NOUMED SERTRALINE sertraline (as hydrochloride) 100mg film coated tablet blister pack

Země: Austrálie

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktivní složka:

sertraline hydrochloride, Quantity: 111.9 mg (Equivalent: sertraline, Qty 100 mg)

Dostupné s:

AVALLON PHARMACEUTICALS PTY LTD

Léková forma:

Tablet, film coated

Složení:

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

Podání:

Oral

Jednotky v balení:

28 tablets, 30 Tablets

Druh předpisu:

(S4) Prescription Only Medicine

Terapeutické indikace:

Treatment of children (aged 6 years and older) and adolescents with obsessive compulsive disorder. Treatment of major depression, obsessive compulsive disorder and panic disorder in adults.

Přehled produktů:

Visual Identification: White, capsule shaped, scored, film-coated, coded SE | 100 on one side.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 4 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Stav Autorizace:

Registered

Datum autorizace:

2018-02-28

Informace pro uživatele

NOUMED SERTRALINE
1
NOUMED SERTRALINE
_sertraline hydrochloride tablets _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about Noumed Sertraline.
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 NOUMED
SERTRALINE IS USED
FOR
This medicine is used to treat
depression and conditions called
obsessive compulsive disorder
(OCD) and panic disorder.
It contains the active ingredient
sertraline hydrochloride.
Sertraline hydrochloride belongs to a
group of medicines called selective
serotonin reuptake inhibitors
(SSRIs).
It works 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.
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.
Noumed Sertraline 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 of Noumed Sertraline for the
treatment of medical conditions
(other than OCD) in this age group
has not been satisfactorily
established.
For the treatment of OCD, Noumed
Sertraline 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 available with
a doctor's prescription.
There is no evidence that Noumed
Sertraline is addictive.
BEFORE YOU TAKE
NOUMED
SERTRALINE
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•

Charakteristika produktu

_Product Information_
_Noumed Sertraline film coated tablets_
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_Page 1 of 22 _
_Avallon Pharmaceuticals Pty Ltd _
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AUSTRALIAN PRODUCT INFORMATION -
NOUMED SERTRALINE
(SERTRALINE) 50 MG AND 100 MG TABLETS
1.
NAME OF THE MEDICINE
Sertraline hydrochloride
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Noumed Sertraline 50 mg tablets contain 50 mg sertraline (as
hydrochloride).
Noumed Sertraline 100 mg tablets contain sertraline 100 mg (as
hydrochloride).
Noumed Sertraline tablets also contain inactive ingredients:
Microcrystalline cellulose, calcium hydrogen phosphate, hyprolose,
sodium starch glycollate,
magnesium stearate, hypromellose, purified talc, titanium dioxide.
3.
PHARMACEUTICAL FORM
Noumed Sertraline 50 mg film-coated tablets are white, capsule shaped,
scored film-coated
tablets, coded SE|50 on one side.
Noumed Sertraline 100 mg film-coated tablets are white, capsule
shaped, scored film-coated
tablets, coded SE|100 on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of children (aged 6 years and older) and adolescents with
obsessive compulsive
disorder.
Treatment of major depression, obsessive compulsive disorder and panic
disorder in adults.
4.2
DOSE AND METHOD OF ADMINISTRATION
Children and adolescents (6 to 18 years)
_Obsessive compulsive disorder _
The administration of sertraline for 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 about 26 hours: a once
daily dose in the morning is
recommended.
_Product Information_
_Noumed Sertraline film coated tablets_
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_Page 2 of 22 _
_Avallon Pharmaceuticals Pty Ltd _
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Adults (18 years and older