Country: Европска Унија
Језик: Енглески
Извор: EMA (European Medicines Agency)
irbesartan
Teva B.V.
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: 16
Authorised
2009-10-30
35 B. PACKAGE LEAFLET 36 PACKAGE LEAFLET: INFORMATION FOR THE USER IRBESARTAN TEVA 75 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 Irbesartan Teva is and what it is used for 2. What you need to know before you take Irbesartan Teva 3. How to take Irbesartan Teva 4. Possible side effects 5. How to store Irbesartan Teva 6. Contents of the pack and other information 1. WHAT IRBESARTAN TEVA IS AND WHAT IT IS USED FOR Irbesartan Teva 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 Teva prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower. Irbesartan Teva slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes. Irbesartan Teva 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 IRBESARTAN TEVA DO NOT TAKE IRBESARTAN TEVA If you are ALLERGIC to irbesartan or to any of the other ingredients of this medicine (listed in section 6). If you are MORE THAN 3 MONTHS PREGNANT (it is also better to avoid Irbesartan Teva in early pregnancy - see pregnanc Прочитајте комплетан документ
1 _ _ ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Irbesartan Teva 75 mg film-coated tablets Irbesartan Teva 150 mg film-coated tablets Irbesartan Teva 300 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Irbesartan Teva 75 mg film-coated tablets Each film-coated tablet contains 75 mg of irbesartan Irbesartan Teva 150 mg film-coated tablets Each film-coated tablet contains 150 mg of irbesartan Irbesartan Teva 300 mg film-coated tablets Each film-coated tablet contains 300 mg of irbesartan For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Irbesartan Teva 75 mg film-coated tablets White to off white capsule shaped, film coated tablet. One side of the tablet debossed with the number “93”. The other side of the tablet debossed with number “7464”. Irbesartan Teva 150 mg film-coated tablets White to off white capsule shaped, film coated tablet. One side of the tablet debossed with the number “93”. The other side of the tablet debossed with number “7465”. Irbesartan Teva 300 mg film-coated tablets White to off white capsule shaped, film coated tablet. One side of the tablet debossed with the number “93”. The other side of the tablet debossed with number “7466”. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Irbesartan Teva 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. 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. 3 In patie Прочитајте комплетан документ