Atomoxetine Accord 40 mg Hard Capsules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Atomoxetine hydrochloride

Available from:

Accord Healthcare Ireland Ltd.

ATC code:

N06BA09

INN (International Name):

Atomoxetine hydrochloride

Dosage:

40 milligram(s)

Pharmaceutical form:

Capsule, hard

Therapeutic area:

atomoxetine

Authorization status:

Marketed

Authorization date:

2019-01-14

Patient Information leaflet

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Details
ATOMOXETINE, ALL STRENGTHS, HARD CAPSULES PIL - UK/IE
Black BBBA3213
R.Wrey
19/10/18
22/10/18
R.Wrey
170x700
9pt
IL/Pharmathen
19/10/18
19/10/18
3
Version 2
01.11.2017
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.
•
The full name of this medicine is Atomoxetine
10mg, 18mg, 25mg, 40mg, 60mg, 80mg,
100mg Hard Capsules but within this leaflet it
will be referred to as Atomoxetine Capsules.
WHAT IS IN THIS LEAFLET
1
WHAT ATOMOXETINE CAPSULES ARE AND
WHAT THEY ARE USED FOR
2
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
ATOMOXETINE CAPSULES
3
HOW TO TAKE ATOMOXETINE CAPSULES
4
POSSIBLE SIDE EFFECTS
5
HOW TO STORE ATOMOXETINE CAPSULES
6
CONTENTS OF THE PACK AND OTHER
INFORMATION
1
WHAT ATOMOXETINE CAPSULES ARE AND
WHAT THEY ARE USED FOR
WHAT IT IS USED FOR
Atomoxetine Capsules contain the active substance
atomoxetine and is used to treat attention-deficit
and hyperactivity disorder (ADHD). It is used:
• in children over six years of age
• in adolescents
• in adults.
It is used only as a part of

Summary of Product characteristics

Health Products Regulatory Authority
28 July 2023
CRN00DCVX
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Atomoxetine Accord 40 mg Hard Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains atomoxetine hydrochloride equivalent to 40
mg atomoxetine.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard.
White powder in a hard gelatin capsule of size No 3 (length of
15.7±0.4 mm), opaque blue cap imprinted in black ink with '40'
and opaque blue body imprinted in black ink with 'mg.'
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Atomoxetine Accord 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 Atomoxetine Accord 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 medicinal 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, m