Country: European Union
Language: English
Source: EMA (European Medicines Agency)
irbesartan
Sanofi Winthrop Industrie
C09CA04
irbesartan
Agents acting on the renin-angiotensin system
Hypertension
Treatment of essential hypertension.Treatment of renal disease in patients with hypertension and type-2 diabetes mellitus as part of an antihypertensive medicinal product regimen.
Revision: 46
Authorised
1997-08-26
103 B. PACKAGE LEAFLET 104 PACKAGE LEAFLET: INFORMATION FOR THE USER KARVEA 75 MG TABLETS irbesartan 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 Karvea is and what it is used for 2. What you need to know before you take Karvea 3. How to take Karvea 4. Possible side effects 5. How to store Karvea 6. Contents of the pack and other information 1. WHAT KARVEA IS AND WHAT IT IS USED FOR Karvea belongs to a group of medicines known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in the body which binds to receptors in blood vessels causing them to tighten. This results in an increase in blood pressure. Karvea prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower. Karvea slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes. Karvea is used in adult patients to treat high blood pressure ( _essential hypertension_ ) to protect the kidney in patients with high blood pressure, type 2 diabetes and laboratory evidence of impaired kidney function. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE KARVEA DO NOT TAKE KARVEA if you are ALLERGIC to irbesartan or any other ingredients of this medicine (listed in section 6) if you are MORE THAN 3 MONTHS PREGNANT . (It is also better to avoid Karvea in early pregnancy – see pregnancy section) IF YOU HAVE DIABETES OR IMPAIRED KIDNEY FUNCTION and you are treated with a blood pressure lowering medicine Read the complete document
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Karvea 75 mg tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 75 mg of irbesartan. Excipient with known effect: 15.37 mg of lactose monohydrate per tablet. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. White to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2771 engraved on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Karvea is indicated in adults for the treatment of essential hypertension. It is also indicated for the treatment of renal disease in adult patients with hypertension and type 2 diabetes mellitus as part of an antihypertensive medicinal product regimen (see sections 4.3, 4.4, 4.5 and 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The usual recommended initial and maintenance dose is 150 mg once daily, with or without food. Karvea at a dose of 150 mg once daily generally provides a better 24-hour blood pressure control than 75 mg. However, initiation of therapy with 75 mg could be considered, particularly in haemodialyzed patients and in the elderly over 75 years. In patients insufficiently controlled with 150 mg once daily, the dose of Karvea can be increased to 300 mg, or other antihypertensive agents can be added (see sections 4.3, 4.4, 4.5 and 5.1). In particular, the addition of a diuretic such as hydrochlorothiazide has been shown to have an additive effect with Karvea (see section 4.5). In hypertensive type 2 diabetic patients, therapy should be initiated at 150 mg irbesartan once daily and titrated up to 300 mg once daily as the preferred maintenance dose for treatment of renal disease. The demonstration of renal benefit of Karvea in hypertensive type 2 diabetic patients is based on studies where irbesartan was used in addition to other antihypertensive agents, as needed, to reach target blood pressure (see sections 4.3, 4.4, 4.5 and 5.1). Special Populations _Renal impairment_ No dos Read the complete document