FLUVOXAMINE AN fluvoxamine maleate 50mg film coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

fluvoxamine maleate

Available from:

Amneal Pharma Australia Pty Ltd

INN (International Name):

Fluvoxamine maleate

Authorization status:

Registered

Patient Information leaflet

_Fluvoxamine AN tablets – Consumer Medicine Information _
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Fluvoxamine AN CMI v6.0
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FLUVOXAMINE AN
Consumer Medicine Information
Fluvoxamine maleate film coated tablets
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WHAT IS IN THIS LEAFLET
This leaflet answers some of the common questions about Fluvoxamine
AN. It does not
contain all of the available information. It does not take the place
of talking to your doctor or
pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
risks of you taking
Fluvoxamine AN against the benefits they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again.
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WHAT IS FLUVOXAMINE AN USED FOR
Fluvoxamine AN belongs to a family of medicines known as selective
serotonin reuptake
inhibitors (SSRIs) and is approved for the conditions listed below.
Depression
Fluvoxamine AN is used to treat depression in adults only. It is not
recommended for
treatment of this condition in children and adolescents as the safety
and effectiveness of this
medicine, when used for depression in this age group, have not been
established.
Depression is longer lasting and/or more severe than the "low moods"
everyone has from
time to time due to the stress of everyday life. It can affect your
whole body and can cause
emotional and physical symptoms such as feeling low in spirit, loss of
interest in activities,
being unable to enjoy life, poor appetite or overeating, disturbed
sleep, often waking up early,
loss of sex drive, lack of energy and feeling guilty for no reason.
Obsessive compulsive disorder (OCD)
Fluvoxamine AN is also used to treat a condition known as obsessive
compulsive disorder
(OCD) in adults and children eight years of age or older.
People
with
OCD
can
have
two
types
of
symptoms
–
obsessions
and
compulsions.
Obsessions are unwanted repeated thoughts or feelings, which are
ongoing. Compulsions are
the need to repeat actions over and over. The symptoms of OCD can vary
from p

Summary of Product characteristics

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_Fluvoxamine AN tablets Product Information _
_ Amneal Pharma Australia Pty Ltd _
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Fluvoxamine AN PI v5.0
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FLUVOXAMINE AN
Product Information
Fluvoxamine maleate film coated tablets
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NAME OF THE MEDICINE
Fluvoxamine
maleate
is
chemically
identified
as
_(E)_-5-methoxy-4

-
trifluoromethylvalerophenone _ 0_-2-aminoethyloxime maleate. It has
the following chemical
structure:
CAS No. 61718-82-9
MW= 434.4
DESCRIPTION
Fluvoxamine maleate is a white to slightly off-white, odourless,
crystalline powder, sparingly
soluble in water, freely soluble in ethanol and chloroform,
practically insoluble in diethylether.
It has a partition coefficient (n-octanol/water, own pH) P=38.7.
Fluvoxamine is a member of a class of antidepressant agents known as
selective serotonin
reuptake inhibitors (SSRI). It is chemically unrelated to the
tricyclic antidepressants, and to
other serotonin reuptake inhibitors as it is a monocyclic compound.
FLUVOXAMINE AN (fluvoxamine maleate) is available in 50mg and 100mg
white, film-
coated, scored tablets. The inactive ingredients are: mannitol, maize
starch, pregelatinised
potato starch, sodium stearylfumarate, colloidal anhydrous silica,
hypromellose, macrogol
6000, purified talc, titanium dioxide.
PHARMACOLOGY
_PHARMACODYNAMICS _
Fluvoxamine has two isomeric forms: an E isomer which is
pharmacologically active, and a
Z isomer which is non-active. FLUVOXAMINE AN tablets contain only the
E isomer.

C
4
H
4
O
4
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_Fluvoxamine AN tablets Product Information _
_ Amneal Pharma Australia Pty Ltd _
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Fluvoxamine AN PI v5.0
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The mechanism of action of fluvoxamine is believed to be related to
its ability to selectively
inhibit presynaptic reuptake of serotonin, and thus increase the
serotonin concentrations
within
the
synaptic
cleft.
This
is
accompanied
by
minimal
interference
with
the
noradrenergic and dopaminergic processes.
Unlike tricyclic antidepressants, fluvoxamine has limited affinity for
alpha adrenergic, beta
adrenergic,
histaminergic,
muscarinic,
dopaminergic
or
se