Šalis: Armėnija
kalba: anglų
Šaltinis: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
valsartan, hydrochlorothiazide
KRKA d.d.
C09DA03
valsartan, hydrochlorothiazide
80mg+ 12,5mg
tablets film-coated
(28/2x14/) in blister
Prescription
Registered
2016-06-08
1.3.1 Valsartan + Hydrochlorothiazide SPC, Labeling and Package Leaflet AM SmPCPIL158308_1 21.10.2020 – Updated: 21.10.2020 Page 1 of 18 1. NAME OF THE MEDICINAL PRODUCT Valsacor ® H 80 80 mg/12.5 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 80 mg valsartan and 12.5 mg hydrochlorothiazide. Excipient with known effect: - lactose monohydrate (17.125 mg), which is equivalent to 16.27 mg lactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Pink, oval, biconvex, film coated tablets. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of essential hypertension in adults. Valsacor H 80 fixed-dose combination is indicated in patients whose blood pressure is not adequately controlled on valsartan or hydrochlorothiazide monotherapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Posology_ The recommended dose of Valsacor H 80 is one film coated tablet once daily. Dose titration with the individual components is recommended. In each case, up-titration of individual components to the next dose should be followed in order to reduce the risk of hypotension and other adverse events. When clinically appropriate, a direct change from monotherapy to the fixed combination may be considered in patients whose blood pressure is not adequately controlled on valsartan or hydrochlorothiazide monotherapy, provided the recommended dose titration sequence for the individual components is followed. The clinical response to Valsacor H 80 should be evaluated after initiating therapy and if blood pressure remains uncontrolled, the dose may be increased by increasing either one of the components to a maximum dose of valsartan/hydrochlorothiazide 320 mg/25 mg. The antihypertensive effect is substantially present within 2 weeks. In most patients, maximal effects are observed within 4 weeks. However, in some patients, 4–8 weeks of treatment may be required. This should be taken into account during dose titration. _Method of administrat Perskaitykite visą dokumentą