Setrof Tablet 50mg

País: Malàisia

Idioma: anglès

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

ingredients actius:

SERTRALINE HYDROCHLORIDE

Disponible des:

HOVID BERHAD

Designació comuna internacional (DCI):

SERTRALINE HYDROCHLORIDE

Unidades en paquete:

30Tablet Tablets; 100 Tablets; 100 Tablets; 100 Tablets

Fabricat per:

HOVID BERHAD

Informació per a l'usuari

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
SETROF TABLET 50 MG
Sertraline 50mg
1
WHAT IS IN THIS LEAFLET
1.
What Setrof is used for
2.
How Setrof works
3.
Before you use Setrof
4.
How to use Setrof
5.
While you are using Setrof
6.
Side effects
7.
Storage and disposal of Setrof
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT SETROF
IS USED FOR
Setrof Tablet is indicated for treatment
of:
•
symptoms of depression including
depression
accompanied
by
symptoms of anxiety
•
obsessions
(persistent
ideas)
and
compulsions (repetitive behaviour)
in
patients
with
obsessive-
compulsive disorder (OCD)
•
panic
disorder
with
or
without
agoraphobia (fear of open spaces)
HOW SETROF
WORKS
This medicine contains Sertraline as the
active ingredient. Sertraline is one of a
group
of
medicines
call
Selective
Serotonin Re-uptake Inhibitors (SSRIs).
SSRIs
block
the
reabsorption
of
the
naturally
occurring
chemicals
called
serotonin
in
the
brain.
Changing
the
balance of serotonin helps control your
mood.
BEFORE YOU USE SETROF
_ _
_- When you must not use it _
Do not take this medicine if:
•
you are allergic to sertraline or any
other ingredients of Setrof.
•
you
are
taking
or
have
taken
medicine called monomine oxidase
inhibitors
(MAOIs)
(such
as
Selegiline, Moclobemide) or MAOI
like drugs such as Linezolid. After
stopping treatment with MAOI, you
must wait at least 2 weeks before
you can start treatment with Setrof.
Do
not
take
this
medicine
after
the
expiry date printed on the pack or if the
packaging is damaged.
If you are not sure whether you should
start taking this medicine, talk to your
pharmacist or doctor.
_- Before you start to use it _
Tell
your
doctor/pharmacist
if
you
suffer from or have suffered in the past:
•
Epilepsy or a history of seizures
•
Liver disease
•
Mania
(feeling
elated
or
over-
excited,
which
causes
unusual
behaviour)
•
Nervous
system
(neurological)
impairment
•
Kidney disease
•
Sensitivity to Sertraline
•
Weight loss
Safety
of
Setr

Fitxa tècnica

857
DESCRIPTION
Oblong, white to off white film-coated tablet, shallow convex with
break bar on one side and HD embossed on the other side.
COMPOSITION
Sertraline Hydrochloride 56 mg equivalent to Sertraline 50 mg/ tablet.
ACTIONS AND PHARMACOLOGY
Sertraline is a potent and selective inhibitor of neuronal uptake of
serotonin (5-hydroxytryptamine [5-HT]). It has very weak effects
on neuronal uptake of norepinephrine and dopamine. Chronic
administration
of
sertraline
in
animals
has
resulted
in
down-regulation of postsynaptic beta-adrenergic receptors.
Sertraline lacks affinity for adrenergic (alpha1, alpha2, or beta)
receptors,
muscarinic
–
cholinergic
receptors,
gamma
aminobutyric acid (GABA) receptors, dopaminergic receptors,
histaminergic receptors, serotonergic (5-HT1A, 5-HT1B, 5-HT2)
receptors, and benzodiazepine receptors. Sertraline does not
inhibit monoamine oxidase.
PHARMACOKINETICS
Sertraline is slowly absorbed from the gastrointestinal tract with
peak plasma concentrations occurring about 4.5 to 8.5 hours after
ingestion. Elimination half time of sertraline is reported to be 24 to
26 hours. Both sertraline and its metabolites are extensively
distributed into body tissues. About 98% is bound to plasma
proteins. Sertraline undergoes extensive first-pass metabolism in
the
liver.
The
main
pathway
is
demethylation
to
N-desmethylsertraline
which
is
inactive.
Both
sertraline
and
N-desmethylsertraline
undergo
oxidative
deamination
and
subsequent reduction, hydroxylation and glucuronide conjugation.
About 40 to 45% of an administered dose is excreted in the urine
and faeces in 9 days, with less than 0.2% recovered unchanged in
urine and 12% to 14% unchanged sertraline in faeces.
INDICATIONS
For treatment of symptoms of depression including depression
accompanied
by
symptoms
of
anxiety.
For
treatment
of
obsessions
and
compulsions
in
patients
with
obsessive-
compulsive disorder (OCD). For treatment of panic disorder with
or without agoraphia.
CONTRAINDICATIONS
Concomitant use of monoamine oxidase inhibitors (MAOI