País: Irlanda
Idioma: inglés
Fuente: HPRA (Health Products Regulatory Authority)
OLMESARTAN MEDOXOMIL
B & S Healthcare
C09CA08
OLMESARTAN MEDOXOMIL
40 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
Angiotensin II antagonists, plain
Authorised
2011-07-15
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Benetor 10 mg Film-coated Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 40 mg tablet contains 40 mg of olmesartan medoxomil Excipients: Also contains lactose monohydrate (see section 4.4) For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Film-coated tablets. _Product imported from France:_ White, circular, film-coated tablets with C15 embossed on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of essential hypertension. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults The recommended starting dose of olmesartan medoxomil is 10 mg once daily. In patients whose blood pressure is not adequately controlled at this dose, the dose of olmesartan medoxomil may be increased to 20 mg once daily as the optimal dose. If additional blood pressure reduction is required, olmesartan medoxomil dose may be increased to a maximum of 40 mg daily or hydrochlorothiazide therapy may be added_._ The antihypertensive effect of olmesartan medoxomil is substantially present within 2 weeks of initiating therapy and is maximal by about 8 weeks after initiating therapy. This should be borne in mind when considering changing the dose regimen for any patient. In order to assist compliance, it is recommended that Benetor tablets be taken at about the same time each day, with or without food, for example at breakfast time. Elderly No adjustment of dosage is generally required in elderly patients (see below for dose recommendations in patients with renal impairment). If up-titration to the maximum dose of 40mg daily is required, blood pressure should be closely monitored. Renal impairment The maximum dose in patients with mild to moderate renal impairment (creatinine clearance of 20 – 60 Leer el documento completo