Страна: Ирландия
Език: английски
Източник: HPRA (Health Products Regulatory Authority)
QUINAPRIL HYDROCHLORIDE
G & A Licensing Limited
5 Milligram
Film Coated Tablet
2008-07-25
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Accupro 5 mg Film-Coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: Quinapril hydrochloride 5.416 mg (Equivalent to 5mg quinapril base). Contains Lactose For excipients, see Section, 6.1. 3 PHARMACEUTICAL FORM Film-coated Tablets _Product Imported from Greece_ Brown, elliptical film-coated tablet with a breakline and imprinted with the dosage strength ‘5’ on both sides 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 patients who are also being treated with a diuretic. After this the dosage of Accupro should be titrated (by doubling the dose allowing adequate time for dosage adjustment) to the optimal response (see section 4.5 Interaction with other medicinal produ Прочетете целия документ