ANZACK TABLETS 20 MG

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

Fluoxetine Hydrochloride.

Boleh didapati daripada:

MALAYSIAN PHARMACEUTICAL INDUSTRIES SDN. BHD.

INN (Nama Antarabangsa):

Fluoxetine Hydrochloride.

Unit dalam pakej:

1000Tablet Tablets; 10 Tablet Tablets; 10Tablet Tablets

Dikeluarkan oleh:

MALAYSIAN PHARMACEUTICAL INDUSTRIES SDN. BHD.

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
_ _
1
ANZACK TABLETS
Fluoxetine Hydrochloride (20mg)
WHAT IS IN THIS LEAFLET:
1.
What Anzack Tablets is used for
2.
How Anzack Tablets works
3.
Before you use Anzack Tablets
4.
How to use Anzack Tablets
5.
While you are using it
6.
Side Effects
7.
Storage
and
Disposal
of
Anzack
Tablets
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
WHAT ANZACK TABLETS IS USED FOR
Fluoxetine is the active ingredient for
Anzack
Tablets.
It
is
used
for
the
traetment
of
the
symptoms
of
depressive
illness,
with
or
without
associated anxiety (feeling of unease,
such as worry or fear that can be mild
or severe) symptoms. It is also used for
obsessive-compulsive
disorder
(a
disorder that characterized by persistent
thoughts
that
lead
to
repetitive
behaviors) and pre-menstrual dysphoric
(a
condition
in
which
a
woman
has
severe depression symptoms, irritability
and
tension
before
menstruation)
disorder.
HOW ANZACK TABLETS WORKS
Fluoxetine
is
a
selective
inhibitor
serotonin
reuptake
and
it
works
by
acting on the brain chemicals.
BEFORE YOU USE ANZACK TABLETS
-
_When you must not use it _

If you have hypersensitivity to
fluoxetine
or
any
of
the
ingredients.

If you have been or are taking
monoamine
oxidase
inhibitors
(MAOIs).
Please
talk
to
your
Pharmacist or Doctor if you are
not sure about this.
-
_Before you start to use it _
You must tell your doctor if:

you
have
allergies
to
any
medicine which you have taken
previously to treat your current
condition.

You
are
pregnant,
trying
to
become
pregnant
or
breast-
feeding.

You have a history of seizures.

You have a history of hypomania
(a less severe form of mania) /
mania (excitement manifested by
mental
and
physical
hyperactivity, disorganization of
behavior,
and
elevation
of
mood).

You
have
significant
liver
dysfunction.

You are diabetic.

You have heart problem.

You have weight loss.

You
are
taking
oral
anticoagulant,
medications
known to affect platelet f

Ciri produk

7158-05
ANZACK TABLETS 20MG
NAME AND STRENGTH OF ACTIVE INGREDIENT(S):
Each tablet contains:
Fluoxetine Hydrochloride equivalent to Fluoxetine
………………20mg
PRODUCT DESCRIPTION:
A round, light green, scored, flat of diameter 7mm tablets with
‘MPI’ logo.
PHARMACODYNAMICS
:
Fluoxetine is a selective inhibitor of serotonin reuptake and has
practically no affinity to other receptors such as

1 - ,

2-,
and

-
adrenergic; serotonergic; dopaminergic; histaminergic; muscarinic; and
GABA receptors.
PHARMACOKINETICS:
Fluoxetine is well absorbed from the gastrointestinal tract following
oral administration. At least 60 – 80% of an oral dose appears
to be absorbed. The bioavailability is not affected by food intake.
Fluoxetine is approximately 94.5% bound to plasma protein and it is
widely distributed with volume of distribution of 20-45 l/kg.
Steady-state plasma concentrations are achieved after dosing for
several weeks. The steady-state concentrations after prolonged
dosing are similar to concentrations seen at 4 to 5 weeks.
Fluoxetine had a non-linear pharmacokinetic profile with first pass
liver effect. Maximum plasma concentration is generally
achieved 6 to 8 hours after administration. Fluoxetine is extensively
metabolized by the polymorphic enzyme CYP2D6.
Fluoxetine is primarily metabolized by the liver to the active
metabolite norfluoxetine (desmethylfluoxetine) by desmethylation.
The elimination half-life of fluoxetine is 4 to 6 days and for
norfluoxetine 4 to 16 days. These long half-lives are responsible for
persistence of the drug for 5-6 weeks after discontinuation. Excretion
of about 60% is mainly via the kidney. Fluoxetine is secreted
into breast milk.
_ _
_At-risk populations: _
The kinetic parameters are not altered in healthy elderly patients. In
case of hepatic insufficiency, fluoxetine and norfluoxetine
half-lives are increased to 7 and 12 days, respectively. A lower or
less frequent dose should be considered. The kinetic parameters
have not been altered in patients with mild, mod