Atomoxetine 25mg capsules

Country: Միացյալ Թագավորություն

language: անգլերեն

source: MHRA (Medicines & Healthcare Products Regulatory Agency)

active_ingredient:

Atomoxetine hydrochloride

MAH:

Genus Pharmaceuticals Ltd

ATC_code:

N06BA09

INN:

Atomoxetine hydrochloride

dosage:

25mg

pharmaceutical_form:

Oral capsule

administration_route:

Oral

class:

No Controlled Drug Status

prescription_type:

Valid as a prescribable product

leaflet_short:

BNF: 04040000; GTIN: 5011309006018

PIL

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ATOMOXETINE 10MG HARD CAPSULES
ATOMOXETINE 18MG HARD CAPSULES
ATOMOXETINE 25MG HARD CAPSULES
ATOMOXETINE 40MG HARD CAPSULES
ATOMOXETINE 60MG HARD CAPSULES
ATOMOXETINE 80MG HARD CAPSULES
ATOMOXETINE 100MG HARD CAPSULES
Atomoxetine (as hydrochloride)
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 the 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 atomoxetine and is used to treat
attention-deficit and hyperactivity
disorder
(ADHD). It is
used
-
in children over six years of
age
-
in young
people
-
in
adults
It 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.
It is not for use as a treatment for ADHD in children under 6 years of
age as it is not known if
the
drug works or is safe in this age group
.
In adults,
Atomoxetine Capsules are used to treat
ADHD when the symptoms are very
troublesome and
affect
your work or social life and when you have had sym

SPC

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Atomoxetine 25mg Hard Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains atomoxetine hydrochloride equivalent to 25
mg of
atomoxetine.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Hard capsule
Atomoxetine 25 mg capsules: hard capsule, size 3 (15.9 mm x 5.82 mm),
opaque blue
(cap) and opaque white (body), imprinted with “A925” in black ink.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Atomoxetine Capsules 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
Capsules 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.