Strattera

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Atomoxetine hydrochloride 45.71mg equivalent to 40 mg atomoxetine free base

Available from:

Eli Lilly and Company (NZ) Limited

INN (International Name):

Atomoxetine hydrochloride 45.71 mg (equivalent to 40 mg atomoxetine free base)

Dosage:

40 mg

Pharmaceutical form:

Capsule

Composition:

Active: Atomoxetine hydrochloride 45.71mg equivalent to 40 mg atomoxetine free base Excipient: Dimeticone Gelatin Indigo carmine Pregelatinised maize starch Sodium laurilsulfate TekPrint black SW-9008 TekPrint black SW-9010 Titanium dioxide

Units in package:

Blister pack, Starter pack, 7 capsules

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Eli Lilly SA

Therapeutic indications:

STRATTERA is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) as defined by DSM-IV criteria in children 6 years of age and older and adolescents.

Product summary:

Package - Contents - Shelf Life: Blister pack, Starter pack - 7 capsules - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/Alcar - 28 capsules - 36 months from date of manufacture stored at or below 25°C

Authorization date:

2002-04-04

Patient Information leaflet

strattera-cmi-vA7
Page 1 of 5
STRATTERA
®
_atomoxetine hydrochloride _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about STRATTERA. 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 STRATTERA and
its use that you should be aware of.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking STRATTERA
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 STRATTERA IS
USED FOR
STRATTERA 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.
STRATTERA 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
STRATTERA does not have a
significant potential for abuse.
This medicine is available only with
a doctor's prescription.
BEFORE YOU TAKE
STRATTERA
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE STRATTERA IF YOU
HAVE AN ALLERGY TO:

any medicine containing
atomoxetine hydrochloride (the
active ingredient in
STRATTERA)

any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
reaction may include sh

Summary of Product characteristics

NEW ZEALAND DATASHEET
Strattera-ds-vA14_3 April 2020
SUPERSEDES: vA13_25mar19
Page 1 of 21
1.
STRATTERA
®
STRATTERA 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg and 100mg capsules.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
10 mg capsules contain atomoxetine hydrochloride equivalent to 10 mg
of atomoxetine.
18 mg capsules contain atomoxetine hydrochloride equivalent to 18 mg
of atomoxetine.
25 mg capsules contain atomoxetine hydrochloride equivalent to 25 mg
of atomoxetine.
40 mg capsules contain atomoxetine hydrochloride equivalent to 40 mg
of atomoxetine.
60 mg capsules contain atomoxetine hydrochloride equivalent to 60 mg
atomoxetine.
80 mg capsules contain atomoxetine hydrochloride equivalent to 80 mg
of atomoxetine.
100 mg capsules contain atomoxetine hydrochloride equivalent to 100 mg
of atomoxetine.
For the full list of excipients, see 6.1 LIST OF EXCIPIENTS.
3.
PHARMACEUTICAL FORM
STRATTERA is available as capsules for oral administration.
10 mg capsules: The capsule cap and body are opaque white in colour
with ‘Lilly 3227’
printed on the cap and 10 mg is printed on the body in black ink.
18 mg capsules: The capsule cap is gold in colour and the body is
opaque white in colour.
‘Lilly 3238’ is printed on the cap and 18 mg is printed on the
body in black ink.
25 mg capsules: The capsule cap is an opaque blue colour and the body
is opaque white in
colour. ‘Lilly 3228’ is printed on the cap and 25 mg is printed on
the body in black ink.
40 mg capsules: The capsule cap and body are an opaque blue colour.
‘Lilly 3229’ is printed
on the cap and 40 mg is printed on the body in black ink.
60 mg capsules: The capsule cap is an opaque blue colour and the
capsule body is a gold
colour. ‘Lilly 3239’ is printed on the cap and 60 mg is printed on
the body in black ink.
80 mg capsules: The capsule cap is an opaque brown colour and the body
is an opaque white
colour. “Lilly 3250” is printed on the cap and “80 mg” is
printed on the body in black ink.
100 mg capsules: The capsule cap and body are o