Atomoxetine 100mg capsules

Страна: Великобритания

Език: английски

Източник: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активна съставка:

Atomoxetine hydrochloride

Предлага се от:

Macleods Pharma UK Ltd

АТС код:

N06BA09

INN (Международно Name):

Atomoxetine hydrochloride

дозиране:

100mg

Лекарствена форма:

Oral capsule

Начин на приложение:

Oral

Клас:

No Controlled Drug Status

Вид предписание :

Valid as a prescribable product

Каталог на резюме:

BNF: 04040000; GTIN: 18901463139117

Листовка

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
-


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.
Atomoxetine
-


Keep this leaflet. You may need to read it again.
ATOMOXETINE MACLEODS 10, 18,
25, 40, 60, 80 AND 100 MG
CAPSULES, HARD
PACKAGE LEAFLET: INFORMATION FOR THE USER
-


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
:
These checks are to decide if Atomoxetine Macleods is the correct
medicine for you.
CHECKS THAT YOUR DOCTOR WILL MAKE BEFORE YOU START TO TAKE
ATOMOXETINE MACLEODS
Tell your doctor or pharmacist if any of the above applies to you
before
starting treatment. This is because Atomoxetine Macleods can make
these problems worse. Your doctor will want to monitor how the
medicine affects you.
-


hard-to-control, repeated twitching of any parts of the body or you
repeat sounds and words.
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different moods than usual (mood swings) or feel very unhappy.
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a history of epilepsy or have had seizures for any other reason.
Atomoxetine Macleods might lead to an increase in seizure frequency.
-


unfriendly and angry (hostility) feelings.
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aggressive feelings.
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mania (feeling elated or over-excited, which causes unusual
behaviour) and agitation.
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psychotic symptoms including hallucinations (hearing voices or
seeing things which are not there), believing things that are not true
or being suspicious.
-


liver problems. You may need a lower dose.
-


cardiovascular disease or past medical history of stroke.
-


problems with sudden changes in your blood pressure or your heart
rate.
-


low blood pressure. Atomoxetine Macleods can cause dizziness or
fainting in people with low blood pressure.
-


high blood pressure. Atomoxetine M

Данни за продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Atomoxetine Macleods 100 mg capsules, hard
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains atomoxetine hydrochloride equivalent to 100
mg of
atomoxetine
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Capsule, hard
Opaque brown cap/ opaque brown body size “1” capsules containing
white to off
white powder, with ‘I 29’ on body imprinted with black ink.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Atomoxetine Macleods 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
Macleods 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
characterized 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