Leaflet: information for the user

IDAPTAN 20 mg film-coated tablets

Trimetazidine

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 yourdoctor or pharmacist.
• This medicine has been prescribed for you only, do not give it to others even if they have similar symptoms to you, 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.

1.What Idaptan is and what it is used for

2.What you need to knowbeforestarting totake Idaptan

3.How to take Idaptan

4.Possible side effects

5Storage of Idaptan

6.Contents of the pack and additional information

This medication is indicated for adult patients, in combination with other medications, to treat angina pectoris (chest pain caused by coronary artery disease).

Do not take Idaptan

• If you are allergic to trimetazidine or any of the other components of this medication (listed in section 6).
• If you have Parkinson's disease: a brain disorder that affects movement (tremors, stiff posture, slow movements, and dragging your feet, instability while walking).
• If you have severe kidney problems.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Idaptan.

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

In case of an angina attack, inform your doctor. You may need to undergo tests and have your treatment modified.

This medication may cause or worsen symptoms such as tremors, stiff posture, slow movements, and dragging your feet, instability while walking, especially in older patients, which must be investigated and notified to your doctor, who may reconsider treatment.

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

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

Athletes

This medication contains an active ingredient that may produce a positive result in doping control tests.

Children and adolescents

Idaptan is not recommended for children under 18 years old.

Use of Idaptan with other medications

No interactions with other medications have been identified.

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Use of Idaptan with food and drinks

Idaptan can be taken with food and drinks.

Pregnancy and breastfeeding

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

In the absence of data on excretion in breast milk, do not take Idaptan during breastfeeding.

If you are pregnant or breastfeeding, believe you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

This medication may cause dizziness and drowsiness that may affect your ability to drive or operate machinery.

Important information about some of the components of Idaptan

This medication may cause allergic reactions because it contains yellow-orange aluminium lake (E 110) and aluminium lake of ponceau 4R (E 124).

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

Follow exactly the administration instructions for this medication as indicated by your doctor. If in 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.

Tablets should be swallowed with a glass of water with meals.

Your doctor will inform you of 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, contact the Toxicological Information Service, phone (91) 562 04 20.

If you forgot to take Idaptan

Do not take a double dose to compensate for the missed doses.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

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

Unknown frequency (cannot be estimated from available data):

• Generalized skin rash, elevated body temperature, increased levels of liver enzymes, blood abnormalities (eosinophilia), enlarged 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 blister formation

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

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

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

Unusual skin sensations, such as tingling or numbness (paresthesia)

Rare (may affect up to 1 in 1000 people):

Fast or irregular heartbeat (also known as palpitations), extra heartbeats, rapid heartbeat, low blood pressure when standing that causes dizziness, fainting, or dizziness, general discomfort (usually indisposition), falls, flushing.

Unknown frequency (cannot be estimated from available data)

• Extrapyramidal symptoms (unusual movements, including trembling hands and fingers, body twisting movements, dragging gait, and stiffness of arms and legs), generally reversible after treatment interruption.

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

• Severe reduction in white blood cell count that increases the risk of infections, decreased platelet count, which increases the risk of bleeding or petechiae.

• Liver disease (nausea, vomiting, loss of appetite, general discomfort, fever, itching, yellowish discoloration of skin and eyes, light-colored stools, dark-colored urine).

• Sensation of spinning (vertigo).

Reporting side effects

If you experience any type of side effect, consult your doctor, 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.

Do not store at a temperature above 86°F (30°C).

Keep out of the reach and sight of children.

Do not use Idaptan after the expiration date shown on the packaging. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

Composition of Idaptan

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

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

Appearance of the product and contents of the packaging

Idaptan is presented in the form of red-coated tablets. The packaging contains 60 tablets for oral administration. The tablets are presented in PVC/aluminium blisters.

Holder of the marketing authorization and manufacturer responsible

Holder of the marketing authorization:

Laboratorios Servier, S.L.

Avda. de los Madroños 33

28043 Madrid - Spain

Manufacturer responsible:

Les Laboratoires Servier Industrie

905 route de Saran

45520 Gidy – France

LABORATORIOS SERVIER, S.L.

Avenida de los Madroños, 33

28043 – Madrid

Last review date of this leaflet: 08/2024

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