APO-ATOMOXETINE atomoxetine (as hydrochloride) 40 mg capsule blister pack

Šalis: Australija

kalba: anglų

Šaltinis: Department of Health (Therapeutic Goods Administration)

Veiklioji medžiaga:

atomoxetine hydrochloride

Prieinama:

Apotex Pty Ltd

INN (Tarptautinis Pavadinimas):

Atomoxetine hydrochloride

Autorizacija statusas:

Registered

Pakuotės lapelis

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:
•
YOU HAVE OR HAVE HAD ANY OF
THE

Prekės savybės

Product Information – Australia
APO-Atomoxetine Capsules
Page 1
APO-ATOMOXETINE 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
PRECAUTIONS).
NAME OF THE MEDICINE
Atomoxetine hydrochloride
Chemical Name:
_R_-(-)-N-Methyl-gamma-(2-methylphenoxy)-benzenepropanamine
hydrochloride
Structural Formula:
Molecular Formula:
C
17
H
21
NO.HCl
Molecular Weight:
291.82
CAS Registry Number:
82248-59-7
DESCRIPTION
Atomoxetine hydrochloride is a white to practically white solid that
has a solubility of 27.8 mg/mL in water.
Atomoxetine hydrochloride is available as capsules for oral
administration. The capsules contain a white to
off-white powder.
Each capsule contains 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg or 100
mg atomoxetine (as
hydrochloride). In addition to atomoxetine hydrochloride, each
atomoxetine capsule contains pregelatinised
maize starch.
The capsule shell consists of gelatin, titanium dioxide, iron oxide
yellow (18 mg, 25 mg, 40 mg, 60 mg, 80
mg,
100
mg),
iron
oxide
red
(80
mg,
100
mg),
indigo
carmine
(25
mg,
40 mg, 60 mg). The capsules are printed with edible black ink
(TekPrint SW-9008/SW-9009).
Product Information – Australia
APO-Atomoxetine Capsules
Page 2
PHARMACOLOGY
PHARMACOLOGICAL ACTIONS
Atomoxetine is used as a treatment for Attention-Deficit/Hyperactivity
Disorder (ADHD). ADHD was formerly
known as Attention Deficit Disorder (ADD) with or without
hyperactivity. Atomoxetine is a relatively potent
inhibitor of the presynaptic n