Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Olmesartan medoxomil; Amlodipine
Menarini International Operations Luxembourg S.A.
C09DB; C09DB02
Olmesartan medoxomil; Amlodipine
20 mg/5 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
Angiotensin II antagonists and calcium channel blockers; olmesartan medoxomil and amlodipine
Marketed
2009-06-19
1 PACKAGE LEAFLET: INFORMATION FOR THE USER KONVERGE 20 MG/5 MG KONVERGE 40 MG/5 MG KONVERGE 40 MG/10 MG FILM-COATED TABLETS OLMESARTAN MEDOXOMIL/AMLODIPINE 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 is and what it is used for 2. What you need to know before you take Konverge 3. How to take Konverge 4. Possible side effects 5. How to store Konverge 6. Contents of the pack and other information 1. WHAT KONVERGE IS AND WHAT IT IS USED FOR Konverge contains two substances called olmesartan medoxomil and amlodipine (as amlodipine besilate). Both of these substances help to control high blood pressure. • Olmesartan medoxomil belongs to a group of medicines called “angiotensin-II receptor antagonists” which lower blood pressure by relaxing the blood vessels. • Amlodipine belongs to a group of substances called “calcium channel blockers”. Amlodipine stops calcium from moving into the blood vessel wall which stops the blood vessels from tightening thereby also reducing blood pressure. The actions of both these substances contribute to stopping the tightening of blood vessels, so that blood vessels relax and blood pressure decreases. Konverge is used for the treatment of high blood pressure in patients whose blood pressure is not controlled enough with either olmesartan medoxomil or amlodipine alone. 2. WHAT YOU NEED TO KNOW B EFORE YOU TAKE KONVERGE DO NOT TAKE KONVERGE ▪ if you are allergic to olmesartan medoxomil or to amlodipine or a special group of calcium channel Read the complete document
Health Products Regulatory Authority 06 September 2022 CRN00D0CV Page 1 of 18 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Konverge 20 mg/5 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Konverge 20 mg/5 mg film-coated tablets: Each film-coated tablet of Konverge contains 20 mg of olmesartan medoxomil and 5 mg of amlodipine (as amlodipine besilate). For the full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet White, round, film-coated tablet of 6mm with C73 debossed on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of essential hypertension. Konverge is indicated in adult patients whose blood pressure is not adequately controlled on olmesartan medoxomil or amlodipine monotherapy (see section 4.2 and section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Adults The recommended dosage of Konverge is 1 tablet per day. Konverge 20 mg/5 mg may be administered in patients whose blood pressure is not adequately controlled by 20 mg olmesartan medoxomil or 5 mg amlodipine alone. A step-wise titration of the dosage of the individual components is recommended before changing to the fixed combination. When clinically appropriate, direct change from monotherapy to the fixed combination may be considered. For convenience, patients receiving olmesartan medoxomil and amlodipine from separate tablets may be switched to Konverge tablets containing the same component doses. Konverge can be taken with or without food. Elderly (age 65 years or over) No adjustment of the recommended dose is generally required for elderly people but increase of the dosage should take place with care (see sections 4.4 and 5.2). If up-titration to the maximum dose of 40 mg olmesartan medoxomil daily is required, blood pressure should be closely monitored. Renal impairment The maximum dose of olmesartan medoxomil in patients with mild to moderate renal impairment (creatinine clearance of 20 – 60 mL/min) is 20 mg olmesartan medoxomil once daily, owing Read the complete document