Land: Sverige
Språk: svenska
Källa: Läkemedelsverket (Medical Products Agency)
amlodipinbesilat; hydroklortiazid; valsartan
Teva B.V.
C09DX01
amlodipinbesilat; hydrochlorothiazide; valsartan
10 mg/ 160 mg/ 25 mg
Filmdragerad tablett
valsartan 160 mg Aktiv substans; laktosmonohydrat Hjälpämne; amlodipinbesilat 13,86 mg Aktiv substans; hydroklortiazid 25 mg Aktiv substans
Receptbelagt
Förpacknings: Blister, 14 tabletter; Blister, 28 tabletter; Blister, 30 tabletter; Blister, 56 tabletter; Blister, 90 tabletter; Blister, 98 tabletter; Burk, 100 tabletter
Avregistrerad
2020-04-15
1 SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Amlodipin/Valsartan/Hydroklortiazid Teva 10 mg/160 mg/12.5 mg film-coated tablets Amlodipin/Valsartan/Hydroklortiazid Teva 5 mg/160 mg/25 mg film-coated tablets Amlodipin/Valsartan/Hydroklortiazid Teva 10 mg/160 mg/25 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION [Product name] 10 mg/160 mg/12.5 mg film-coated tablets Each film-coated tablet contains amlodipine besilate equivalent to 10 mg amlodipine, 160 mg of valsartan, and 12.5 mg of hydrochlorothiazide. [Product name] 5 mg/160 mg/25 mg film-coated tablets Each film-coated tablet containsamlodipine besilate equivalent to 5 mg amlodipine, 160 mg of valsartan, and 25 mg of hydrochlorothiazide. [Product name] 10 mg/160 mg/25 mg film-coated tablets Each film-coated tablet containsamlodipine besilate equivalent to 10 mg amlodipine, 160 mg of valsartan, and 25 mg of hydrochlorothiazide. Excipient(s) with known effect [Product name] 10 mg/160 mg/12.5 mg film-coated tablets Each tablet contains 5 mg of lactose. [Product name] 5 mg/160 mg/25 mg film-coated tablets Each tablet contains 5 mg of lactose. [Product name] 10 mg/160 mg/25 mg film-coated tablets Each tablet contains 5 mg of lactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet) [Product name] 10 mg/160 mg/12.5 mg film-coated tablets Oval, light yellow, 14.5 mm x 7.5 mm film-coated tablets with bevelled edges, with debossing VIL on one side of the tablet. [Product name] 5 mg/160 mg/25 mg film-coated tablets Oval, yellow, 14.5 mm x 7.5 mm film-coated tablets with bevelled edges, with debossing VIH on one side of the tablet [Product name] 10 mg/160 mg/25 mg film-coated tablets Oval, dark yellow, 14.5 mm x 7.5 mm film-coated tablets with bevelled edges, with debossing VIT on one side of the tablet. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 3 Treatment of essential hypertension as substitution therapy in adult patients whose blood pressure is adequately contro Läs hela dokumentet