Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
VALSARTAN
Ranbaxy Ireland Limited
160 Milligram
Film Coated Tablet
2011-10-21
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Valsartan Ranbaxy 160 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 160 mg valsartan. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablets. Pink coloured, film-coated, oval tablets debossed with ‘V &1’ 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 a Read the complete document