Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
Olmesartan medoxomil; Amlodipine; Hydrochlorothiazide
Menarini International Operations Luxembourg S.A.
C09DX; C09DX03
Olmesartan medoxomil; Amlodipine; Hydrochlorothiazide
40 mg/10 mg/12.5 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
Angiotensin II antagonists, other combinations; olmesartan medoxomil, amlodipine and hydrochlorothiazide
Marketed
2011-09-23
1 PACKAGE LEAFLET: INFORMATION FOR THE USER KONVERGE PLUS 20 MG/5 MG/12.5 MG FILM-COATED TABLETS KONVERGE PLUS 40 MG/5 MG/12.5 MG FILM-COATED TABLETS KONVERGE PLUS 40 MG/10 MG/12.5 MG FILM-COATED TABLETS KONVERGE PLUS 40 MG/5 MG/25 MG FILM-COATED TABLETS KONVERGE PLUS 40 MG/10 MG/25 MG FILM-COATED TABLETS OLMESARTAN MEDOXOMIL/AMLODIPINE/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 Konverge Plus is and what it is used for 2. What you need to know before you take Konverge Plus 3. How to take Konverge Plus 4. Possible side effects 5. How to store Konverge Plus 6. Contents of the pack and other information 1. WHAT KONVERGE PLUS IS AND WHAT IT IS USED FOR Konverge Plus 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 relaxing the blood vessels. • Amlodipine belongs to a group of substances called “calcium channel blockers”. Amlodipine also lowers blood pressure by relaxing 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. The actions of these substances contribute to decrease your blood pressure. Konverge Plus is used f Lugege kogu dokumenti
Health Products Regulatory Authority 21 June 2023 CRN00DHYF Page 1 of 24 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Konverge Plus 40mg/10mg/12.5mg film coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 40 mg olmesartan medoxomil, 10 mg amlodipine (as amlodipine besilate) and 12.5 mg hydrochlorothiazide. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Greyish red, round, film-coated tablet of 9.5 mm debossed C55 on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of essential hypertension. _ADD-ON THERAPY _ Konverge Plus 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_ Konverge Plus 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 Konverge Plus is 1 tablet per day. _ADD-ON THERAPY_ Konverge Plus 40 mg/10 mg/12.5 mg may be administered in patients whose blood pressure is not adequately controlled on olmesartan medoxomil 40 mg and amlodipine 10 mg taken as dual-component combination or by Konverge Plus 40 mg/5 mg/12.5 mg. A step-wise titration of the dosage of the individual components is recommended before changing to the triple-component combination. When clinically appropriate, direct change from dual-component combination to the triple-component combination may be considered. _SUBSTITUTION THERAPY_ Patients controlled on stable doses of olmesartan medoxomil, amlodipine and hydrochlorothiazide taken at the same time as a dual-component (olmesartan Lugege kogu dokumenti