Country: Irlanda
Lingwa: Ingliż
Sors: HPRA (Health Products Regulatory Authority)
Irbesartan
Rowex Ltd
C09CA; C09CA04
Irbesartan
300 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
Angiotensin II antagonists, plain; irbesartan
Marketed
2009-06-19
PACKAGE LEAFLET: INFORMATION FOR THE USER IRBESAN 75 MG FILM-COATED TABLETS IRBESAN 150 MG FILM-COATED TABLETS IRBESAN 300 MG FILM-COATED 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 Irbesan is and what it is used for 2. What you need to know before you take Irbesan 3. How to take Irbesan 4. Possible side effects 5. How to store Irbesan 6. Contents of the pack and other information 1. WHAT IRBESAN IS AND WHAT IT IS USED FOR_ _ Irbesan 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. Irbesan prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower. Irbesan slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes. Irbesan tablets are 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 IRBESAN _ _ DO NOT TAKE IRBESAN: if you are ALLERGIC to irbesartan or any of the ingredients of this medicine (listed in section 6) if you are MORE THAN 3 MONTHS PREGNANT. (It is also better to avoid Irbesan in early pregnancy – see pregnancy section.) IF YOU HAVE DIABETES OR IMPAI Aqra d-dokument sħiħ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Irbesan 300mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film- coated tablet contains 300 mg irbesartan. Excipient with known effect: 25.850 of lactose monohydrate per tablet. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet White, oval, biconvex, film- coated tablets, debossed with ‘300’ on one side and scored on the other side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Irbesan 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. Irbesartan 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 haemodialysed patients and in the elderly over 75 years. In patients insufficiently controlled with 150 mg once daily, the dose of irbesartan 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 irbesartan (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 irbesartan 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 b Aqra d-dokument sħiħ