IDAPTAN 20 mg FILM-COATED TABLETS

2. What you need to know before you take Idaptan

Do not take Idaptan

• If you are allergic to trimetazidine or any of the other ingredients of this medicinal product (listed in section 6).
• If you have Parkinson's disease: a brain disease that affects movement (tremors, rigid posture, slow movements, and shuffling gait, instability when walking).
• If you have severe kidney problems.

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with Idaptan.

This medicinal product is not a curative treatment for angina pectoris attacks, nor is it indicated as initial treatment for unstable angina pectoris. It is not a treatment for myocardial infarction.

In the event of an angina pectoris attack, inform your doctor. You may need to undergo tests and your treatment may need to be modified.

This medicinal product may cause or worsen symptoms such as tremors, rigid posture, slow movements, and shuffling gait, instability when walking, especially in elderly patients, who should be investigated and reported to your doctor, who may reconsider treatment.

Severe skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis (AGEP), have been reported in association with Idaptan. Stop using Idaptan and seek immediate medical attention if you notice any of the symptoms related to this severe skin reaction described in section 4.

Falls may occur due to a drop in blood pressure or loss of balance (see description in adverse effects).

Athletes

This medicinal product contains an active substance that may produce a positive result in doping tests.

Children and adolescents

Idaptan is not recommended for children under 18 years of age.

Use of Idaptan with other medicinal products

No interactions with other medicinal products have been identified.

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicinal products.

Use of Idaptan with food anddrinks

Idaptan can be taken with food and drinks.

Pregnancy and breast-feeding

It is preferable that you do not take this medicinal product during pregnancy. If you discover that you are pregnant while taking this medicinal product, consult your doctor, as only he can judge the need to continue treatment.

In the absence of data on excretion in breast milk, you should not take Idaptan during breast-feeding.

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicinal product.

Driving and using machines

This medicinal product may cause dizziness and somnolence that may affect your ability to drive or use machines.

Important information about some of the ingredients of Idaptan

This medicinal product may cause allergic reactions because it contains yellow-orange aluminum lake (E 110) and ponceau 4R aluminum lake (E 124).

It may cause asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take Idaptan

Follow exactly the administration instructions of this medicinal product given by your doctor. In case of doubt, consult your doctor or pharmacist again.

The recommended dose of Idaptan 20 mg is 1 tablet three times a day with meals.

If you have kidney problems or are over 75 years old, your doctor may adjust the recommended dose.

The tablets should be swallowed with a glass of water with meals.

Your doctor will indicate the duration of your treatment with Idaptan.

If you take more Idaptan than you should

If you have taken more tablets than you should, consult your doctor or pharmacist immediately. In case of overdose or accidental ingestion, consult the Toxicology Information Service, telephone (91) 562 04 20.

If you forget to take Idaptan

Do not take a double dose to make up for forgotten doses.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicinal products, this medicinal product can cause side effects, although not everybody gets them.

Stop using Idaptan and contact a doctor immediately if you notice any of the following side effects:

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

• Generalized skin rash, elevated body temperature, increased liver enzyme levels, blood abnormalities (eosinophilia), increased lymph nodes, and involvement of other body organs (Drug Reaction with Eosinophilia and Systemic Symptoms, also known as DRESS). See also section 2.
• Severe generalized red skin rash with blistering

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

Dizziness, headache, abdominal pain, diarrhea, indigestion, feeling of dizziness, vomiting, skin rash, itching, urticaria, and feeling of weakness.

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

Unusual sensation in the skin, such as tingling or prickling (paresthesia)

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

Fast or irregular heartbeats (also called palpitations), extra heartbeats, rapid heartbeat, drop in blood pressure when standing up that causes dizziness, fainting, or fainting spells, general malaise (usually indisposition), falls, flushing.

Frequency not known (cannot be estimated from the available data)

• Extrapyramidal symptoms (abnormal movements, including trembling hands and fingers, body twisting movements, shuffling gait, and stiffness of arms and legs), usually reversible after treatment discontinuation.

• Sleep disorders (difficulty sleeping, somnolence), constipation, swelling of the face, lips, mouth, tongue, or throat that may cause difficulty swallowing or breathing.

• Severe decrease in the number of white blood cells that increases the risk of infections, decrease in blood platelets, which increases the risk of bleeding or bruising.

• Liver disease (nausea, vomiting, loss of appetite, general malaise, fever, itching, yellowing of the skin and eyes, pale stools, dark urine).

• Dizzy sensation (vertigo).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines and Health Products Agency's website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicinal product.

5. Storage of Idaptan

Do not store above 30°C.

Keep out of the reach and sight of children.

Do not use Idaptan after the expiry date stated on the pack. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Idaptan

• The active substance is trimetazidine. Each film-coated tablet contains 20 mg of trimetazidine.

• The other ingredients of the tablet are: maize starch, mannitol, povidone, magnesium stearate, talc, titanium dioxide (E171), glycerol, yellow-orange aluminum lake (E110), ponceau 4R aluminum lake (E124), macrogol 6000, hypromellose.

Appearance and packaging

Idaptan is presented as red film-coated tablets. The pack contains 60 tablets for oral administration. The tablets are presented in PVC/aluminum blisters.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Laboratorios Servier, S.L.

Avda. de los Madroños 33

28043 Madrid - Spain

Manufacturer:

Les Laboratoires Servier Industrie

905 route de Saran

45520 Gidy – France

LABORATORIOS SERVIER, S.L.

Avenida de los Madroños, 33

28043 – Madrid

Date of last revision of this leaflet: 08/2024

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