Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
Olmesartan medoxomil; Hydrochlorothiazide
Daiichi Sankyo Ireland Ltd
C09DA; C09DA08
Olmesartan medoxomil; Hydrochlorothiazide
20 mg/25 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
Angiotensin II antagonists and diuretics; olmesartan medoxomil and diuretics
Marketed
2005-05-12
Page 1 of 10 PACKAGE LEAFLET: INFORMATION FOR THE USER BENETOR PLUS 20 MG/12.5 MG BENETOR PLUS 20 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. Page 2 of 10 High blood pressure can be controlled with medicines such as Benetor Plus tablets. Your docto Lugege kogu dokumenti
Health Products Regulatory Authority 22 April 2022 CRN00CTZ7 Page 1 of 18 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Benetor Plus 20 mg/25 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 20 mg olmesartan medoxomil and 25 mg hydrochlorothiazide Excipient(s) with known effect Benetor Plus 20 mg/25 mg film-coated tablets: Each film-coated tablet contains 98.2 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet Pinkish, round, film-coated tablets of 8.5 mm with C24 debossed on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of essential hypertension. Benetor Plus fixed dose combination is indicated in adult patients whose blood pressure is not adequately controlled on olmesartan medoxomil alone. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _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 theantihypertensive 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/ 12.5 mg hydrochlorothiazide. _Elderly people (age 65 years or over)_ In elderly people the same dosage of the combination is recommended as for adults. _Renal impairment_ When Benetor Plus is used in pat Lugege kogu dokumenti