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

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Valsartan; Hydrochlorothiazide

Available from:

Novartis Ireland Limited

ATC code:

C09DA; C09DA03

INN (International Name):

Valsartan; Hydrochlorothiazide

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:

Marketed

Authorization date:

1998-12-10

Patient Information leaflet

1
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 increases the workload

Summary of Product characteristics

Health Products Regulatory Authority
22 March 2022
CRN00CT4W
Page 1 of 15
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 tablets.
Light orange, ovaloid tablet imprinted with HGH on one side and CG 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 impa