Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
QUINAPRIL
B & S Healthcare
20 Milligram
Film Coated Tablet
2006-10-20
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Accupro 20mg Film - coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 20mg quinapril base (equivalent to 21.664 quinapril hydrochloride). Excipients: Lactose monohydrate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. _Product imported from Italy_: Brown round tablet with a scoreline on both sides and the strength '20' on one side _Product imported from Germany:_ White, round tablet with a scoreline on both sides and the strength '20' imprinted on one side only. The scoreline is to allow for breaking for ease of swallowing and not to divide into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS (1) For the treatment of all grades of essential hypertension. Accupro is effective as monotherapy or concomitantly with diuretics in patients with hypertension. (2) 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 p Read the complete document