APO-SERTRALINE sertraline (as hydrochloride) 50mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

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Patient Information leaflet (PIL)

23-09-2021

Summary of Product characteristics (SPC)

26-08-2022

Public Assessment Report (PAR)

26-11-2017

Active ingredient:

sertraline hydrochloride, Quantity: 55.95 mg (Equivalent: sertraline, Qty 50 mg)

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

Sertraline hydrochloride

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: macrogol 400; titanium dioxide; microcrystalline cellulose; polysorbate 80; calcium hydrogen phosphate; magnesium stearate; sodium starch glycollate type A; hyprolose; hypromellose

Administration route:

Oral

Units in package:

30 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Children and Adolescents Sertraline hydrochloride is indicated for the treatment of children (aged 6 years of age and older) and adolescents with OCD.,Adults Sertraline hydrochloride is indicated for the treatment of: ? Major depression, obsessive compulsive disorder (OCD) and panic disorder ? Social phobia (social anxiety disorder) and the prevention of its relapse ? Pre-menstrual dysphoric disorder (PMDD) as defined by DSM-IV criteria

Product summary:

Visual Identification: White to off-white, capsule shaped, biconvex film coated tablets with '50' and 'BL' debossed on either side of the breakline; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 48 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2013-09-27

Patient Information leaflet

APO-SERTRALINE TABLETS
1
APO-SERTRALINE TABLETS
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING APO-SERTRALINE?
APO-Sertraline contains the active ingredient sertraline
hydrochloride. APO-Sertraline is used to treat obsessive compulsive
disorder (OCD) in children over the age of 6 and depression, OCD,
panic disorder, social anxiety disorder and pre-menstrual
dysphoric disorder (PMDD) in adults. For more information, see Section
1. Why am I using APO-Sertraline?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE APO-SERTRALINE?
Do not use if you have ever had an allergic reaction to sertraline or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
APO-Sertraline?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with APO-Sertraline and affect how it
works.
A list of these medicines is in Section 3. What if I am taking other
medicines?
in the full CMI.
4.
HOW DO I USE APO-SERTRALINE?
OBSESSIVE
COMPULSIVE DISORDER
Starting dose is 25 mg a day (half a 50 mg tablet) for children and 50
mg tablet per day for adults
and adolescents.
DEPRESSION
Starting dose is one 50 mg tablet per day.
PANIC DISORDER AND
SOCIAL PHOBIA
Starting dose is 25 mg per day (half a 50 mg tablet).
PMDD
Starting dose is one 50 mg tablet each day, either throughout the
menstrual cycle (to a maximum of
150 mg daily) or for the last 14 days before the start of your period
(to a maximum of 100 mg daily).
More instructions can be found in Section 4. How do I use
APO-Sertraline? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING APO-SERTRALINE?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
APO-Sertraline.
•

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Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION –
APO-SERTRALINE (SERTRALINE HYDROCHLORIDE) 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’ debossed on either side of the breakline.
100 MG TABLETS
White to off white, capsule shaped, biconvex, film coated tablets with
‘100’ and ‘BL’ debossed
on one side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
CHILDREN AND ADOLESCENTS
Sertraline hydrochloride is indicated for the treatment of children
(aged 6 years of age and
older) and adolescents with OCD.
ADULTS
Sertraline hydrochloride is indicated for the treatment of:
•
Major depression, obsessive compulsive disorder (OCD) and panic
disorder
•
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
APO-Sertraline tablets are intended for oral administration.
CHILDREN AND ADOLESCENTS (6-18 YEARS)
Obsessive Compulsive Disorder
The administration of sertraline hydrochloride in children with OCD
(ages 6-12 years) is
recommended to commence at 25 mg/day (half a 50 mg tablet) for the
first week and then
increasing to 50 mg/day. Adolescents (ages 13-18 years) may commence
at 50 mg/day.
Clinical effects may be noted after 2 weeks of treatment but clinical
responses should be
monitored for 6 weeks before any increase in dose. In children, a dose
of 200 mg/day should
not be exceeded. Sertraline hydrochloride has an elimination half-life
of approximately 26
hours; a once daily dose in the morning is recommended.
ADULTS (18 YEARS AND OLDER)
2
Major Depression/ Obsessive Compulsive Disorder
Initial Treatment – Sertraline treatment should be initiated w

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