Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
Telmisartan, amlodipine
Boehringer Ingelheim International GmbH
C09DB04
telmisartan, amlodipine
Agents acting on the renin-angiotensin system
Hypertension
Treatment of essential hypertension in adults:Add-on therapyTwynsta is indicated in adults whose blood pressure is not adequately controlled on amlodipine.Replacement therapyAdult patients receiving telmisartan and amlodipine from separate tablets can instead receive tablets of Twynsta containing the same component doses.
Revision: 13
Authorised
2010-10-07
114 B. PACKAGE LEAFLET 115 PACKAGE LEAFLET: INFORMATION FOR THE USER TWYNSTA 40 MG/5 MG TABLETS telmisartan/amlodipine 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 Twynsta is and what it is used for 2. What you need to know before you take Twynsta 3. How to take Twynsta 4. Possible side effects 5. How to store Twynsta 6. Contents of the pack and other information 1. WHAT TWYNSTA IS AND WHAT IT IS USED FOR Twynsta tablets contain two active substances called telmisartan and amlodipine. Both of these substances help to control your high blood pressure: Telmisartan belongs to a group of substances called “angiotensin-II receptor blockers”. Angiotensin II is a substance produced in the body which causes blood vessels to narrow, thus increasing blood pressure. Telmisartan works by blocking the effect of angiotensin II. 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. This means that both of these active substances work together to help stop your blood vessels tightening. As a result, the blood vessels relax and blood pressure is lowered. TWYNSTA IS USED TO treat high blood pressure in adult patients whose blood pressure is not controlled enough with amlodipine alone. in adult patients who already receive telmisartan and amlodipine from separate tablets and who wish to take instead the same doses in one tablet for convenience. High bloo Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Twynsta 40 mg/5 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 40 mg telmisartan and 5 mg amlodipine (as amlodipine besilate). Excipient(s) with known effect: Each tablet contains 168.64 mg sorbitol (E420). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet Blue and white oval shaped two layer tablets of approximately 14 mm length engraved with the product code A1 and the company logo on the white layer. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of essential hypertension in adults: Add on therapy Twynsta 40 mg/5 mg is indicated in adults whose blood pressure is not adequately controlled on amlodipine 5 mg alone. Replacement therapy Adult patients receiving telmisartan and amlodipine from separate tablets can instead receive tablets of Twynsta containing the same component doses. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose of this medicinal product is one tablet per day. The maximum recommended dose is one tablet 80 mg telmisartan/10 mg amlodipine per day. This medicinal product is indicated for long term treatment. Administration of amlodipine with grapefruit or grapefruit juice is not recommended as bioavailability may be increased in some patients resulting in increased blood pressure lowering effects (see section 4.5). _Add on therapy_ Twynsta 40 mg/5 mg may be administered in patients whose blood pressure is not adequately controlled on amlodipine 5 mg alone. Individual dose titration with the components (i.e. amlodipine and telmisartan) is recommended before changing to the fixed dose combination. When clinically appropriate, direct change from monotherapy to the fixed combination may be considered. 3 Patients treated with 10 mg amlodipine who experience any dose limiting adverse reactions such as oedema, may be switched to Twynsta 40 mg/5 mg once daily, reducing the dose of amlodipine without reducing the overall expected an Прочетете целия документ