Metylfenidat Actavis Tablet Prolonged Release 36mg

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 36 mg

Gyógyszerészeti forma:

PROLONGED-RELEASE TABLET

Összetétel:

METHYLPHENIDATE HYDROCHLORIDE 36 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Withdrawn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

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Metylfenidat Actavis 36mg Prolonged-release Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release tablet contains 36 mg of methylphenidate
hydrochloride equivalent to 31.1 mg of methylphenidate.
Excipient with known effect: contains 178.1 mg of lactose (as
monohydrate).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Prolonged-release tablet.
36 mg Tablet: Capsule-shaped, biconvex, white tablet, 6.7 mm x 12.0
mm,
with “2394” 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.
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
assessment of the severity a