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

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Hydrochlorothiazide; Olmesartan medoxomil; Amlodipine

Boleh didapati daripada:

PCO Manufacturing Ltd.

Kod ATC:

C09DX; C09DX03

INN (Nama Antarabangsa):

Hydrochlorothiazide; Olmesartan medoxomil; Amlodipine

Dos:

40/10/12.5 milligram(s)

Borang farmaseutikal:

Film-coated tablet

Jenis preskripsi:

Product subject to prescription which may be renewed (B)

Kawasan terapeutik:

Angiotensin II antagonists, other combinations; olmesartan medoxomil, amlodipine and hydrochlorothiazide

Status kebenaran:

Authorised

Tarikh kebenaran:

2017-01-20

Risalah maklumat

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

Ciri produk

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/10 mg/12.5 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 40 mg of olmesartan medoxomil, 10 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_
Greyish Red, round, film-coated tablet with ‘C55’ debossed on one
side.
4 CLINICAL PARTICULARS
As per PA0865/019/003
5 PHARMACOLOGICAL PROPERTIES
As per PA0865/019/003
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)
Iron (III) oxide red (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
Health Products Regulatory Authority
21 January 2020
CRN009DC2
Page 2 of 2
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
PPA0465/421/003
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