Country: আর্মেনিয়া
ভাষা: ইংরেজি
সূত্র: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
valsartan, hydrochlorothiazide
KRKA d.d.
C09DA03
valsartan, hydrochlorothiazide
160mg+ 12,5mg
tablets film-coated
(28/2x14/) in blister
Prescription
Registered
2021-06-09
1.3.1 Valsartan + Hydrochlorothiazide SPC, Labeling and Package Leaflet AM SmPCPIL158310_1 21.10.2020 – Updated: 21.10.2020 Page 1 of 18 1. NAME OF THE MEDICINAL PRODUCT Valsacor ® H 160 160 mg/12.5 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 160 mg valsartan and 12.5 mg hydrochlorothiazide. Excipient with known effect: - lactose monohydrate (46.75 mg), which is equivalent to 44.41 mg lactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Red-brown, oval, biconvex film coated tablets. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of essential hypertension in adults. Valsacor H 160 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 160 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 160 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 ad সম্পূর্ণ নথি পড়ুন