PAROXETINE GH paroxetine (as hydrochloride) 20mg tablet blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
10-06-2021
Summary of Product characteristics
(SPC)
10-06-2021
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
paroxetine hydrochloride, Quantity: 22.2 mg
Available from:
Sandoz Pty Ltd
INN (International Name):
paroxetine hydrochloride
Pharmaceutical form:
Tablet, film coated
Composition:
Excipient Ingredients: mannitol; titanium dioxide; magnesium stearate; copovidone; colloidal anhydrous silica; microcrystalline cellulose; hypromellose; sodium starch glycollate; purified talc
Administration route:
Oral
Units in package:
30 tablets
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
Paroxetine GH is indicated for the treatment of : - Major Depression and for the prevention of relapse of depressive symptoms - Obsessive Compulsive Disorder (OCD) and prevention of relapse of OCD - Panic Disorder and for the prevention of relapse of Panic Disorder - Social Anxiety Disorder/Social Phobia - General Anxiety Disorder - Post-traumatic Stress Disorder.
Product summary:
Visual Identification: White, round bi-sected film-coated tablet with a one-sided breaking notch ("Snap-tab") and embossment 'PX 20' on opposite side, intact surface.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Authorization status:
Licence status A
Authorization date:
2014-12-18
Patient Information leaflet
CONSUMER MEDICINE INFORMATION
PAROXETINE GH
(PAROXETINE HYDROCHLORIDE) FILM COATED TABLET
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you take Paroxetine GH
tablets. This leaflet answers
some common questions about
Paroxetine GH.
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 taking
Paroxetine GH against the
benefits it is expected to 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 need to read it again.
WHAT PAROXETINE GH IS
USED FOR
The name of your medicine is
Paroxetine GH. It contains the
active ingredient paroxetine
hydrochloride.
Paroxetine hydrochloride
belongs to a group of medicines
called selective serotonin
reuptake inhibitors (SSRIs)
antidepressants. They are
thought to work by their action
on brain chemicals called
amines which are involved in
controlling mood.
Depression is longer lasting
and/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, loss of interest in usual
activities, being unable to enjoy
life, have poor appetite or
overeat, disturbed sleep, often
waking up early, loss of sex
drive, low energy and feeling
guilty over nothing.
Paroxetine GH 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 GH may also be
used to help prevent panic
attacks.
Paroxetine GH may also be
used to treat patients who may
avoid and/or are fearful of social
situations.
Paroxetine GH 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 GH may also be
used to
Read the complete document
Summary of Product characteristics
AUSTRALIAN PRODUCT INFORMATION – PAROXETINE GH
(PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED
1
NAME OF THE MEDICINE
Paroxetine hydrochloride.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Paroxetine GH 20 mg film-coated tablets contains 22.2 mg of
paroxetine hydrochloride equivalent
to 20 mg of paroxetine.
List of excipients with known effects: Mannitol.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Paroxetine GH 20 mg film-coated tablets are round, white tablets with
a score notch on one side and
embossed with ‘PX 20’ on the other side.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Paroxetine GH is indicated for the treatment of:
•
Major depression and for the prevention of relapse of depressive
symptoms.
•
Obsessive compulsive disorder (OCD) and prevention of relapse of OCD.
•
Panic disorder and for the prevention of relapse of panic disorder.
•
Social anxiety disorder/social phobia
•
General Anxiety Disorder
•
Post-traumatic Stress Disorder.
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSAGE
It is recommended that paroxetine be administered once daily in the
morning with food. The tablet
should be swallowed rather than chewed.
Depression
The recommended dose is 20 mg (1 tablet) 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.
Paroxetine GH v4.1
Page 2 of 28
(paroxetine hydrochloride) tablet, film coated
As with all antidepressant drugs, dosage should be reviewed and
adjusted if necessary within two or
three weeks of initiation of therapy and thereafter as judged
clinically appropriate. Dose changes should
occur at intervals of at least one week.
It is generally recommended that a course of antidepressant drug
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 w
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