Χώρα: Ηνωμένο Βασίλειο
Γλώσσα: Αγγλικά
Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)
Irbesartan
Sanofi
C09CA04
Irbesartan
150mg
Tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02050502; GTIN: 5000283642800
Code : 688021-G620686 Update : V4- 21/09/2017 PA code : 194507 Product/Item type : PRO APROVEL 150MG Country : GB Artwork by : M.PACHO Format : 170 x 310 mm (Plegado 170 X 34,5 mm) Laetus Code : 947 Colours : 1 BLACK Fonts : Ocean Sans Pro San (9pt) Assembly Card : M-B421 Reason of change: TRANSFER SANOFI-AVENTIS RIELLS PACKAGING TEAM 688021-G620686 170 x 310 mm PACKAGE LEAFLET: INFORMATION FOR THE USER 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 Aprovel is and what it is used for 2. What you need to know before you take Aprovel 3. How to take Aprovel 4. Possible side effects 5. How to store Aprovel 6. Contents of the pack and other information 1. WHAT APROVEL IS AND WHAT IT IS USED FOR Aprovel 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. Aprovel prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower. Aprovel slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes. Aprovel 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 APROVEL DO NOT TAKE APR Διαβάστε το πλήρες έγγραφο
OBJECT 1 APROVEL 150MG FILM-COATED TABLETS Summary of Product Characteristics Updated 14-Jul-2016 | SANOFI 1. Name of the medicinal product Aprovel 150 mg film-coated tablets. 2. Qualitative and quantitative composition Each film-coated tablet contains 150 mg of irbesartan. Excipient with known effect: 51.00 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 to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2872 engraved on the other side. 4. Clinical particulars 4.1 Therapeutic indications Aprovel 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. Aprovel 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 Aprovel 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 Aprovel (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 Aprovel in hypertensive type 2 diabetic patients is based on studies where irbesartan was used in addition to other antihypertensive agents, as needed Διαβάστε το πλήρες έγγραφο