ARIPTOR TABLET 10 MG

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

ARIPIPRAZOLE

Boleh didapati daripada:

LABORATORIES TORRENT (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

ARIPIPRAZOLE

Unit dalam pakej:

10tablet Tablets; 30tablet Tablets; 100tablet Tablets

Dikeluarkan oleh:

TORRENT PHARMACEUTICALS LTD.

Risalah maklumat

ARIPTOR TABLET
_ _
Aripiprazole (10 mg, 15 mg)
_ _
_ _
1
_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What is ARIPTOR used for
2.
How ARIPTOR works
3.
Before you use ARIPTOR
4.
How to use ARIPTOR
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of ARIPTOR
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT ARIPTOR IS USED FOR
ARIPTOR
contains
the
active
substance Aripiprazole and belongs to a
group
of
medicines
called
antipsychotics.
It
is
used
to
treat
schizophrenia-
a
mental
disorder
characterized
by
abnormal
social
behavior and failure to understand what
is real and in brain disorder that causes
mania, unusual shifts in mood, energy
and activity levels.
HOW ARIPTOR WORKS
It
acts
on
brain
cells
and
corrects
chemical imbalance.
BEFORE YOU USE ARIPTOR
-
_When you must not use it _
Do not take ARIPTOR
Talk
to
your
doctor
before
taking
Aripiprazole if you suffer from:
•
Seizure.
•
Involuntary, irregular muscle
movements, especially in the face.
•
Cardiovascular
diseases,
family
history
of
cardiovascular
disease,
stroke or "mini" stroke, abnormal
blood pressure
•
Blood clots, or family history of
blood clots, as antipsychotics have
been associated with formation of
blood clots
•
Past experience
of
excessive
gambling.
•
Suicidal
thoughts
and
behaviors
have
been
reported
during
Aripiprazole treatment. Do not take
ARIPTOR if the above applies to
you. If you are not sure, talk
to your doctor or pharmacist before
taking ARIPTOR.
_ _
_ _
_ _
_Pregnancy and lactation _
If you are pregnant or breast-feeding,
think
you
may
be
pregnant
or
are
planning
to
have
a
baby,
ask
your
doctor
for
advice
before
taking
this
medicine.
The following symptoms may occur in
newborn babies, of mothers that have
used Aripiprazole in the last trimester
(last three months of their pregnancy):
•
Shaking.
•
Muscle stiffness and/or weakness.
•
Sleepiness.
•
Agitation.
•
Breathing problems.
•
Difficulty in feeding.

Ciri produk

Proposed Prescribing Information
For the use of a Registered Medical Practitioner or a Hospital or a
Laboratory
ARIPTOR TABLET 5 MG
ARIPTOR TABLET 10 MG
ARIPTOR TABLET 15 MG
ARIPTOR TABLET 20 MG
ARIPIPRAZOLE TABLETS USP 5 MG, 10MG, 15 MG AND 20 MG
BRAND OR PRODUCT NAME
ARIPTOR TABLET 5 MG
ARIPTOR TABLET 10 MG
ARIPTOR TABLET 15 MG
ARIPTOR TABLET 20 MG
NAME AND STRENGTH OF ACTIVE SUBSTANCE(S)
ARIPTOR TABLET 5 MG
Each uncoated tablet contains:
Aripiprazole USP....................... 5 mg
Excipients .................... q.s.
ARIPTOR TABLET 10 MG
Each uncoated tablet contains:
Aripiprazole USP....................... 10mg
Excipients .................... q.s.
ARIPTOR TABLET 15 MG
Each uncoated tablet contains:
Aripiprazole USP....................... 15 mg
Excipients .................... q.s.
ARIPTOR TABLET 20 MG
Each uncoated tablet contains:
Aripiprazole USP....................... 20 mg
Excipients .................... q.s.
PRODUCT DESCRIPTION
ARIPTOR TABLET 5 MG
White to off-white, round uncoated tablets debossed with “5” on
one side and “17” on other side.
ARIPTOR TABLET 10 MG
White to off-white, round uncoated tablets debossed with “10” on
one side and “18” on other side.
ARIPTOR TABLET 15 MG
White to off-white, round uncoated tablets debossed with “15” on
one side and “19” on other side.
ARIPTOR TABLET 20 MG
White to off-white, round uncoated tablets debossed with “20” on
both sides.
DOSAGE FORM
Uncoated tablets
PHARMACODYNAMIC PROPERTIES
_Mechanism of action_
It has been proposed that aripiprazole's efficacy in schizophrenia and
Bipolar I Disorder is mediated
through a combination of partial agonism at dopamine D2 and serotonin
5HT1a receptors and
antagonism of serotonin 5HT2a receptors. Aripiprazole exhibited
antagonist properties in animal
models of dopaminergic hyperactivity and agonist properties in animal
models of dopaminergic
hypoactivity. Aripiprazole exhibited high binding affinity
_in vitro _
for dopamine D2 and D3,
serotonin 5HT1a and 5HT2a receptors and moderate affinity for