Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
HYDROCHLOROTHIAZIDE, OLMESARTAN MEDOXOMIL
Actavis Group PTC ehf
C09CA08
HYDROCHLOROTHIAZIDE, OLMESARTAN MEDOXOMIL
20mg/12.5 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
Angiotensin II antagonists, plain
Authorised
2016-12-16
29 PACKAGE LEAFLET: INFORMATION FOR THE USER /…/ 20 MG/12.5 MG FILM-COATED TABLETS /…/ 20 MG/25 MG FILM-COATED TABLETS /…/ 40 MG/12.5 MG FILM-COATED TABLETS /…/ 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 /…/ is and what it is used for 2. What you need to know before you take /…/ 3. How to take /…/ 4. Possible side effects 5. How to store /…/ 6. Contents of the pack and other information 1. WHAT /…/ IS AND WHAT IT IS USED FOR /…/ 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 /…/ if olmesartan medoxomil alone has not adequately controlled your blood pressure. When given together, the two active substances in /…/ 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 wa Olvassa el a teljes dokumentumot
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Olmesartan Hydrochlorothiazide Actavis 20 mg/12.5 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 20 mg olmesartan medoxomil and 12.5 mg hydrochlorothiazide. Excipients with known effect: Each film-coated tablet contains 139.94 mg lactose monohydrate and 0.003 mg sunset yellow FCF (E110). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Olmesartan Hydrochlorothiazide Actavis 20 mg/12.5 mg film-coated tablets are orange, round, biconvex, 8.5 mm in diameter and with OH 21 debossed on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of essential hypertension. Olmesartan Hydrochlorothiazide Actavis 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_ Olmesartan Hydrochlorothiazide is not for use as initial therapy, but in patients whose blood pressure is not adequately controlled by 20 mg olmesartan medoxomil alone. Olmesartan Hydrochlorothiazide 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: Olmesartan Hydrochlorothiazide Actavis 20 mg/12.5 mg may be administered in patients whose blood pressure is not adequately controlled by the optimal monotherapy olmesartan medoxomil 20 mg alone. _Elderly (age 65 years or older)_ In elderly people the same dosage of the combination is recommended as for adults. _Renal impairment_ When Olmesartan Hydrochlorothiazide is used in patients with mild to moderate renal impairment (creatinine clearance of 30 - 60 ml/min) periodic monitori Olvassa el a teljes dokumentumot