Χώρα: Ιρλανδία
Γλώσσα: Αγγλικά
Πηγή: HPRA (Health Products Regulatory Authority)
IRBESARTAN
Niche Generics Limited
C09CA04
IRBESARTAN
150 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
irbesartan
Not Marketed
2013-02-15
PA 1063/056/001-002 1 28/09/2017 PACKAGE LEAFLET: INFORMATION FOR THE USER IRBESARTAN NICHE 150MG FILM-COATED TABLETS IRBESARTAN NICHE 300MG 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. The name of your medicine is Irbesartan Niche 150 mg or 300 mg Film-Coated Tablets. It will be called Irbesartan Niche for ease from here on. WHAT IS IN THIS LEAFLET: 1. What Irbesartan Niche is and what it is used for 2. What you need to know before you take Irbesartan Niche 3. How to take Irbesartan Niche 4. Possible side effects 5. How to store Irbesartan Niche 6. Contents of the pack and other information 1. WHAT IRBESARTAN NICHE IS AND WHAT IT IS USED FOR Irbesartan Niche 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 Niche prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower. Irbesartan Niche slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes. Irbesartan Niche 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 NICHE DO NOT TAKE IRBESARTAN NICHE: if you are Διαβάστε το πλήρες έγγραφο
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Irbesartan Niche 150mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 150mg tablet contains 150mg of irbesartan. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Irbesartan Niche 150mg film-coated tablets are white to off-white coloured, oval shaped, biconvex, film-coated tablets with “U” debossed on one side and “I” debossed on the other side. The tablet is approximately 4.8 mm thick, 12.5 mm long and 6.5 mm wide. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Irbesartan Niche 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 Niche 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. A dose of 75 mg cannot be given with Irbesartan Niche. Another appropriate formulation should be used for this dose. In patients insufficiently controlled with 150 mg once daily, the dose of Irbesartan Niche 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 Niche (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 Niche in h Διαβάστε το πλήρες έγγραφο