Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
PERINDOPRIL ARGININE
Imbat Limited
10 Milligram
Film Coated Tablet
2007-11-09
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Coversyl Arginine 10 mg film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains perindopril 6.790 mg corresponding to 10 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 Poland and Hungary_ Green, round, biconvex, film-coated tablet engraved with a heart on on one face and the Servier logo on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hypertension: Treatment of hypertension. 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 10 mg, film-coated tablet 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 10 mg 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 medical supervision. The dose may be increased to 10 mg once daily after one month of treatment. Symptomatic hypotension may occur following initiation of therapy with Coversyl Arginin Read the complete document