Country: Malaysia
Language: English
Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
HYDROCHLOROTHIAZIDE; IRBESARTAN
SANOFI-AVENTIS (MALAYSIA) SDN. BHD.
HYDROCHLOROTHIAZIDE; IRBESARTAN
28Tablet Tablets; 14Tablet Tablets
SANOFI WINTHROP INDUSTRIE
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ COAPROVEL ® FILM-COATED TABLET _ _ Irbesartan/ Hydrochlorothiazide (150 mg/12.5 mg) Irbesartan/ Hydrochlorothiazide (300 mg/12.5 mg) Irbesartan/ Hydrochlorothiazide (300 mg/25 mg) 1 WHAT IS IN THIS LEAFLET 1. What CoAprovel is used for 2. How CoAprovel works 3. Before you use CoAprovel 4. How to use CoAprovel 5. While you are using it 6. Side effects 7. Storage and Disposal of CoAprovel 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT COAPROVEL IS USED FOR COAPROVEL IS USED TO TREAT HIGH BLOOD PRESSURE , when treatment with irbesartan or hydrochlorothiazide alone did not provide adequate control of your blood pressure. HOW COAPROVEL WORKS 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. BEFORE YOU USE COAPROVEL _-When you must not use it _ DO NOT TAKE COAPROVEL • if you are ALLERGIC (hypersensitive) to irbesartan or any of the other ingredients of CoAprovel • if you are ALLERGIC (hypersensitive) to hydrochlorothiazide or any other sulfonamide-derived medicines • if you are MORE THAN 3 MONTHS PREGNANT . (It is also better to avoid CoAprovel in early pregnancy – see pregnancy section) • if you have SEVERE LIVER or KIDNEY PROBLEMS • if you have DIFFICULTY IN PRODUCING URINE • if your doctor determines that you Read the complete document
MY/COA/0922/SmPC0222 1 NAME OF THE MEDICINAL PRODUCT CoAprovel 150 mg/12.5 mg film-coated tablets CoAprovel 300 mg/12.5 mg film-coated tablets CoAprovel 300 mg/25 mg film-coated tablets QUALITATIVE AND QUANTITATIVE COMPOSITION COAPROVEL 150 MG/12.5 MG FILM-COATED TABLETS Each tablet contains 150 mg of irbesartan and 12.5 mg of hydrochlorothiazide. COAPROVEL 300 MG/12.5 MG FILM-COATED TABLETS Each tablet contains 300 mg of irbesartan and 12.5 mg of hydrochlorothiazide. COAPROVEL 300 MG/25 MG FILM-COATED TABLETS Each tablet contains 300 mg of irbesartan and 25 mg of hydrochlorothiazide. PHARMACEUTICAL FORM COAPROVEL 150/12.5 MG Peach, biconvex, oval-shaped, with a heart debossed on one side and the number 2875 engraved on the other side. COAPROVEL 300/12.5 MG Peach, biconvex, oval-shaped, with a heart debossed on one side and the number 2876 engraved on the other side. COAPROVEL 300/25 MG Pink, biconvex, oval-shaped, with a heart debossed on one side and the number 2788 engraved on the other side. CLINICAL PARTICULARS 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. 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 d Read the complete document