Abilimac 15 (Aripiprazole Tablets 15mg)

Țară: Malaezia

Limbă: engleză

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

Ingredient activ:

ARIPIPRAZOLE

Disponibil de la:

HEALOL PHARMACEUTICALS SDN. BHD.

INN (nume internaţional):

ARIPIPRAZOLE

Unități în pachet:

3 x 10 Tablets

Produs de:

Macleods Pharmaceuticals Limited

Prospect

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
ABILIMAC 10 (ARIPIPRAZOLE TABLETS 10MG)
ABILIMAC 15 (ARIPIPRAZOLE TABLETS 15MG)
Aripiprazole (10mg & 15mg)
1
WHAT IS IN THIS LEAFLET
1.
What Abilimac is used for
2.
How Abilimac works
3.
Before you use Abilimac
4.
How to use Abilimac
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
Abilimac
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
11.
Serial Number
WHAT IS ABILIMAC USED FOR
Abilimac
is
indicated
for
the
treatment of:
•
Acute
episodes
of
schizophrenia
(a
brain
disorder
where
people
interpret reality abnormally)
and
for
maintenance
of
clinical improvement during
continuation therapy.
•
Acute
manic
episodes
(uncontrollable
unusual
behaviour)
associated
with
Bipolar I Disorder (extreme
mood swings ranging from
episodes
of
depression
to
mania)
HOW ABILIMAC WORKS
Its exact mode of action is not fully
understood. Aripiprazole is thought to
work by affecting the activity of some
brain
chemicals
by
adjusting
the
activities
of
both
dopamine
and
serotonin.
BEFORE YOU USE ABILIMAC
_-When you must not use it _
Do
not
use
Abilimac
if
you
are
allergic
to
the
active
ingredient
Aripiprazole
or
any
inactive
ingredients listed in this leaflet
_ _
_ _
_-Before you start to use it _
Before treatment with Abilimac, tell
your doctor if you suffer from:
•
Neuroleptic
malignant
syndrome
(a
reaction
to
some medicines)
•
Tardive
dyskinesia
(a
reaction to some medicines
causing jerking movements
of the face and body)
•
Problems with your heart or
blood vessels
•
Low blood pressure
•
Problems with blood clots
•
Seizures (fits)
•
Alzheimer’s
disease
or
dementia
•
History of suicidal episodes
•
History
of
alcohol
and/or
drug abuse or dependence
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).
Talk to your doctor or pharmacist if
you:
•
Have
or
are
at
a
risk
of

Caracteristicilor produsului

ABILIMAC 15 (
ARIPIPRAZOLE TABLETS 15 MG)
No dosage adjustment is required for patients with hepatic impairment
(Child-Pugh Class A,
B, or C)
Pediatric
The safety and efficacy of Aripiprazole in patients under 18 years of
age have not been
established.
Elderly
No dosage adjustment is required for patients ≥ 65 years of age.
However, experience with
this patient population is limited.
Gender
No dosage adjustment is required for female patients relative to male
patients.
Patients taking medications metabolized by CYP2D6 or 3A4
Dosage adjustment for patients taking aripiprazole concomitantly with
potent CYP3A4 or
CYP2D6 inhibitors: When concomitant administration of a potent CYP3A4
or CYP2D6
inhibitor with aripiprazole occurs, the aripiprazole dose should be
reduced to one-half of the
usual dose. When the CYP3A4 or CYP2D6 inhibitor is withdrawn from the
combination
therapy, the aripiprazole dose should then be increased.
Dosage adjustment for patients taking potent CYP3A4 inducers: When a
potent CYP3A4
inducer is added to aripiprazole therapy, the aripiprazole dose should
be doubled. Additional
dose increases of aripiprazole should be based on clinical evaluation.
When the CYP3A4
inducer is withdrawn from the combination therapy, the aripiprazole
dose should be reduced.
Consideration should be given to reducing the daily dose in individual
patients who are on
multiple concomitant medications that inhibit CYP3A4 and CYP2D6
enzymes.
Smoking Status
No dosage adjustment is required for smoking patients relative to
non-smoking patients.
ROUTE OF ADMINISTRATION
Oral
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients.
WARNINGS AND PRECAUTIONS
During antipsychotic treatment, improvement in the patient's clinical
condition may take
several days to some weeks. Patients should be closely monitored
throughout this period.
The occurrence of suicidal behaviour is inherent in psychotic
illnesses and mood disorders
and in some cases has been reported early after initiation or switch
of antipsyc