Quốc gia: Ai-len
Ngôn ngữ: Tiếng Anh
Nguồn: HPRA (Health Products Regulatory Authority)
OLMESARTAN MEDOXOMIL, HYDROCHLOROTHIAZIDE
B & S Healthcare
C09DA08
OLMESARTAN MEDOXOMIL, HYDROCHLOROTHIAZIDE
20/12.5 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
Angiotensin II antagonists and diuretics
Authorised
2011-07-29
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Benetor Plus 20 mg/12.5 mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Benetor Plus 20 mg/12.5 mg film coated tablets: Each film-coated tablet contains 20 mg olmesartan medoxomil and 12.5 mg hydrochlorothiazide. Excipients: Benetor Plus 20 mg/12.5 mg film coated tablets: Each film-coated tablet contains lactose monohydrate (l10.7mg). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated Tablets _Product imported from France:_ Reddish-yellow round film-coated tablet with ‘C22’ debossed on one side 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of essential hypertension. Benetor Plus fixed dose combination is indicated in patients whose blood pressure is not adequately controlled on olmesartan medoxomil alone. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ADULTS Benetor Plus is not for use as initial therapy, but in patients whose blood pressure is not adequately controlled by 20 mg olmesartan medoxomil alone. Benetor Plus is administered once daily, with or without food. When clinically appropriate, direct change from monotherapy with 20 mg olmesartan medoxomil to the fixed combination may be considered, taking into account that the antihypertensive effect of olmesartan medoxomil is maximal by about 8 weeks after initiating therapy (see section 5.1). Dose titration of the individual components is recommended: 20 mg olmesartan medoxomil/12.5 mg hydrochlorothiazide may be administered in patients whose blood pressure is not adequately controlled by the optimal monotherapy olmesartan medoxomil 20 mg alone. 20 mg olmesartan medoxomil/25 mg hydrochlorothiazide may be administered in patients whose blood pressure is not adequately controlled by 20 mg olmesartan medoxomil/ Đọc toàn bộ tài liệu