Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
amlodipine, valsartan
Novartis Europharm Limited
C09DB01
amlodipine, valsartan
Agents acting on the renin-angiotensin system
Hypertension
Treatment of essential hypertension. Dafiro is indicated in patients whose blood pressure is not adequately controlled on amlodipine or valsartan monotherapy.,
Revision: 30
Authorised
2007-01-15
51 B. PACKAGE LEAFLET 52 PACKAGE LEAFLET: INFORMATION FOR THE USER DAFIRO 5 MG/80 MG FILM-COATED TABLETS DAFIRO 5 MG/160 MG FILM-COATED TABLETS DAFIRO 10 MG/160 MG FILM-COATED TABLETS amlodipine/valsartan 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 is and what it is used for 2. What you need to know before you take Dafiro 3. How to take Dafiro 4. Possible side effects 5. How to store Dafiro 6. Contents of the pack and other information 1. WHAT DAFIRO IS AND WHAT IT IS USED FOR Dafiro tablets contain two substances called amlodipine and valsartan. Both 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. This means that both of these substances help to stop the blood vessels tightening. As a result, the blood vessels relax and blood pressure is lowered. Dafiro is used to treat high blood pressure in adults whose blood pressure is not controlled enough with either amlodipine or valsartan on its own. 53 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DAFIRO DO NOT TAKE DAFIRO − if you are allergic to amlodipine or to any other cal Przeczytaj cały dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Dafiro 5 mg/80 mg film-coated tablets Dafiro 5 mg/160 mg film-coated tablets Dafiro 10 mg/160 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Dafiro 5 mg/80 mg film-coated tablets Each film-coated tablet contains 5 mg of amlodipine (as amlodipine besylate) and 80 mg of valsartan. Dafiro 5 mg/160 mg film-coated tablets Each film-coated tablet contains 5 mg of amlodipine (as amlodipine besylate) and 160 mg of valsartan. Dafiro 10 mg/160 mg film-coated tablets Each film-coated tablet contains 10 mg of amlodipine (as amlodipine besylate) and 160 mg of valsartan. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet Dafiro 5 mg/80 mg film-coated tablets Dark yellow, round film-coated tablet with bevelled edges, imprinted with “NVR” on one side and “NV” on the other side. Approximate size: diameter 8.20 mm. Dafiro 5 mg/160 mg film-coated tablets Dark yellow, oval film-coated tablet, imprinted with “NVR” on one side and “ECE” on the other side. Approximate size: 14.2 mm (length) x 5.7 mm (width). Dafiro 10 mg/160 mg film-coated tablets Light yellow, oval film-coated tablet, imprinted with “NVR” on one side and “UIC” on the other side. Approximate size: 14.2 mm (length) x 5.7 mm (width). 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of essential hypertension. Dafiro is indicated in adults whose blood pressure is not adequately controlled on amlodipine or valsartan monotherapy. 3 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose of Dafiro is one tablet per day. Dafiro 5 mg/80 mg may be administered in patients whose blood pressure is not adequately controlled with amlodipine 5 mg or valsartan 80 mg alone. Dafiro 5 mg/160 mg may be administered in patients whose blood pressure is not adequately controlled with amlodipine 5 mg or valsartan 160 mg alone. Dafiro 10 mg/160 mg may be administered in patients whose blood pressure is Przeczytaj cały dokument