ABILIFY aripiprazole 15mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

aripiprazole, Quantity: 15 mg

Available from:

Otsuka Australia Pharmaceutical Pty Ltd

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: magnesium stearate; hyprolose; iron oxide yellow; maize starch; microcrystalline cellulose; lactose monohydrate

Administration route:

Oral

Units in package:

7 tablets, 60 tablets, 14 tablets, 10 tablets, 98 tablets, 30 tablets, 90 tablets, 20 tablets, 28 tablets, 5 tablets, 56 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

- ABILIFY 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: Yellow, round tablets, debossed on one side with "A-009" and "15".; 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 30 degrees Celsius

Authorization status:

Registered

Authorization date:

2003-05-21

Patient Information leaflet

ABILIFY™
A
B
I
L
I
F
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™
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING ABILIFY?
ABILIFY contains the active ingredient aripiprazole. ABILIFY is used
to treat symptoms of schizophrenia. ABILIFY may be given
to treat acute episodes of sustained upward mood swings (mania) in
adult patients with Bipolar 1 Disorder. During mania, patients
experience episodes of overactivity, elation or irritability.
For more information, see Section 1. Why am I using ABILIFY? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE ABILIFY?
Do not use if you have ever had an allergic reaction to ABILIFY or any
of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
ABILIFY? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with ABILIFY and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE ABILIFY?
•
Unless your doctor gives you other directions, you should take ABILIFY
only once a day.
•
Take ABILIFY at about the same time each day.
More instructions can be found in Section 4. How do I use ABILIFY? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING ABILIFY?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
ABILIFY.
•
If you become pregnant while taking ABILIFY, tell your doctor
immediately.
THINGS YOU
SHOULD NOT DO
•
Do not give ABILIFY to anyone else, even if their symptoms seem
similar or they have the same
condition as you.
•
Do not stop taking ABILIFY or lower the dosage, even if you are
feeling better, without checking with your
doctor.
DRIVING
OR USING
MACHINES
•
Make sure that you know how you react t

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – ABILIFY
TM
(ARIPIPRAZOLE) TABLETS
1
NAME OF THE MEDICINE
Aripiprazole
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet of Abilify contains aripiprazole as the active ingredient.
Abilify is available in 2
mg , 5 mg, 10 mg, 15 mg , 20 mg , and 30 mg tablets.
Abilify
tablets contain lactose monohydrate. For the full list of excipients,
see Section 6.1 List
of excipients.
3
PHARMACEUTICAL FORM
Abilify (aripiprazole) is available as:
2 mg green, unscored, modified rectangular, shallow convex,
bevel-edged, tablets, marked on
one side with “A-006” and “2”;
5 mg blue, unscored, modified rectangular, shallow convex,
bevel-edged, tablets, marked on
one side with “A-007” and “5”;
10 mg pink, unscored, modified rectangular, shallow convex,
bevel-edged, tablets, marked on
one side with “A-008” and “10”;
15 mg yellow, unscored, round, shallow convex, bevel-edged, tablets,
marked on one side with
“A-009” and “15”;
20 mg white to pale yellowish white, unscored, round, shallow convex,
bevel-edged, tablets,
marked on one side with “A-010” and “20”;
30 mg pink, unscored, round, shallow convex, bevel-edged, tablets,
marked on one side with
“A-011” and “30”.
Not all presentations may be available in Australia.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Abilify is indicated for the treatment of schizophrenia including
maintenance of clinical
improvement during continuation therapy.
2
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.
4.2
DOSE AND METHOD OF ADMINISTRATION
RECOMMENDED DOSAGE
_SCHIZOPHRENIA _
ADULTS
The recommended starting dose for Abilify tablets is 10 or 15 mg/day
administered orally on
a once-a-day schedule without regard to meals. Doses in the range of
10 to 30 mg/day have
been effective in clinical trials. Daily dosage may be