Strattera 40mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Atomoxetine hydrochloride

Available from:

Eli Lilly and Company Ltd

ATC code:

N06BA09

INN (International Name):

Atomoxetine hydrochloride

Dosage:

40mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04040000; GTIN: 5014602300821 5014602300920

Patient Information leaflet

PA000SPAA09
STRATTERA
®
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
pharmacist.
•
This medicine has been prescribed for you only. Do not
pass it on to others. It may harm them, even if their signs
of

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
STRATTERA 40 mg hard capsules.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains atomoxetine hydrochloride equivalent to 40
mg of atomoxetine.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Capsule, hard
STRATTERA 40 mg capsules: hard capsule, opaque blue, imprinted with
“Lilly
3229” and “40 mg” in black ink, approximately 155-161 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.
Pharmacological treatment