Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
irbesartan
Bristol-Myers Squibb Pharma EEIG
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 (see section 5.1).
Revision: 7
Withdrawn
2007-01-19
87 B. PACKAGE LEAFLET Medicinal product no longer authorised 88 PACKAGE LEAFLET: INFORMATION FOR THE USER IRBESARTAN BMS 75 MG TABLETS irbesartan 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 BMS is and what it is used for 2. Before you take Irbesartan BMS 3. How to take Irbesartan BMS 4. Possible side effects 5. How to store Irbesartan BMS 6. Further information 1. WHAT IRBESARTAN BMS IS AND WHAT IT IS USED FOR Irbesartan BMS 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. Irbesartan BMS prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower. Irbesartan BMS slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes. Irbesartan BMS is used 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. BEFORE YOU TAKE IRBESARTAN BMS DO NOT TAKE IRBESARTAN BMS if you are ALLERGIC (hypersensitive) to irbesartan or any other ingredients of Irbesartan BMS if you are MORE THAN 3 MONTHS PREGNANT . (It is also better to avoid Irbesartan BMS in early pregnancy – see pregnancy section) Irbesartan BMS should not be given to children and adolescents (under 18 years). TAKE SPECIAL CARE WITH IRBESARTAN BMS TELL YOUR DOCTOR if any of the following apply to Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT Irbesartan BMS 75 mg tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 75 mg of irbesartan. Excipient: 15.37 mg of lactose monohydrate per tablet. For a 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 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 (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The usual recommended initial and maintenance dose is 150 mg once daily, with or without food. Irbesartan BMS 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 BMS can be increased to 300 mg, or other antihypertensive agents can be added. In particular, the addition of a diuretic such as hydrochlorothiazide has been shown to have an additive effect with Irbesartan BMS (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 BMS 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 section 5.1). Renal impairment : no dosage adjustment is necessary in patients with impaired renal function. A lower starting dose (75 mg) should be consider Aqra d-dokument sħiħ