Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
Amlodipine besilate, valsartan
Mylan Pharmaceuticals Limited
C09DB01
amlodipine, valsartan
Agents acting on the renin-angiotensin system
Hypertension
Treatment of essential hypertension.Amlodipine/Valsartan Mylan is indicated in adults whose blood pressure is not adequately controlled on amlodipine or valsartan monotherapy.
Revision: 11
Authorised
2016-03-22
45 B. PACKAGE LEAFLET 46 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT AMLODIPINE/VALSARTAN MYLAN 5 MG/80 MG FILM-COATED TABLETS AMLODIPINE/VALSARTAN MYLAN 5 MG/160 MG FILM-COATED TABLETS AMLODIPINE/VALSARTAN MYLAN 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 Amlodipine/Valsartan Mylan is and what it is used for 2. What you need to know before you take Amlodipine/Valsartan Mylan 3. How to take Amlodipine/Valsartan Mylan 4. Possible side effects 5. How to store Amlodipine/Valsartan Mylan 6. Contents of the pack and other information 1. WHAT AMLODIPINE/VALSARTAN MYLAN IS AND WHAT IT IS USED FOR Amlodipine/Valsartan Mylan tablets contain two active 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. Amlodipine/Valsartan Mylan is used to treat high blood pressure in adults whose blood p Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Amlodipine/Valsartan Mylan 5 mg/80 mg film-coated tablets Amlodipine/Valsartan Mylan 5 mg/160 mg film-coated tablets Amlodipine/Valsartan Mylan 10 mg/160 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Amlodipine/Valsartan Mylan 5 mg/80 mg film-coated tablets Each film-coated tablet contains 5 mg of amlodipine (as amlodipine besilate) and 80 mg of valsartan. Amlodipine/Valsartan Mylan 5 mg/160 mg film-coated tablets Each film-coated tablet contains 5 mg of amlodipine (as amlodipine besilate) and 160 mg of valsartan. Amlodipine/Valsartan Mylan 10 mg/160 mg film-coated tablets Each film-coated tablet contains 10 mg of amlodipine (as amlodipine besilate) and 160 mg of valsartan. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet Amlodipine/Valsartan Mylan 5 mg/80 mg film-coated tablets Light yellow, round, approximately 9 mm diameter, biconvex film-coated tablet debossed with “AV1” on one side and “M” on the other side. Amlodipine/Valsartan Mylan 5 mg/160 mg film-coated tablets Yellow, oval, approximately 15.6 mm × 7.8 mm, biconvex film-coated tablet debossed with “AV2” on one side and “M” on the other side. Amlodipine/Valsartan Mylan 10 mg/160 mg film-coated tablets Light brown, oval, approximately 15.6 mm × 7.8 mm, biconvex film-coated tablet debossed with “AV3” on one side and “M” on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of essential hypertension. Amlodipine/Valsartan Mylan is indicated in adults whose blood pressure is not adequately controlled on amlodipine or valsartan monotherapy. _ _ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology 3 The recommended dose of Amlodipine/Valsartan Mylan is one tablet per day. _Amlodipine/Valsartan Mylan 5 mg/80 mg film-coated tablets _ Amlodipine/Valsartan Mylan 5 mg/80 mg may be administered in patients whose blood pressure is not adequately controlled with amlodipine 5 mg Прочетете целия документ