Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
irbesartan, hydrochlorothiazide
Teva B.V.
C09DA04
irbesartan, hydrochlorothiazide
Agents acting on the renin-angiotensin system
Hypertension
Treatment of essential hypertension. This fixed-dose combination is indicated in adult patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone.
Revision: 22
Authorised
2009-11-26
40 B. PACKAGE LEAFLET 41 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT IRBESARTAN/HYDROCHLOROTHIAZIDE TEVA 150 MG/12.5 MG FILM-COATED TABLETS irbesartan / 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 Irbesartan/Hydrochlorothiazide Teva is and what it is used for 2. What you need to know before you take Irbesartan/Hydrochlorothiazide Teva 3. How to take Irbesartan/Hydrochlorothiazide Teva 4. Possible side effects 5. How to store Irbesartan/Hydrochlorothiazide Teva 6. Contents of the pack and other information 1. WHAT IRBESARTAN/HYDROCHLOROTHIAZIDE TEVA IS AND WHAT IT IS USED FOR Irbesartan/Hydrochlorothiazide Teva is a combination of two active substances, irbesartan and hydrochlorothiazide. Irbesartan belongs to a group of medicines known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in the body that binds to receptors in blood vessels causing them to tighten. This results in an increase in blood pressure. Irbesartan prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower. Hydrochlorothiazide is one of a group of medicines (called thiazide diuretics) that causes increased urine output and so causes a lowering of blood pressure. The two active ingredients in Irbesartan/Hydrochlorothiazide Teva work together to lower blood pressure further than if either was given alone. IRBESARTAN/HYDROCHLOROTHIAZIDE TEVA IS USED TO TREAT HIGH BLOOD PRESSURE, when treatment with ir Aqra d-dokument sħiħ
1 _ _ _ _ ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Irbesartan/Hydrochlorothiazide Teva 150 mg/12.5 mg film-coated tablets Irbesartan/Hydrochlorothiazide Teva 300 mg/12.5 mg film-coated tablets Irbesartan/Hydrochlorothiazide Teva 300 mg/25 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Irbesartan/Hydrochlorothiazide Teva 150 mg/12.5 mg film-coated tablets Each film-coated tablet contains 150 mg of irbesartan and 12.5 mg of hydrochlorothiazide. Irbesartan/Hydrochlorothiazide Teva 300 mg/12.5 mg film-coated tablets Each film-coated tablet contains 300 mg of irbesartan and 12.5 mg of hydrochlorothiazide. Irbesartan/Hydrochlorothiazide Teva 300 mg/25 mg film-coated tablets Each film-coated tablet contains 300 mg of irbesartan and 25 mg of hydrochlorothiazide. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Irbesartan/Hydrochlorothiazide Teva 150 mg/12.5 mg film-coated tablets Light pink to pink, film-coated capsule shaped tablet. One side of the tablet debossed with the number "93". The other side of the tablet debossed with the number "7238". Irbesartan/Hydrochlorothiazide Teva 300 mg/12.5 mg film-coated tablets Light pink to pink, round film-coated tablet. One side of the tablet debossed with the number "2" and plain on the other side. Irbesartan/Hydrochlorothiazide Teva 300 mg/25 mg film-coated tablets Pink to dark pink, round film-coated tablet. One side of the tablet debossed with the number "3" and plain on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of essential hypertension. This fixed dose combination is indicated in adult patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Irbesartan/Hydrochlorothiazide Teva can be taken once daily, with or without food. Dose titration with the individual components (i.e. irbesartan and hydrochlorothiazide) may be recommend Aqra d-dokument sħiħ