STRATTERA 4 Mg/Ml Oral Solution

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

ATOMOXETINE HYDROCHLORIDE

Tilgjengelig fra:

Eli Lilly and Company Limited

ATC-kode:

N06BA09

INN (International Name):

ATOMOXETINE HYDROCHLORIDE

Dosering :

4 Mg/Ml

Legemiddelform:

Oral Solution

Resept typen:

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

Terapeutisk område:

Centrally acting sympathomimetics

Autorisasjon status:

Transfer Pending

Autorisasjon dato:

2014-11-07

Informasjon til brukeren

1 

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 RE

Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Strattera 4mg/ml Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of oral solution contains atomoxetine hydrochloride equivalent
to 4 mg of atomoxetine.
Excipient with known effect: contains 32.97 mg of sorbitol per mL.
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 abnormal EEG. Learning may or may not be
impaired.
Pharmacological treatment is not indicated in all patients with this
syndrome and t