Diovan 80mg Film-coated Tablet

Riik: Malaisia

keel: inglise

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

Toimeaine:

VALSARTAN

Saadav alates:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN (Rahvusvaheline Nimetus):

VALSARTAN

Ühikuid pakis:

28Tablet Tablets; 14Tablet Tablets; 7Tablet Tablets

Valmistatud:

NOVARTIS FARMACEUTICA S.A.

Infovoldik

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ DIOVAN
®
FILM-COATED TABLET
Valsartan (40mg, 80mg, 160mg and 320mg)
_ _
1
WHAT IS IN THIS LEAFLET
1.
WHAT DIOVAN IS USED FOR
2.
HOW DIOVAN WORKS
3.
BEFORE YOU USE DIOVAN
4.
HOW TO USE DIOVAN
5.
WHILE YOU ARE USING DIOVAN
6.
SIDE EFFECTS
7.
STORAGE AND DISPOSAL OF DIOVAN
8.
PRODUCT DESCRIPTION
9.
MANUFACTURER AND PRODUCT
REGISTRATION HOLDER
10.
DATE OF REVISION
WHAT DIOVAN IS USED FOR
Diovan is used to treat high blood
pressure in adults. High blood
pressure increases the workload of
the heart and arteries. If it continues
for a long time, it can damage the
blood vessels of the brain, heart, and
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.
Diovan is used to treat adult heart
failure patients. Heart failure is
associated with shortness of breath,
and swelling of the feet and legs due
to fluid build-up. Heart failure means
that the heart muscle cannot pump
blood strongly enough to supply all
the blood needed throughout the
body.
Diovan can also be used to treat
adults after a heart attack (myocardial
infarction) to improve survival and
reduce further heart problems.
HOW DIOVAN WORKS
Angiotensin II is a natural substance
in the body that causes blood vessels
to tighten, thus causing your blood
pressure to increase. Diovan works
by blocking the effect of angiotensin
II. As a result, blood vessels relax and
blood pressure is lowered.
If you have any question about how
Diovan works or why this medicine
has been prescribed for you, ask your
doctor.
BEFORE YOU USE DIOVAN
Follow all the doctor’s instructions
carefully. They may differ from the
general information contained in this
leaflet.
_-When you must not use it _

If you have ever had an unusual or
allergic reaction to valsartan or to
any
other
ingredients
of
this
product listed at the end of this
leaflet.

If you are pregnant or planning to
b

Toote omadused

Regulatory Affairs
DIOVAN

(VALSARTAN)
40 mg, 80 mg, 160 mg, 320 mg Film-coated tablets
MALAYSIA PACKAGE LEAFLET (SEP 2018)
(
Without Hypertensive patients with Impaired Glucose Tolerance
Indication
,
Paediatric Indication & Oral Solution
)
IPL Author:
Sravanthi Diddi
CDS Author:
Sriram Narayanan
GLC approval:
10-Apr-2018
Effective date:
10-Sep-2018
Safety Label
Change (SLC)
Tracking number:
Not Applicable
Document status:
Final
Number of pages:
17
Novartis
Page 2
Malaysia Package Leaflet
10-Sep-2018
Diovan film-coated tablets
DIOVAN

Angiotensin II antagonist
DESCRIPTION AND
COMPOSITION
PHARMACEUTICAL FORM
FILM-COATED TABLET (FCT)
Diovan 40 mg: Yellow, ovaloid with bevelled edges, scored on one side;
with debossing
“DO” on the scored side and “NVR” on the other side. The score
line on one side of Diovan
40mg FCT is to divide the tablet into equal doses.
Diovan 80 mg: Pale red, round with bevelled edges, scored on one side;
with debossing
“D/V” on the scored side and “NVR” on the other side.
Diovan 160 mg: Grey-orange, ovaloid, scored on one side; with
debossing “DX/DX” on the
scored side and “NVR” on the other side.
Diovan 320 mg: Dark grey-violet, ovaloid with bevelled edges with
debossing “DXL” on one
side and “NVR” on the other side.
The score line on one side of Diovan 80mg, 160mg or 320mg FCT is only
to facilitate
breaking for ease of swallowing and not to divide into equal doses.
Appearance of tablets may differ between countries. Certain dosage
strengths may not be
available in all countries.
ACTIVE SUBSTANCE
One tablet contains 40 mg, 80 mg, 160 mg or 320 mg
of
valsartan
.
EXCIPIENTS
TABLETS
: microcrystalline cellulose, crospovidone, colloidal anhydrous
silica, magnesium
stearate, hypromellose, titanium dioxide (E171), macrogol 8000, red
iron oxide (E172),
yellow iron oxide (E172), black iron oxide (E172; 40 mg, 160 mg and
320 mg tablets only),
brown iron oxide (mixture of red iron oxide and black iron oxide (320
mg tablets only).
Pharmaceutical formulations may var