국가: 아일랜드
언어: 영어
출처: HPRA (Health Products Regulatory Authority)
TRIMETAZIDINE DIHYDROCHLORIDE
Servier Laboratories (Ireland) Ltd
35 Milligram
Tablet Prolonged Release
2005-11-04
SUMMARY OF PRODUCT CHARACTERISTICS 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 It is intended for use in the management of angina pectoris. It has been shown in a few studies to be useful in the management of certain disorders of ischaemic origin affecting the cochleovestibular structures or the chorioretinal tissues. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Oral administration. One tablet at mealtimes in the morning and evening. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE This product should be used with caution in patients who are predisposed to closed angle glaucoma. The drug is not a curative treatment for angina attacks, nor is indicated as an initial treatment for unstable angina, or myocardial infarction. It should not be used in the pre-hospital phase nor during the first days of hospitalisation. In the event of an angina attack, angina pectoris disease should be re-evaluated and an adaptation of the treatment considered. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION No drug interactions have been identified. 4.6 FERTILITY, PREGNANCY AND LACTATION _Pregnancy:_ Studies in animals have not demonstrated a teratogenic effect; however, in the absence of clinical data, the risk of malformation cannot be excluded. Therefore, for safety reasons, prescription should be avoided during pregnancy. IRISH MEDICINES BOARD ________________________________ 전체 문서 읽기