ARIAN 15MG TABLETS (Aripiprazole USP 15mg Tablets)

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

ARIPIPRAZOLE

Boleh didapati daripada:

UNIMED SDN BHD

INN (Nama Antarabangsa):

ARIPIPRAZOLE

Unit dalam pakej:

100tablet Tablets; 30tablets Tablets

Dikeluarkan oleh:

Indoco Remedies Limited

Risalah maklumat

ARIAN TABLETS
Aripiprazole USP (10mg, 15mg, 20mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What ARIAN is used for
2.
How ARIAN works
3.
Before you use ARIAN
4.
How to use ARIAN
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of ARIAN
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT ARIAN IS USED FOR
ARIAN is one of a group of medicines
called antipsychotics. It is used to treat
schizophrenia
and
related
manic
disorders in patients who suffer from a
disease characterized by symptoms such
as
hearing,
seeing
or
sensing
things
which
are
not
there,
suspiciousness,
mistaken beliefs, incoherent speech and
behavior and emotional flatness. People
with
this
conditions
may
also
feel
depressed, guilty, anxious or tense.
HOW ARIAN
WORKS
ARIAN
works
by
acting
on
various
receptors
in
the
brain,
particularly
dopamine receptors and serotonin (5HT)
receptors. Dopamine and serotonin are
natural
compounds
called
neurotransmitters,
and
are
involved
in
transmitting
messages
between
brain
cells. Psychotic illness is considered to
be caused by disturbances in the activity
of neurotransmitters (mainly dopamine)
in the brain. Aripiprazole is thought to
work mainly by stabilising the dopamine
activity in the brain.
BEFORE YOU USE ARIAN
BEFORE YOU START TO USE IT
Talk to your doctor or pharmacist if you
have:
-
a history of excessive gambling or
other unusual urges (e.g. increased
sexual urges, binge or compulsive
eating, and compulsive shopping).
-
_When you must not use it _
_ _
_ _
_ _
_ _
DO NOT TAKE ARIAN:
If
you
are
allergic
(hypersensitive)
to
ARIAN or any of the other ingredients of
ARIAN.
_ _
_Pregnancy and lactation _
Pregnancy
Ask your doctor or pharmacist for advice
before taking any medicine.
Be sure to
tell your doctor immediately if you are
pregnant, think you may be pregnant, or
if you are planning to become pregnant.
Breastfeeding
Ask your doctor or pharmacist for advice
before taking any medicine.
If you are taking ARIAN

Ciri produk

Y:\A\Arian\Arian 10\malaysia\Current 23\Arian 10 mg\Arian mg Leaflet
2008567.cdr
Item: LEAFLET
Item Code:
2008567
Open Size: 110 x 260 mm
Folding Size: H:Unfolded:
mm Folded:
130 mm
260
W:Unfolded:
110
mm Folded:
27.
5 mm
GSM/ Paper:
40 gsm ITC Superfine paper
Colour: Black
Pharmacode: 257 std
9919934-002
Layout No.:
INDOCO REMEDIES LTD.
PACKAGING DEVELOPMENT DEPARTMENT
REASON FOR PREPARATION
/ REVISION
:
1) Text Change
Path
DATE: 16.01.23/ 18.01.23
Prepared by
Checked by
Approved by
R1
2008567
110 mm
260 mm
260 mm
110 mm
16 mm
130 mm
SMOKING STATUS
No dosage adjustment is required for smoking patients
relative to non-smoking patients.
ROUTE OF ADMINISTRATION
Oral
CONTRAINDICATION
Known hypersensitivity reaction to Aripiprazole tablets.
Reactions have ranged from pruritus/ urticarial to
anaphylaxis.
WARNING AND PRECAUTIONS
NEUROLEPTIC MALIGNANT SYNDROME (NMS)
A potentially fatal symptom complex sometimes referred to
as Neuroleptic Malignant Syndrome (NMS) has been
reported in association with administration of antipsychotic
drugs, including Aripiprazole. The management of NMS
should include:
1. Immediate discontinuation of antipsychotic drugs and
other drugs not essential to concurrent therapy.
2.
Intensive symptomatic treatment and medical
monitoring; and
3.
Treatment of any concomitant serious medical
problems for which specific treatments are available.
TARDIVE DYSKINESIA
If signs and symptoms of tardive dyskinesia appear in a
patient on Aripiprazole, drug discontinuation should be
considered. However, some patients may require
treatment with Aripiprazole despite the presence of the
syndrome.
HYPERGLYCEMIA AND DIABETES MELLITUS:
Hyperglycemia in some cases extreme and associated
with ketoacidosis
or hyperosmolar
coma or death in
patients treated with atypical antipsychotics. Assessment
of the relationship between atypical antipsychotics use
and glucose abnormalities is complicated by the possibility
of an increased background risk of diabetes mellitus in
patients with schizophrenia and the increasing inciden