ARIPIPRAZOLE GH aripiprazole 10 mg tablet blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
24-08-2020
Summary of Product characteristics
(SPC)
24-08-2020
Public Assessment Report
(PAR)
29-11-2017
Active ingredient:
aripiprazole, Quantity: 10 mg
Available from:
Generic Health Pty Ltd
INN (International Name):
aripiprazole
Pharmaceutical form:
Tablet, uncoated
Composition:
Excipient Ingredients: lactose monohydrate; microcrystalline cellulose; maize starch; hyprolose; magnesium stearate
Administration route:
Oral
Units in package:
30 (3 Blisters each containing 10 tablets)
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
Aripiprazole GH 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: White, oval-shaped, biconvex bevelled edgeduncoated tablets, plain on both sides; 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:
Licence status A
Authorization date:
2011-11-18
Patient Information leaflet
Aripiprazole GH
CMI v4.0
Page 1 of 4
CONSUMER MEDICINE INFORMATION
ARIPIPRAZOLE GH
_aripiprazole _
WHAT IS IN THIS LEAFLET?
This leaflet answers some common
questions about Aripiprazole GH. 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 Aripiprazole GH against
the benefits it is expected to have for
you.
IF YOU HAVE CONCERNS ABOUT TAKING
THIS MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
Keep this leaflet with the medicine as
you may need to read it again.
WHAT IS ARIPIPRAZOLE GH?
Aripiprazole (Ari-pip-rah-zol) belongs
to a group of medicines called
antipsychotic agents.
Aripiprazole GH is used to treat
symptoms of Schizophrenia.
Schizophrenia is a mental illness with
disturbances in thinking, feelings and
behaviour.
Ask your doctor if you have any
questions about why this medicine
has been prescribed for you.
There is no evidence that
Aripiprazole GH is addictive.
This medicine is available only with a
doctor’s prescription.
Aripiprazole GH is not recommended
for use in children under the age of
18, as safety and efficacy has not
been established in this age group.
BEFORE TAKING ARIPIPRAZOLE GH
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE ARIPIPRAZOLE GH IF YOU
HAVE AN ALLERGY TO:
•
aripiprazole;
•
any ingredients listed at the
end of this leaflet.
Symptoms of an allergic reaction
include:
•
rash, itching, or hives on the
skin;
•
shortness of breath, wheezing
or difficulty breathing;
•
swelling of the face, lips,
tongue, throat or other parts of
the body.
Do not take Aripiprazole GH after the
expiry date printed on the pack as it
may not work as well.
Do not take Aripiprazole GH if the
packaging is torn or show signs of
tampering. If this is the case, return it
to your pharmacist.
If you are not sure whether you
should start taking this medicine, talk
to your doctor or pharmacist.
_
Read the complete document
Summary of Product characteristics
AUSTRALIAN PRODUCT INFORMATION – ARIPIPRAZOLE GH
(ARIPIPRAZOLE) TABLET, UNCOATED
1
NAME OF THE MEDICINE
Aripiprazole
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg, 10 mg, 15 mg, 20 mg or 30 mg aripiprazole.
List of excipients with known effects: lactose monohydrate.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Aripiprazole GH is available in the following forms:
Aripiprazole GH 5 mg tablets:
White, round, biconvex bevelled edged uncoated tablets plain on both
sides.
Aripiprazole GH 10 mg tablets:
White, oval-shaped, biconvex bevelled edged uncoated tablets plain on
both sides.
Aripiprazole GH 15 mg tablets:
White, round, biconvex bevelled edged uncoated tablets plain on both
sides.
Aripiprazole GH 20 mg tablets:
White, round, biconvex uncoated tablets plain on both sides.
Aripiprazole GH 30 mg tablets:
White, round, biconvex bevelled edged uncoated tablets plain on both
sides.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Aripiprazole GH is indicated for the treatment of schizophrenia
including maintenance of clinical
improvement during continuation therapy.
4.2 DOSE AND METHOD OF ADMINISTRATION
RECOMMENDED DOSAGE
Aripiprazole GH v5
Page 2 of 29
(aripiprazole) tablet, uncoated
SCHIZOPHRENIA
Adults
The recommended starting dose for aripiprazole tablets 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 in
clinical trials. Daily dosage may be adjusted on the basis of
individual clinical status within the range of
10-30 mg daily. Dosage increases should not be made before 2 weeks,
the time needed to achieve
steady state. There is no evidence that doses higher than 15 mg/day
are more effective than the
recommended starting dose of 10-15 mg.
The maintenance dose for aripiprazole is 15 mg/day.
RENAL IMPAIRMENT
No dosage adjustment is required for adult patients with renal
impairment.
HEPATIC IMPAIRMENT
No dosage adjustment is required for adult patients wi
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