Patient Information Leaflet: Package Insert

Teriflunomida Stada 14 mg Film-Coated Tablets

Read this 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. Do not give it to others even if they have similar symptoms, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

What is Teriflunomida Stada

Teriflunomida Stada 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 Stada 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 with relapsing-remitting 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 works

This medication 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 Stada if:

Ask your doctor or pharmacist before taking this medication if you are unsure.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Teriflunomida Stada if:

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 Stada

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:

Pregnancy and breastfeeding

Do not taketeriflunomida 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.

Inform your doctor if your daughter starts menstruating while taking teriflunomida. Your doctor 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 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 medications to accelerate the elimination of teriflunomida from your body.

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 recommend treatment with certain medications to eliminate teriflunomida from your body quickly and effectively, as this may reduce the risk to your baby.

Pregnancy prevention

You must use an effective contraceptive method during and after treatment with teriflunomida. Follow these steps:

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 Stada contains lactose and sodium

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

This medication contains less than 1 mmolof 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 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: one 14 mg tablet once a day.
• children with a body weight less than or equal to 40 kg: 7 mg of teriflunomida once a day.

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

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

Form/administration route

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

The tabletcan be divided into equal doses.

The tablet should be swallowed with water.

This medication 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

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 forget to take Teriflunomida Stada

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

If you interrupt treatment with Teriflunomida Stada

Do not interrupt treatment or change the teriflunomida dose 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 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).

Rare(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 may be potentially fatal) that may include symptoms such as high fever, chills, decreased urine flow, or confusion.
• lung inflammation that may include symptoms such as shortness of breath or persistent cough.

Unknown(frequency cannot be estimated with available data):

-severe liver disease that may include symptoms such as yellowing of the skin or eyes, darker than normal 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 illness.
• increase in ALT (increase in certain liver enzymes in the blood) shown 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 (bladder inflammation), viral gastroenteritis (stomach flu), dental 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.
• lab test results: 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.
• muscle cramps, 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 of illness (vomiting), toothache, upper abdominal pain.
• acne, rash.
• joint, tendon, bone, or muscle pain (musculoskeletal pain).
• need to urinate more frequently than normal.
• heavy periods.
• pain.
• lack of energy or weakness (asthenia).
• weight loss.

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 (high blood pressure affecting the arteries of the lungs).

Side effects in children (10 years of age and older) and adolescents

The side 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):

-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 the Spanish 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 in the packaging 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 packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition of Teriflunomida Stada

• Core of the tablet : lactose monohydrate ( see section 2 “ Teriflunomida Stada contains lactose and sodium”), cornstarch, microcrystalline cellulose, hydroxypropylcellulose, carboxymethyl starch sodium (type A) (from potato), talc, and calcium stearate.
• Coating of the tablet : hypromellose, titanium dioxide (E171), macrogol 8000, and aluminum lake Carmín Índigo (E132)

Appearance of the product and contents of the package

Teriflunomida Stada are film-coated tablets, round, light blue in color, with a notch 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 cartons of cardboard that contain blisters of Alu/PVC/Alu/OPA of 14 tablets each .

The package size is 14, 28, 84, or 98 tablets.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for manufacturing

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 with the following names:

Island Teriflunomide STADA 14 mg film-coated tablets

Austria Teriflunomid STADA 14 mg Filmtabletten

Belgium Teriflunomide EG 14 mg film-coated tablets

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 Te riflunomide CF 14 mg, film-coated tablets

Norway Teriflunomide STADA 14 mg filmdragerade tabletter

Romania Teriflunomida Stada 14 mg film-coated tablets

Sweden Teriflunomide STADA 14 mg filmdragerade tabletter

Slovakia Teriflunomide Stada 14 mg film-coated tablets

Last review date of this leaflet : September 2022

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