País: Irlanda
Língua: inglês
Origem: HPRA (Health Products Regulatory Authority)
TRIMETAZIDINE DIHYDROCHLORIDE
Servier Laboratories (Ireland) Ltd
TRIMETAZIDINE DIHYDROCHLORIDE
35 Milligram
Tablet Prolonged Release
Product subject to prescription which may be renewed (B)
Withdrawn
2014-09-23
_ _ _ _ PACKAGE LEAFLET: INFORMATION FOR THE USER TRIMETAZIDINE 35MG PROLONGED-RELEASE TABLETS TRIMETAZIDINE DIHYDROCHLORIDE This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. - 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Trimetazidine 35mg Prolonged-Release Tablets is and what it is used for 2. What you need to know before you take Trimetazidine 35mg Prolonged-Release Tablets 3. How to take Trimetazidine 35mg Prolonged-Release Tablets 4. Possible side effects 5. How to store Trimetazidine 35mg Prolonged-Release Tablets 6. Further information 1. WHAT TRIMETAZIDINE 35MG PROLONGED-RELEASE TABLETSIS AND WHAT IT IS USED FOR This medicine is intended for use in adult patient, in combination with other medicines to treat angina pectoris (chest pain caused by coronary disease). It protects the heart cells from the effects of a reduced oxygen supply during an episode of angina. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TRIMETAZIDINE 35MG PROLONGED-RELEASE TABLETS DO NOT TAKE TRIMETAZIDINE 35MG PROLONGED-RELEASE TABLETS - if you are allergic to trimetazidine or any of the other ingredients of this medicine (listed in section 6 Leia o documento completo
SUMMARY OF PRODUCT CHARACTERISTICS This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1 NAME OF THE MEDICINAL PRODUCT Trimetazidine 35 mg Prolonged-Release Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each prolonged-release tablet contains 35mg trimetazidine dihydrochloride. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged-release tablet. Pink round biconvex tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Trimetazidine is indicated in adults as add-on therapy for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled by or intolerant to first-line antianginal therapies. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Oral administration. The dose is one tablet of 35mg of trimetazidine twice daily during meals. Special populations _Patients with renal impairment_ In patients with moderate renal impairment (creatinine clearance [30-60] ml/min) (see sections 4.4 and 5.2), the recommended dose is 1 tablet of 35mg in the morning during breakfast. _Elderly patients_ Elderly patients may have increased trimetazidine exposure due to age-related decrease in renal function (see section 5.2). In patients with moderate renal impairment (creatinine clearance [30-60] ml/min), the recommended dose is 1 tablet of 35mg in the morning during breakfast. Dose titration in elderly patients should be exercised with caution (see section 4.4). _Paediatric population:_ The safety and efficacy of trimetazidine in children aged below 18 years have not been established. No data are available. HEALTH PRODUCTS REGULATORY AUTHORITY _______________ Leia o documento completo