Abilify
Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Patient Information leaflet
(PIL)
28-04-2021
Summary of Product characteristics
(SPC)
24-11-2020
Active ingredient:
Aripiprazole 15mg;
Available from:
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
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
Units in package:
Blister pack, AL/AL - 5 tablets, 5 tablets
Class:
Prescription
Prescription type:
Prescription
Manufactured by:
Otsuka Pharmaceutical Co Ltd
Therapeutic indications:
ABILIFY is indicated of the treatment of schizophrenia including maintenance of clinical improvement during continuation therapy.
Product summary:
Package - Contents - Shelf Life: Blister pack, Al/Al - 5 tablets - 3 years from date of manufacture stored at or below 30°C - Blister pack, Al/Al - 7 tablets - 3 years from date of manufacture stored at or below 30°C - Blister pack, Al/Al - 10 tablets - 3 years from date of manufacture stored at or below 30°C - Blister pack, Al/Al - 14 tablets - 3 years from date of manufacture stored at or below 30°C - Blister pack, Al/Al - 20 tablets - 3 years from date of manufacture stored at or below 30°C - Blister pack, Al/Al - 28 tablets - 3 years from date of manufacture stored at or below 30°C - Blister pack, Al/Al - 30 tablets - 3 years from date of manufacture stored at or below 30°C - Blister pack, Al/Al - 56 tablets - 3 years from date of manufacture stored at or below 30°C - Blister pack, Al/Al - 60 tablets - 3 years from date of manufacture stored at or below 30°C - Blister pack, Al/Al - 90 tablets - 3 years from date of manufacture stored at or below 30°C - Blister pack, Al/Al - 98 tablets - 3 years from date of manufacture stored at or below 30°C
Authorization date:
2006-08-18
Patient Information leaflet
ABILIFY™
1
ABILIFY™
5mg, 10mg, 15mg, 20mg & 30mg tablet
Aripiprazole
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common
questions about ABILIFY. It does
not contain all the available
information. Some of the information
contained in this leaflet may not
apply to you.
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 taking ABILIFY
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 need to read it again.
What ABILIFY is used
for
ABILIFY is a trade name
(manufacturer's name) for the
medicine aripiprazole (Ari-pip-rah-
zol).
ABILIFY belongs to a group of
medicines called antipsychotic agents
which improve the symptoms of
certain types of mental illness.
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.
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.
Your doctor may have prescribed
ABILIFY for another reason. Ask
your doctor if you have any questions
about why ABILIFY has been
prescribed for you.
There is no evidence that ABILIFY
is addictive.
This medicine is available only with
a doctor's prescription.
ABILIFY 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
ABILIFY
When you must not take it
Do not take ABILIFY if you have
an allergy to:
aripiprazole
any of the ingredients listed at the
Read the complete document
Summary of Product characteristics
New Zealand Data sheet
NZ_DS_Abilify_V6.0_ February 2022
Page 1 of 34
1
ABILIFY
TM TABLETS
Abilify
TM
5 mg, 10 mg, 15 mg, 20 mg & 30 mg tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Aripiprazole.
Each tablet contains 5 mg, 10 mg, 15 mg, 20 mg or 30 mg of
aripiprazole.
Excipient with known effect: Lactose monohydrate
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Abilify (aripiprazole) is available as:
5 mg blue, modified rectangular, shallow convex, bevel-edged, tablets,
marked on one side
with “A-007” and “5”;
10 mg pink, modified rectangular, shallow convex, bevel-edged,
tablets, marked on one side
with “A-008” and “10”;
15 mg yellow, round, shallow convex, bevel-edged, tablets, marked on
one side with “A-009”
and “15”;
20 mg white to pale yellowish white, round, shallow convex,
bevel-edged, tablets, marked on
one side with “A-010” and “20”;
30 mg pink, round, shallow convex, bevel-edged, tablets, marked on one
side with “A-011”
and “30”.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Abilify is indicated for the treatment of schizophrenia including
maintenance of clinical
improvement during continuation therapy.
Abilify monotherapy is indicated for acute and maintenance treatment
of manic and mixed
episodes with Bipolar I Disorder with or without psychotic features.
Abilify is indicated 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
DOSE AND METHOD OF ADMINISTRATION
_RECOMMENDED DOSAGE _
SCHIZOPHRENIA
ADULTS
The recommended starting dose for Abilify 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
mg/day have been effective
New Zealand Data sheet
NZ_DS_Abilify_V6.0_ February 2022
Page 2 of 34
in clinical trials. Daily dosage may be adjusted on the basis of
individual clinical status within
the range of 10 to 30 mg daily. Dosage increases sho
Read the complete document
