País: Suécia
Língua: sueco
Origem: Läkemedelsverket (Medical Products Agency)
amlodipinbesilat; hydroklortiazid; valsartan
DOC Generici Srl
C09DX01
amlodipinbesilat; hydrochlorothiazide; valsartan
10 mg/320 mg/25 mg
Filmdragerad tablett
hydroklortiazid 25 mg Aktiv substans; valsartan 320 mg Aktiv substans; amlodipinbesilat 13,88 mg Aktiv substans
Receptbelagt
Förpacknings: Blister, 28 tabletter
Godkänd
2020-08-27
1 SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT5 mg/160 mg/12.5 mg film-coated tablet [Name in the RMS: Amlodipine/Valsartan/Hydroklortiazid DOC 5 mg/160 mg/12,5 mg filmdragerade tabletter] Leia o documento completo10 mg/320 mg/25 mg film-coated tablet [Name in the RMS: Amlodipine/Valsartan/Hydroklortiazid DOC 10 mg/320 mg/25 mg filmdragerade tabletter] 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 5 mg/160 mg/12.5 mg film-coated tablet Each film-coated tablet contains 5 mg of amlodipine (as amlodipine besilate), 160 mg of valsartan, and 12.5 mg of hydrochlorothiazide. 10 mg/320 mg/25 mg film-coated tablet Each film-coated tablet contains 10 mg of amlodipine (as amlodipine besilate), 320 mg of valsartan and 25 mg of 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 film-coated tablet White, oval, 7.70 mm x 16 mm tablets with “C12” marked on one side. 10 mg/320 mg/25 mg film-coated tablet Dark yellow, oval, 9.70 mm x 20 mm tablets with “C72” marked on one side. 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 is one tablet per day, to be taken preferably in the morning. Before switching to , patients should be controlled on stable doses of the monocomponents taken at the same time. The dose of should be based on the doses of the individual components of the combination at the time of switching. The maximum recommended dose of is 10 mg/320 mg/25 mg. _Special populations_ 3 _Renal i