EFEXOR XR 150MG CAPSULE

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

VENLAFAXINE HYDROCHLORIDE

Boleh didapati daripada:

VIATRIS SDN. BHD.

INN (Nama Antarabangsa):

VENLAFAXINE HYDROCHLORIDE

Unit dalam pakej:

28Capsule Capsules; 14 Capsule Capsules

Dikeluarkan oleh:

PFIZER IRELAND PHARMACEUTICALS

Risalah maklumat

_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 EFEXOR XR is 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 EFEXOR XR IS 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 concerned, contact y

Ciri produk

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 hydrochloride
equivalent to 37.5 mg
venlafaxine.
EFEXOR
®
XR 75 MG
Each
extended-release
capsule
contains
venlafaxine
hydrochloride
equivalent
to
75 mg
venlafaxine.
EFEXOR
®
XR 150 MG
Each extended-release capsule contains venlafaxine hydrochloride
equivalent to 150 mg
venlafaxine.
3. PHARMACEUTICAL FORM
EFEXOR
®
XR 37.5 MG
Hard gelatin capsule,
opaque light grey cap and opaque peach body branded with a flying
“W” on the cap and “37.5” on the body with red ink, containing
white to off-white spheroids
of about 1 mm in diameter.
EFEXOR
®
XR 75 MG
Hard gelatin capsule, opaque light peach cap and body branded with a
flying “W” on the cap
and “75” on the body in red ink,
containing white to off-white spheroids of about 1 mm in
diameter.
EFEXOR
®
XR 150 MG
Elongated hard gelatin capsule, opaque dark orange cap and body
branded with flying “W”
on cap and ‘150’ on body in white ink containing white to
off-white spheroids of about 1 mm
in diameter.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATION
Venlafaxine is indicated for the treatment of depression, 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 up to
6 months in controlled clinical trials.
For prevention of relapse of an episode of depression or for
prevention of the recurrence of
new depressive episodes.
2
Venlafaxine is indicated for the treatment of Social Anxiety Disorder,
also known as Social
Phobia, as defined in DSM-IV.
Social Anxiety Disorder (DSM-IV) is characterized by a marked and
persistent fear of one or
more social or performance situations in which the person is exposed
to unfamiliar people or
to possible scrutiny by others. Exposure to the feared situation
al