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SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Valsartan Ranbaxy 80 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 80 mg valsartan.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablets.
Orange coloured, film-coated, oval tablets debossed with ‘V & 2’ 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
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