EXFORGE 10MG160MG FILM-COATED TABLET

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

VALSARTAN; AMLODIPINE BESYLATE

Boleh didapati daripada:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

VALSARTAN; AMLODIPINE BESYLATE

Unit dalam pakej:

7Tablet Tablets; 28Tablet Tablets; 14Tablet Tablets

Dikeluarkan oleh:

NOVARTIS FARMA S.P.A.

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP)_
EXFORGE
®
FILM-COATED TABLET
amlodipine besylate/valsartan
5/80 mg, 5/160mg, and 10/160mg
1
WHAT IS IN THIS LEAFLET
1.
WHAT EXFORGE IS USED FOR
2.
HOW EXFORGE WORKS
3.
BEFORE YOU TAKE EXFORGE
4.
HOW TO TAKE EXFORGE
5.
WHILE USING EXFORGE
6.
SIDE EFFECTS
7.
STORAGE AND DISPOSAL OF EXFORGE
8.
PRODUCT DESCRIPTION
9.
MANUFACTURER
AND
PRODUCT
REGISTRATION HOLDER
10.
DATE OF REVISION
11.
SERIAL NUMBER
WHAT EXFORGE IS USED FOR
Your medicine is called Exforge and is
available as a film-coated tablet.
Exforge
contains
amlodipine,
a
medicine that belongs to the class of
calcium
antagonists
and
valsartan,
which
belongs
to
angiotensin-II
receptor antagonists. They both help to
control high blood pressure.
Exforge is indicated to treat high blood
pressure
which
is
not
adequately
controlled by a single drug.
HOW EXFORGE WORKS
Amlodipine blocks calcium channels
at the blood vessels. Angiotensin II is a
natural
substance
produced
by
the
body
that
causes
blood
vessels
to
tighten,
thus
increasing
the
blood
pressure. Valsartan works by blocking
the effect of angiotensin II. As a result
of
both
mechanisms,
blood
vessels
relax and blood pressure is lowered.
If you have any questions about how
Exforge works or why this medicine
has been prescribed for you, ask your
doctor.
BEFORE YOU USE EXFORGE
Follow
your
doctor’s
instructions
carefully. They may differ from the
general instructions in this leaflet.
_When you must not use it _
•
If you have ever had an unusual or
allergic
reaction
to
amlodipine
besylate or valsartan or to any other
ingredients of this product listed at
the end of this leaflet. If you think
you may be allergic, ask your doctor
for advice.
•
If you are pregnant or planning to
become pregnant.
•
If you have high level of sugar in the
blood and you are suffering from
type 2 diabetes (also called non-
insulin dependent diabetes mellitus)
while
you
are
taking
a
blood
pressure lowering medicine called
aliskiren
•
If you have severe liver impairment;
biliary
cirrh

Ciri produk

Novartis
Page 2
Malaysia Package Leaflet
10-Sep-2018
Exforge
EXFORGE

Angiotensin
II
antagonists
combinations
(valsartan)
with
dihydropyridine
derivatives
(amlodipine)
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORM
Film-coated tablets.
ACTIVE SUBSTANCES:
Amlodipine besylate
Valsartan
Three strengths are available. One tablet of Exforge contains:
•
5 mg of amlodipine (as amlodipine besylate) and 80 mg of valsartan,
dark yellow, round
shaped film-coated tablet with bevelled edge, debossed with “NVR”
on one side and
“NV” on the reverse side.
•
5 mg of amlodipine (as amlodipine besylate) and 160 mg of valsartan,
dark yellow,
ovaloid shaped film-coated tablet with bevelled edge, debossed with
“NVR” on one side
and “ECE” on the reverse side.
•
10 mg of amlodipine (as amlodipine besylate) and 160 mg of valsartan,
light yellow,
ovaloid shaped film-coated tablet with bevelled edge, debossed with
“NVR” on one side
and “UIC” on the reverse side.
Exforge FCT are non-divisible and cannot be divided into equal doses.
Certain dosage strengths may not be available in all countries.
EXCIPIENTS
5/80 mg: Cellulose microcrystalline; crospovidone; silica, colloidal
anhydrous; magnesium
stearate; hypromellose, macrogol 4000, talc, titanium dioxide (E171),
iron oxide, yellow
(E172)
5/160 mg: Cellulose microcrystalline; crospovidone; silica, colloidal
anhydrous; magnesium
stearate; hypromellose, macrogol 4000, talc, titanium dioxide (E171),
iron oxide, yellow
(E172)
10/160 mg: Cellulose microcrystalline; crospovidone; silica, colloidal
anhydrous, magnesium
stearate, hypromellose, macrogol 4000, talc, titanium dioxide (E171),
iron oxide, yellow
(E172), iron oxide, red (E172)
Pharmaceutical formulations may vary between countries.
INDICATIONS
Treatment of essential hypertension.
Novartis
Page 3
Malaysia Package Leaflet
10-Sep-2018
Exforge
Exforge is indicated in patients whose blood pressure is not
adequately controlled by
monotherapy.
Exforge is indicated for the initial treatment of hypertension. The
ch