देश: आयरलैंड
भाषा: अंग्रेज़ी
स्रोत: HPRA (Health Products Regulatory Authority)
VALSARTAN
IPS Healthcare Limited
160 Milligram
Film Coated Tablet
2011-05-03
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Diovan 160 mg Film coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One film-coated tablet contains 160 mg valsartan. For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablets. Grey-orange, ovaloid film-coated tablet, slightly convex, scored on one side with debossing “DX” on one side of the score and “DX” on the other side of the score and “NVR” on the reverse side of the tablet. The tablet can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hypertension Treatment of essential hypertension in adults, and hypertension in children and adolescents 6 to 18 years of age. Recent myocardial infarction Treatment of clinically stable adult patients with symptomatic heart failure or asymptomatic left ventricular systolic dysfunction after a recent (12 hours-10 days) myocardial infarction (see sections 4.4 and 5.1). Heart failure Treatment of symptomatic heart failure in adult patients when Angiotensin Converting Enzyme (ACE) inhibitors cannot be used, or as add-on therapy to ACE inhibitors when beta blockers cannot be used (see sections 4.4 and 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Posology_ Hypertension The recommended starting dose of Diovan is 80 mg once daily. The antihypertensive effect is substantially present within 2 weeks, and maximal effects are attained within 4 weeks. In some patients whose blood pressure is not adequately controlled, the dose can be increased to 160 mg and to a maximum of 320 mg. Diovan may also be administered with other antihypertensive agents. The addition of a diuretic such as hydrochlorothiazide will decrease blood pressure even further in these patients. Recent myocardial infarction In cli पूरा दस्तावेज़ पढ़ें