Country: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
VALSARTAN
Ranbaxy Ireland Limited
40 Milligram
Film Coated Tablet
2011-10-21
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Valsartan Ranbaxy 40 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 40 mg valsartan. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablets. Yellow coloured, film-coated, oval tablets debossed with ‘V & 3’ on either side of breakline on one side and breakline on the other side. The tablets 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 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 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 Valsartan Ranbaxy 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. Valsartan Ranbaxy 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 clinically stable patients, therapy may be initiated as early as 12 hours after Lestu allt skjalið