STRATTERA 60 Milligram Capsules Hard

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

ATOMOXETINE HYDROCHLORIDE

Available from:

Eli Lilly and Company Limited

ATC code:

N06BA09

INN (International Name):

ATOMOXETINE HYDROCHLORIDE

Dosage:

60 Milligram

Pharmaceutical form:

Capsules Hard

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Centrally acting sympathomimetics

Authorization status:

Transfer Pending

Authorization date:

2006-02-10

Patient Information leaflet

IMPORTANT THINGS YOU NEED TO KNOW ABOUT YOUR MEDICINE
THIS MEDICINE IS USED TO TREAT ADHD
•   The full name for ADHD is ‘Attention Deficit 
Hyperactivity Disorder’.
•   The medicine helps with your
brain activity. It can help 
improve your attention, help you concentrate, and make 
you less impulsive.
•   You need to have other help for ADHD as well as this 
medicine.
READ SECTION 1 FOR MORE INFORMATION.
BEFORE YOU TAKE THIS MEDICINE, TALK TO YOUR DOCTOR IF 
YOU:
•  have mental health problems
•  have a problem with your heart or blood circulation
•   have serious problems with the blood vessels in your 
brain such as a stroke
READ SECTION 2 FOR MORE INFORMATION.
WHILE TAKING THIS MEDICINE:
•   See your doctor regularly. This is because your doctor 
will want to check how the medicine is working.
•   Do not stop taking the medicine without first talking to 
your doctor.
•   Your doctor may stop your medicine to see if it is still 
needed, if you take it for more than a year.
•   The most common side effects in children and young 
people are: 
   headache, stomach ache, not feeling hungry, feeling 
or being sick, feeling sleepy, increased blood pressure, 
increased heart rate (pulse).
•  The most common side effects in adults are: 
   feeling sick, dry mouth, headache, not feeling hungry, 
not being able to sleep, increased blood pressure, 
increased heart rate (pulse).
READ SECTIONS 3 AND 4 FOR MORE INFORMATION.
TALK TO YOUR DOCTOR STRAIGHT AWAY IF ANY OF THE 
FOLLOWING HAPPEN:
•  your mood and how you feel changes 
•   you feel any problems with your heart e.g. a fast or 
unusual heartbeat rhythm
READ SECTION 2 AND 4 FOR MORE INFORMATION.
THE REST OF THIS LEAFLET INCLUDES MORE DETAIL AND OTHER 
IMPORTANT INFORMATION ON THE SAFE AND EFFECTIVE USE OF 
THIS MEDICINE.
•  Keep this leaflet. You may need to read it again.
•   If you have any further questions, ask your doctor or 
pharmacis

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Strattera 60 mg hard capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains atomoxetine hydrochloride equivalent to 60
mg of atomoxetine.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard
STRATTERA 60 mg capsules: hard capsule, opaque blue (cap) and gold
(body), imprinted with “Lilly 3239” and
“60 mg” in black ink, approximately 17.5-18.1 mm length.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Strattera is indicated for the treatment of
Attention-Deficit/Hyperactivity Disorder (ADHD) in children of 6 years
and
older, in adolescents and in adults as part of a comprehensive
treatment programme. Treatment must be initiated by a
specialist in the treatment of ADHD, such as a paediatrician,
child/adolescent psychiatrist, or psychiatrist. Diagnosis
should be made according to current DSM criteria or the guidelines in
ICD.
In adults, the presence of symptoms of ADHD that were pre-existing in
childhood should be confirmed. Third-party
corroboration is desirable and Strattera should not be initiated when
the verification of childhood ADHD symptoms is
uncertain. Diagnosis cannot be made solely on the presence of one or
more symptoms of ADHD.
Based on clinical
judgment, patients should have ADHD of at least moderate severity as
indicated by at least moderate functional
impairment in 2 or more settings (for example, social, academic,
and/or occupational functioning), affecting several
aspects of an individual’s life.
Additional information for the safe use of this product:
A comprehensive treatment programme typically includes psychological,
educational and social measures and is aimed
at stabilising patients with a behavioural syndrome characterised by
symptoms which may include chronic history of
short attention span, distractibility, emotional lability,
impulsivity, moderate to severe hyperactivity, minor
neurological signs and abnormal EEG. Learning may or may not be
impaired.
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