Exforge 10/320mg Film-coated Tablet

Negara: Malaysia

Bahasa: Inggris

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

Bahan aktif:

AMLODIPINE BESYLATE; VALSARTAN

Tersedia dari:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN (Nama Internasional):

AMLODIPINE BESYLATE; VALSARTAN

Unit dalam paket:

14Tablet Tablets; 28Tablet Tablets; 7Tablet Tablets

Diproduksi oleh:

NOVARTIS PHARMA STEIN AG

Selebaran informasi

_Consumer Medication Information Leaflet (RiMUP)_
EXFORGE
®
FILM-COATED TABLET
amlodipine besylate/valsartan
5/80 mg, 5/160mg, 10/160mg, 5/320mg and 10/320mg
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 impairm

Karakteristik produk

Regulatory Affairs
EXFORGE ®
(amlodipine besylate /valsartan)
5 mg/80 mg, 5 mg/160 mg, 10 mg/160 mg ,
5 mg/320 mg and 10 mg/320 mg Film -coated tablets
Malaysia Package Leaflet (Sept 2018 )
IPL creator:
CDS Author:
GLC approval:
Kiran Kumar Chilipi
Sririam Narayanan
10 -Apr -2018
Release date: 10 -Sep -2018
Tracking Number: Not applicable
Document status: Final
Number of pages: 20