Maa: Irlanti
Kieli: englanti
Lähde: HPRA (Health Products Regulatory Authority)
IRBESARTAN
Ranbaxy Ireland Limited
IRBESARTAN
75 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
Authorised
0000-00-00
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SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Irbesartan Ranbaxy 75 mg Film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 75 mg irbesartan. Each tablet also contains 25.84 mg lactose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. White to off white, film-coated oval shaped, biconvex tablet debossed with ‘I3’ on one side and plain on the other 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Irbesartan Ranbaxy 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 section 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 Ranbaxy 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 Ranbaxy can be increased to 300 mg, or other anti-hypertensive agents can be added. In particular, the addition of a diuretic such as hydrochlorothiazide has been shown to have an additive effect with Irbesartan Ranbaxy (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 Ranbaxy in hyperten Lue koko asiakirja