Konverge 40 mg/10 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Olmesartan medoxomil; Amlodipine besilate

Available from:

PCO Manufacturing Ltd.

ATC code:

C09DB; C09DB02

INN (International Name):

Olmesartan medoxomil; Amlodipine besilate

Dosage:

40/10 mg/mg

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

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

Authorization status:

Authorised

Authorization date:

2013-08-02

Patient Information leaflet

_ _
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 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 or a
special group of calci

Summary of Product characteristics

Health Products Regulatory Authority
22 October 2021
CRN00CL72
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Konverge 40 mg/10 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Konverge 40 mg/10 mg film-coated tablets:
Each film-coated tablet of Konverge contains 40 mg of olmesartan
medoxomil and 10 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 Italy and Greece:_
Brownish-red, round, film-coated tablet with ‘C 77’ debossed on
one side.
4 CLINICAL PARTICULARS
As per PA0865/017/003
5 PHARMACOLOGICAL PROPERTIES
As per PA0865/017/003
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Tablet core:
Starch, pregelatinised maize
Silicified microcrystalline cellulose (microcrystalline cellulose with
colloidal silicon dioxide)
Croscarmellose sodium
Magnesium stearate
Tablet coat:
Polyvinyl alcohol
Macrogol 3350
Talc
Titanium dioxide (E171)
Iron (III) oxide red (E172)
Iron (III) oxide yellow
6.2 INCOMPATIBILITIES
Not applicable.
Health Products Regulatory Authority
22 October 2021
CRN00CL72
Page 2 of 2
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.
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
PPA0465/313/002
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 2
nd
August 2013
10 DATE OF REVISION OF THE TEXT
October 2021