Strattera 4mg/ml Oral solution

Země: Malta

Jazyk: angličtina

Zdroj: Medicines Authority

Aktivní složka:

ATOMOXETINE

Dostupné s:

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

ATC kód:

N06BA09

INN (Mezinárodní Name):

ATOMOXETINE 4 mg/ml

Léková forma:

ORAL SOLUTION

Složení:

ATOMOXETINE 4 mg/ml

Druh předpisu:

POM

Terapeutické oblasti:

PSYCHOANALEPTICS

Stav Autorizace:

Withdrawn

Datum autorizace:

2014-11-24

Informace pro uživatele

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PACKAGE LEAFLET: INFORMATION FOR THE USER
STRATTERA 4 MG/ML ORAL SOLUTION
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 medicine has been prescribed for you on

Charakteristika produktu

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SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
STRATTERA 4 mg/mL oral solution.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of oral solution contains atomoxetine hydrochloride equivalent
to 4 mg of atomoxetine.
Excipients with known effect
Each millilitre contains 32.97 mg of sorbitol (E420), 0.8 mg of sodium
benzoate (E211), 9.8 mg
propylene glycol (E1520), and 2.64 mg of sodium in total.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Oral solution
Clear, colourless
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 abno