Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
PERINDOPRIL TERT-BUTYLAMINE SALT
Primecrown Ltd.
4 Milligram
Tablets
2002-11-11
License Part II Summary of Product Characteristics 1 NAME OF THE MEDICINAL PRODUCT Coversyl 4 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 4 mg of Perindopril tert-butylamine salt. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Tablet White, rod-shaped tablets, scored on both sides. 4 CLINICAL PARTICULARS 4.1 Therapeutic Indications ○ Essential Hypertension: in the treatment of essential hypertension as monotherapy or combined with thiazide type diuretics. ○ Congestive heart failure: in the treatment of congestive heart failure as adjunctive therapy with non-potassium sparing diuretics and, where appropriate digitalis. Treatment with Coversyl should always be initiated under medical supervision (for severe heart failure, it should be initiated in hospital). 4.2 Posology and method of administration Oral Administration Adults Essential hypertension: The usual initial dosage is 4 mg given as a single dose in the morning which may be increased after one month of treatment to 8 mg if necessary. The long-term maintenance regimen is a single daily dose. In the case of previous diuretic treatment, the diuretic should be discontinued for at least 3 days before commencing Perindopril and reinstituted subsequently if Read the complete document