Држава: Шведска
Језик: Шведски
Извор: Läkemedelsverket (Medical Products Agency)
amlodipinbesilat; hydroklortiazid; valsartan
Sigillata Limited
C09DX01
amlodipinbesilat; hydrochlorothiazide; valsartan
10 mg/160 mg/12,5 mg
Filmdragerad tablett
valsartan 160 mg Aktiv substans; laktosmonohydrat Hjälpämne; hydroklortiazid 12,5 mg Aktiv substans; amlodipinbesilat 13,86 mg Aktiv substans
Receptbelagt
Förpacknings: Blister, 28 tabletter; Blister, 30 tabletter; Blister, 56 tabletter; Blister, 90 tabletter; Blister, 98 tabletter; Burk, 100 tabletter
Avregistrerad
2020-06-04
1 SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Fjallirone 10 mg/160 mg/12.5 mg film-coated tablets Fjallirone 5 mg/160 mg/25 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Fjallirone 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. Fjallirone 5 mg/160 mg/25 mg film-coated tablets Each film-coated tablet contains amlodipine besilate equivalent to 5 mg amlodipine, 160 mg of valsartan, and 25 mg of hydrochlorothiazide. Excipient(s) with known effect Fjallirone 10 mg/160 mg/12.5 mg film-coated tablets Each tablet contains 5 mg of lactose. Fjallirone 5 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) Fjallirone 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. Fjallirone 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. 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 Fjallirone is one tablet per day, to be taken preferably in the morning. 3 Before switching to Fjallirone, patients should be controlled on stable doses of the monocomponents taken at the same time. The dose of Fjallirone should be based on the doses of the individual components of the combination at the time of switching. The maximum recommended dose of Fja Прочитајте комплетан документ