Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Telmisartan
Boehringer Ingelheim International GmbH
C09DB04
telmisartan, amlodipine
Cardiovascular system
Hypertension
Treatment of essential hypertension in adults:Add on therapyOnduarp 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 Onduarp containing the same component doses.
Revision: 2
Withdrawn
2011-11-24
96 B. PACKAGE LEAFLET Medicinal product no longer authorised 97 PACKAGE LEAFLET: INFORMATION FOR THE USER ONDUARP 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 of the side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. WHAT IS IN THIS LEAFLET: 1. What Onduarp is and what it is used for 2. What you need to know before you take Onduarp 3. How to take Onduarp 4. Possible side effects 5. How to store Onduarp 6. Contents of the pack and other information 1. WHAT ONDUARP IS AND WHAT IT IS USED FOR _ _ Onduarp 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 antagonists”. 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. ONDUARP IS USED TO treat high blood pressure - in adult patients whose blood pressure is not controlled enough with amlodipine. - 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 Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT Onduarp 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 engraved with the product code A1 and the company logo on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of essential hypertension in adults: Add on therapy Onduarp is indicated in adults whose blood pressure is not adequately controlled on amlodipine. Replacement therapy Adult patients receiving telmisartan and amlodipine from separate tablets can instead receive tablets of Onduarp containing the same component doses. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose of Onduarp is one tablet per day. The maximum recommended dose is Onduarp 80 mg/10 mg, one tablet per day. Onduarp 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_ _ _ Onduarp 40 mg/5 mg tablets may be administered in patients whose blood pressure is not adequately controlled with 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. Medicinal product no longer authorised 3 Patients treated with 10 mg amlodipine who experience any dose limiting adverse reactions such as oedema, may be switched to Onduarp 40 mg/5 mg once daily, reducing the dose of amlodipine without reducing the overall expected an Aqra d-dokument sħiħ