Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
PERINDOPRIL ARGININE
Imbat Limited
5 Milligram
Film Coated Tablet
2007-11-09
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Coversyl Arginine 5 mg film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains perindopril 3.395 mg corresponding to 5 mg perindopril arginine. Excipients: lactose monohydrate For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet _Product imported from Greece, Poland and Hungary:_ _Poland and Greece_ Light-green, rod-shaped film-coated tablet engraved with the Servier logo on one face and plain on ther other. _Hungary:_ Light-green, rod-shaped film-coated tablet engraved with the servier logo on one face and plain on the other, scored on both edges. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hypertension: Treatment of hypertension. Heart failure: Treatment of symptomatic heart failure. Stable coronary artery disease: Reduction of risk of cardiac events in patients with a history of myocardial infarction and/or revascularisation. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION It is recommended that COVERSYL ARGININE is taken once daily in the morning before a meal. The dose should be individualised according to the patient profile (see section 4.4) and blood pressure response. Hypertension: COVERSYL ARGININE may be used in monotherapy or in combination with other classes of antihypertensive therapy. The recommended starting dose is 5 mg given once daily in the morning. Patients with a strongly activated renin-angiotensin-aldosterone system (in particular, renovascular hypertension, salt and/or volume depletion, cardiac decompensation or severe hypertension) may experience an excessive drop in blood pressure following the initial dose. A starting dose of 2.5 mg is recommended in such patients and the initiation of treatment should take place under medi Read the complete document