Idaptan 20 mg film-coated tablets
Spain
Table of Contents
Package Leaflet: Information for the User
Introduction
Package Leaflet: Information for the user
IDAPTAN 20 mg film-coated tablets
Trimetazidine
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 you should not give it to others, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.
Leaflet Contents
- What Idaptan is and what it is used for
- What you need to know before taking Idaptan
- How to take Idaptan
- Possible side effects
- How to store Idaptan
- Contents of the pack and other information
1. What Idaptan is and what it is used for
This medicine is indicated in adult patients, in combination with other medicines for the treatment of angina pectoris (chest pain caused by coronary artery disease).
2. What you need to know before taking Idaptan
Do not take Idaptan
- If you are allergic to trimetazidine or to any of the other ingredients of this medicine (listed in section 6).
- If you have Parkinson's disease: a brain disorder affecting movement (tremors, rigid posture, slow movements, shuffling gait, gait instability).
- If you have severe kidney problems.
Warnings and precautions
Talk to your doctor or pharmacist before taking Idaptan.
This medicine 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.
If you experience an angina attack, inform your doctor. You may need further tests and your treatment may need to be adjusted.
This medicine may cause or worsen symptoms such as tremors, rigid posture, slow movements, shuffling gait, and gait instability, particularly in elderly patients. These symptoms should be investigated and reported to your doctor, who may reconsider your treatment.
Serious skin reactions have been reported in association with Idaptan, including drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis (AGEP). Stop taking Idaptan and seek immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.
Falls may occur following a drop in blood pressure or loss of balance (see description in adverse effects).
Athletes
This medicine contains an active substance that may result in a positive test in anti-doping controls.
Children and adolescents
Idaptan is not recommended for children and adolescents under 18 years of age.
Taking Idaptan with other medicines
No interactions with other medicines have been identified.
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Taking Idaptan with food and drink
Idaptan may be taken with food and drink.
Pregnancy and breastfeeding
It is preferable not to take this medicine during pregnancy. If you find out you are pregnant while taking this medicine, consult your doctor, as only they can assess whether continuing treatment is necessary.
Due to lack of data on excretion in breast milk, Idaptan should not be taken during breastfeeding.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Driving and using machines
This medicine may cause dizziness and drowsiness, which could affect your ability to drive or operate machinery.
Important information about some of the ingredients of Idaptan
This medicine may cause allergic reactions as it contains Sunset Yellow aluminium lake (E 110) and Ponceau 4R aluminium lake (E 124).
It may provoke asthma, especially in patients allergic to acetylsalicylic acid.
3. How to take Idaptan
Follow exactly the instructions given by your doctor for taking this medicine. If you are unsure, 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 and taken with meals.
Your doctor will advise you on how long your treatment with Idaptan should last.
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 Toxicology Information Service, telephone (91) 562 04 20.
If you forget to take Idaptan
Do not take a double dose to make up for missed doses.
If you have any further questions about the use of this product, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
Stop using Idaptan and contact a doctor immediately if you notice any of the following adverse effects:
Frequency not known (cannot be estimated from available data):
- Widespread skin rash, high body temperature, increased levels of liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes, and involvement of other body organs (Drug Reaction with Eosinophilia and Systemic Symptoms, also known as DRESS). See also section 2.
- Severe widespread red skin rash with blistering
Frequent (may affect up to 1 in 10 people):
Dizziness, headache, abdominal pain, diarrhoea, indigestion, feeling dizzy, vomiting, skin rash, itching, urticaria, and feeling weak.
Uncommon (may affect up to 1 in 100 people):
Unusual skin sensations, such as tingling or pins and needles (paraesthesia).
Rare (may affect up to 1 in 1000 people):
Rapid or irregular heartbeat (also known as palpitations), extra heartbeats, accelerated heartbeat, drop in blood pressure upon standing causing dizziness, fainting or collapse, general malaise (generally feeling unwell), falls, flushing.
Frequency not known (cannot be estimated from available data):
-
Extrapyramidal symptoms (unusual movements, including tremors of hands and fingers, twisting body movements, shuffling gait, and stiffness of arms and legs), usually reversible after discontinuation of treatment.
-
Sleep disorders (difficulty sleeping, drowsiness), constipation, swelling of the face, lips, mouth, tongue, or throat, which may cause difficulty swallowing or breathing.
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Severe reduction in the number of white blood cells, increasing the likelihood of infections; decreased blood platelets, increasing the risk of bleeding or bruising.
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Liver disease (nausea, vomiting, loss of appetite, general malaise, fever, itching, yellowing of the skin and eyes, pale stools, dark urine).
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Sensation of spinning (vertigo).
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through 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 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 container. The expiry date is the last day of the month indicated.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Idaptan
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The active substance is trimetazidine. Each film-coated tablet contains 20 mg of trimetazidine.
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The other components of the tablet are: maize starch, mannitol, povidone, magnesium stearate, talc, titanium dioxide (E171), glycerol, aluminium lake of orange yellow (E110), aluminium lake of ponceau 4R (E124), macrogol 6000, hypromellose.
Appearance of the product and contents of the pack
Idaptan is presented as red film-coated tablets. The pack contains 60 tablets for oral administration. The tablets are supplied in PVC/aluminum blisters.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Laboratorios Servier, S.L.
Glorieta Mar Caribe, 1
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 the most recent review of this leaflet: 08/2024
Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.