Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
irbesartan, hydrochlorothiazide
Bristol-Myers Squibb Pharma EEIG
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 (see section 5.1).
Revision: 8
Withdrawn
2007-01-19
86 B. PACKAGE LEAFLET Medicinal product no longer authorised 87 PACKAGE LEAFLET: INFORMATION FOR THE USER IRBESARTAN HYDROCHLOROTHIAZIDE BMS 150 MG/12.5 MG TABLETS irbesartan/hydrochlorothiazide READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Irbesartan Hydrochlorothiazide BMS is and what it is used for 2. Before you take Irbesartan Hydrochlorothiazide BMS 3. How to take Irbesartan Hydrochlorothiazide BMS 4. Possible side effects 5. How to store Irbesartan Hydrochlorothiazide BMS 6. Further information 1. WHAT IRBESARTAN HYDROCHLOROTHIAZIDE BMS IS AND WHAT IT IS USED FOR Irbesartan Hydrochlorothiazide BMS 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 BMS work together to lower blood pressure further than if either was given alone. IRBESARTAN HYDROCHLOROTHIAZIDE BMS IS USED TO TREAT HIGH BLOOD PRESSURE , when treatment with irbesartan or hydrochlorothiazide alone did not provide adequate control of your blood pressure. 2. BEFORE YOU TAKE IRBESARTA Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT Irbesartan Hydrochlorothiazide BMS 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: Each tablet contains 26.65 mg of lactose (as lactose monohydrate). For a 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 Irbesartan Hydrochlorothiazide BMS 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 BMS 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 BMS 300 mg/12.5 mg may be administered in patients insufficiently controlled by irbesartan 300 mg or by Irbesartan Hydrochlorothiazide BMS 150 mg/12.5 mg. Irbesartan Hydrochlorothiazide BMS 300 mg/25 mg may be administered in patients insufficiently controlled by Irbesartan Hydrochlorothiazide BMS 300 mg/12.5 mg. Doses higher than 300 mg irbesartan/25 mg hydrochlorothiazide once daily are not recommended. When necessary, Irbesartan Hydrochlorothiazide BMS may be administered with another antihypertensive medicinal product (see section 4.5). Renal impairment: due to the hydrochlorothiazide component, Irbesartan Hydrochlorothiazide BMS is not recommended for pa Прочетете целия документ