AURO-ARIPIPRAZOLE 10 aripiprazole 10 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

aripiprazole, Quantity: 10 mg

Available from:

Strides Pharma Science Pty Ltd

INN (International Name):

aripiprazole

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: magnesium stearate; microcrystalline cellulose; maize starch; lactose monohydrate; hyprolose; colloidal anhydrous silica

Administration route:

Oral

Units in package:

28, 56, 60, 30

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Aripiprazole is indicated for the treatment of schizophrenia including maintenance of clinical improvement during continuation therapy.

Product summary:

Visual Identification: White coloured, modified rectangular shaped, uncoated tablets debossed with '63' on one side and 'H' on other side; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2013-08-09

Patient Information leaflet

AURO-ARIPIPRAZOLE
CONSUMER MEDICINE INFORMATION
Ver 1.1
Page 1 of 5
AURO-ARIPIPRAZOLE 2, 5, 10, 15, 20 & 30
Aripiprazole
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions
about
AURO-
ARIPIPRAZOLE.
It
does
not
contain all the available information.
Some of the information contained
in this leaflet may not apply to you.
It does not take the place of talking
to your doctor or pharmacist.
All
medicines
have
risks
and
benefits. Your doctor has weighed
the
risks
of
you
taking
AURO-
ARIPIPRAZOLE
against
the
benefits it is expected to have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING
THIS
MEDICINE,
ASK
YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT AURO-
ARIPIPRAZOLE IS USED FOR
AURO-ARIPIPRAZOLE belongs to
a
group
of
medicines
called
antipsychotic agents which improve
the
symptoms
of
certain
types
of
mental illness.
AURO-ARIPIPRAZOLE is used to
treat symptoms of schizophrenia.
Schizophrenia
is
a
mental
illness
with
disturbances
in
thinking,
feelings and behaviour.
Your
doctor
may
have
prescribed
AURO-ARIPIPRAZOLE for another
reason. Ask your doctor if you have
any
questions
about
why
AURO-
ARIPIPRAZOLE
has
been
prescribed for you.
There is no evidence that AURO-
ARIPIPRAZOLE is addictive.
This medicine is available only with
a doctor's prescription.
AURO-ARIPIPRAZOLE
is
not
recommended
for
use
in
children
under the age of 18, as safety and
efficacy have not been established in
this age group.
BEFORE YOU TAKE
AURO-ARIPIPRAZOLE
WHEN YOU MUST NOT TAKE IT
DO
NOT
TAKE
AURO-
ARIPIPRAZOLE IF YOU HAVE AN
ALLERGY TO:
•
aripiprazole
•
any of the ingredients listed at the
end of this leaflet
Symptoms
of
an
allergic
reaction
include:
•
rash, itching or hives on the skin
•
shortness of breath, wheezing or
difficulty breathing
•
swelling of the face, lips, tongue,
throat or other parts of the body
DO
NOT
TAKE
AURO-
ARIPIPRAZOLE AFTER THE EXPIRY
OR USE BY DATE PRINTED ON THE PACK.
If you take this medicine after this
date ha

Summary of Product characteristics

Product Information:
AURO-ARIPIPRAZOLE (Aripiprazole Tablets 2, 5, 10, 15, 20 & 30 mg) Ver
1.1
Page 1 of 28
PRODUCT INFORMATION
AURO-ARIPIPRAZOLE 2 (ARIPIPRAZOLE 2 MG TABLETS)
AURO-ARIPIPRAZOLE 5 (ARIPIPRAZOLE 5 MG TABLETS)
AURO-ARIPIPRAZOLE 10 (ARIPIPRAZOLE 10 MG TABLETS)
AURO-ARIPIPRAZOLE 15 (ARIPIPRAZOLE 15 MG TABLETS)
AURO-ARIPIPRAZOLE 20 (ARIPIPRAZOLE 20 MG TABLETS)
AURO-ARIPIPRAZOLE 30 (ARIPIPRAZOLE 30 MG TABLETS)
NAME OF THE MEDICINE
The name of the medicine is aripiprazole.
CHEMICAL NAME:
7-{4-[4-(2,3-dichlorophenyl)piperazin-1-yl]butoxy}-3,4-dihydroquinolin-2(1
_H_
)-one
MOLECULAR FORMULA:
C
23
H
27
Cl
2
N
3
O
2
MOLECULAR WEIGHT:
448.39
CAS REGISTRY NUMBER:
[129722-12-9]
DESCRIPTION
Aripiprazole is a novel antipsychotic agent with unique pharmacologic
properties and a chemical
structure that differs from current antipsychotic agents.
Since aripiprazole is insoluble in water with its equilibrium
solubility being about 0.00001% w/v, its
pKa was established in 20% aqueous ethanol pKa = 7.6 (20% ethanol, at
25°C). The partition
coefficients (P
o/w
) of aripiprazole range from 3.4 at pH 2.0 to > 1000 at pH 6.0.
AURO-ARIPIPRAZOLE is available as tablets containing 2, 5, 10, 15, 20
& 30 mg aripiprazole.
AURO-ARIPIPRAZOLE tablets contain the following inactive ingredients:
Lactose, microcrystalline
cellulose,
maize
starch,
hydroxypropylcellulose,
colloidal
anhydrous
silica,
magnesium
stearate,
indigo carmine CI73015 (2 mg & 5 mg tablets) & iron oxide yellow
CI77492 (2 mg tablets).
PHARMACOLOGY
PHARMACODYNAMICS
The mechanism of action of aripiprazole, as well as other drugs having
efficacy in schizophrenia, is
unknown. However, it has been proposed that the efficacy of
aripiprazole is mediated through a
Product Information:
AURO-ARIPIPRAZOLE (Aripiprazole Tablets 2, 5, 10, 15, 20 & 30 mg) Ver
1.1
Page 2 of 28
combination of partial agonist activity at dopamine D
2
and serotonin 5HT
1A
receptors and antagonist
activity at serotonin 5HT
2A
receptors.
Aripiprazole activity is primarily due to the parent drug,
aripi