Co-Diovan 320 mg/12.5 mg film-coated tablets

Kraj: Irlandia

Język: angielski

Źródło: HPRA (Health Products Regulatory Authority)

Składnik aktywny:

Valsartan; Hydrochlorothiazide

Dostępny od:

PCO Manufacturing Ltd.

Kod ATC:

C09DA03

INN (International Nazwa):

Valsartan; Hydrochlorothiazide

Dawkowanie:

320 mg/12.5 milligram(s)

Forma farmaceutyczna:

Film-coated tablet

Typ recepty:

Product subject to prescription which may be renewed (B)

Dziedzina terapeutyczna:

valsartan and diuretics

Status autoryzacji:

Authorised

Data autoryzacji:

2013-04-12

Ulotka dla pacjenta

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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

Charakterystyka produktu

Health Products Regulatory Authority
15 March 2019
CRN008WLC
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Co-Diovan 320 mg/12.5 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 320 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 Italy:_
Pink, ovaloid shaped, beveled edge tablets, imprinted with “NVR”
on one side and “HIL” on the other side.
4 CLINICAL PARTICULARS
As per PA0896/007/004
5 PHARMACOLOGICAL PROPERTIES
As per PA0896/007/004
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
_Tablet core:_
Microcrystalline cellulose
Silica, Colloidal anhydrous
Crospovidone
Magnesium stearate
_Coating:_
Hypromellose
Macrogol 4000
Talc
Titanium dioxide (E171)
Black iron oxide (E172)
Red iron oxide (E172)
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf-life expiry date of this product shall be the date shown on
the blister and on the outer carton.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 30 °C.
Store in the original package in order to protect from moisture.
Health Products Regulatory Authority
15 March 2019
CRN008WLC
Page 2 of 2
6.5 NATURE AND CONTENTS OF CONTAINER
Blisters: 28 (calendar pack) film-coated tablets in a 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
PPA0465/226/005
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 12th April 2013
10 DATE OF REVISION OF THE TEXT
March 2019
CRN008WLC