BINOVEN-ER 37.5 (Venlafaxine Extended Release Capsules 37.5 mg)

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

VENLAFAXINE HYDROCHLORIDE

Boleh didapati daripada:

UNIMED SDN BHD

INN (Nama Antarabangsa):

VENLAFAXINE HYDROCHLORIDE

Unit dalam pakej:

3 X 10 Capsules

Dikeluarkan oleh:

Aurobindo Pharma Limited (Unit III),

Risalah maklumat

BINOVEN-ER CAPSULES
®
Venlafaxine Extended Release Capsules (37.5 mg, 75 mg & 150 mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What BINOVEN-ER is used for
2.
How BINOVEN-ER works
3.
Before you use BINOVEN-ER
4.
How to use BINOVEN-ER
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of BINOVEN-
ER
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT BINOVEN-ER
IS USED FOR?
BINOVEN-ER is used in the treatment
and prevention of relapse of depression.
It is also used in the treatment of
generalized anxiety disorder (generally
feeling very anxious or nervous, even
when there is little or no reason to worry
about them) and social anxiety disorder /
social phobia (fear or avoidance of social
situations).
HOW BINOVEN-ER WORKS
BINOVEN-ER contains the active
substance venlafaxine hydrochloride
which is an antidepressant that belongs
to a group called selective serotonin and
noradrenaline reuptake inhibitor (SNRI).
It is thought that people who are
depressed 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 BINOVEN-ER
-
_When you must not use it? _
DO NOT TAKE BINOVEN-ER CAPSULE IF;
• If you are allergic to venlafaxine or any
of the other ingredients of this medicine.
• 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.
Taking an irreversible MAOI together
with BINOVEN-ER, can cause serious
or even life-threatening side effects.
Also, you must wait at least 7 days after
you stop taking BINOVEN-ER before
you take any MAOI (see also the section
entitled “medicines and
BINOVEN-ER” and the information in
that section about 'Serotonin Syndrome').
-
_Before you start use it _
CONSULT YOUR DOCTOR OR PHARMACIST IF;
• If you us

Ciri produk

DESCRIPTION AND COMPOSITION:
BINOVEN-ER 37.5(Venlafaxine Extended Release Capsules
37.5 mg);
White to off white spherical to oval pellets filled in Empty hard
gelatin capsule shell (size ‘3’) of Opaque Grey color cap and
Opaque Peach color body imprinted with “E” on cap and “73”
on the body with edible black ink.
Each
extended-
release
capsule
contains
Venlafaxine
hydrochloride Ph. Eur. equivalent to 37.5 mg Venlafaxine.
BINOVEN-ER 75 (Venlafaxine Extended Release Capsules
75 mg):
White to off white spherical to oval pellets filled in Empty hard
gelatin capsule shell (size ‘1’) of Opaque Peach color cap and
Opaque Peach color body imprinted with “E” on cap and “74”
on the body with edible black ink.
Each
extended-
release
capsule
contains
Venlafaxine
hydrochloride Ph. Eur. equivalent to 75 mg Venlafaxine.
BINOVEN-ER 150 (Venlafaxine Extended Release Capsules
150 mg)
White to off white spherical to oval pellets filled in Empty hard
gelatin capsule shell (size ‘0’) of Opaque Dark Orange color
cap and Opaque Dark Orange color body imprinted with “E” on
cap and “89” on the body with edible black ink.
Each
extended-
release
capsule
contains
Venlafaxine
hydrochloride Ph. Eur. equivalent to 150 mg Venlafaxine.
PHARMACODYNAMICS
Antidepressants
The mechanism of venlafaxine’s antidepressant action in
humans is believed to be associated with its potentiation
of neurotransmitter activity in the central nervous system.
Venlafaxine and its major metabolite, O-desmethyl venlafaxine
(ODV), are inhibitors of serotonin and noradrenaline reuptake.
Venlafaxine also weakly inhibits dopamine uptake. Venlafaxine
and its active metabolite reduce β-adrenergic responsiveness
after both acute (single dose) and chronic administration.
Venlafaxine and ODV are very similar with respect to their
overall
action
on
neurotransmitter
reuptake
and
receptor
binding. Venlafaxine has virtually no affinity for rat brain
muscarinic, cholinergic, H1- histaminergic or α1-adrenergic
receptors in vitro. Pharmacologica