Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
VALSARTAN HYDROCHLOROTHIAZIDE
Clear Pharmacy
80/12.5 Milligram
Film Coated Tablet
2010-10-15
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Co-Diovan 80 mg/12.5 mg film-coated tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 80 mg of valsartan and 12.5 mg of hydrochlorothiazide. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. _Product imported from Italy:_ Light orange, ovaloid tablet imprinted with “HGH" on one side and "CG" on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of essential hypertension in adults. Co-Diovan fixed-dose combination is indicated in patients whose blood pressure is not adequately controlled on valsartan or hydrochlorothiazide monotherapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Posology_ The recommended dose of Co-Diovan 80 mg/12.5 mg is one film-coated tablet once daily. Dose titration with the individual components is recommended. In each case, up-titration of individual components to the next dose should be followed in order to reduce the risk of hypotension and other adverse events. When clinically appropriate direct change from monotherapy to the fixed combination may be considered in patients whose blood pressure is not adequately controlled on valsartan or hydrochlorothiazide monotherapy, provided the recommended dose titration sequence for the individual components is followed. The clinical response to Co-Diovan should be evaluated after initiating therapy and if blood pressure remains uncontrolled, the dose may be increased by increasing either one of the components to a maximum dose of Co-Diovan 320 mg/25 mg. The antihypertensive effect is substantially present within 2 weeks. In most patients, maximal effects are observed within 4 weeks. However, in some patients 4 -8 weeks treatment may be required. This should be ta Les hele dokumentet