国: アルメニア
言語: 英語
ソース: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
amlodipine (amlodipine besilate), valsartan, hydrochlorothiazide
KRKA-RUS LLC
C09DX01
amlodipine (amlodipine besilate), valsartan, hydrochlorothiazide
10mg+160mg+12,5mg
tablets film-coated
(30/3x10/) in blister
Prescription
Registered
2019-12-03
1.3.1 Amlodipine + Valsartan + HCTZ SPC, Labeling and Package Leaflet AM SmPCPIL123774_2 20.12.2018 – Updated: 28.08.2019 Page 1 of 26 1. NAME OF THE MEDICINAL PRODUCT Co-Vamloset 5 mg/160 mg/12.5 mg film-coated tablets Co-Vamloset 10 mg/160 mg/12.5 mg film-coated tablets Co-Vamloset 10 mg/160 mg/25 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _5 mg/160 mg/12.5 mg:_ Each film-coated tablet contains 5 mg amlodipine (as amlodipine besilate), 160 mg valsartan and 12.5 mg hydrochlorothiazide. _10 mg/160 mg/12.5 mg:_ Each film-coated tablet contains 10 mg amlodipine (as amlodipine besilate), 160 mg valsartan and 12.5 mg hydrochlorothiazide. _10 mg/160 mg/25 mg:_ Each film-coated tablet contains 10 mg amlodipine (as amlodipine besilate), 160 mg valsartan and 25 mg hydrochlorothiazide. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet) _5 mg/160 mg/12.5 mg:_ White or almost white, oval, biconvex, film-coated tablets, engraved with mark K1 on one side of the tablet _10 mg/160 mg/12.5 mg:_ Pink, oval, biconvex, film-coated tablets, engraved with mark K2 on one side of the tablet _10 mg/160 mg/25 mg:_ Brown yellow, oval, biconvex, film-coated tablets, engraved with mark K4 on one side of the tablet 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of essential hypertension as substitution therapy in adult patients whose blood pressure is adequately controlled on the combination of amlodipine, valsartan and hydrochlorothiazide (HCT), taken either as three single-component formulations or as a dual-component and a single-component formulation. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose of Co-Vamloset is one tablet per day, to be taken preferably in the morning. Before switching to Co-Vamloset patients should be controlled on stable doses of the monocomponents taken at the same time. The dose of Co-Vamloset should be based on the doses of the individual components of the combination at the time of switching. CONF 完全なドキュメントを読む