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EXTINE- Consumer Medicine Information
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EXTINE
paroxetine (as hydrochloride)
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about EXTINE.
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 EXTINE against
the benefits they expect it will have
for you.
TALK TO YOUR DOCTOR OR
PHARMACIST IF YOU HAVE ANY
CONCERNS ABOUT TAKING THIS
MEDICINE.
KEEP THIS LEAFLET WITH YOUR
MEDICINE. You may need to read
it again.
WHAT EXTINE IS USED FOR
EXTINE is used to:
treat depression
treat irrational fears or
obsessional behaviour
prevent panic attacks
treat patients who avoid or are
fearful of social situations
treat patients with excessive
anxiety and worry, and who feel
irritable, restless, and/or tense in
the muscles
treat repetitive and distressing
recollections of a past traumatic
event.
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 wake up early, have
low energy and feel guilty over
nothing. EXTINE corrects the
chemical imbalance and so helps
relieving the symptoms of
depression.
EXTINE belongs to a group of
medicines called selective serotonin
reuptake inhibitor (SSRI)
antidepressants. They are thought
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EXTINE- Product Information
Page 1 of 21
Extine
PRODUCT INFORMATION
NAME OF THE MEDICINE
Paroxetine (as hydrochloride). The chemical name for paroxetine hydrochloride is (3S,4R)-3-[(1,3-
benzodioxol-5-yloxy)methyl]-4-(4-fluorophenyl)piperidine hydrochloride. Its structural
formula is:
H
N
H
H
O
O
O
F
HCl
3
4
C
19
H
20
NO
3
F∙HCl
Molecular weight: 365.83
Cas No.: 78246-49-8
DESCRIPTION
Paroxetine hydrochloride is a white to off-white crystalline powder that is slightly soluble in water
and sparingly soluble in ethanol and dichloromethane. It has a chemical structure unrelated to
other selective serotonin reuptake inhibitors or to tricyclic, tetracyclic or other available
antidepressant agents. It is the hydrochloride salt of
a phenylpiperidine compound.
Extine tablets come in three strengths and contain either 10 mg, 20 mg or 30 mg of paroxetine (as
the hydrochloride). The tablets also contain the following excipients: magnesium stearate, sodium
starch glycollate, mannitol, microcrystalline cellulose, Eudragit E100 (ARTG No. 1753) and Opadry
Yellow AMB 80W12287 (ARTG No. 11507; 10 mg only) or Opadry White AMB OY-B-28920 (ARTG
No. 4271; 20 mg only) or Opadry Blue AMB 80W90536 (ARTG No. 11506; 30 mg only). The tablets
are gluten free.
PHARMACOLOGY
Paroxetine is a potent and selective inhibitor of 5-hydroxytryptamine (5HT, serotonin) uptake and
its antidepressant action and efficacy in the treatment of Obsessive Compulsive Disorder (OCD),
Panic Disorder, Social Anxiety Disorder, Social Phobia, Generalised Anxiety Disorder and
Posttraumatic Stress Disorder are thought to be related to its specific inhibit
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