Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
Hydrochlorothiazide; Amlodipine; Olmesartan medoxomil
PCO Manufacturing Ltd.
C09DX; C09DX03
Hydrochlorothiazide; Amlodipine; Olmesartan medoxomil
40/5/12.5 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
Angiotensin II antagonists, other combinations; olmesartan medoxomil, amlodipine and hydrochlorothiazide
Authorised
2017-01-20
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 P Baca dokumen lengkap
Health Products Regulatory Authority 21 January 2020 CRN009DC2 Page 1 of 2 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Konverge Plus 40 mg/5 mg/12.5 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 40 mg of olmesartan medoxomil, 5 mg amlodipine (as amlodipine besilate) and 12.5mg hydrochlorothiazide. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet _Product imported from Greece_ Light yellow, round, film-coated tablet with ‘C53’ debossed on one side. 4 CLINICAL PARTICULARS As per PA0865/019/002 5 PHARMACOLOGICAL PROPERTIES As per PA0865/019/002 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Tablet core Starch, pregelatinised maize Silicified microcrystalline cellulose (microcrystalline cellulose and silica colloidal anhydrous) Croscarmellose sodium Magnesium stearate Film coat Polyvinyl alcohol Macrogol 3350 Talc Titanium dioxide (E 171) Iron (III) oxide yellow (E 172) 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf-life expiry date of this product shall be the date shown on the container and outer package of the product on the market in the country of origin. 6.4 SPECIAL PRECAUTIONS FOR STORAGE This medicinal product does not require any special storage conditions. Health Products Regulatory Authority 21 January 2020 CRN009DC2 Page 2 of 2 6.5 NATURE AND CONTENTS OF CONTAINER Blister pack containing 28 film-coated tablets in a cardboard carton. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING No special requirements. 7 PARALLEL PRODUCT AUTHORISATION HOLDER PCO Manufacturing Ltd. Unit 10, Ashbourne Business Park Rath Ashbourne Co. Meath Ireland 8 PARALLEL PRODUCT AUTHORISATION NUMBER PPA0465/421/002 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20 th January 2017 10 DATE OF REVISION OF THE TEXT January 2020 Baca dokumen lengkap