Country: Malta
Language: English
Source: Medicines Authority
AMLODIPINE, HYDROCHLOROTHIAZIDE, OLMESARTAN MEDOXOMIL
Menarini International Operations Luxembourg S.A 1 Avenue de la Gare, L-1611, Luxembourg
C09DX03
AMLODIPINE 5 mg HYDROCHLOROTHIAZIDE 12.5 mg OLMESARTAN MEDOXOMIL 40 mg
FILM-COATED TABLET
AMLODIPINE 5 mg HYDROCHLOROTHIAZIDE 12.5 mg OLMESARTAN MEDOXOMIL 40 mg
POM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
Authorised
2011-04-06
Page 1 of 11 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 Plu Read the complete document
Page 1 of 32 1. NAME OF THE MEDICINAL PRODUCT 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 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Konverge Plus 20 mg/5 mg/12.5 mg film-coated tablets: Each film-coated tablet contains 20 mg olmesartan medoxomil, 5 mg amlodipine (as amlodipine besilate) and 12.5 mg hydrochlorothiazide. Konverge Plus 40 mg/5 mg/12.5 mg film-coated tablets: Each film-coated tablet contains 40 mg olmesartan medoxomil, 5 mg amlodipine (as amlodipine besilate) and 12.5 mg hydrochlorothiazide. Konverge Plus 40 mg/10 mg/12.5 mg film-coated tablets: Each film-coated tablet contains 40 mg olmesartan medoxomil, 10 mg amlodipine (as amlodipine besilate) and 12.5 mg hydrochlorothiazide. Konverge Plus 40 mg/5 mg/25 mg film-coated tablets: Each film-coated tablet contains 40 mg olmesartan medoxomil, 5 mg amlodipine (as amlodipine besilate) and 25 mg hydrochlorothiazide. Konverge Plus 40 mg/10 mg/25 mg film-coated tablets: Each film-coated tablet contains 40 mg olmesartan medoxomil, 10 mg amlodipine (as amlodipine besilate) and 25 mg hydrochlorothiazide. Excipients with known effect For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Konverge Plus 20 mg/5 mg/12.5 mg film-coated tablets: Light orange, round, film-coated tablet of 8 mm debossed C51 on one side. Konverge Plus 40 mg/5 mg/12.5 mg film-coated tablets: Light yellow, round, film-coated tablet of 9.5 mm debossed C53 on one side. Konverge Plus 40 mg/10 mg/12.5 mg film-coated tablets: Greyish red, round, film-coated tablet of 9.5 mm debossed C55 on one side. Konverge Plus 40 mg/5 mg/25 mg film-coated tablets: Light yellow, oval, film-coated tablet of 15 x 7 mm debossed C54 on one side. Page 2 of 32 Konverge Plus 40 mg/10 mg/25 mg film-coated tablets: Greyish red, oval, film-coated tablet of 15 x 7 Read the complete document