ARIPIPRAZOLE SANDOZ 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:

Sandoz Pty Ltd

INN (International Name):

aripiprazole

Pharmaceutical form:

Tablet, uncoated

Composition:

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

Administration route:

Oral

Units in package:

30

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of schizophrenia including maintenance of clinical improvement during continuation therapy.

Product summary:

Visual Identification: Yellow colored, mottled, round shaped tablets, debossed with 'SZ' on one side and '447' on the other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

2010-04-18

Patient Information leaflet

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

Summary of Product characteristics

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Page 1 of 31
AUSTRALIAN PRODUCT INFORMATION
ARIPIPRAZOLE SANDOZ
® (ARIPIPRAZOLE) TABLETS
1
NAME OF THE MEDICINE
Aripiprazole
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Aripiprazole Sandoz
®
5 mg tablet contains 5 mg Aripiprazole.
Each Aripiprazole Sandoz
®
10 mg tablet contains 10 mg Aripiprazole.
Each Aripiprazole Sandoz
®
15 mg tablet contains 15 mg Aripiprazole.
Each Aripiprazole Sandoz
®
20 mg tablet contains 20 mg Aripiprazole.
Each Aripiprazole Sandoz
®
30 mg tablet contains 30 mg Aripiprazole.
_Excipients with known effect: _
Each tablet contains lactose monohydrate.
For the full list of excipients, see Section 6.1 List of excipients.
_Not all strengths may be marketed in Australia. _
3
PHARMACEUTICAL FORM
Aripiprazole Sandoz 5 mg tablets are blue, mottled, round shaped
tablets, debossed with ‘SZ’
on one side and ‘444’ on the other side.
Aripiprazole Sandoz 10 mg tablets are pink, mottled, round shaped
tablets, debossed with ‘SZ’
on one side and ‘446’ on the other side.
Aripiprazole Sandoz 15 mg tablets are yellow, mottled, round shaped
tablets, debossed with
‘SZ’ on one side and ‘447’ on the other side.
Aripiprazole Sandoz 20 mg tablets are white, round shaped tablets,
debossed with ‘SZ’ on one
side and ‘448’ on the other side.
Aripiprazole Sandoz 30 mg tablets are pink, mottled, round shaped
tablets, debossed with ‘SZ’
on one side and ‘449’ on the other side.
_ _
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Aripiprazole Sandoz is indicated for the treatment of schizophrenia
including maintenance of
clinical improvement during continuation therapy.
4.2
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
_SCHIZOPHRENIA _
_ADULTS _
The recommended starting dose for aripiprazole is 10 or 15 mg/day.
Doses in the range of 10
to 30 mg/day have been effective in clinical trials. Daily dosage may
be adjusted on the basis
210624-Aripiprazole Sandoz-pi
Page 2 of 31
of individual clinical status within the range of 10-30 mg daily.
Dosage i