Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
VALSARTAN
Laboratorios LICONSA, S.A.
VALSARTAN
80 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
Withdrawn
2013-04-16
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Saldanar 80 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One film-coated tablet contains 80 mg of valsartan. EXCIPIENTS: Each tablet contains: sorbitol 9.25 mg lactose 1.1 mg sodium 0.32 mg (0.01 mmol) For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Cylindrical, coated, scored on one side, pink film-coated tablets. The tablet can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hypertension Treatment of essential hypertension. 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 Saldanar 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. Saldanar 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 myocardial infarction. After an initial dose of 20 mg twice daily, valsartan should b Lugege kogu dokumenti