Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
PERINDOPRIL TERT-BUTYLAMINE SALT
Primecrown Ltd.
4 Milligram
Tablets
2002-11-11
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 necessary. If the diuretic therapy cannot be discontinued, the initial dose of Perindopril should be 2 mg. _Congestive heart failure_: The treatment should be initiated under close medical supervision with a recommended starting dose of 2 mg as a single dose in the morning which in most cases, in the absence of symptomatic hypotension can be increased to 4 mg daily. In severe heart failure, treatment should be initiated in hospital. _Elderly_: The usual initial dose of 2 mg once daily may be increased after one month of treatment to 4 mg if Lire le document complet