Konverge 40mg/5mg film-coated tablets

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

Amlodipine besylate; Olmesartan medoxomil

Tilgængelig fra:

IMED Healthcare Ltd.

ATC-kode:

C09DB; C09DB02

INN (International Name):

Amlodipine besylate; Olmesartan medoxomil

Dosering:

40/5 mg/mg

Lægemiddelform:

Film-coated tablet

Recept type:

Product subject to prescription which may be renewed (B)

Terapeutisk område:

Angiotensin II antagonists and calcium channel blockers; olmesartan medoxomil and amlodipine

Autorisation status:

Authorised

Autorisation dato:

2015-12-04

Indlægsseddel

PACKAGE LEAFLET: INFORMATION FOR THE USER
KONVERGE 20 MG/5 MG FILM-COATED TABLETS
KONVERGE 40 MG/5 MG FILM-COATED TABLETS
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 BEFORE YOU TAKE KONVERGE
DO NOT TAKE KONVERGE
• if you are allergic to olmesartan medoxomil or to amlodipine o

Produktets egenskaber

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Konverge 40mg/5mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Konverge 40 mg/5 mg film-coated tablets:
Each film-coated tablet of Konverge contains 40 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
_Product imported from Greece_
Cream, round, film-coated tablet of 8mm with C75 debossed on one side.
4 CLINICAL PARTICULARS
As per PA0865/017/002
5 PHARMACOLOGICAL PROPERTIES
As per PA0865/017/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Tablet core:
Starch, pregelatinised maize
Silicified microcrystalline cellulose
Croscarmellose sodium
Magnesium stearate
Tablet coat:
Polyvinyl alcohol
Macrogol 3350
Talc
Titanium dioxide (E171)
Iron (III) oxide yellow (E172)
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf-life expiry date of this product is the date shown on the
container and outer carton of the product on the
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market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
This medicinal product does not require any special storage
conditions.
6.5 NATURE AND CONTENTS OF CONTAINER
Aluminium / PVC / Aluminium blister.
Pack sizes: 28 film-coated tablets.
6.6 SPECIAL PRECAU