País: Irlanda
Língua: inglês
Origem: HPRA (Health Products Regulatory Authority)
PERINDOPRIL ARGININE INDAPAMIDE
Imbat Limited
5/1.25 Milligram
Film Coated Tablet
2008-11-14
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Coversyl Arginine Plus 5mg/1.25mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 3.395 mg perindopril equivalent to 5mg perindopril arginine and 1.25 mg indapamide. Excipients : lactose monohydrate For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. _Product imported from the UK, Hungary and Poland_ White, rod-shaped film-coated tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of essential hypertension, COVERSYL ARGININE PLUS 5mg/1.25mg film-coated tablet is indicated in patients whose blood pressure is not adequately controlled on perindopril alone. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Oral route One COVERSYL ARGININE PLUS 5mg/1.25mg film-coated tablet per day as a single dose, preferably to be taken in the morning, and before a meal. When possible individual dose titration with the components is recommended. COVERSYL ARGININE PLUS 5mg/1.25mg film- coated tablet should be used when blood pressure is not adequately controlled on COVERSYL ARGININE PLUS 2.5mg/0.625mg film-coated tablet (where available).When clinically appropriate, direct change from monotherapy to COVERSYL ARGININE PLUS 5mg/1.25mg film-coated tablet may be considered. _Elderly (see section 4.4)_ Treatment should be initiated after considering blood pressure response and renal function. _Patients with renal impairment (see section 4.4)_ In severe renal impairment (creatinine clearance below 30 ml/min), treatment is contraindicated. In patients with moderate renal impairment (creatinine clearance 30-60 ml/min), it is recommended to start treatment with the adequate dosage of the free combination. In patients with creatinine clearance greater than or equal to Leia o documento completo