Страна: Європейський Союз
мова: англійська
Джерело: EMA (European Medicines Agency)
valsartan, hydrochlorothiazide, Amlodipine besilate
Novartis Europharm Limited
C09DX01
amlodipine besilate, valsartan, hydrochlorothiazide
Agents acting on the renin-angiotensin system
Hypertension
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.
Revision: 26
Authorised
2009-11-03
74 B. PACKAGE LEAFLET 75 PACKAGE LEAFLET: INFORMATION FOR THE USER DAFIRO HCT 5 MG/160 MG/12.5 MG FILM-COATED TABLETS DAFIRO HCT 10 MG/160 MG/12.5 MG FILM-COATED TABLETS DAFIRO HCT 5 MG/160 MG/25 MG FILM-COATED TABLETS DAFIRO HCT 10 MG/160 MG/25 MG FILM-COATED TABLETS DAFIRO HCT 10 MG/320 MG/25 MG FILM-COATED TABLETS amlodipine/valsartan/hydrochlorothiazide READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Dafiro HCT is and what it is used for 2. What you need to know before you take Dafiro HCT 3. How to take Dafiro HCT 4. Possible side effects 5. How to store Dafiro HCT 6. Contents of the pack and other information 1. WHAT DAFIRO HCT IS AND WHAT IT IS USED FOR Dafiro HCT tablets contain three substances called amlodipine, valsartan and hydrochlorothiazide. All of these substances help to control high blood pressure. − Amlodipine belongs to a group of substances called “calcium channel blockers”. Amlodipine stops calcium from moving into the blood vessel wall, which stops the blood vessels from tightening. − Valsartan belongs to a group of substances called “angiotensin-II receptor antagonists”. Angiotensin II is produced by the body and makes the blood vessels tighten, thus increasing the blood pressure. Valsartan works by blocking the effect of angiotensin II. − Hydrochlorothiazide belongs to a group of substances called “thiazide diuretics”. Hydrochlorothiazide increases urine output, which also lowers blood pressure. As a result of all three mechanisms, the blood vessels rela Прочитайте повний документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Dafiro HCT 5 mg/160 mg/12.5 mg film-coated tablets Dafiro HCT 10 mg/160 mg/12.5 mg film-coated tablets Dafiro HCT 5 mg/160 mg/25 mg film-coated tablets Dafiro HCT 10 mg/160 mg/25 mg film-coated tablets Dafiro HCT 10 mg/320 mg/25 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Dafiro HCT 5 mg/160 mg/12.5 mg film-coated tablets Each film-coated tablet contains 5 mg of amlodipine (as amlodipine besylate), 160 mg of valsartan, and 12.5 mg of hydrochlorothiazide. Dafiro HCT 10 mg/160 mg/12.5 mg film-coated tablets Each film-coated tablet contains 10 mg of amlodipine (as amlodipine besylate), 160 mg of valsartan, and 12.5 mg of hydrochlorothiazide. Dafiro HCT 5 mg/160 mg/25 mg film-coated tablets Each film-coated tablet contains 5 mg of amlodipine (as amlodipine besylate), 160 mg of valsartan, and 25 mg of hydrochlorothiazide. Dafiro HCT 10 mg/160 mg/25 mg film-coated tablets Each film-coated tablet contains 10 mg of amlodipine (as amlodipine besylate), 160 mg of valsartan, and 25 mg of hydrochlorothiazide. Dafiro HCT 10 mg/320 mg/25 mg film-coated tablets Each film-coated tablet contains 10 mg of amlodipine (as amlodipine besylate), 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) Dafiro HCT 5 mg/160 mg/12.5 mg film-coated tablets White, ovaloid, biconvex tablets with bevelled edge, debossed “NVR” on one side and “VCL” on the other side. Approximate size: 15 mm (length) x 5.9 mm (width). Dafiro HCT 10 mg/160 mg/12.5 mg film-coated tablets Pale yellow, ovaloid, biconvex tablets with bevelled edge, debossed “NVR” on one side and “VDL” on the other side. Approximate size: 15 mm (length) x 5.9 mm (width). Dafiro HCT 5 mg/160 mg/25 mg film-coated tablets Yellow, ovaloid, biconvex tablets with bevelled edge, debossed “NVR” on one side and “VEL” on the other side. Approximate size: 15 mm (length) x 5 Прочитайте повний документ