Strattera 10mg hard capsules

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ATOMOXETINE

Available from:

Eli Lilly Nederland B.V Papendorpseweg 83, 3528 BJ, Utrecht, NL-3991, Netherlands

ATC code:

N06BA09

INN (International Name):

ATOMOXETINE 10 mg

Pharmaceutical form:

HARD CAPSULE

Composition:

ATOMOXETINE 10 mg

Prescription type:

POM

Therapeutic area:

PSYCHOANALEPTICS

Authorization status:

Withdrawn

Authorization date:

2007-01-31

Patient Information leaflet

Page
1
of
14
PACKAGE LEAFLET: INFORMATION FOR THE USER
STRATTERA
® 10, 18, 25, 40, 60, 80 AND 100 MG HARD CAPSULES
ATOMOXETINE
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 me

Summary of Product characteristics

Page 1 of 20
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
STRATTERA 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg or 100 mg hard
capsules.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains atomoxetine hydrochloride equivalent to 10
mg, 18 mg, 25 mg, 40 mg,
60 mg, 80 mg or 100 mg of atomoxetine.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Capsule, hard
STRATTERA 10 mg capsules: hard capsule, opaque white, imprinted with
“Lilly 3227” and
“10 mg” in black ink, approximately 15.5-16.1 mm length
STRATTERA 18 mg capsules: hard capsule, gold (cap) and opaque white
(body), imprinted with
“Lilly 3238” and “18 mg” in black ink, approximately 15.5-16.1
mm length.
STRATTERA 25 mg capsules: hard capsule, opaque blue (cap) and opaque
white (body), imprinted
with “Lilly 3228” and “25 mg” in black ink, approximately
15.5-16.1 mm length.
STRATTERA 40 mg capsules: hard capsule, opaque blue, imprinted with
“Lilly 3229” and
“40 mg” in black ink, approximately 15.5-16.1 mm length.
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.
STRATTERA 80 mg capsules: hard capsule, opaque brown (cap) and opaque
white (body),
imprinted with “Lilly 3250” and “80 mg” in black ink,
approximately 17.5-18.1 mm length.
STRATTERA 100 mg capsules: hard capsule, opaque brown, imprinted with
“Lilly 3251” and
“100 mg” in black ink, approximately 19.2-19.8 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 guidelin