Maa: Irlanti
Kieli: englanti
Lähde: HPRA (Health Products Regulatory Authority)
TRIMETAZIDINE DIHYDROCHLORIDE
PCO Manufacturing
20 Milligram
Film Coated Tablet
2005-02-04
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Vastarel 20mg Film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 20 mg trimetazidine dihydrochloride. Excipients: Ponceau 4R (E124) and sunset yellow (E110) For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablets (tablets) Round, red film-coated tablets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • Prophylactic treatment of angina pectoris (see Section 4.4) • Symptomatic treatment of vertigo, Meniere's disease, tinnitus. • Symptomatic treatment of chorioretinal ischaemic disorders. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Oral administration The usual daily dose is 40 to 60mg in divided doses Trimetazidine is not recommended for use in children due to a lack of data. For patients with impaired renal function (creatinine clearance between 15 and 90 mL.min -1 ), the starting dose is one tablet twice daily respectively in the morning and in the evening. Trimetazidine is not recommended in patients with severe renal impairment (creatinine clearance below 15 mL.min -1 ) due to lack of data. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE This 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 prehospital phase nor during the first days of hospitalisation. In the event of an angina attack, angina pectoris disease should be reevaluated and an adaptation of the treatment considered. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 14/04/2011_ _CRN 209126 Lue koko asiakirja