Country: Իռլանդիա
language: անգլերեն
source: HPRA (Health Products Regulatory Authority)
QUINAPRIL HYDROCHLORIDE
PCO Manufacturing
20 Milligram
Film Coated Tablet
2004-11-12
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Accupro 20 mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 20 mg quinapril (as hydrochloride). Excipients: Contains lactose monohydrate For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Film-coated tablets _Product imported from Greece and The Netherlands:_ Brown, film-coated, round tablets with a breakline on one side and ‘20’ on the other side. _Product imported from Germany:_ White, film-coated, round tablets with a breakline on one side and ‘20’ on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ○ For the treatment of all grades of essential hypertension. Accupro is effective as monotherapy or concomitantly with diuretics in patients with hypertension. ○ For the treatment of congestive heart failure when given concomitantly with a diuretic and/or cardiac glycoside. Treatment of congestive heart failure with Accupro should always be initiated under close medical supervision. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral use. _Adults:_ _Hypertension_ _Monotherapy: _The recommended initial dosage is 10 mg once daily. Depending upon clinical response, patient’s dosage may be titrated (by doubling the dose allowing adequate time for dosage adjustment) to a maintenance dosage of 20 to 40 mg/day given as a single dose or divided into 2 doses. Long-term control is maintained in most patients with a single daily dosage regimen. Patients have been treated with dosages up to 80 mg/day. _Concomitant Diuretics: _In order to determine if excess hypotension will occur, an initial dosage of 5 mg of Accupro is recommended in patients who are also being treated with a diuretic. After this the dosage of Accupro should be titrated ( read_full_document