Serenata Tablets 50mg

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

SERTRALINE HYDROCHLORIDE

Boleh didapati daripada:

LABORATORIES TORRENT (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

SERTRALINE HYDROCHLORIDE

Unit dalam pakej:

30Tablet Tablets

Dikeluarkan oleh:

TORRENT PHARMACEUTICALS LTD

Risalah maklumat

SERENATA TABLETS
_ _
Sertraline Hydrochloride (50 mg, 100 mg)
_ _
_ _
1
_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What is Serenata used for
2.
How Serenata works
3.
Before you use Serenata
4.
How to use Serenata
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Serenata
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT SERENATA IS USED FOR
In adults it is used to treat and prevent
the recurrence of depression and any
connected
feelings
of
anxiety,
Obsessive Compulsive Disorder (OCD)
and
Post
Traumatic
Stress
Disorder
(PTSD).
OCD is an illness whereby a persistent
(obsessive) unpleasant thought, feeling
or action causes anxiety and may make
you
carry
out
a
repetitive
impulse
(compulsion).
PTSD is an anxiety disorder caused by
the major personal stress of a serious,
frightening or traumatic event.
Serenata may help, if you suffer from
either OCD or PTSD.
Ask your doctor if you are still unsure
why
you
have
been
prescribed
this
medicine.
HOW SERENATA WORKS
Serenata belongs to a group of anti-
depressant
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 is one of the chemicals that
involved in controlling mood.
BEFORE YOU USE SERENATA
-
_When you must not use it _
Do not take Serenata if you:

Are allergic to setraline, or any of
the other tablet ingredients.

Are taking, or have taken at any
time within the last two weeks, any
medicines
known
as
Monoamine
oxidase inhibitors (also known as
MAOIS).

Have any serious liver problems.

Are
taking
a
medicine
called
pimozide.

Are a child under 18 years old with
more severe form of depression.
_Pregnancy and lactation _
_ _
_ _
Do
not
take
Serenata
if
you
are
pregnant, trying to get pregnant or think
you may be pregnant.
Do not take Serenata if you are breast-
feeding
as
sertraline
is
known
to
be
found in breast milk. Ask yo

Ciri produk

SERENATA TABLET 50MG: Sertraline Hydrochloride equivalent to
Sertraline 50mg.
White to off white capsule shaped, biconvex film coated tablets with
bisecting line on one side
(Thickness 3.1 ± 0.2mm and size/dimension 10.5mm x 4.3mm).
SERENATA TABLET 100MG: SERTRALINE HYDROCHLORIDE EQUIVALENT TO
SERTRALINE 100MG.
White to off white capsule shaped, biconvex film coated tablets, with
bisecting line on one side (Thickness 4.0 ± 0.2mm and size/dimension
13.3mm
x 5.4mm).
PHARMACODYNAMIC
Sertraline is a potent and specific inhibitor of neuronal serotonin
(5-HT) uptake in vitro and in vivo, but is without affinity for
muscarinic, serotonergic,
dopaminergic, adrenergic, histaminergic, GABA or benzodiazepine
receptors.
Sertraline is devoid of stimulant, sedative or anticholinergic
activity or cardiotoxicity in animals.
Unlike tricyclic antidepressants, no weight gain is observed with
sertraline treatment for depression.
Sertraline has not been observed to produce physical or psychological
dependence.
PHARMACOKINETICS:
Sertraline exhibits dose proportional pharmacokinetics over the range
of 50 to 200mg.
After oral administration of sertraline in man, peak blood levels
occur within 4.5 to 8.4 hours. Daily doses of sertraline achieve
steady-state after one
week. Sertraline has a plasma half-life of approximately 26 hours with
a mean half-life for young and elderly adults ranging from 22 to 36
hours.
Sertraline is approximately 98% is bound to plasma proteins. The
principle metabolite, N- desmethylsertraline, is inactive in in-vivo
models of
depression and has a half-life of approximately 62 to 104 hours.
Sertraline and N-desmethylsertraline are both extensively metabolized
in man and
the resultant metabolites excreted in faeces and urine in equal
amounts. Only a small amount (<0.2%) of unchanged sertraline is
excreted in the
urine.
The pharmacokinetic of Sertraline in paediatric OCD patients have been
shown to be comparable with adults, although peadiatric patients
metabolise
sertraline with slightly higher efficiency. Howev