ATOMOXETINE SANDOZ atomoxetine (as hydrochloride) 18 mg capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

atomoxetine hydrochloride, Quantity: 20.57 mg (Equivalent: atomoxetine, Qty 18 mg)

Available from:

Sandoz Pty Ltd

INN (International Name):

Atomoxetine hydrochloride

Pharmaceutical form:

Capsule, hard

Composition:

Excipient Ingredients: dimeticone 350; sodium starch glycollate type A; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide; maize starch; pregelatinised maize starch; titanium dioxide; iron oxide yellow; sorbitan monolaurate; Gelatin; sodium lauryl sulfate

Administration route:

Oral

Units in package:

28, 7

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: Gold opaque cap and white opaque body, with A918 printed on cap and body in black ink; Container Type: Blister Pack; Container Material: Other plastic laminate/Al; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2015-11-10

Patient Information leaflet

1
ATOMOXETINE SANDOZ

ATOMOXETINE SANDOZ

ATOMOXETINE (AS HYDROCHLORIDE) CAPSULES
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
This leaflet answers some
common questions about
ATOMOXETINE SANDOZ.
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
SANDOZ 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 SANDOZ
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
SANDOZ USED FOR
ATOMOXETINE SANDOZ 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 SANDOZ
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 SANDOZ
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 SANDOZ
IF YOU HAVE AN ALLERGY TO:
•
any medicine containing
atomoxetine hydrochloride
(the active ingredient in
ATOMOXETINE
SANDOZ)
•
any of the ingredi

Summary of Product characteristics

190605-atomoxetine-sandoz-pi
Page 1 of 27
AUSTRALIAN PRODUCT INFORMATION
ATOMOXETINE SANDOZ
® (ATOMOXETINE HYDROCHLORIDE)
1
NAME OF THE MEDICINE
Atomoxetine hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Atomoxetine Sandoz 10 mg capsule contains 11.43 mg of atomoxetine
hydrochloride
equivalent to 10 mg of atomoxetine.
Each Atomoxetine Sandoz 18 mg capsule contains 20.57 mg of atomoxetine
hydrochloride
equivalent to 18 mg of atomoxetine.
Each Atomoxetine Sandoz 25 mg capsule contains 28.58 mg of atomoxetine
hydrochloride
equivalent to 25 mg of atomoxetine.
Each Atomoxetine Sandoz 40 mg capsule contains 45.72 mg of atomoxetine
hydrochloride
equivalent to 40 mg of atomoxetine.
Each Atomoxetine Sandoz 60 mg capsule contains 68.58 mg of atomoxetine
hydrochloride
equivalent to 60 mg of atomoxetine.
Each Atomoxetine Sandoz 80 mg capsule contains 91.44 mg of atomoxetine
hydrochloride
equivalent to 80 mg of atomoxetine.
Each Atomoxetine Sandoz 100 mg capsule contains 114.3 mg of
atomoxetine hydrochloride
equivalent to 100 mg of atomoxetine.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Atomoxetine Sandoz 10 mg capsules
are white opaque cap and body and marked with “A910”
on cap and body in black ink.
Atomoxetine Sandoz 18 mg capsules
are gold opaque cap and white opaque body and marked
with “A918” on cap and body in black ink.
Atomoxetine Sandoz 25 mg capsules
are blue opaque cap and white opaque body and marked
with “A925” on cap and body in black ink.
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