ARIZOLE aripiprazole 15 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

aripiprazole, Quantity: 15 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

aripiprazole

Pharmaceutical form:

Tablet, uncoated

Composition:

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

Administration route:

Oral

Units in package:

28, 56, 30, 60

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, round shaped, uncoated tablets debossed with '64' 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

ARIZOLE
CONSUMER MEDICINE INFORMATION
Ver 1.1
Page 1 of 5
ARIZOLE 2, 5, 10, 15, 20 & 30
Aripiprazole
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ARIZOLE. 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 ARIZOLE
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 ARIZOLE IS USED FOR
ARIZOLE
belongs
to
a
group
of
medicines
called
antipsychotic
agents which improve the symptoms
of certain types of mental illness.
ARIZOLE is used to treat symptoms
of schizophrenia.
Schizophrenia
is
a
mental
illness
with
disturbances
in
thinking,
feelings and behaviour.
Your
doctor
may
have
prescribed
ARIZOLE for another reason. Ask
your
doctor
if
you
have
any
questions about why ARIZOLE has
been prescribed for you.
There is no evidence that ARIZOLE
is addictive.
This medicine is available only with
a doctor's prescription.
ARIZOLE 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 ARIZOLE
WHEN YOU MUST NOT TAKE IT
DO NOT TAKE ARIZOLE 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 ARIZOLE AFTER THE
EXPIRY OR USE BY DATE PRINTED ON
THE PACK.
If you take this medicine after this
date has passed, it may not work as
well.
DO
NOT
TAKE
ARIZOLE
IF
THE
PACKAGING IS TORN OR SHOWS SIGNS OF
TAMPERING.
If this is the case, return it to your

Summary of Product characteristics

Product Information:
ARIZOLE (Aripiprazole Tablets 2, 5, 10, 15, 20 & 30 mg) Ver 1.1
Page 1 of 28
PRODUCT INFORMATION
ARIZOLE 2 (ARIPIPRAZOLE 2 MG TABLETS)
ARIZOLE 5 (ARIPIPRAZOLE 5 MG TABLETS)
ARIZOLE 10 (ARIPIPRAZOLE 10 MG TABLETS)
ARIZOLE 15 (ARIPIPRAZOLE 15 MG TABLETS)
ARIZOLE 20 (ARIPIPRAZOLE 20 MG TABLETS)
ARIZOLE 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.
ARIZOLE is available as tablets containing 2, 5, 10, 15, 20 & 30 mg
aripiprazole.
ARIZOLE 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:
ARIZOLE (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,
aripiprazole.
Aripiprazole exhibited higher affinity binding
_in vitro _
for dopamine D
2
and D
3
, serot