Quốc gia: Liên Minh Châu Âu
Ngôn ngữ: Tiếng Anh
Nguồn: EMA (European Medicines Agency)
irbesartan
Pharmathen S.A.
C09CA04
irbesartan
Agents acting on the renin-angiotensin system
Hypertension
Sabervel 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.
Revision: 2
Withdrawn
2012-04-13
B. PACKAGE LEAFLET 48 Medicinal product no longer authorised PACKAGE LEAFLET: INFORMATION FOR THE USER SABERVEL 75 MG FILM-COATED 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 Sabervel is and what it is used for 2. Before you take Sabervel 3. How to take Sabervel 4. Possible side effects 5. How to store Sabervel 6. Further information 1. WHAT SABERVEL IS AND WHAT IT IS USED FOR Sabervel 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. Sabervel prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower. Sabervel slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes. Sabervel 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. BEFORE YOU TAKE SABERVEL DO NOT TAKE SABERVEL • if you are ALLERGIC (hypersensitive) to irbesartan or any other ingredients of Sabervel • if you are MORE THAN 3 MONTHS PREGNANT . (It is also better to avoid Sabervel in early pregnancy – see pregnancy section) • if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren. WARNINGS AND PRECAUTIONS TELL YOUR DOCTOR if any of the fol Đọc toàn bộ tài liệu
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 Medicinal product no longer authorised 1. NAME OF THE MEDICINAL PRODUCT Sabervel 75 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 75 mg of irbesartan Excipient with known effect: 20 mg of lactose monohydrate per film-coated tablet For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. White, concave, round, film-coated tablet with 7 mm diameter. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Sabervel 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. Sabervel 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 Sabervel 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 Sabervel (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 Sabervel 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). Spec Đọc toàn bộ tài liệu