Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Olmesartan medoxomil; Amlodipine; Hydrochlorothiazide
Accord Healthcare Ireland Ltd.
C09DX03
Olmesartan medoxomil; Amlodipine; Hydrochlorothiazide
40 mg/5 mg/12.5 milligram(s)
Film-coated tablet
olmesartan medoxomil, amlodipine and hydrochlorothiazide
Marketed
2021-01-08
PACKAGE LEAFLET: INFORMATION FOR THE USER OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE ACCORD 20 MG/5 MG/12.5 MG FILM COATED TABLETS OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE ACCORD 40 MG/5 MG/12.5 MG FILM-COATED TABLETS OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE ACCORD 40 MG/10 MG/12.5 MG FILM-COATED TABLETS OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE ACCORD 40 MG/5 MG/25 MG FILM-COATED TABLETS OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE ACCORD 40 MG/10 MG/25 MG FILM-COATED TABLETS olmesartan medoxomil/amlodipine/hydrochlorothiazide READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 Olmesartan medoxomil/Amlodipine/Hydrochlorothiazide Accord is and what it is used for 2. What you need to know before you take Olmesartan medoxomil/Amlodipine/Hydrochlorothiazide Accord 3. How to take Olmesartan medoxomil/Amlodipine/Hydrochlorothiazide Accord 4. Possible side effects 5. How to store Olmesartan medoxomil/Amlodipine/Hydrochlorothiazide Accord 6. Contents of the pack and other information 1. WHAT OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE ACCORD IS AND WHAT IT IS USED FOR Olmesartan medoxomil/Amlodipine/Hydrochlorothiazide Accord contains three active substances called olmesartan medoxomil, amlodipine (as amlodipine besilate) and hydrochlorothiazide. All three substances help to control high blood pressure. • Olmesartan medoxomil belongs to a group of medicines called “angiotensin-II receptor antagonists”, which lowers blood pressure by relax Les hele dokumentet
Health Products Regulatory Authority 12 June 2023 CRN00DF4K Page 1 of 26 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Olmesartan medoxomil/Amlodipine/Hydrochlorothiazide Accord 40 mg/5 mg/12.5 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film‑coated tablet contains 40 mg olmesartan medoxomil, 5 mg amlodipine (as besilate) and 12.5 mg hydrochlorothiazide. Excipient with known effect: Each film‑coated tablet contains 14.25 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film coated tablet. Light yellow, approximate 9.50 mm in diameter, round, bevel-edged, film-coated tablets debossed with "OC2" on one side and plain on other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of essential hypertension. _ _ _Add-on therapy_ Olmesartan medoxomil/Amlodipine/Hydrochlorothiazide Accord is indicated in adult patients whose blood pressure is not adequately controlled on the combination of olmesartan medoxomil and amlodipine taken as dual-component formulation. _Substitution therapy_ Olmesartan medoxomil/Amlodipine/Hydrochlorothiazide Accord is indicated as substitution therapy in adult patients whose blood pressure is adequately controlled on the combination of olmesartan medoxomil, amlodipine and hydrochlorothiazide, taken as a dual-component (olmesartan medoxomil and amlodipine or olmesartan medoxomil and hydrochlorothiazide) and a single-component formulation (hydrochlorothiazide or amlodipine). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY _ADULTS_ The recommended dose of Olmesartan medoxomil/Amlodipine/Hydrochlorothiazide Accord is 1 tablet per day. _ _ _Add-on therapy_ Olmesartan medoxomil/Amlodipine/Hydrochlorothiazide Accord 40 mg/5 mg/12.5 mg may be administered in patients whose blood pressure is not adequately controlled on olmesartan medoxomil 40 mg and amlodipine 5 mg taken as dual-component combination or in patients whose blood pressure is not adequately controlled on Olmesartan medox Les hele dokumentet