VENLA RBX venlafaxine (as hydrochloride) 150 mg modified release capsule blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
14-02-2017
Summary of Product characteristics
(SPC)
14-02-2017
Public Assessment Report
(PAR)
27-11-2017
Active ingredient:
Venlafaxine hydrochloride
Available from:
Sun Pharma ANZ Pty Ltd
INN (International Name):
Venlafaxine hydrochloride
Patient Information leaflet
VENLA RBX CMI V5 Aug 2013
Page 1 of 13
VENLA RBX
VENLAFAXINE MODIFIED RELEASE CAPSULES
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about VENLA RBX
(venlafaxine
hydrochloride) modified release capsules.
It does not contain all the available information.
It does not take the place of talking to your doctor or pharmacist.
This leaflet was last updated on the date at the end of this leaflet.
More recent information may be available. The latest Consumer Medicine
Information is available from
https://www.ebs.tga.gov.au/ and may
contain important information about the medicine and its use of which
you should be aware.
All medicines have risks and benefits. Your doctor has weighed the
risks of you taking VENLA RBX against the benefits it is expected to
have for you.
IF YOU HAVE ANY CONCERNS ABOUT USING/TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THIS MEDICINE.
You may need to read it again.
WHAT VENLA RBX IS USED FOR
VENLA
RBX
contains
the
active
ingredient
venlafaxine
(as
hydrochloride).
VENLA RBX is used for the treatment and prevention of relapse of
depression, and for the treatment of panic attacks and anxiety,
including avoidance or fear of social situations.
Depression can affect your whole body and may cause emotional and
physical symptoms such as feeling low in spirit, being unable to enjoy
life, poor appetite or overeating, disturbed sleep, loss of sex drive,
lack of energy and feeling guilty over nothing.
Excessive anxiety is a condition in which you feel constantly and
uncontrollably worried and distressed. It may also make you feel
irritable, and cause difficulty in thinking and sleeping. Other common
symptoms associated with anxiety may include a dry mouth, a lump in
the
throat, cold clammy hands, diarrhoea and nausea.
VENLA RBX CMI V5 Aug 2013
Page 2 of 13
Depression and anxiety are treatable illnesses. Anxiety or tension
associated with the normal stress of everyday life usually does not
require treatment with medicines.
V
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Summary of Product characteristics
VENLA RBX PI V6
Page 1 of 28
VENLA RBX
VENLAFAXINE MODIFIED RELEASE CAPSULES
NAME OF THE MEDICINE
Venlafaxine hydrochloride
Structural formula:
Molecular formula: C
17
H
27
NO
2
HCl_ _
Molecular weight: 313.87
Chemical structure:
(_R/S_)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol
hydrochloride or (±)-1-[α-[(dimethyl-amino)methyl]-p-methoxybenzyl]
cyclohexanol hydrochloride
CAS Number: 93413 – 69 -5 (venlafaxine)
99300-78-4 (venlafaxine hydrochloride)
DESCRIPTION
VENLA
RBX
modified
release
capsules
are
a
structurally
novel
antidepressant
for
oral
administration.
Each
capsule
of
VENLA
RBX
contains
37.5
mg,
75
mg
or
150
mg
of
venlafaxine
(as
hydrochloride).
VENLA RBX modified release capsules contain the following inactive
ingredients: microcrystalline
cellulose, povidone, purified talc, colloidal anhydrous silica,
magnesium stearate, ethylcellulose,
copovidone, gelatin and titanium dioxide. In addition to these, the
37.5 mg capsules also contain
iron oxide black, iron oxide red, iron oxide yellow and TekPrint
SB-1033 Red Ink (proprietary
ingredient # 106948), the 75 mg capsules also contain iron oxide
black, iron oxide red and TekPrint
SB-1033 Red Ink (proprietary ingredient # 106948), and the 150 mg
capsules also contain Brilliant
Blue FCF, Allura Red AC, Sunset Yellow FCF and TekPrint SB-0007P White
Ink (proprietary
ingredient # 2216).
PHARMACOLOGY
VENLA RBX PI V6
Page 2 of 28
PHARMACODYNAMIC PROPERTIES
Venlafaxine is a structurally novel antidepressant for oral
administration; it is chemically unrelated
to tricyclic, tetracyclic, or other available antidepressant agents.
The
antidepressant
action
of
venlafaxine
in
humans
is
believed
to
be
associated
with
its
potentiation of neurotransmitter activity in the central nervous
system. Preclinical studies have
shown that venlafaxine and its major metabolite, _
O_-desmethylvenlafaxine (ODV), are potent
inhibitors of serotonin and noradrenaline reuptake, and also weakly
inhibit dopamine reuptake.
Venlafaxine is a racemate. The _R_-enantiomer is rela
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