Land: Evrópusambandið
Tungumál: enska
Heimild: EMA (European Medicines Agency)
irbesartan, hydrochlorothiazide
sanofi-aventis groupe
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: 34
Authorised
2007-01-18
110 B. PACKAGE LEAFLET 111 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT IRBESARTAN HYDROCHLOROTHIAZIDE ZENTIVA 150 MG/12.5 MG 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 Zentiva is and what it is used for 2. What you need to know before you take Irbesartan Hydrochlorothiazide Zentiva 3. How to take Irbesartan Hydrochlorothiazide Zentiva 4. Possible side effects 5. How to store Irbesartan Hydrochlorothiazide Zentiva 6. Contents of the pack and other information 1. WHAT IRBESARTAN HYDROCHLOROTHIAZIDE ZENTIVA IS AND WHAT IT IS USED FOR Irbesartan Hydrochlorothiazide Zentiva 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 Zentiva work together to lower blood pressure further than if either was given alone. IRBESARTAN HYDROCHLOROTHIAZIDE ZENTIVA IS USED TO TREAT HIGH BLOOD PRESSURE, when treatment w Lestu allt skjalið
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Irbesartan Hydrochlorothiazide Zentiva 150 mg/12.5 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 150 mg of irbesartan and 12.5 mg of hydrochlorothiazide. Excipient with known effect Each tablet contains 26.65 mg of lactose (as lactose monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. Peach, biconvex, oval-shaped, with a heart debossed on one side and the number 2775 engraved 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 Zentiva can be taken once daily, with or without food. Dose titration with the individual components (i.e. irbesartan and hydrochlorothiazide) may be recommended. When clinically appropriate direct change from monotherapy to the fixed combinations may be considered: • Irbesartan Hydrochlorothiazide Zentiva 150 mg/12.5 mg may be administered in patients whose blood pressure is not adequately controlled with hydrochlorothiazide or irbesartan 150 mg alone; • Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg may be administered in patients insufficiently controlled by irbesartan 300 mg or by Irbesartan Hydrochlorothiazide Zentiva 150 mg/12.5 mg. • Irbesartan Hydrochlorothiazide Zentiva 300 mg/25 mg may be administered in patients insufficiently controlled by Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg. Doses higher than 300 mg irbesartan/25 mg hydrochlorothiazide once daily are not recommended. When necessary, Irbesartan Hydrochlorothiazide Zentiva may be administered with another antihypertensive medicinal product (see sections 4.3, 4.4, 4.5 and 5.1). 3 _Special populations _ _Renal impairment _ Due to the hydrochloroth Lestu allt skjalið