ATOMOXETINE AMNEAL atomoxetine (as hydrochloride) 100 mg capsule blister pack

Quốc gia: Úc

Ngôn ngữ: Tiếng Anh

Nguồn: Department of Health (Therapeutic Goods Administration)

Thành phần hoạt chất:

Atomoxetine hydrochloride

Sẵn có từ:

Amneal Pharma Australia Pty Ltd

INN (Tên quốc tế):

Atomoxetine hydrochloride

Tờ rơi thông tin

ATOMOXETINE-AMNEAL CMI v0.3
ATOMOXETINE AMNEAL
_ATOMOXETINE (AS HYDROCHLORIDE) 10MG, 18MG, 25MG, 40MG, 60MG, 80MG AND
100MG _
_HARD CAPSULES _
WHAT IS IN THIS LEAFLET?
This leaflet answers some
common questions about
ATOMOXETINE AMNEAL. 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 shown
on the final page. More recent
information on this medicine may
be available.
Make sure you speak to your
pharmacist or doctor to obtain the
most up to date information on
this medicine. You can also
download the most up to date
leaflet from www.lilly.com.au. The
updated leaflet may contain
important information about
ATOMOXETINE AMNEAL and its
use that you should be aware of.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you taking
ATOMOXETINE AMNEAL
against the benefits it may have
for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE.
WHAT IS ATOMOXETINE
AMNEAL USED FOR
ATOMOXETINE AMNEAL 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 AMNEAL 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 PRESCRIBED
FOR YOU. YOUR DOCTOR MAY HAVE
PRESCRIBED IT FOR ANOTHER
REASON.
Available evidence suggests that
ATOMOXETINE AMNEAL does
not have a significant potential for
abuse.
This medicine is available only
with a doctor's prescription.
BEFORE YOU TAKE IT
_ _
_WHEN YOU MUST NOT TAKE IT _
_ _
DO NOT TAKE ATOMOXETINE
AMNEAL IF YOU HAVE AN ALLERGY
TO:
•
any medicine containing
atomoxetine hydrochloride
(the active ingredient in
ATOMOXETINE AMNEA

Đặc tính sản phẩm

Page 1 of 25
ATOMOXETINE AMNEAL PI v1.0
PRODUCT INFORMATION
ATOMOXETINE AMNEAL
atomoxetine (as 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 PRECAUTIONS).
NAME OF THE MEDICINE
ATOMOXETINE AMNEAL
atomoxetine (as hydrochloride) capsules
The active ingredient in ATOMOXETINE AMNEAL capsules is atomoxetine
hydrochloride.
Chemically, atomoxetine hydrochloride is
(3_R_)-_N_-Methyl-3-(2-methylphenoxy)-3-
phenylpropan-1-amine hydrochloride.
The empirical formula is C
17
H
21
NO•HCl which corresponds to a molecular weight of 291.82
daltons.
The chemical structure is:
The CAS number for atomoxetine hydrochloride is 82248-59-7.
Page 2 of 25
ATOMOXETINE AMNEAL PI v1.0
DESCRIPTION
Atomoxetine hydrochloride is a white to practically white solid which
has a solubility of 27.8
mg/mL in water.
ATOMOXETINE AMNEAL is available as capsules for oral administration.
Each capsule contains 10, 18, 25, 40, 60, 80 or 100 mg of atomoxetine
(as hydrochloride).
The capsules also contain StarCap 1500 (ARTG No. 12847), dimethicone
350, sodium starch
glycollate type A.
The following details relate to the capsule shells and lids in which
the capsule
contents are
encapsulated: Empty hard gelatin capsules size 4, 0999 White Opaque
‐
0999 White Opaque
(ARTG No. 109783; 10 mg); Empty hard gelatin capsules size 3, 0999
White Opaque
‐
2306
Gold Opaque (ARTG No. 109778; 18 mg); Empty hard gelatin capsules size
3 0999 White Op
‐
1516 Blue Opaque (ARTG No.