Country: Իռլանդիա
language: անգլերեն
source: HPRA (Health Products Regulatory Authority)
Olmesartan medoxomil; Hydrochlorothiazide
Daiichi Sankyo Ireland Ltd
C09DA; C09DA08
Olmesartan medoxomil; Hydrochlorothiazide
40 mg/12.5 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
Angiotensin II antagonists and diuretics; olmesartan medoxomil and diuretics
Not marketed
2010-08-06
Page 1 of 10 PACKAGE LEAFLET: INFORMATION FOR THE USER BENETOR PLUS 40 MG/12.5 MG BENETOR PLUS 40 MG/25 MG FILM-COATED TABLETS OLMESARTAN MEDOXOMIL/HYDROCHLOROTHIAZIDE 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 Benetor Plus is and what it is used for 2. What you need to know before you take Benetor Plus 3. How to take Benetor Plus 4. Possible side effects 5. How to store Benetor Plus 6. Contents of the pack and other information 1. WHAT BENETOR PLUS IS AND WHAT IT IS USED FOR Benetor Plus contains two active substances, olmesartan medoxomil and hydrochlorothiazide, that are used to treat high blood pressure (hypertension): Olmesartan medoxomil is one of a group of medicines called angiotensin II-receptor antagonists. It lowers blood pressure by relaxing the blood vessels. Hydrochlorothiazide is one of a group of medicines called thiazide diuretics (“water tablets”). It lowers blood pressure by helping the body to get rid of extra fluid by making your kidneys produce more urine. You will only be given Benetor Plus if Benetor (olmesartan medoxomil) alone has not adequately controlled your blood pressure. When given together, the two active substances in Benetor Plus help to lower blood pressure more than if either of them were given alone. You may already be taking medicines to treat your high blood pressure, but your doctor may want you to take Benetor Plus to lower it more. High blood pressure can be controlled with medicines such as Benetor Plus tablets. Your doctor has probabl read_full_document
Health Products Regulatory Authority 22 April 2022 CRN00CTZ7 Page 1 of 19 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Benetor Plus 40 mg/12.5 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 40 mg olmesartan medoxomil and 12.5 mg hydrochlorothiazide. Excipient(s) with known effect Benetor Plus 40 mg/12.5 mg film-coated tablets: Each film-coated tablet contains 233.9 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablets. Reddish-yellow, oval, film-coated tablets of 15 x 7 mm with C23 debossed on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of essential hypertension. Benetor Plus 40 mg/12.5 mg and 40 mg/25 mg fixed dose combinations are indicated in adult patients whose blood pressure is not adequately controlled on olmesartan medoxomil 40 mg alone. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults_ The recommended dose of Benetor Plus 40 mg/12.5 mg or 40 mg/25 mg is 1 tablet per day. Benetor Plus 40 mg/12.5 mg may be administered in patients whose blood pressure is not adequately controlled by olmesartan medoxomil 40 mg alone. Benetor Plus 40 mg /25 mg may be administered in patients whose blood pressure is not adequately controlled on Benetor Plus 40 mg/12.5 mg fixed dose combination.” For convenience, patients receiving olmesartan medoxomil and hydrochlorothiazide from separate tablets may be switched to Benetor Plus 40 mg/12.5 mg and 40 mg/25 mg tablets containing the same component doses. Benetor Plus 40 mg/12.5 mg and 40 mg/25 mg can be taken with or without food. _Elderly (age 65 years or over)_ In elderly people the same dosage of the combination is recommended as for adults. Blood pressure should be closely monitored. _Renal impairment_ Benetor Plus is contraindicated in patients with severe renal impairment (creatinine clearance < 30 mL/min). Health Products Regulatory Authority 22 April 2022 CRN00CTZ7 Page 2 of 19 The maximum dose of o read_full_document