Krajina: Švédsko
Jazyk: švédčina
Zdroj: Läkemedelsverket (Medical Products Agency)
hydroklortiazid; valsartan
ratiopharm GmbH
C09DA03
hydrochlorothiazide; valsartan
160 mg/12,5 mg
Filmdragerad tablett
hydroklortiazid 12,5 mg Aktiv substans; valsartan 160 mg Aktiv substans
Apotek
Receptbelagt
Valsartan och diuretika
Förpacknings: Blister, 14 tabletter; Burk, 100 tabletter; Blister, 20 tabletter; Blister, 28 tabletter; Blister, 30 tabletter; Blister, 56 tabletter; Blister, 60 tabletter; Blister, 90 tabletter; Blister, 98 tabletter; Blister, 100 tabletter; Blister, 280 tabletter; Burk, 500 tabletter
Godkänd
2010-02-26
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Valsartan/Hydrochlorothiazide ratiopharm 80 mg/12.5 mg film-coated tablets Valsartan/Hydrochlorothiazide ratiopharm 160 mg/12.5 mg film-coated tablets Valsartan/Hydrochlorothiazide ratiopharm 160 mg/25 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 80 mg valsartan and 12.5 mg hydrochlorothiazide. Each film-coated tablet contains 160 mg valsartan and 12.5 mg hydrochlorothiazide. Each film-coated tablet contains 160 mg valsartan and 25 mg hydrochlorothiazide. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet 80 mg/12.5 mg: Light orange, oval shaped film-coated tablet (dimension: approx. 5.3 x 10.2 mm). 160 mg/12.5 mg: Dark-red, oval shaped film-coated tablets (dimension: approx. 6.1 x 15.2 mm). 160 mg/25 mg: Brown, oval shaped, film-coated tablet, scored on one side (dimension: approx. 5.6 x 14.2 mm). The tablet can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of essential hypertension in adults. _Valsartan/Hydrochlorothiazide ratiopharm_ 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 _Valsartan/Hydrochlorothiazide ratiopharm _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 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. 2 The clinical response to _Valsartan/Hydrochlorothiazide ratiopharm _should be e Prečítajte si celý dokument
MARKNADSFÖRS EJ FÖR NÄRVARANDE. _Produktinformation_ Prečítajte si celý dokument