STRATTERA atomoxetine as hydrochloride 25mg capsule blister pack

देश: ऑस्ट्रेलिया

भाषा: अंग्रेज़ी

स्रोत: Department of Health (Therapeutic Goods Administration)

सक्रिय संघटक:

atomoxetine hydrochloride, Quantity: 28.57 mg (Equivalent: atomoxetine, Qty 25 mg)

थमां उपलब्ध:

Eli Lilly Australia Pty Ltd

फार्मास्यूटिकल फॉर्म:

Capsule, hard

रचना:

Excipient Ingredients: titanium dioxide; pregelatinised maize starch; dimeticone 350; Gelatin; indigo carmine; sodium lauryl sulfate; propylene glycol; ethanol; butan-1-ol; purified water; isopropyl alcohol; Shellac; iron oxide black; simethicone; strong ammonia solution; potassium hydroxide

प्रशासन का मार्ग:

Oral

पैकेज में यूनिट:

56 capsules, 28 capsules, 7 capsules, 14 capsules

प्रिस्क्रिप्शन प्रकार:

(S4) Prescription Only Medicine

चिकित्सीय संकेत:

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, adolescents and adults.

उत्पाद समीक्षा:

Visual Identification: Blue and white capsules marked with "Lilly 3228" and "25 mg".; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

प्राधिकरण का दर्जा:

Registered

प्राधिकरण की तारीख:

2004-01-27

सूचना पत्रक

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 shortness of
breath, wheezing or d

उत्पाद विशेषताएं

vA15_06May2020
SUPERSEDES: vA14_03Jan2020
Page 1 of 29
AUSTRALIAN PRODUCT INFORMATION
STRATTERA (ATOMOXETINE HYDROCHLORIDE)
WARNINGS
SHORT-TERM PLACEBO CONTROLLED STUDIES EVALUATED OVER 2200 CHILDREN AND
ADOLESCENTS WITH
ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD). AMONG THE 1357
PATIENTS ON STRATTERA,
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 STRATTERA IN CHILDREN MUST
BALANCE THE RISK OF
SUICIDALITY (SUICIDAL THOUGHTS OR BEHAVIOURS) AGAINST THE CLINICAL
NEED. PATIENTS WHO ARE
STARTED ON STRATTERA SHOULD BE CLOSELY MONITORED FOR SUICIDALITY (SEE
SECTION 4.4 SPECIAL
WARNINGS AND PRECAUTIONS FOR USE).
1.
NAME OF THE MEDICINE
STRATTERA
®
(atomoxetine hydrochloride) tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Capsules containing 5, 10, 18, 25, 40, 60, 80 and 100 mg of
atomoxetine hydrochloride.
For the full list of excipients, see section 6.1 LIST OF EXCIPIENTS.
3.
PHARMACEUTICAL FORM
STRATTERA is available as capsules for oral administration.
Each capsule contains 10, 18, 25, 40, 60, 80 or 100 mg of atomoxetine
(as the hydrochloride).
The capsule colours and markings are as follows:
*5 mg capsules: gold and marked with “Lilly 3226” and 5 mg”
10 mg capsules: opaque white and marked with “Lilly 3227” and
“10 mg”
18 mg capsules: gold and opaque white and marked with “Lilly 3238”
and “18 mg”
25 mg capsules: opaque blue and opaque white and marked with “Lilly
3228” and “25 mg”
40 mg capsules: opaque blue and marked with “Lilly 3229” and “40
mg”
60 mg capsules: opaque blue and gold and marked with “Lilly 3239”
and “60 mg
80 mg capsules: opaque brown and opaque white and marked with “Lilly
3250” and “80 mg”
vA15_06May2020
SUPERSEDES: vA14_03Jan2020
Page 2 of 29
100 mg capsules: opaque brown and marked with “Lilly 3251” and
“100 mg”.
* _Not currently available_
4.
CLINI