Nazione: Irlanda
Lingua: inglese
Fonte: HPRA (Health Products Regulatory Authority)
CAPTOPRIL HYDROCHLOROTHIAZIDE
PCO Manufacturing
CAPTOPRIL HYDROCHLOROTHIAZIDE
%v/v
Tablets
Withdrawn
2010-12-31
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Capozide 50mg/25mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 50mg captopril and 25mg hydrochlorothiazide. Excipients: Contains lactose. Product imported from Spain contains Sunset Yellow (E110) _For a full list of excipients, see section 6.1._ 3 PHARMACEUTICAL FORM Tablet _Product imported from the U.K._ White, oval, biconvex tablets with a breakline on one side and ‘SQUIBB 390’ on the other. _Product imported from Spain_ Peach, oval, biconvex tablets with a breakline on one side and ‘390’ on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of essential hypertension. This fixed dose combination is indicated in patients whose blood pressure is not adequately controlled by captopril alone or hydrochlorothiazide alone. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Capozide can be administered in a single or two divided doses/day with or without food in patients whose blood pressure is not adequately controlled by captopril alone or hydrochlorothiazide alone. A maximum daily dose of 100mg captopril/30mg hydrochlorothiazide should not be exceeded. If satisfactory reduction of blood pressure has not been achieved, additional antihypertensive medication may be added _(see 4.5)._ _Adults: _The administration of the fixed combination of captopril and hydrochlorothiazide is usually recommended after dosage titration with the individual components. The usual maintenance dose is 50/25mg, once a day, in the morning. When clinically appropriate a direct change from monotherapy to the fixed combination may be considered. The 25/25mg* strength may be used once a day for patients whose blood pressure is not adequately controlled by hydrochlorothiazide 25mg monotherapy and before t Leggi il documento completo