CO-DIOVAN 16012.5 MG FILM-COATED TABLETS

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

HYDROCHLOROTHIAZIDE; VALSARTAN

Available from:

NOVARTIS ISRAEL LTD

ATC code:

C09DA03

Pharmaceutical form:

FILM COATED TABLETS

Composition:

VALSARTAN 160 MG; HYDROCHLOROTHIAZIDE 12.5 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

NOVARTIS FARMA S.P.A., ITALY

Therapeutic group:

VALSARTAN AND DIURETICS

Therapeutic area:

VALSARTAN AND DIURETICS

Therapeutic indications:

Co-diovan is indicated for the treatment of hypertension in patients whose blood pressure is not adequately controlled by monotherapy. This fixed combination should be used as second-line therapy.

Authorization date:

2023-04-30

Patient Information leaflet

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed with a doctor’s prescription only
CO-DIOVAN 80/12.5 MG
FILM-COATED TABLETS
Each tablet contains:
Valsartan 80 mg
Hydrochlorothiazide 12.5 mg
CO-DIOVAN 160/12.5 MG
FILM-COATED TABLETS
Each tablet contains:
Valsartan 160 mg
Hydrochlorothiazide 12.5 mg
CO-DIOVAN 160/25 MG
FILM-COATED TABLETS
Each tablet contains:
Valsartan 160 mg
Hydrochlorothiazide 25 mg
INACTIVE INGREDIENTS: See section 6 ”Further Information”.
READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING
THE MEDICINE. This leaflet contains concise information about
the medicine. If you have further questions, refer to the doctor
or pharmacist.
This medicine has been prescribed for the treatment of your
ailment. Do not pass it on to others. It may harm them, even if
it seems to you that their ailment is similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
For the treatment of hypertension in patients who need
combined treatment with two active ingredients.
THERAPEUTIC GROUP:
A combination of angiotensin II receptor antagonist with a
thiazide diuretic.
Co-Diovan contains two active ingredients, called Valsartan and
Hydrochlorothiazide. These two ingredients help to control high
blood pressure (hypertension).
∙ VALSARTAN belongs to a class of medicines known as
“angiotensin II receptor antagonists” (acting to block
the receptor), which help to control high blood pressure.
Angiotensin II is a substance in the body that causes blood
vessels to contract, thus causing the blood pressure to
increase. Valsartan blocks the effect of angiotensin II. As a
result, blood vessels relax and blood pressure is lowered.
∙ HYDROCHLOROTHIAZIDE belongs to a class of medicines called
thiazide diuretics. Hydrochlorothiazide increases urine output,
which helps to lower blood pressure.
Co-Diovan is used to treat high blood pressure which is not
adequately controlled by a single ingredient alone.
Hypertension increases the workload of the heart and art

Summary of Product characteristics

CO-DIO API APR22 V1
Page
1
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Sweden SmPC 03.2022
1.
NAME OF THE MEDICINAL PRODUCT
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
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
CO-DIOVAN
®
80 mg/12.5 mg each film-coated tablet contains 80 mg of valsartan and
12.5 mg of
hydrochlorothiazide.
CO-DIOVAN
®
160 mg/12.5 mg each film-coated tablet contains 160 mg of valsartan
and 12.5 mg of
hydrochlorothiazide
CO-DIOVAN
®
160 mg/25 mg each film-coated tablet contains 160 mg of valsartan and
25 mg of
hydrochlorothiazide.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets.
CO-DIOVAN
®
80 mg/12.5 mg: Light orange, ovaloid tablet imprinted with HGH on one
side and CG
on the other side.
CO-DIOVAN
®
160 mg/12.5 mg: Dark red, ovaloid tablet imprinted with HHH on one
side and CG on
the other side.
CO-DIOVAN
®
160 mg/25 mg: Brown, ovaloid tablet imprinted with HXH on one side and
NVR on
the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Co-Diovan
®
80mg/12.5mg is indicated for the treatment of hypertension for
patients in whom
combination therapy is appropriate.
Co-Diovan 160mg/12.5mg, 160mg/25mg is indicated for the treatment of
hypertension in patients
whose blood pressure is not adequately controlled by monotherapy.
These fixed dose combinations
should be used as second-line therapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The recommended dose of Co-Diovan is 1 coated tablet per day. When
clinically appropriate either 80
mg valsartan and 12.5 mg hydrochlorothiazide or 160 mg valsartan and
12.5 mg hydrochlorothiazide
may be used. When necessary 160 mg valsartan and 25 mg may be used.
The maximum daily dose is
320 mg/25 mg. The maximum antihypertensive effect is seen within 2 to
4 weeks. Co-Diovan must
not be used in combination with aliskiren in patients with diabetes
mellitus.
_RENAL IMPAIRMENT _
No dosage adjustment is required for patients with mild to moderate
rena