APO-PAROXETINE paroxetine 20mg (as hydrochloride) tablets blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

paroxetine hydrochloride, Quantity: 22.2 mg (Equivalent: paroxetine, Qty 20 mg)

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

paroxetine hydrochloride

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: magnesium stearate; sodium starch glycollate; lactose; hyprolose; hypromellose; macrogol 8000; titanium dioxide

Administration route:

Oral

Units in package:

30 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of major depression and prevention of relapse of depressive symptoms. Treatment of Obsessive Compulsive Disorder (OCD) and prevention of relapse of OCD. Treatment of Panic Disorder and prevention of relapse of Panic Disorder. Treatment of Social Anxiety Disorder / Social Phobia. Treatment of Generalised Anxiety Disorder. Treatment of Post-traumatic Stress Disorder.

Product summary:

Visual Identification: WHITE, OVAL-SHAPED, BICONVEX, FILM-COATED TABLET WITH A PARTIAL BISECT AND ENGRAVED "20" ON ONE SIDE, OTHER SIDE PLAIN; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2008-08-15

Patient Information leaflet

APO-PAROXETINE TABLETS
1
APO-PAROXETINE
TABLETS
_Paroxetine hydrochloride _
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about paroxetine. It does
not contain all 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 using this medicine
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
Paroxetine is used to treat:
•
depression
•
Obsessive Compulsive Disorder
(OCD)
•
panic disorder
•
social anxiety disorder or social
phobia
•
generalised anxiety disorder
•
post-traumatic stress disorder.
It is also used to prevent the
symptoms of depression, Obsessive
Compulsive Disorder and panic
disorder from coming back.
Paroxetine belongs to a group of
medicines called selective serotonin
reuptake inhibitors (SSRIs).
_HOW IT WORKS _
Paroxetine is thought to work by
acting on brain chemicals called
amines which are involved in
controlling mood. Paroxetine corrects
the chemical imbalance and helps to
relieve the symptoms of depression
and stop them coming back.
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 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, not interested in usual
activities, being unable to enjoy life,
poor appetite or overeat, disturbed
sleep, often waking up early, loss of
sex drive, lack of energy and feeling
guilty over nothing.
Paroxetine is thought to have a
similar action when it used to for
irrational fears, obsessional
behaviour or panic attacks, and when
it

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
APO-PAROXETINE (PAROXETINE HYDROCHLORIDE)
TABLETS
1
NAME OF THE MEDICINE
Paroxetine hydrochloride.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains paroxetine 20mg (as hydrochloride), as the active
ingredient.
EXCIPIENTS WITH KNOWN EFFECT
Lactose
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS
3
PHARMACEUTICAL FORM
White, oval-shaped, biconvex, film-coated tablets, partial bisect and
engraved “20” on one
side, other side plain.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Paroxetine is indicated for the treatment of:
•
Major depression and for the prevention of relapse of depressive
symptoms
•
Obsessive Compulsive Disorder (OCD) and for the prevention of relapse
of OCD
•
Panic Disorder and for the prevention of relapse of Panic Disorder
•
Social Anxiety Disorder / Social Phobia
•
Generalised Anxiety Disorder
•
Post-Traumatic Stress Disorder.
4.2
DOSE AND METHOD OF ADMINISTRATION
APO-Paroxetine tablets are intended for oral administration.
DOSAGE
It is recommended that paroxetine is administered once daily in the
morning with food. The
tablet should be swallowed rather than chewed.
DEPRESSION
The recommended dose of paroxetine is 20 mg daily. Many patients will
respond to a 20 mg
daily dose. Patients not responding to a 20 mg dose may benefit from
dose increases in 10
mg/day increments, up to a maximum of 50 mg/day according to the
patient's response.
As with all antidepressant medicines, dosage should be reviewed and
adjusted if necessary
within 2 to 3 weeks of initiation of therapy and thereafter as judged
clinically appropriate. Dose
changes should occur at intervals of at least 1 week.
It is generally recommended that a course of antidepressant medicine
treatment should
continue for a sufficient period, often for several months. There is
no body of evidence
available to answer the question of how long the patient treated with
paroxetine should remain
on it. It is generally agreed that acute episodes of depression
require sev