Metylfenidat Actavis Tablet Prolonged Release 18mg

Ország: Málta

Nyelv: angol

Forrás: Medicines Authority

Aktív összetevők:

METHYLPHENIDATE HYDROCHLORIDE

Beszerezhető a:

Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland

ATC-kód:

N06BA04

INN (nemzetközi neve):

METHYLPHENIDATE HYDROCHLORIDE 18 mg

Gyógyszerészeti forma:

PROLONGED-RELEASE TABLET

Összetétel:

METHYLPHENIDATE HYDROCHLORIDE 18 mg

Recept típusa:

POM

Terápiás terület:

PSYCHOANALEPTICS

Engedélyezési státusz:

Withdrawn

Engedély dátuma:

2016-07-06

Betegtájékoztató

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
METYLFENIDAT ACTAVIS 18 MG PROLONGED-RELEASE TABLETS
METYLFENIDAT ACTAVIS 27 MG PROLONGED-RELEASE TABLETS
METYLFENIDAT ACTAVIS 36 MG PROLONGED-RELEASE TABLETS
METYLFENIDAT ACTAVIS 54 MG PROLONGED-RELEASE TABLETS
Methylphenidate hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD STARTS
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 or your child only. Do not
pass it on to others. It may harm
them, even if their signs of illness are the same as yours or your
child’s ones.
-
If you or your child 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 METYLFENIDAT ACTAVIS IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU OR YOUR CHILD TAKE METYLFENIDAT
ACTAVIS
3.
HOW TO TAKE METYLFENIDAT ACTAVIS
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE METYLFENIDAT ACTAVIS
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT METYLFENIDAT ACTAVIS IS AND WHAT IT IS USED FOR
WHAT IT IS USED FOR
Metylfenidat Actavis is used to treat ‘attention deficit
hyperactivity disorder’ (ADHD).

it is used in children and young people between the ages of 6 and 18.

it is used only after trying treatments which do not involve medicines
such as counselling and
behavioural therapy.
Metylfenidat Actavis is not for use as a treatment for ADHD in
children under 6 years of age or for initiation
of treatment in adults. When treatment was started at a younger age,
it might be appropriate to continue
taking Metylfenidat Actavis when you become an adult. Your doctor will
advise you about this.
HOW IT WORKS
Metylfenidat Actavis improves the activity of certain parts of the
brain which are under-active. The medicine
can help improve attention (attention

Termékjellemzők

Page 1 of 22
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Metylfenidat Actavis 18mg Prolonged-release Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release tablet contains 18 mg of methylphenidate
hydrochloride
equivalent to 15.6 mg of methylphenidate.
Excipient with known effect: contains 183.8 mg of lactose (as
monohydrate).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Prolonged-release tablet.
18 mg Tablet: Capsule-shaped, biconvex, yellow tablet, 6.6 mm x 11.9
mm, with
“2392” printed on one side in black ink.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Attention-Deficit/Hyperactivity Disorder (ADHD)
Metylfenidat Actavis is indicated as part of a comprehensive treatment
programme for
Attention Deficit Hyperactivity Disorder (ADHD) in children aged 6
years of age and
over when remedial measures alone prove insufficient. Treatment must
be under the
supervision of a specialist in childhood behavioural disorders.
Diagnosis should be
made according to DSM-IV criteria or the guidelines in ICD-10 and
should be based
on a complete history and evaluation of the patient. Diagnosis cannot
be made solely
on the presence of one or more symptom.
The specific aetiology of this syndrome is unknown, and there is no
single diagnostic
test. Adequate diagnosis requires the use of medical and specialised
psychological,
educational, and social resources.
A comprehensive treatment programme typically includes psychological,
educational
and social measures as well as pharmacotherapy and is aimed at
stabilising children
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.
Page 2 of 22
Metylfenidat Actavis treatment is not indicated in all children with
ADHD and the
decision to use the medicinal product must be based on a very thorough
a