Aripiprazole Sandoz

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Aripiprazole 15mg

Available from:

Sandoz New Zealand Limited

INN (International Name):

Aripiprazole 15 mg

Dosage:

15 mg

Pharmaceutical form:

Tablet

Composition:

Active: Aripiprazole 15mg Excipient: Hyprolose Iron oxide yellow Lactose monohydrate Magnesium stearate Maize starch Microcrystalline cellulose

Prescription type:

Prescription

Manufactured by:

Sandoz Private Limited

Therapeutic indications:

Indicated for the treatment of schizophrenia including maintenance of clinical improvement during continuation therapy.

Product summary:

Package - Contents - Shelf Life: Blister pack, Alu-Alu blisters in cardboard carton - 30 tablets - 24 months from date of manufacture stored at or below 30°C

Authorization date:

2017-05-05

Patient Information leaflet

ARIPIPRAZOLE SANDOZ
®
1
ARIPIPRAZOLE
SANDOZ
®
_Aripiprazole tablets _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Aripiprazole Sandoz.
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 risk of you taking Aripiprazole
Sandoz 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 want to read it again.
WHAT ARIPIPRAZOLE
SANDOZ IS USED FOR
_WHAT IT DOES _
Aripiprazole Sandoz belongs to a
group of medicines called
antipsychotic agents which improve
the symptoms of certain types of
mental illness.
Aripiprazole Sandoz is used to treat
symptoms of schizophrenia.
Aripiprazole Sandoz 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.
Schizophrenia is a mental illness
with disturbances in thinking,
feelings and behaviour.
Bipolar disorder is a condition with
symptoms such as feeling "high",
having excessive amounts of energy,
needing much less sleep than usual,
talking very quickly with racing
ideas and sometimes severe
irritability.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your
doctor may have prescribed it for
another reason.
There is no evidence that this
medicine is addictive. This medicine
is available only with a doctor's
prescription.
Aripiprazole Sandoz 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
ARIPIPRAZOLE SANDOZ
_WHEN YOU MUST NOT TAKE _
_ARIPIPRAZOLE SANDOZ _
Do not take Aripiprazole Sandoz if
you have an allergy to:
•
aripiprazole the active ingredient
or to any of the ingredients listed

Summary of Product characteristics

230320-aripiprazole sandoz-ds
Page 1 of 31
NEW ZEALAND DATA SHEET
ARIPIPRAZOLE SANDOZ
® (ARIPIPRAZOLE)
1.
PRODUCT NAME
Aripiprazole Sandoz 5 mg, 10 mg, 15 mg, 20 mg & 30 mg tablet.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Aripiprazole Sandoz tablet contains 5 mg, 10 mg, 15 mg, 20 mg or
30 mg aripiprazole.
_Excipients with known effect:_
Lactose monohydrate.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Tablet, uncoated
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.
•
for acute and maintenance treatment of manic and mixed episodes with
Bipolar I
Disorder with or without psychotic features.
•
as an adjunctive therapy to either lithium or valproate for the acute
treatment of manic
and mixed episodes associated with Bipolar I Disorder with or without
psychotic
features.
4.2.
D
OSE AND METHOD OF ADMINISTRATION
_ RECOMMENDED DOSAGE _
Schizophrenia
_Adults_
:
The
recommended
starting
dose
for
Aripiprazole
Sandoz
is
10
or
15
mg/day
administered on a once-a-day schedule without regard to meals. Doses
in the range of 10 to 30
230320-aripiprazole sandoz-ds
Page 2 of 31
mg/day have been effective in clinical trials. Dail