Страна: Европейский союз
Язык: английский
Источник: EMA (European Medicines Agency)
irbesartan, hydrochlorothiazide
Sanofi Winthrop Industrie
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: 49
Authorised
1998-10-14
109 B. PACKAGE LEAFLET 110 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT COAPROVEL 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 CoAprovel is and what it is used for 2. What you need to know before you take CoAprovel 3. How to take CoAprovel 4. Possible side effects 5. How to store CoAprovel 6. Contents of the pack and other information 1. WHAT COAPROVEL IS AND WHAT IT IS USED FOR CoAprovel 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 CoAprovel work together to lower blood pressure further than if either was given alone. COAPROVEL IS USED TO TREAT HIGH BLOOD PRESSURE , when treatment with irbesartan or hydrochlorothiazide alone did not provide adequate control of your blood pressure. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE COAPROVEL DO NOT TAKE COAPROVEL ▪ if you are ALLERGIC to irbesartan or any of the other ingredients of this Прочитать полный документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT CoAprovel 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 CoAprovel 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: ▪ CoAprovel 150 mg/12.5 mg may be administered in patients whose blood pressure is not adequately controlled with hydrochlorothiazide or irbesartan 150 mg alone. ▪ CoAprovel 300 mg/12.5 mg may be administered in patients insufficiently controlled by irbesartan 300 mg or by CoAprovel 150 mg/12.5 mg. ▪ CoAprovel 300 mg/25 mg may be administered in patients insufficiently controlled by CoAprovel 300 mg/12.5 mg. Doses higher than 300 mg irbesartan/25 mg hydrochlorothiazide once daily are not recommended. When necessary, CoAprovel 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 hydrochlorothiazide component, CoAprovel is not recommended for patients with severe renal dysfunction (creatinine clearance < 30 ml/min). Loop diuretics are preferred to thiazides in this population. No dosage adjustment is necessary in patients Прочитать полный документ