SETRONA sertraline (as hydrochloride) 100 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

sertraline hydrochloride, Quantity: 111.92 mg (Equivalent: sertraline, Qty 100 mg)

Available from:

Sun Pharma ANZ Pty Ltd

INN (International Name):

Sertraline hydrochloride

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: microcrystalline cellulose; calcium hydrogen phosphate dihydrate; sodium starch glycollate; hyprolose; magnesium stearate; titanium dioxide; hypromellose; purified talc; macrogol 400

Administration route:

Oral

Units in package:

30 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Adults: Setrona is indicated for the treatment of major depression. Setrona is indicated for the treatment of Premenstrual Dysphoric Disorder (PMDD) as defined by DSM-IV criteria.

Product summary:

Visual Identification: White film coated caplet shaped tablets debossed with '100' on one side and a break-line on the other.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2006-06-22

Patient Information leaflet

SETRONA
1
SETRONA
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 SETRONA?
SETRONA contains the active ingredient sertraline hydrochloride.
SETRONA is used to treat depression and conditions called
obsessive compulsive disorder (OCD), panic disorder, social phobia
(social anxiety disorder) and premenstrual dysphoric
disorder (PMDD).
For more information, see Section 1. Why am I using SETRONA? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE SETRONA?
Do not use if you have ever had an allergic reaction to SETRONA 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
SETRONA? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with SETRONA 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 SETRONA?
•
SETRONA is to be taken by mouth, every morning or evening with or
without food. Swallow the tablet whole with a full
glass of water.
•
Take SETRONA exactly as your doctor has prescribed.
More instructions can be found in Section 4. How do I use SETRONA? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING SETRONA?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
SETRONA.
•
Take SETRONA exactly as your doctor tells you to.
•
Visit your doctor regularly for check ups.
THINGS YOU
SHOULD NOT DO
•
Do not give this medicine to anyone else, even if they have the same
condition as you.
•
Do not use SETRONA tablets to treat any other complaints unless your
doctor tells you to.
•
Do not stop taking SETRONA tablets, or lower the dose, without first
checking with your doctor.
DRIVING OR USIN

Summary of Product characteristics

SETRONA PI V13_Aug 2022
Page 1 of 39
AUSTRALIAN PRODUCT INFORMATION -SETRONA
(
SERTRALINE HYDROCHLORIDE
) TABLETS
1.
NAME OF THE MEDICINE
Sertraline Hydrochloride
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each white, film coated caplet shaped tablet contains 50 mg or 100 mg
of sertraline as
sertraline hydrochloride.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
SERTONA 50 mg tablet is debossed with “50” on one side and a break
line on the
other.
SERTONA 100 mg tablet is imprinted with “100” on one side and a
break line on the
other.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
CHILDREN AND ADOLESCENTS
Setrona
is indicated for the treatment of children (aged 6 years of age and
older) and
adolescents with Obsessive Compulsive Disorder (OCD).
ADULTS
Setrona
is indicated for the treatment of major depression, OCD and panic
disorder.
Setrona
is indicated for the treatment of social phobia (social anxiety
disorder) and the
prevention of its relapse.
Setrona
is indicated for the treatment of Premenstrual Dysphoric Disorder
(PMDD) as
defined by DSM-IV criteria.
4.2
DOSE AND METHOD OF ADMINISTRATION
_CHILDREN AND ADOLESCENTS_ (6-18 YEARS)
_Obsessive Compulsive Disorder: _
The administration of sertraline in children with
OCD (ages 6-12 years) is recommended to commence at 25 mg/day (half a
50 mg
SETRONA PI V13_Aug 2022
Page 2 of 39
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 has an
elimination half-life of approximately 26 hours; a once daily dose in
the morning is
recommended.
_ADULTS (18 YEARS AND OLDER) _
_Major Depression/Obsessive Compulsive Disorder _
Sertraline treatment should be initiated with a dose of 50 mg once
daily. The usual
therapeutic dose for depression and OCD i