EFEXOR XR 75MG CAPSULE

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

VENLAFAXINE HYDROCHLORIDE

Boleh didapati daripada:

UPJOHN (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

VENLAFAXINE HYDROCHLORIDE

Unit dalam pakej:

28Capsule Capsules; 14 Capsule Capsules

Dikeluarkan oleh:

PFIZER IRELAND PHARMACEUTICALS

Risalah maklumat

Pfizer Confidential
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
EFEXOR
®
XR CAPSULE
Venlafaxine hydrochloride (37.5 mg, 75 mg, 150 mg)
2
WHAT IS IN THIS LEAFLET
1.
What is EFEXOR XR used for
2.
How EFEXOR XR works
3.
Before you use EFEXOR XR
4.
How to use EFEXOR XR
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of EFEXOR
XR
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
11.
Serial Number
WHAT IS EFEXOR XR USED FOR
EFEXOR XR is an antidepressant.
EFEXOR XR capsules are given to
people suffering from depression,
anxiety disorders or panic disorder.
HOW EFEXOR XR WORKS
EFEXOR XR belongs to a group of
medicines called serotonin and
norepinephrine reuptake inhibitors
(SNRIs). Serotonin and noradrenaline are
chemical messengers that allow certain
nerves in the brain to work. It is thought
that people who are depressed and/or
anxious may have lower levels of
serotonin and noradrenaline in the brain.
It is not fully understood how
antidepressants work, but they may help
by increasing the levels of serotonin and
noradrenaline in the brain.
BEFORE YOU USE EFEXOR XR
-
_When you must not use it_
-
If you are allergic to venlafaxine or
to any of the other ingredients in
EFEXOR XR capsules
-
If you are also taking, or have taken
within the last 14 days, any
medicines known as irreversible
monoamine oxidase inhibitors
(MAOIs) used to treat depression or
Parkinson’s disease (a progressive
movement disorder). Also, you must
wait at least 7 days after you stop
taking EFEXOR XR before you take
any MAOI
_Pregnancy and lactation_
Tell your doctor if you become
pregnant, or you are trying to become
pregnant. You should use EFEXOR
XR only after discussing the potential
benefits and the potential risks to your
unborn child with your doctor.
If you are taking this medicine during
pregnancy, the baby born might
experience some symptoms like not
feeding properly,, in addition to having
breathing difficulties. If your baby has
these symptoms when it is born and
you are

Ciri produk

Pfizer Confidential
1
1. NAME OF THE MEDICINAL PRODUCT
Efexor ®XR capsule
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Efexor ®XR 37.5 mg
Each
extended -release
capsule
contains
venlafaxine
hy
drochloride
equivalent
to
37.5 mg
venlafaxine.
Efexor ®XR 75 mg
Each
extended -release
capsule
contains
venlafaxine
hy
drochloride
equivalent
to
75 mg
venlafaxine.
Efexor ®XR 150 mg
Each
extended -release
capsule
contains
venlafaxine
hy
drochloride
equivalent
to
150 mg
venlafaxine.
3. PHARM ACEUTICAL FORM
Efexor ®XR 37.5 mg
Hard
gelatin
capsule, opaque
lig ht
grey c
ap
and
opaque
peach
body branded
with
a
fly
ing
“W ”
on
the
cap
and
“37.5”
on
the
body w
ith
red ink,
containing
white
to
off -white
spheroids
of about 1 mm in dia meter.
Efexor ®XR 7 5mg
Hard
gelatin
ca psule,
opaque
lig htpeach
cap
and
body br
anded
with
a
fl
ying
“ W ”
on
the
cap
and
“75”
on
the
body i
n
red
ink, containing
white
to
off -white
spheroids
of
about
1 mm
in
dia meter.
Efexor ®XR 150 mg
Elongated
hard
gelatin
capsule,
opaque
da rk
orange
cap
and
body b
randed
with
fly
ing
“ W ”
on cap and ‘150’ on body in white ink containing white to o ff-white
spheroids
of
about
1 mm
in dia meter.
4. CLINICAL PARTICULARS
4.1 Therapeutic Indication
Venlafaxine
is indicated for the treatment of dep ression, including depression with associated
anxiety
, in hospitalized patients.
Treatment of anxiety or Generalized Anxiety Disorder (GAD), including long -term treatment.
The
effectiveness
of
Venlafaxine
in
long
term
use
for
GAD
has
been
evaluated
for
u p to
6months in controlled clinical trials.
For
prevention
of
relapse
of
an
episode
of
depression
or
for
prevention
of
the
recurrence
of
new depressive episodes.