TEVARIPIPRAZOLE aripiprazole 10 mg uncoated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

aripiprazole, Quantity: 10 mg

Available from:

Teva Pharma Australia Pty Ltd

INN (International Name):

aripiprazole

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: lactose monohydrate; microcrystalline cellulose; maize starch; iron oxide red; hyprolose; croscarmellose sodium; magnesium stearate

Administration route:

Oral

Units in package:

30 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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

Product summary:

Visual Identification: Aripiprazole tablets 10 mg are pink to light pink coloured, oblong tablets with debossed 10 on one side and breakline on the 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

Authorization status:

Licence status A

Authorization date:

2016-03-10

Patient Information leaflet

TEVARIPIPRAZOLE
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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 TEVARIPIPRAZOLE?
TEVARIPIPRAZOLE contains the active ingredient aripiprazole.
TEVARIPIPRAZOLE is used to treat symptoms of schizophrenia.
For more information, see Section 1. Why am I using TEVARIPIPRAZOLE?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE TEVARIPIPRAZOLE?
Do not use if you have ever had an allergic reaction to
TEVARIPIPRAZOLE 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
TEVARIPIPRAZOLE? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with TEVARIPIPRAZOLE 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 TEVARIPIPRAZOLE?
•
Unless your doctor gives you other directions, you should take
TEVARIPIPRAZOLE only once a day.
•
Take TEVARIPIPRAZOLE at about the same time each day
More instructions can be found in Section 4. How do I use
TEVARIPIPRAZOLE? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING TEVARIPIPRAZOLE?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
TEVARIPIPRAZOLE.
•
If you become pregnant while taking TEVARIPIPRAZOLE, tell your doctor
immediately.
THINGS YOU
SHOULD NOT DO
•
Do not give TEVARIPIPRAZOLE to anyone else, even if their symptoms
seem similar or they have the
same condition as you.
•
Do not stop taking TEVARIPIPRAZOLE 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 to TEVARIPIPRAZOLE before you
drive a car, operate
m

Summary of Product characteristics

Teva Pharma Australia Pty Limited Ver 5 1
AUSTRALIAN PRODUCT INFORMATION – TEVARIPIPRAZOLE
®
(ARIPIPRAZOLE) TABLETS
1
NAME OF THE MEDICINE
Aripiprazole
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tevaripiprazole tablets contain Aripiprazole as the active ingredient.
Tevaripiprazole tablets are available as 5
mg, 10 mg, 15 mg, 20 mg or 30 mg tablets.
Excipients with known effect: Sugars as lactose.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Tevaripiprazole 5 mg
uncoated tablet:
Light yellow coloured round flat faced bevelled edge tablet with
debossed ‘5’ on one
side and plain on the other side.
Tevaripiprazole
10
mg uncoated tablet:
Pink to light pink coloured, oblong tablet with debossed ‘10’ on
one side and breakline
on the other side.
Tevaripiprazole
15
mg uncoated tablet:
Light yellow coloured, round flat faced bevelled edge tablet with
debossed ‘15’ on one
side and breakline on the other side.
Tevaripiprazole
20
mg uncoated tablet
White to off white or pale cream coloured, capsule shaped biconvex
tablet with
debossed ‘20’ on one side and breakline on the other side.
Tevaripiprazole
30
mg uncoated tablet:
Pink to light pink coloured, round biconvex tablet with debossed
‘30’ on one side and
breakline on the other side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Tevaripiprazole is indicated for the treatment of schizophrenia
including maintenance of clinical
improvement during continuation therapy.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Tevaripiprazole is available as 5 mg, 10 mg, 15 mg, 20 mg and 30 mg
tablets for oral administration.
Teva Pharma Australia Pty Limited Ver 5 2
RECOMMENDED DOSAGE
SCHIZOPHRENIA
_Adults _
The recommended starting dose for aripiprazole
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 adjusted on the basis of
individual clinical status within the range of 10
to