Co-Diovan 80 mg/12.5 mg film-coated tablets

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Hydrochlorothiazide; Valsartan

Verfügbar ab:

PCO Manufacturing Ltd.

ATC-Code:

C09DA03

INN (Internationale Bezeichnung):

Hydrochlorothiazide; Valsartan

Dosierung:

80 mg/12.5 milligram(s)

Darreichungsform:

Film-coated tablet

Verschreibungstyp:

Product subject to prescription which may be renewed (B)

Therapiebereich:

valsartan and diuretics

Berechtigungsstatus:

Authorised

Berechtigungsdatum:

2009-07-31

Gebrauchsinformation

_ _
_ _
_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
CO-DIOVAN
® 80 MG/12.5 MG FILM-COATED TABLETS
CO-DIOVAN
® 160 MG/12.5 MG FILM-COATED TABLETS
CO-DIOVAN
® 160 MG/25 MG FILM-COATED TABLETS
CO-DIOVAN
® 320 MG/12.5 MG FILM-COATED TABLETS
CO-DIOVAN
® 320 MG/25 MG FILM-COATED TABLETS
valsartan/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 Co-Diovan is and what it is used for
2.
What you need to know before you take Co-Diovan
3.
How to take Co-Diovan
4.
Possible side effects
5.
How to store Co-Diovan
6.
Contents of the pack and other information
1.
WHAT CO-DIOVAN IS AND WHAT IT IS USED FOR
Co-Diovan film-coated tablets contain two active substances called
valsartan and
hydrochlorothiazide. Both of these substances help to control high
blood pressure (hypertension).

VALSARTAN belongs to a class of medicines known as “angiotensin II
receptor antagonists”, which
help to control high blood pressure. Angiotensin II is a substance in
the body that causes
vessels to tighten, thus causing your blood pressure to increase.
Valsartan works by blocking
the effect of angiotensin II. As a result, blood vessels relax and
blood pressure is lowered.

HYDROCHLOROTHIAZIDE belongs to a group of medicines called thiazide
diuretics (also known as
“water tablets”). Hydrochlorothiazide increases urine output,
which also lowers blood pressure.
Co-Diovan is used to treat high blood pressure which is not adequately
controlled by a single
substance alone.
High blood pressure

Fachinformation

Health Products Regulatory Authority
15 March 2019
CRN008WLC
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Co-Diovan 80 mg/12.5 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 80 mg of valsartan and 12.5 mg of
hydrochlorothiazide.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
_ _
_Product imported from the UK and Italy_
Light orange, ovaloid tablet imprinted with "HGH" on one side and "CG"
on the other side.
4 CLINICAL PARTICULARS
As per PA0896/007/001
5 PHARMACOLOGICAL PROPERTIES
As per PA0896/007/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
_Tablet core:_
Microcrystalline cellulose
Colloidal anhydrous silica
Crospovidone
Magnesium stearate
_Coating:_
Hypromellose
Macrogol 8000
Talc
Red iron oxide (E172)
Yellow iron oxide (E172)
Titanium dioxide (E171)
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf-life expiry date of this product is the date shown on the
blister and outer package of the product on the market in
the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 30 °C
Health Products Regulatory Authority
15 March 2019
CRN008WLC
Page 2 of 2
Store in the original package in order to protect from moisture.
6.5 NATURE AND CONTENTS OF CONTAINER
28 film-coated tablets contained in blister packs in an outer carton.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE MATERIALS DERIVED FROM SUCH MEDICINAL
PRODUCT AND OTHER HANDLING OF THE PRODUCT
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
PPA0465/226/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 31
st
July 2009
10 DATE OF REVISION OF THE TEXT
March 2019
CRN008WLC