PAROXETINE AN paroxetine (as hydrochloride hemihydrate) 20 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

paroxetine hydrochloride hemihydrate

Available from:

Amneal Pharma Australia Pty Ltd

INN (International Name):

paroxetine hydrochloride hemihydrate

Authorization status:

Registered

Patient Information leaflet

_Paroxetine AN tablets – Consumer Medicine Information _
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_Doc ID: 87AN.M.4.0 _
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_Page 1 _
PAROXETINE AN TABLETS
_Paroxetine Hydrochloride Hemihydrate _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
questions
about
PAROXETINE 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 benefits and
risks. Your doctor has weighed
the
risks
of
you
taking
PAROXETINE
AN
against
the
benefits they expect it will have
for you.
IF
YOU
HAVE
ANY
CONCERNS
ABOUT
TAKING
THIS
MEDICINE,
TALK
TO
YOUR
DOCTOR
OR
PHARMACIST.
Keep
this
leaflet
with
your
medicine.
You may need to read it again.
WHAT PAROXETINE
AN IS USED FOR
The name of your medicine is
PAROXETINE
AN;
it
is
also
known as paroxetine.
PAROXETINE AN belongs to a
group
of
medicines
called
selective
serotonin
reuptake
inhibitor (SSRI) antidepressants.
They are thought to work by their
action on brain chemicals called
amines
which
are
involved
in
controlling mood.
Depression is longer lasting or
more
severe
than
the
'low
moods' that everyone has from
time to time. It is thought to be
caused by a chemical imbalance
in
parts
of
the
brain.
This
imbalance
affects
your
whole
body and can cause emotional
and
physical
symptoms.
You
may
feel
low
in
spirit,
lose
interest
in
usual
activities,
be
unable to enjoy life, have poor
appetite
or
over
eat,
have
disturbed sleep, often waking up
early, low energy and feel guilty
over nothing.
PAROXETINE AN may also be
used to treat irrational fears or
obsessional
behaviour.
These
can
also
be
due
to
chemical
imbalance in parts of the brain.
PAROXETINE AN may also be
used
to
help
prevent
panic
attacks.
PAROXETINE AN may also be
used to treat patients who may
avoid and/or are fearful of social
situations.
PAROXETINE AN may also be
used to treat patients who have
excessive
anxiety
and
worry,
and who feel irritable, restless,
and/or tense in the muscles.
PAROXETINE AN may also be
used
to
treat
repetitive
and
dist

Summary of Product characteristics

_Paroxetine AN tablets Product Information Amneal Pharma Australia Pty
Ltd _
Paroxetine AN PI v4
Page 1
PAROXETINE AN
_ _
_(PAROXETINE (AS HYDROCHLORIDE HEMIHYDRATE) TABLETS) _
_ _
PRODUCT INFORMATION
NAME OF THE MEDICINE
The name of the medicine is paroxetine, as hydrochloride hemihydrate.
CHEMICAL NAME:
(3S,4R)-3-[(1,3-Benzodioxol-5-yloxy)methyl]-4-(4-fluorophenyl)piperidine
hydrochloride hemihydrate
MOLECULAR FORMULA:
C
19
H
21
ClFNO
3
.
½ H
2
O
MOLECULAR WEIGHT:
374.8
CAS REGISTRY NUMBER: _[110429-35-1]_
DESCRIPTION
Paroxetine hydrochloride hemihydrate is a white or almost white,
crystalline powder. It is freely
soluble in methanol, slightly soluble in water, sparingly soluble in
alcohol and in methylene
chloride.
INACTIVE:
Calcium hydrogen phosphate dihydrate, lactose, sodium starch
glycollate type A,
calcium
hydrogen phosphate, magnesium stearate, Opadry Complete Film Coating
System
15B58810 White.
PAROXETINE AN tablets do not contain sucrose, gluten, tartrazine or
any
other azo dyes.
PHARMACOLOGY
Paroxetine is a potent and selective inhibitor of 5-hydroxytryptamine
(5-HT, serotonin) uptake
and its antidepressant action and efficacy in the treatment of OCD,
Panic Disorder, Social
Anxiety Disorder/Social Phobia, Generalised Anxiety Disorder and
Posttraumatic Stress Disorder
is thought to be related to its specific inhibition of 5-HT uptake in
brain neurones.
In vitro studies have indicated that, in contrast to tricyclic
anti-depressants, paroxetine has little
affinity for α
1
, α
2
and β-adrenoceptors, dopamine (D
2
), 5-HT
1
like, 5-HT
2
and histamine (H
1
)
receptors. This lack of interaction with post-synaptic receptors in
vitro is substantiated by in vivo
studies which demonstrate lack of CNS depressant and hypotensive
properties. Paroxetine has
low affinity for muscarinic cholinergic receptors and animal studies
have indicated only weak
anticholinergic properties.
_Paroxetine AN tablets Product Information Amneal Pharma Australia Pty
Ltd _
Paroxetine AN PI v4
Page 2
Because the relative potencies of