Konverge Plus 40mg/10mg/12.5mg film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

AMLODIPINE, HYDROCHLOROTHIAZIDE, OLMESARTAN MEDOXOMIL

Available from:

Menarini International Operations Luxembourg S.A 1 Avenue de la Gare, L-1611, Luxembourg

ATC code:

C09DX03

INN (International Name):

AMLODIPINE 10 mg HYDROCHLOROTHIAZIDE 12.5 mg OLMESARTAN MEDOXOMIL 40 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

AMLODIPINE 10 mg HYDROCHLOROTHIAZIDE 12.5 mg OLMESARTAN MEDOXOMIL 40 mg

Prescription type:

POM

Therapeutic area:

AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM

Authorization status:

Authorised

Authorization date:

2011-04-06

Patient Information leaflet

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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

Summary of Product characteristics

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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.
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Konverge Plus 40 mg/10 mg/25 mg film-coated tablets:
Greyish red, oval, film-coated tablet of 15 x 7