SERTRA 50 sertraline (as hydrochloride) 50 mg tablet blister pack

Land: Ástralía

Tungumál: enska

Heimild: Department of Health (Therapeutic Goods Administration)

Virkt innihaldsefni:

sertraline hydrochloride, Quantity: 55.96 mg (Equivalent: sertraline, Qty 50 mg)

Fáanlegur frá:

Arrotex Pharmaceuticals Pty Ltd

INN (Alþjóðlegt nafn):

Sertraline hydrochloride

Lyfjaform:

Tablet, film coated

Samsetning:

Excipient Ingredients: microcrystalline cellulose; hyprolose; sodium starch glycollate type A; magnesium stearate; calcium hydrogen phosphate dihydrate; titanium dioxide; hypromellose; polysorbate 80; macrogol 400; PEG-150 distearate; lauromacrogol 400

Stjórnsýsluleið:

Oral

Einingar í pakka:

30 tablets

Gerð lyfseðils:

(S4) Prescription Only Medicine

Ábendingar:

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. Sertraline hydrochloride is indicated for the treatment of social phobia (social anxiety disorder) and the prevention of its relapse. Sertraline hydrochloride is indicated for the treatment of premenstrual dysphoric disorder (PMDD) as defined by DSM-IV criteria.

Vörulýsing:

Visual Identification: Oblong, biconvex, white, film-coated tablet scored on one side and debossed with SR50 on the other.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Leyfisstaða:

Registered

Leyfisdagur:

2005-08-04

Upplýsingar fylgiseðill

SERTRA- Consumer Medicine Information
Page 1 of 5
Sertra
sertraline
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about SERTRA.
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 SERTRA against the
benefits it is expected to have for
you.
ASK YOUR DOCTOR OR PHARMACIST
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
WHAT SERTRA IS USED
FOR
SERTRA is used to treat depression
and conditions called obsessive
compulsive disorder (OCD), panic
disorder, social phobia (social
anxiety disorder) and premenstrual
dysphoric disorder (PMDD)
PMDD affects some women in the
days before their period. PMDD is
different from premenstrual
syndrome (PMS). The mood
symptoms (anger, sadness, tension,
etc) in PMDD are more severe than
in PMS and affect the woman’s daily
activities and relationships with
others.
SERTRA belongs to a group of
medicines called selective serotonin
reuptake inhibitors (SSRIs). They
are thought to work by blocking the
uptake of a chemical called
serotonin into nerve cells in the
brain. Serotonin and other
chemicals called amines are
involved in controlling mood.
Your doctor, however, may
prescribe SERTRA for another
purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED
FOR YOU.
SERTRA should not be used in
children and adolescents under the
age of 18 years for the treatment of
any medical condition other than
obsessive compulsive disorder
(OCD). The safety and efficacy for
the treatment of medical conditions
(other than OCD) in this age group
has not been satisfactorily
established.
For the treatment of OCD, this
medicine is not recommended for
use in children under the age of 6,
as the safety and efficacy in
children of this age group has not
been established.
This medicine is only avail

Vara einkenni

1
AUSTRALIAN PI – SERTRA (SERTRALINE HYDROCHLORIDE) TABLETS
1
NAME OF THE MEDICINE
Sertraline hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
SERTRA 50 tablets contain 50 mg of sertraline (as hydrochloride).
SERTRA 100 tablets contain 100 mg of sertraline (as hydrochloride).
EXCIPIENTS:
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
SERTRA 50 tablets are oval, white film-coated tablet, scored on one
side.
SERTRA 100 tablets are oval, white film-coated tablet.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC 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.
Sertraline hydrochloride is indicated for the treatment of social
phobia (social anxiety disorder) and
the prevention of its relapse.
Sertraline hydrochloride is indicated for the treatment of
premenstrual dysphoric disorder (PMDD)
as defined by DSM-IV criteria.
2
4.2
D
OSE AND METHOD OF ADMINISTRATION
CHILDREN AND ADOLESCENTS (6 TO 18 YEARS)
Obsessive compulsive disorder
The administration of sertraline in children with OCD (ages 6 to 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 to 18 years) may commence at 50 mg/day. Clinical
effects may be noted after
two weeks of treatment but clinical responses should be monitored for
six 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
Major depression/ obsessive compulsive disorder
Initial treatment. Sertraline (sertraline hydrochloride) treatment
should be initiated with a dose of
50 mg once daily. The usual therapeutic dose for depression and OCD is
50 mg/day. Wh