VENLAFAXINE SANDOZ XR venlafaxine (as hydrochloride) 75mg modified release capsule blister

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

venlafaxine hydrochloride

Available from:

Generic Health Pty Ltd

INN (International Name):

Venlafaxine hydrochloride

Authorization status:

Registered

Patient Information leaflet

[Venlafaxine Sandoz CMI]
1
VENLAFAXINE SANDOZ XR

_ _
VENLAFAXINE HYDROCHLORIDE, MODIFIED RELEASE CAPSULES _ _
CONSUMER MEDICINE INFORMATION
_ _
VENLAFAXINE SANDOZ XR
Venlafaxine Hydrochloride, Modified Release Capsules
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Venlafaxine Sandoz XR
capsules. It does
not contain all the available information.
It does not take the place of talking to your doctor or pharmacist or
asking questions.
All medicines have risks and benefits. Your doctor has weighed the
risks of you taking
Venlafaxine Sandoz XR against the expected benefits it will have for
you.
IF YOU HAVE ANY QUESTIONS ABOUT VENLAFAXINE SANDOZ XR, ASK YOUR DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR VENLAFAXINE SANDOZ XR CAPSULES.
You may need to read it again.
WHAT VENLAFAXINE SANDOZ XR IS FOR
The name of your medicine is Venlafaxine Sandoz XR. It contains the
active ingredient called
venlafaxine hydrochloride.
Venlafaxine Sandoz XR capsules are used in the treatment and
prevention of relapse of
depression.
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.
Depression is a treatable illnesses. Anxiety or tension associated
with the normal stress of
everyday life usually does not require treatment with medicines.
Venlafaxine Sandoz XR capsules belong to a class of medications for
depression and anxiety,
called Serotonin-Noradrenaline Reuptake Inhibitors (SNRIs).
Serotonin and noradrenaline are chemical messengers that allow certain
nerves in the brain
to work.
Venlafaxine Sandoz XR capsules increase the level of these two
messengers. Experts think this
is how it helps to restore your feeling of wellness.
[Venlafaxine Sandoz CMI]
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Venlafaxine Sandoz XR is not addictive.
Your doctor may have prescribed Venlafaxine Sandoz XR capsules for
another purpos

Summary of Product characteristics

Sandoz Pty Ltd
Marketed Version
1410 Venlafaxine Sandoz PI v3
Page 1 of 27
PRODUCT INFORMATION
VENLAFAXINE SANDOZ XR 75MG/150 MG
CAPSULE
NAME OF THE MEDICINE
Non Proprietary name: Venlafaxine hydrochloride
Chemical name: 1-[(1_RS_)-2-( Dimethylamino)-1-(4-methoxyphenyl)ethyl]
cyclohexanol
hydrochloride
Molecular formula: C
17
H
27
NO
2
.HCl.
MW: 313.87.
CAS: 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
Sandoz XR capsules are a modified release formulation which release
the active constituent
venlafaxine hydrochloride from a tablet(s)
within the capsule.
Drug is
released by a
combination of swelling of the hydrophilic polymer (hypromellose),
diffusion and erosion.
Active. Venlafaxine hydrochloride.
Inactive. Hypromellose, sodium lauryl sulfate, magnesium stearate,
ammonio methacrylate
copolymer
and basic
butylated
methacrylate
copolymer.
The
capsules
contain
titanium
dioxide (E171, CI 77891) and gelatin. The 75mg capsules also contain
red iron oxide (E172,
CI77491). The 150mg capsules also contain Erythrosine (E127, CI
45430) and Indigo
carmine (E132, CI 73015).
PHARMACOLOGY
Actions
Venlafaxine is a structurally novel antidepressant for oral
administration; it is
chemically
unrelated to tricyclic, tetracyclic or other available antidepressant
agents.
_PHARMACODYNAMICS_
The antidepressant action of venlafaxine in humans is believed to be
associated with its
potentiation of neurotransmitter activity in the central nervous
system.
Sandoz Pty Ltd
Marketed Version
1410 Venlafaxine Sandoz PI v3
Page 2 of 27
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; th