CO-DIOVAN 320/12.5 mg/mg Film Coated Tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

VALSARTAN, HYDROCHLOROTHIAZIDE, MICRONIZED

Available from:

Novartis Pharmaceuticals UK Ltd

ATC code:

C09DA03

INN (International Name):

VALSARTAN, HYDROCHLOROTHIAZIDE, MICRONIZED

Dosage:

320/12.5 mg/mg

Pharmaceutical form:

Film Coated Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Angiotensin II antagonists and diuretics

Authorization status:

Authorised

Authorization date:

2008-02-01

Patient Information leaflet

Live Text:
 
Yes /   
 
No /   
 
Both Production Site:
Torre
WO:
1387650
CTM:
Gargiulo, Nicola
Comp. Description:
LFT_CO-DIOVAN_FCT IE
Printing Colours:
Black
Comp. No. New:
1222613 IE TA
Comp. No. Old:
1222037 IE TA
Format/Dimension:
148 x 630 mm
Tech. Drawing No.:
5666/O
Technical Colours:
Cutting
Min. Font Size Text:
9 pt
Font Type:
News Gothic
Version No.: 2
Date: 13 Jun 2015
J.N.: 252441
Braille: 
N/A
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1222613 IE TA
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

Summary of Product characteristics

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 film-coated 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 tablets.
Pink, ovaloid shaped, beveled edge tablet, imprinted with NVR on one
side and HIL on the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of essential hypertension in adults.
Co-Diovan fixed-dose combination is indicated in patients whose blood
pressure is not adequately controlled on
valsartan or hydrochlorothiazide monotherapy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Posology_
The recommended dose of Co-Diovan is one film-coated tablet once
daily. Dose titration with the individual
components is recommended. In each case, up-titration of individual
components to the next dose should be followed
in order to reduce the risk of hypotension and other adverse events.
When clinically appropriate direct change from monotherapy to the
fixed combination may be considered in patients
whose blood pressure is not adequately controlled on valsartan or
hydrochlorothiazide monotherapy, provided the
recommended dose titration sequence for the individual components is
followed.
The clinical response to Co-Diovan should be evaluated after
initiating therapy and if blood pressure remains
uncontrolled, the dose may be increased by increasing either one of
the components to a maximum dose of Co-Diovan
320 mg/25 mg.
The antihypertensive effect is substantially present within 2 weeks.
In most patients, maximal effects are observed within 4 weeks.
However, in some patients 4
-
8 weeks treatment may be
required. This should be taken into account during dose titration.
_Method of administration_
Co-Diovan can be taken with or without food and should be administered
with water.
_Special populations_
_Patients with Renal impairment_
No dose adjustment is required for patients with