Valsts: Armēnija
Valoda: angļu
Klimata pārmaiņas: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
valsartan
KRKA d.d.
C09CA03
valsartan
80mg
tablets film-coated
(28/4x7/) in blister
Prescription
Registered
2020-10-21
1 1. NAME OF THE MEDICINAL PRODUCT Valsacor 80 mg film-coated tablets Valsacor 160 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 80 mg or 160 mg valsartan. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. 80 mg tablets: pink, round, biconvex, scored on one side. The tablet can be divided into equal doses. 160 mg tablets: yellow-brown, oval, biconvex, scored on one side. The tablet can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hypertension Treatment of hypertension. _Heart failure_ Treatment of heart failure (NYHA class II-IV) in patients not treated with ACE inhibitors. In these patients, valsartan reduces mortality and morbidity and the number of hospital days due to heart failure. Valsartan also slows the progression of heart failure, improves left ventricular ejection fraction and left ventricular internal diastolic diameter and compared to placebo improves the signs and symptoms of heart failure (see section 5.1). Recent myocardial infarction Valsartan is indicated to improve survival following myocardial infarction in clinically stable patients with signs, symptoms or radiological evidence of left ventricular failure and/or left ventricular systolic dysfunction (see section 5.1). POSOLOGY AND METHOD OF ADMINISTRATION Hypertension The recommended dose of valsartan is 80 mg once daily regardless of age, sex or race of the patient. The antihypertensive effect occurs in two weeks and the maximum antihypertensive effect after four weeks. In patients whose blood pressure is not adequately controlled, the daily dose can be increased to 160 mg or a diuretic can be added. The maximum daily dose is 320 mg. Dosage adjustment is not required in patients with impaired renal function or impaired hepatic function of non-biliary origin and without cholestasis. Valsartan may also be administered concomitantly with other antihypertensive drugs. _Heart failure_ The recommended initial dose of Izlasiet visu dokumentu