TERRY WHITE CHEMISTS SERTRALINE sertraline (as hydrochloride) 50mg tablet blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
24-08-2020
Summary of Product characteristics
(SPC)
24-08-2020
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
sertraline hydrochloride
Available from:
Apotex Pty Ltd
INN (International Name):
Sertraline hydrochloride
Authorization status:
Registered
Patient Information leaflet
TERRY WHITE CHEMISTS
SERTRALINE TABLETS
_Sertraline (as sertraline 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 this medicine. 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 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 need to read it again.
WHAT THIS MEDICINE IS
USED FOR
Sertraline is used to treat:
•
depression
•
social anxiety disorder or social
phobia
•
Pre-Menstrual Dysphoric
Disorder (PMDD)
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 that
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, loss of sex drive and lack of
energy.
PMDD affects some women in the
days before their period. It is
different from premenstrual
syndrome (PMS). The mood
symptoms (such as anger, sadness,
tension, etc.) in PMDD are more
severe than in PMS and affect the
woman's daily activities and
relationships with others.
Sertraline belongs to a group of
medicines called Selective Serotonin
Re-uptake Inhibitors (SSRIs).
Serotonin is one of the chemicals in
your brain that helps control your
mood. Sertraline and other SSRIs are
thought to help by increasing the
amount of serotonin in your brain.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is not addictive.
This medicine is available only with
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Summary of Product characteristics
1
AUSTRALIAN PRODUCT INFORMATION –
TERRY WHITE CHEMISTS SERTRALINE (SERTRALINE) TABLETS
1
NAME OF THE MEDICINE
Sertraline hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg or 100 mg sertraline (as sertraline
hydrochloride).
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
50 MG TABLETS
White to off white, capsule shaped, biconvex, film coated tablets with
breakline on one side and ‘50’
and ‘BL’ embossed on either side of the breakline.
100 MG TABLETS
White to off-white, capsule shaped, biconvex film coated tablets with
'100' and 'BL' embossed on one
side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Indicated in adults for the treatment of:
•
Major depression
•
Social phobia (social anxiety disorder) and the prevention of its
relapse
•
Pre-menstrual dysphoric disorder (PMDD) as defined by DSM-IV criteria
4.2
DOSE AND METHOD OF ADMINISTRATION
Terry White Chemists Sertraline tablets are intended for oral
administration.
ADULTS (18 YEARS AND OLDER)
Major Depression
Initial Treatment – Sertraline treatment should be initiated with a
dose of 50 mg once daily.
The usual therapeutic dose for depression is 50 mg/day. While a
relationship between dose
and antidepressant effect has not been established, patients were
dosed in a range of 50–
200 mg/day in the clinical trials demonstrating the antidepressive
effectiveness of sertraline.
Consequently, patients not responding to a 50 mg/day dose may benefit
from dose increases
up to a maximum of 200 mg/day. Given the 24 hour elimination half-life
of sertraline, dose
changes should not occur at intervals of less than 1 week. The onset
of therapeutic effect may
be seen within 7 days; however for full activity 2 to 4 weeks are
usually necessary for
depression.
If no effect is apparent after 6 to 8 weeks, discontinuation of
treatment should be considered.
Studies of efficacy did not examine the role of psychotherapy.
2
Social Phobia (Social Anxiety Disorder)
Initial treatment – T
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