País: Irlanda
Língua: inglês
Origem: HPRA (Health Products Regulatory Authority)
Olmesartan medoxomil; Amlodipine; Hydrochlorothiazide
Clonmel Healthcare Ltd
C09DX03
Olmesartan medoxomil; Amlodipine; Hydrochlorothiazide
20 mg/5 mg/12.5 milligram(s)
Film-coated tablet
olmesartan medoxomil, amlodipine and hydrochlorothiazide
Marketed
2020-07-24
Page 1 of 13 PACKAGE LEAFLET: INFORMATION FOR THE USER OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE CLONMEL 20 MG/5 MG/12.5 MG FILM- COATED TABLETS OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE CLONMEL 40 MG/5 MG/12.5 MG FILM- COATED TABLETS OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE CLONMEL 40 MG/10 MG/12.5 MG FILM- COATED TABLETS OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE CLONMEL 40 MG/5 MG/25 MG FILM- COATED TABLETS OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE CLONMEL 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 Olmesartan medoxomil/Amlodipine/Hydrochlorothiazide Clonmel is and what it is used for 2. What you need to know before you take Olmesartan medoxomil/Amlodipine/Hydrochlorothiazide Clonmel 3. How to take Olmesartan medoxomil/Amlodipine/Hydrochlorothiazide Clonmel 4. Possible side effects 5. How to store Olmesartan medoxomil/Amlodipine/Hydrochlorothiazide Clonmel 6. Contents of the pack and other information 1. WHAT OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE CLONMEL IS AND WHAT IT IS USED FOR Olmesartan medoxomil/Amlodipine/Hydrochlorothiazide Clonmel 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 Leia o documento completo
Health Products Regulatory Authority 22 August 2022 CRN00CZCP Page 1 of 24 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Olmesartan medoxomil/Amlodipine/Hydrochlorothiazide Clonmel 20 mg/5 mg/12.5 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 20 mg olmesartan medoxomil, 5 mg amlodipine (as amlodipine besilate) and 12.5 mg hydrochlorothiazide. Excipient with known effect One film-coated tablet contains 99.30 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet (tablet) Orange white, round, biconvex film-coated tablets with a diameter of 8.1 ± 0.2 mm. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of essential hypertension. _ADD-ON THERAPY_ Olmesartan medoxomil/Amlodipine/Hydrochlorothiazide Clonmel 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 Clonmel 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 Clonmel is 1 tablet per day. _ADD-ON THERAPY_ Olmesartan medoxomil/Amlodipine/Hydrochlorothiazide Clonmel 20 mg/5 mg/12.5 mg may be administered in patients whose blood pressure is not adequately controlled on olmesartan medoxomil 20 mg and amlodipine 5 mg taken as dual-component combination. A step-wise titration of the dosage of the individual components is recommended before changing to the triple-component combination. Leia o documento completo