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

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Hydrochlorothiazide; Valsartan

Available from:

IMED Healthcare Ltd.

ATC code:

C09DA; C09DA03

INN (International Name):

Hydrochlorothiazide; Valsartan

Dosage:

80 mg/12.5 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Angiotensin II antagonists and diuretics; valsartan and diuretics

Authorization status:

Authorised

Authorization date:

2011-01-21

Patient Information leaflet

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
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 increases the workload of the
heart and arteries. If not
treated, it can damage the blood vessels of the brain, h

Summary of Product characteristics

Health Products Regulatory Authority
29 January 2021
CRN00C221
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 film-coated 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 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
Tabletcore:
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
container and outer carton of the product as marketed in the
country of origin.
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
29 January 2021
CRN00C221
Page 2 of 2
6.5 NATURE AND CONTENTS OF CONTAINER
Foil blisters in a cardboard carton containing 28 tablets.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
IMED Healthcare Ltd.
Unit 625 Kilshane Avenue
Northwest Business Park
Ballycoolin
Dublin 15
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA1463/043/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 21
st
January 2011
10 DATE OF REVISION OF THE TEXT
January 2021