that affects the arteries of the lungs).

Adverse Effects in Children (10 years of age 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 Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Teriflunomida Stada

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

Do not use this medicine after the expiration date that appears on the packaging after "CAD". The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Teriflunomida Stada

• The active ingredient is teriflunomide. Each tablet contains 14 mg of teriflunomide.
• The other components are:

• Tablet core: lactose monohydrate (see section 2 "Teriflunomida Stada contains lactose and sodium"), cornstarch, microcrystalline cellulose, hydroxypropylcellulose, sodium carboxymethylcellulose (type A) (from potato), talc, and calcium stearate.
• Tablet coating: hypromellose, titanium dioxide (E171), macrogol 8000, and aluminum lake Carmine Indigo (E132)

Appearance of the Product and Package Contents

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

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

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

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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

or

STADA Arzneimittel GmbH

Muthgasse 36/2,

Wien, 1190,

Austria

or

Centrafarm Services B.V.

Van de Reijtstraat 31 E,

Breda, 4814NE,

Netherlands

This medicine is authorized in the Member States of the European Economic Area under the following names:

Iceland Teriflunomide STADA 14 mg film-coated tablets

Austria Teriflunomide STADA 14 mg Filmtabletten

Belgium Teriflunomide EG 14 mg film-coated tablets

Germany Teriflunomide 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 last revision of this prospectus: September 2022

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