APO-ATOMOXETINE atomoxetine (as hydrochloride) 25 mg capsule blister

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

atomoxetine hydrochloride, Quantity: 28.5 mg (Equivalent: atomoxetine, Qty 25 mg)

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

Atomoxetine hydrochloride

Pharmaceutical form:

Capsule, hard

Composition:

Excipient Ingredients: iron oxide yellow; Gelatin; titanium dioxide; pregelatinised maize starch; indigo carmine; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide

Administration route:

Oral

Units in package:

28 capsules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

For the treatment of Attention Deficit Hyperactivity Disorder (ADHD) as defined by DSM-IV criteria in children 6 years of age and older, adolescents and adults.

Product summary:

Visual Identification: Hard gelatin capsule, white opaque body and blue opaque cap, printed in black APO AM25, containing white to off white powder; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2017-09-29

Patient Information leaflet

APO-ATOMOXETINE Capsules
1
APO-ATOMOXETINE
CAPSULES
_Contains the active ingredient atomoxetine (as hydrochloride) _
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about atomoxetine. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
last page. More recent information on
this medicine may be available.
ASK YOUR DOCTOR OR PHARMACIST:
•
if there is anything you do not
understand in this leaflet,
•
if you are worried about taking
your medicine, or
•
to obtain the most up-to-date
information.
You can also download the most up
to date leaflet from
www.apotex.com.au.
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.
Pharmaceutical companies cannot
give you medical advice or an
individual diagnosis.
Keep this leaflet. You may want to
read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is APO-
Atomoxetine capsules. It contains the
active ingredient atomoxetine (as
hydrochloride).
It is used to treat Attention Deficit
Hyperactivity Disorder (ADHD) in
children 6 years and older,
adolescents and adults. ADHD is a
behavioural disorder that causes lack
of focus and/or hyperactivity that is
much more frequent or severe than
others who are close in age or
development.
Atomoxetine works by acting on
brain chemicals called amines which
are involved in controlling
behaviour.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN CHOSEN FOR YOU. YOUR
DOCTOR MAY HAVE GIVEN YOU THIS
MEDICINE FOR ANOTHER REASON.
There is no evidence that this
medicine is addictive.
This medicine is available only with
a doctor's prescription.
BEFORE YOU ARE GIVEN
THIS MEDICINE
_WHEN YOU MUST NOT BE GIVEN _
_IT _
YOU MUST NOT BE GIVEN THIS
MEDICINE IF:
•
YO

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
APO- ATOMOXETINE (ATOMOXETINE HYDROCHLORIDE)
CAPSULES
WARNINGS
SHORT-TERM PLACEBO CONTROLLED STUDIES EVALUATED OVER 2200 CHILDREN AND
ADOLESCENTS
WITH ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD). AMONG THE 1357
PATIENTS ON
ATOMOXETINE, THERE WAS A POSITIVE SIGNAL FOR SUICIDAL THOUGHTS (5
PATIENTS) AND
BEHAVIOURS (1 PATIENT) IN CHILDREN 12 YEARS OF AGE AND YOUNGER
COMPARED TO PLACEBO
(0/851).
NO
SUICIDES
OCCURRED
IN
THESE
TRIALS.
ANYONE
CONSIDERING
THE
USE
OF
ATOMOXETINE IN CHILDREN MUST BALANCE THE RISK OF SUICIDALITY (SUICIDAL
THOUGHTS OR
BEHAVIOURS) AGAINST THE CLINICAL NEED. PATIENTS WHO ARE STARTED ON
ATOMOXETINE
SHOULD BE CLOSELY MONITORED FOR SUICIDALITY (SEE SECTION 4.4 SPECIAL
WARNINGS AND
PRECAUTIONS FOR USE).
1
NAME OF THE MEDICINE
Atomoxetine hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg or 100
mg of atomoxetine (as
hydrochloride), as the active ingredient.
EXCIPIENTS WITH KNOWN EFFECT
Gelatin (may contain trace amounts of sulfites)
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Atomoxetine hydrochloride is available as capsules for oral
administration. The capsules
contain a white to off-white powder.
10 MG CAPSULES:
Hard gelatin capsule, white opaque body and white opaque cap, printed
in black APO AM10,
containing white to off-white powder.
18 MG CAPSULES:
Hard gelatin capsule, white opaque body and gold opaque cap, printed
in black APO AM18,
containing white to off-white powder.
25 MG CAPSULES:
Hard gelatin capsule, white opaque body and blue opaque cap, printed
in black APO AM25,
containing white to off-white powder.
40 MG CAPSULES:
Hard gelatin capsule, blue opaque body and blue opaque cap, printed in
black APO AM40,
containing white to off-white powder.
2
60 MG CAPSULES:
Hard gelatin capsule, gold opaque body and blue opaque cap, printed in
black APO AM60,
containing white to off-white powder.
80 MG CAPSULES:
Hard gelatin capsule, white opaque b