CO-DIOVAN 320/12.5 mg valsartan 320 mg/hydrochlorothiazide 12.5 mg film-coated tablet blister pack

País: Australia

Idioma: inglés

Fuente: Department of Health (Therapeutic Goods Administration)

Ingredientes activos:

hydrochlorothiazide, Quantity: 12.5 mg; valsartan, Quantity: 320 mg

Disponible desde:

Novartis Pharmaceuticals Australia Pty Ltd

Designación común internacional (DCI):

Hydrochlorothiazide,Valsartan

formulario farmacéutico:

Tablet, film coated

Composición:

Excipient Ingredients: colloidal anhydrous silica; crospovidone; microcrystalline cellulose; magnesium stearate; hypromellose; purified talc; iron oxide red; macrogol 4000; iron oxide black; titanium dioxide

Vía de administración:

Oral

Unidades en paquete:

14, 56, 28

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

Co-Diovan is indicated for the treatment of hypertension. Treatment should not be initiated with these combinations.

Resumen del producto:

Visual Identification: pink, ovaloid shaped, bevelled-edge and imprinted with HIL on one side and NVR on the reverse side; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Estado de Autorización:

Licence status A

Fecha de autorización:

2008-05-22

Información para el usuario

CO-DIOVAN
®
_Valsartan/hydrochlorothiazide_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Co-Diovan.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
final page. More recent information
on the medicine may be available.
YOU SHOULD ENSURE THAT YOU SPEAK
TO YOUR PHARMACIST OR DOCTOR TO
OBTAIN THE MOST UP TO DATE
INFORMATION ON THE MEDICINE. YOU
CAN ALSO DOWNLOAD THE MOST UP TO
DATE LEAFLET FROM
WWW.NOVARTIS.COM.AU.
Those updates may contain important
information about the medicine and
its use of which you should be aware.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking this medicine
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT CO-DIOVAN IS
USED FOR
Co-Diovan is used to control high
blood pressure, also called
hypertension.
Everybody has blood pressure. This
pressure helps get your blood all
around your body.
Your blood pressure may be different
at different times of the day,
depending on how busy or worried
you are. You have hypertension (high
blood pressure) when your blood
pressure stays higher than is needed,
even when you are calm and relaxed.
High blood pressure increases the
workload of the heart and blood
vessels. If it continues for a long
time, it can damage the blood vessels
in the brain, heart and kidneys. This
can lead to stroke, heart failure or
kidney failure. High blood pressure
increases the risk of heart attacks.
Lowering your blood pressure
reduces the chance of these disorders
happening.
Co-Diovan contains valsartan and
hydrochlorothiazide. These
medicines reduce blood pressure in
two different ways.
1.
Valsartan blocks the effect of
angiotensin II, which is a
substance in the body that
tightens

Ficha técnica

1
AUSTRALIAN PRODUCT INFORMATION
CO-DIOVAN
 80/12.5
(VALSARTAN/HYDROCHLOROTHIAZIDE) FILM-COATED TABLET
CO-DIOVAN
 160/12.5
(VALSARTAN/HYDROCHLOROTHIAZIDE) FILM-COATED TABLET
CO-DIOVAN
 160/25
(VALSARTAN/HYDROCHLOROTHIAZIDE) FILM-COATED TABLET
CO-DIOVAN
 320/12.5
(VALSARTAN/HYDROCHLOROTHIAZIDE) FILM-COATED TABLET
CO-DIOVAN
 320/25
(VALSARTAN/HYDROCHLOROTHIAZIDE) FILM-COATED TABLET
1
NAME OF THE MEDICINE
Valsartan/hydrochlorothiazide.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Valsartan
[_N_-Pentanoyl-_N_-[2’-(1_H_-tetrazol-5-yl)biphenyl-4ylmethyl]-L-valine]
is a fine white powder
soluble in methanol, neutral and basic aqueous solutions, and very
slightly soluble in solutions with
pH < 7.
Hydrochlorothiazide
[6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide-1,1-dioxide]
is
structurally related to the thiazide group of diuretics. It is a white
or almost white powder.
Hydrochlorothiazide is very slightly soluble in water and freely
soluble in dimethylsulfoxide.
Co-Diovan 80/12.5 contains valsartan 80 mg and hydrochlorothiazide
12.5 mg; Co-Diovan 160/12.5
contains valsartan 160 mg and hydrochlorothiazide 12.5 mg; Co-Diovan
160/25 contains valsartan
160 mg and hydrochlorothiazide 25 mg; Co-Diovan 320/12.5 contains
valsartan 320 mg and
hydrochlorothiazide 12.5 mg; Co-Diovan 320/25 contains valsartan 320
mg and hydrochlorothiazide
25 mg.
Co-Diovan is available in five strengths: Co-Diovan 80/12.5, Co-Diovan
160/12.5, Co-Diovan 160/25,
Co-Diovan 320/12.5 and Co-Diovan 320/25.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Co-Diovan 80/12.5: Ovaloid, non-divisible, film-coated tablets
coloured light orange and imprinted
with HGH on one side and CG on the other side.
2
Co-Diovan 160/12.5: Ovaloid, non-divisible, film-coated tablets
coloured dark red and imprinted with
HHH on one side and CG on the other side.
Co-Diovan 160/25: Ovaloid, non-divisible, film-coated tablets coloured
brown-orange and imprinted
with HXH on one side and NVR on the other side.