Co-Diovan 160/12.5mg Film-coated Tablet

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

HYDROCHLOROTHIAZIDE; VALSARTAN

Boleh didapati daripada:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

HYDROCHLOROTHIAZIDE; VALSARTAN

Unit dalam pakej:

28Tablet Tablets; 7Tablet Tablets; 14Tablet Tablets

Dikeluarkan oleh:

NOVARTIS FARMA S.P.A.

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP)_
CO-DIOVAN
®
FILM-COATED TABLET
Valsartan/Hydrochlorothiazide(80/12.5 mg, 160/12.5 mg, 160/25mg)
_ _
1
WHAT IS IN THIS LEAFLET
1.
What Co-Diovan is used for
2.
How Co-Diovan works
3.
Before you use Co-Diovan
4.
How to use Co-Diovan
5.
While you are using Co-Diovan
6.
Side effects
7.
Storage and Disposal of Co-Diovan
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT CO-DIOVAN IS USED FOR
Co-Diovan contains an angiotensin-II
receptor antagonist and a diuretic, which
help control high blood pressure.
Co-Diovan is used to treat high blood
pressure. High blood pressure increases
the workload of the heart and arteries
(blood vessels). If it continues for a long
time, it can damage the blood vessels of
the brain, heart, kidneys, and may result
in a stroke, heart failure, or kidney
failure. High blood pressure increases the
risk of heart attacks. Lowering your
blood pressure to normal reduces the risk
of developing these disorders.
HOW CO-DIOVAN WORKS
Angiotensin II is a natural substance in
the body that causes blood vessels to
tighten, thus causing your blood pressure
to increase. Valsartan in Co-Diovan
blocks the effect of angiotensin II. As a
result, blood vessels relax and blood
pressure is lowered.
Diuretics reduce the amount of salt and
water in the body by increasing the flow
of urine. With longer use this helps to
reduce and control blood pressure.
If you have any questions about how Co-
Diovan works or why this medicine has
been prescribed for you, ask your doctor.
BEFORE YOU USE CO-DIOVAN
You may take Co-Diovan only after a
medical examination. Co-Diovan may not
be suitable for all patients. Follow your
doctor’s instructions carefully. They may
differ from the general information
contained in this leaflet.
_When you must not use it _
•
If you have had any unusual or
allergic reaction to valsartan or to
hydrochlorothiazide or sulfonamides
or to any other component of this
product listed at the end of this
leafle

Ciri produk

Novartis
Page 2
Malaysia Package Leaflet
01-Feb-2021
Co-Diovan
®
CO-DIOVAN

Angiotensin II antagonists combination (valsartan) with diuretics
(hydrochlorothiazide)
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORM
Film-coated tablets (FCT) 80/12.5 mg, 160/12.5 mg, 160/25 mg
Co-Diovan 80/12.5 mg: Ovaloid slightly convex, non-divisible,
film-coated tablets measuring
approximately
10.2 mm
in
length
and
approximately
5.4 mm
in
width,
and
weighing
approximately 156 mg. The tablets are colored light orange and
debossed “HGH” on one side
and “CG” on the other side.
Co-Diovan
160/12.5 mg:
Ovaloid
slightly
convex,
non-divisible,
film-coated
tablets
measuring
approximately
15.2 mm
in
length
and
approximately
6.2 mm
in
width,
and
weighing approximately 312 mg. The tablets are colored dark red and
debossed “HHH” on
one side and “CG” on the other side.
Co-Diovan 160/25 mg: Ovaloid slightly convex, non-divisible,
film-coated tablets measuring
approximately 14.2
mm
in
length and
approximately
5.7
mm
in
width,
and weighing
approximately 310 mg. The tablets are colored brown-orange and
debossed “HXH” on one
side and “NVR” on the other side.
Co-Diovan FCT cannot be divided into equal doses.
ACTIVE SUBSTANCES
One tablet contains 80 mg valsartan and 12.5 mg hydrochlorothiazide,
or 160 mg valsartan
and 12.5 mg hydrochlorothiazide, or 160 mg valsartan and 25 mg
hydrochlorothiazide
Certain dosage strengths and dosage forms may not be available in all
countries.
EXCIPIENTS
Co-Diovan
80/12.5 mg:
Colloidal
silicon
dioxide;
crospovidone;
hydroxypropyl
methylcellulose; magnesium stearate; microcrystalline cellulose;
polyethylene glycol; talc;
titanium dioxide (E171); red iron oxide (E172); yellow iron oxide
(E172).
Co-Diovan
160/12.5 mg:
Colloidal
silicon
dioxide;
crospovidone;
hydroxypropyl-
methylcellulose; magnesium stearate; microcrystalline cellulose;
polyethylene glycol; talc;
titanium dioxide (E171); red iron oxide (E172).
Co-Diovan
160/25 mg:
Colloidal
silicon
dioxide;
crospovidone;
hydroxypropyl
methylcell