APO-ARIPIPRAZOLE 10 mg aripiprazole tablets blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

aripiprazole, Quantity: 10 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

aripiprazole

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: tartaric acid; microcrystalline cellulose; croscarmellose sodium; iron oxide red; magnesium stearate

Administration route:

Oral

Units in package:

30 and 100

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Aripiprazole is indicated for the treatment of schizophrenia including maintenance of clinical improvement during continuation therapy.,Acute treatment of manic or mixed episodes associated with Bipolar I Disorder in adults as monotherapy and in combination with lithium or valproate;,Maintenance treatment of manic or mixed episodes in Bipolar I Disorder in adults as monotherapy.

Product summary:

Visual Identification: Pink, rectangular, slightly biconvex tablets, engraved "10" on one side, "A" on the other side; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2009-07-09

Patient Information leaflet

APO- ARIPIPRAZOLE TABLETS
1
APO- ARIPIPRAZOLE
TABLETS
_Aripiprazole _
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE.
This leaflet answers some common
questions about aripiprazole. It does
not contain all the available
information.
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 using this medicine
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
This medicine contains the active
ingredient aripiprazole.
Aripiprazole belongs to a group of
medicines called antipsychotic
agents.
It is used to treat schizophrenia.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
This medicine is available only with
a doctor's prescription.
There is no evidence that this
medicine is addictive.
This medicine 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 THIS
MEDICINE
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
aripiprazole
•
any of the ingredients listed at the
end of this leaflet
•
Always check the ingredients to
make sure you can use this
medicine.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue,
throat or other parts of the body
•
rash, itching or hives on the skin
DO NOT BREASTFEED IF YOU ARE TAKING
THIS MEDICINE.
Aripiprazole passes into breast milk.
and there is a possibility that your
baby may be affected.
DO NOT TAKE THIS MEDICINE AFTER THE
EXPIRY DATE PRINTED ON THE PACK OR
IF THE PACKAGING IS TORN OR SHOWS
SIGNS OF TAMPERING.

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION -
APO- ARIPIPRAZOLE (ARIPIPRAZOLE) TABLETS
1
NAME OF THE MEDICINE
Aripiprazole.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2mg, 5mg, 10mg, 15mg, 20mg and 30mg aripiprazole
as the active
ingredient.
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
2 MG TABLETS
Green, rectangular, slightly biconvex tablets, engraved “2” on one
side, “A” on the other side.
5 MG TABLETS
Blue, rectangular, slightly biconvex tablets, engraved “5” on one
side, “A” on the other side.
10 MG TABLETS
Pink, rectangular, slightly biconvex tablets, engraved “10” on one
side, “A” on the other side.
15 MG TABLETS
Yellow, round, slightly biconvex tablets, engraved “ARI” over
“15” on one side, “APO” on the other
side.
20 MG TABLETS
White to off-white, round, slightly biconvex tablets, engraved
“ARI” over “20” on one side, “APO”
on the other side.
30 MG TABLETS
Pink, round, slightly biconvex tablets, engraved “ARI” over
“30” on one side, “APO” on the other
side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Aripiprazole is indicated for the treatment of schizophrenia including
maintenance of clinical
improvement during continuation therapy.
Although this document refers to the results of studies of
aripiprazole in conditions other than
schizophrenia, the APO- Aripiprazole tablets are not indicated for use
in the treatment of
conditions other than schizophrenia.
2
4.2
DOSE AND METHOD OF ADMINISTRATION
Aripiprazole tablets are intended for oral administration.
DOSAGE
ADULTS
Recommended Dosage – Schizophrenia
The recommended starting dose for aripiprazole
is 10 or 15 mg/day administered on a once-a-
day schedule without regard to meals. In clinical trial, doses in the
range of 10 to 30 mg/day have
been effective. Daily dosage may be adjusted with regard to individual
clinical status within the
range of 10-30 mg daily. Dosage increases should not be made prior to
the time needed to
achieve ste