TERRY WHITE CHEMISTS VENLAFAXINE XR venlafaxine (as hydrochloride) 75mg modified release capsule blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
01-12-2017
Summary of Product characteristics
(SPC)
01-12-2017
Public Assessment Report
(PAR)
29-11-2017
Active ingredient:
venlafaxine hydrochloride
Available from:
Apotex Pty Ltd
INN (International Name):
Venlafaxine hydrochloride
Authorization status:
Registered
Patient Information leaflet
TERRY WHITE CHEMISTS
VENLAFAXINE XR
CAPSULES
_Contains the active ingredient venlafaxine (as venlafaxine
hydrochloride)_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE.
This leaflet answers some common
questions about venlafaxine. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
last page. More recent information on
this medicine may be available.
ASK YOUR DOCTOR OR PHARMACIST:
•
if there is anything you do not
understand in this leaflet,
•
if you are worried about taking
your medicine, or
•
to obtain the most up-to-date
information.
You can also download the most up
to date leaflet from
www.apotex.com.au.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will have for you.
Pharmaceutical companies cannot
give you medical advice or an
individual diagnosis.
Keep this leaflet with your medicine.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is Terry
White Chemists Venlafaxine XR
Capsules. It contains the active
ingredient venlafaxine (as
venlafaxine hydrochloride).
It is used to treat major depression,
and to prevent it coming back. It is
also used in the treatment of panic
attacks and anxiety, including
avoidance or fear of social situations.
_HOW IT WORKS_
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 associat
Read the complete document
Summary of Product characteristics
Product Information – Australia
Terry White chemists Venlafaxine XR Modified Release Capsules
Page 1
TERRY WHITE CHEMISTS VENLAFAXINE XR CAPSULES
NAME OF THE MEDICINE
Venlafaxine hydrochloride
Chemical name:
1-[(1RS)-2-(Dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol
hydrochloride
Structural Formula:
Molecular Formula:
C
17
H
27
NO
2
.HCl
Molecular Weight:
313.87
CAS Registry Number:
99300-78-4
DESCRIPTION
Venlafaxine hydrochloride is a white to off white crystalline solid
with a solubility of 572 mg/mL in water
(adjusted to ionic strength of 0.2 M with sodium chloride).
Venlafaxine XR capsules are a modified release formulation, which
release the active constituent
venlafaxine hydrochloride from a tablet or tablets within the capsule.
Drug is released by a combination
of swelling of the hydrophilic polymer (hypromellose), diffusion and
erosion.
Each modified release capsule contains venlafaxine 75 mg (as 84.86 mg
venlafaxine hydrochloride) as
the active ingredient. In addition, each capsule contains the
following inactive ingredients: hypromellose,
sodium lauryl sulfate, magnesium stearate, ammonio methacrylate
copolymer and basic butylated
methacrylate copolymer. The capsules contain titanium dioxide (E171,
CI 77891), gelatin and red iron
oxide (E172, CI77491).
PHARMACOLOGY
PHARMACOLOGICAL ACTIONS
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 relatively
more potent than the _S_-enantiomer
with regard to inhibition of noradrenaline reuptake; the
_S_-enantiomer is mo
Read the complete document
