ATOMOXETINE

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

ATOMOXETINE HYDROCHLORIDE

Available from:

Generics (UK) 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:

atomoxetine

Authorization status:

Not Marketed

Authorization date:

2017-11-24

Patient Information leaflet

Page 1 of 11
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ATOMOXETINE 10 MG HARD CAPSULES
ATOMOXETINE 18 MG HARD CAPSULES
ATOMOXETINE 25 MG HARD CAPSULES
ATOMOXETINE 40 MG HARD CAPSULES
ATOMOXETINE 60 MG HARD CAPSULES
ATOMOXETINE 80 MG HARD CAPSULES
ATOMOXETINE 100 MG HARD CAPSULES
atomoxetine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
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 illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible
side effects not listed in this leaflet. See section 4
WHAT IS IN THIS LEAFLET
1.
What Atomoxetine is and what it is used for
2.
What you need to know before you take Atomoxetine
3.
How to take Atomoxetine
4.
Possible side effects
5.
How to store Atomoxetine
6.
Contents of the pack and other information
1.
WHAT ATOMOXETINE IS AND WHAT IT IS USED FOR
Atomoxetine hard capsules contains the active substance atomoxetine,
which is used to treat
attention-deficit and hyperactivity disorder (ADHD). It is used:
-
in children over six years of age
-
in adolescents
-
in adults
Atomoxetine is used only as a part of the total treatment of the
disease which also requires
treatments which do not involve medicines, such as counselling and
behavioural therapy.
Atomoxetine is not for use as a treatment for ADHD in children under 6
years of age as it is
not known if the medicine works or is safe in these people.
In adults, atomoxetine is used to treat ADHD when the symptoms are
very troublesome and
affect your work or social life and when you have had symptoms of the
disease as a child.
HOW IT WORKS
Page 2 of 11
Atomoxetine increases the amount of noradrenaline in the brain. This
is a chemical that is
produced naturally, and increases attention and decreases
impu

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Atomoxetine 60 mg hard capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains atomoxetine hydrochloride equivalent to 60
mg atomoxetine.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Hard capsule
60 mg Hard Capsules are hard gelatine capsules with blue opaque cap
and gold opaque body, approximately 18 mm in
length, printed with “A960” on the cap and body in black ink.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Atomoxetine is indicated for the treatment of
Attention-Deficit/Hyperactivity Disorder (ADHD) in children aged 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 atomoxetine 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 impa