ARILIFT 10mg Tablets

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

ARIPIPRAZOLE

Boleh didapati daripada:

GENPHARMA SDN. BHD

INN (Nama Antarabangsa):

ARIPIPRAZOLE

Unit dalam pakej:

30 Tablets

Dikeluarkan oleh:

Alembic Pharmaceuticals Limited (Formulation Division)

Risalah maklumat

ARILIFT TABLETS
_ _
_Aripiprazole_
(10mg, 15mg)
_ _
_ _
1
_ _
_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What is ARILIFT used for
2.
How ARILIFT works
3.
Before you use ARILIFT
4.
How to use ARILIFT
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of ARILIFT
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
11.
Serial Number
WHAT ARILIFT IS USED FOR
ARILIFT is indicated for the treatment
of:
•
Schizophrenia
(a
severe
brain
disorder in which people interpret
reality
abnormally)
and
for
maintenance of
clinical
improvement.
•
Acute
manic
episodes
(uncontrollable
excitement
that
causes
unusual
behaviour)
associated with Bipolar 1 Disorder
(extreme
mood
swings
ranging
from
episodes
of
depression
to
mania).
HOW ARILIFT WORKS
The exact way Aripiprazole works is
not known but it attaches in the brain to
receptors
for
two
substances
(neurotransmitters)
called
dopamine
and
serotonin
(5HT),
which
are
believed to play a role in schizophrenia
and bipolar disorder. By attaching to
these
receptors
it
is
thought
that
Aripiprazole
helps
normalize
the
activity of the brain, reducing psychotic
or
manic
symptoms
and
preventing
them from returning.
BEFORE YOU USE ARILIFT
-
_When you must not use it _
Do not use ARILIFT if:
•
You are allergic (hypersensitive) to
_Aripiprazole_
or
any of
the other
ingredients of
_Aripiprazole_
Tablet
(see section
PRODUCT DESCRIPTION
).
_Pregnancy and breastfeeding _
_ _
Tell your doctor if you are pregnant,
think that you may be pregnant or are
planning to become pregnant. Do not
take
ARILIFT
until
you
and
your
doctor
have
discussed
the
risks
and
benefits involved.
The
following
extrapyramidal
and/or
withdrawal
symptoms
may
occur
in
newborn babies, of mothers that have
used ARILIFT in the last trimester (last
three months of their pregnancy):
•
Agitation.
•
Muscle stiffness and/or weakness.
•
Shaking.
•
Sleepiness.
•
Breathing problems.
•
Difficulty in feeding.
If
your
baby
develops
any
of
th

Ciri produk

1
1.
NAME OF THE MEDICINAL PRODUCT
ARILIFT 10 mg tablets
ARILIFT 15 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ARILIFT 10 mg tablets
Each Uncoated Tablet contains:
Aripiprazole 10 mg
Excipients q.s.
ARILIFT 15 mg tablets
Each Uncoated Tablet contains:
Aripiprazole 15 mg
Excipients q.s.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
ARILIFT 10 mg tablets
Pink color, modified rectangular shaped, uncoated mottled tablets
debossed with ‘252’ on one side and
plain on other side.
ARILIFT 15 mg tablets
Yellow color, round shaped, beveled edge, uncoated mottled tablets
debossed with‘253’ on one side
and plain on other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
I.
For
the
treatment
of
acute
episodes
of
schizophrenia
and
for
maintenance
of
clinical
improvement during continuation therapy
II.
For the treatment of acute manic episodes associated with Bipolar I
Disorder.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Mode of administration
Oral
Instructions for Use
May be taken with or without food.
Posology
_Adults _
_Schizophrenia_
: The recommended starting dose for Aripiprazole is 10 or 15 mg/day
administered
on a once a day schedule without regard to meals. The maintenance dose
for Aripiprazole is 15
2
mg/day. Doses in the range of 10 to 30 mg/day have been established as
effective.
_Bipolar Mania: _
The recommended starting and target dose for Aripiprazole is 15 mg
given once a day, without regard to meals. The dose can be increased
to 30 mg/day based
on clinical response. Dose adjustments, if indicated, should occur at
intervals of not less
than 24 hours. Anti-manic efficacy (3-12 weeks) was demonstrated in
doses of 15 or 30
mg/day. The safety of doses above 30 mg/day has not been evaluated.
_Special Populations _
Renal impairment: No dosage adjustment is required in patients with
renal impairment.
Hepatic impairment: No dosage adjustment is required for patients with
hepatic impairment (Child-
Pugh Class A, B, or C).
Pediatric: The safety and efficacy of A