ARIPIPRAZOLE GENERICHEALTH aripiprazole 30 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

aripiprazole, Quantity: 30 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: microcrystalline cellulose; iron oxide red; tartaric acid; croscarmellose sodium; magnesium stearate

Administration route:

Oral

Units in package:

30 and 100

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Aripiprazole 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: Pink, round, slightly biconvex tablets, engraved "ARI" over "30" on one side, "APO" on the other side; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2019-07-08

Patient Information leaflet

ARIPIPRAZOLE GENERICHEALTH TABLETS
1
CONSUMER MEDICINE INFORMATION
ARIPIPRAZOLE GENERICHEALTH
TABLETS
_Aripiprazole _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE.
This leaflet answers some common
questions about aripiprazole. 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 risks of you using this medicine
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
This medicine contains the active
ingredient aripiprazole.
Aripiprazole belongs to a group of
medicines called antipsychotic
agents.
It is used to treat schizophrenia.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
This medicine is available only with
a doctor's prescription.
There is no evidence that this
medicine is addictive.
This medicine 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 THIS
MEDICINE
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
aripiprazole
•
any of the ingredients listed at the
end of this leaflet
•
Always check the ingredients to
make sure you can use this
medicine.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue,
throat or other parts of the body
•
rash, itching or hives on the skin
DO NOT BREASTFEED IF YOU ARE TAKING
THIS MEDICINE.
Aripiprazole passes into breast milk.
and there is a possibility that your
baby may be affected.
DO NOT TAKE THIS MEDICINE AFTER THE
EXPIRY DATE PRINTED ON THE PACK OR
IF THE PACKAGING IS TORN OR SHOWS
SIGNS OF TAMPERING.
If it has

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION – ARIPIPRAZOLE GENERICHEALTH
(ARIPIPRAZOLE) TABLETS
1
NAME OF THE MEDICINE
Aripiprazole.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg, 10 mg, 15 mg, 20 mg and 30 mg aripiprazole
as the active ingredient.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
5 MG TABLETS
Blue, rectangular, slightly biconvex tablets, engraved “5” on one
side, “A” on the other side.
10 MG TABLETS
Pink, rectangular, slightly biconvex tablets, engraved “10” on one
side, “A” on the other side.
15 MG TABLETS
Yellow, round, slightly biconvex tablets, engraved “ARI” over
“15” on one side, “APO” on the other side.
20 MG TABLETS
White to off-white, round, slightly biconvex tablets, engraved
“ARI” over “20” on one side, “APO” on the
other side.
30 MG TABLETS
Pink, round, slightly biconvex tablets, engraved “ARI” over
“30” on one side, “APO” on the other side.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Aripiprazole
is
indicated
for
the
treatment
of
schizophrenia
including
maintenance
of
clinical
improvement during continuation therapy.
Although this document refers to the results of studies of
aripiprazole in conditions other than
schizophrenia, the Aripiprazole generichealth tablets are not
indicated for use in the treatment of
conditions other than schizophrenia.
4.2 DOSE AND METHOD OF ADMINISTRATION
Aripiprazole tablets are intended for oral administration.
Aripiprazole generichealth v0.1
Page 2 of 32
(aripiprazole) tablets
DOSAGE
Adults
_Recommended Dosage – Schizophrenia _
The recommended starting dose for aripiprazole
is 10 or 15 mg/day administered on a once-a-day
schedule without regard to meals. In clinical trial, doses in the
range of 10 to 30 mg/day have been
effective. Daily dosage may be adjusted with regard to individual
clinical status within the range of 10-
30 mg daily. Dosage increases should not be made prior to the time
needed to achieve steady state, 2
weeks.
There
is