Kraj: Irlandia
Język: angielski
Źródło: HPRA (Health Products Regulatory Authority)
RAMIPRIL
G & A Licensing Limited
10 Milligram
Tablets
2010-01-15
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Tritace 10mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Tritace 10 mg Tablets contains 10 mg Ramipril per tablet. For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Tablets _Product imported from Germany:_ White oblong tablets with a scoreline on both sides. The tablets are stamped twice with HMO on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Tritace is indicated in the treatment of all grades hypertension. Congestive heart failure; as adjunctive therapy to diuretics with or without cardiac glycosides. Tritace has been shown to reduce mortality when administered to patients surviving acute myocardial infarction with clinical evidence of heart failure. Prevention of myocardial infarction, stroke or cardiovascular death in patients with an increased cardiovascular risk who are already taking standard therapy. Prevention of myocardial infarction, stroke or cardiovascular death in type 2 diabetic patients with an increased cardiovascular risk. Prevention of progression of microalbuminuria to overt nephropathy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Oral Administration. Tritace Tablets should be taken with plenty of liquid. The absorption of ramipril is not affected by food. The tablets must not be chewed. _Hypertension: _The recommended initial dosage in patients not on diuretics and without congestive heart failure is 2.5 mg Tritace once a day. Dosage should be increased incrementally at intervals of 1-2 weeks, based on patient response, up to a maximum of 10 mg once a day. A 1.25 mg dose will only achieve a therapeutic response in a minority of patients. The usual maintenance dose range is 2.5-5 mg Tritace as a single daily dose. If the patient response is still u Przeczytaj cały dokument