Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
TRIMETAZIDINE DIHYDROCHLORIDE
Servier Laboratories (Ireland) Ltd
C01EB15
TRIMETAZIDINE DIHYDROCHLORIDE
35 Milligram
Modified-release Tablets
Product subject to prescription which may be renewed (B)
Other cardiac preparations
Authorised
2005-11-04
_ _ 11 PACKAGE LEAFLET: INFORMATION FOR THE USER VASTAREL 35 MG MODIFIED-RELEASE TABLETS TRIMETAZIDINE DIHYDROCHLORIDE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk toyour doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. - WHAT IS IN THIS LEAFLET: 1. What Vastarel 35 mg Modified-Release Tablets is and what it is used for 2. What you need to know before you take Vastarel 35 mg Modified-Release Tablets 3. How to take Vastarel 35 mg Modified-Release Tablets 4. Possible side effects 5. How to store Vastarel 35 mg Modified-Release Tablets 6. Contents of the pack and other information 1. WHAT VASTAREL 35 MG MODIFIED-RELEASE TABLETS IS 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 VASTAREL 35 MG MODIFIED-RELEASE TABLETS DO NOT TAKE VASTAREL 35 MG MODIFIED-RELEASE TABLETS - if you are allergic to trimetazidine or any of the other ingredients of this medicine (listed in section 6), - if you have a Parkinson disease: disease of the brain affecting movement (trembling, rigid posture, slow movements and a shuffling, unbalanced walk), - if you have severe kidney problems. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Vastarel 35 mg Modified-Release Tablets This drug is not a cure for angina attacks, and should not be used as a treatment for unstable angina or heart attack. In the event of an angina Lugege kogu dokumenti
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT VASTAREL 35mg Modified-Release Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each modified-release tablet contains 35 mg trimetazidine dihydrochloride. For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Modified-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. Posology The dose is one tablet of 35mg of trimetazidine twice daily during meals. Special populations _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_ 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. 4.3 CONTRAINDICATIONS - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ Lugege kogu dokumenti