Metidate XL 18 mg Prolonged-Release Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Methylphenidate hydrochloride; Methylphenidate hydrochloride

Available from:

Rowex Ltd

ATC code:

N06BA; N06BA04

INN (International Name):

Methylphenidate hydrochloride; Methylphenidate hydrochloride

Dosage:

18 milligram(s)

Pharmaceutical form:

Prolonged-release tablet

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Centrally acting sympathomimetics; methylphenidate

Authorization status:

Not marketed

Authorization date:

2012-04-13

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
METIDATE XL18 MG PROLONGED-RELEASE TABLETS
METIDATE XL 36 MG PROLONGED
-R
ELEASE TABLETS
METIDATE XL 54 MG PROLONGED
-R
ELEASE TABLETS
methylphenidate 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.
WHAT IS IN THIS LEAFLET
1.
What Metidate XL is and what it is used for
2.
What you need to know before you take Metidate XL
3.
How to take Metidate XL
4.
Possible side effects
5.
How to store Metidate XL
6.
Contents of the pack and other information
1. WHAT METIDATE XL IS AND WHAT IT IS USED FOR_ _
WHAT IT IS USED FOR
Metidate XL is used to treat ‘Attention Deficit Hyperactivity
Disorder’ (ADHD).

It is used in children, 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.
Metidate XL is not for use as a treatment for ADHD in children under 6
years of age or for the
initiation of treatment in adults. When treatment was started at a
younger age, it might be appropriate
to continue taking Metidate XL when you become an adult. Your doctor
will advise you about this.
HOW IT WORKS
Metidate XL improves the activity of certain parts of the brain which
are under-active. The medicine
can help improve attention (attention span), concentration and reduce
impulsive behaviour.
The medicine is given as part of a treatment programme, which usually
includes:

psychological

educational and

social therapy.
It is prescribed only by doctors who have experience in chi

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Metidate XL 18 mg Prolonged-Release Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 18 mg of methylphenidate hydrochloride.
Excipient(s) with known effect: contains 5.99 mg of lactose (as
lactose monohydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release tablet.
Light yellow film-coated tablet of round shape (diameter 8 mm) with a
delivery orifice (visible round small hole) on
one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Attention-Deficit/Hyperactivity Disorder (ADHD)
Metidate XL 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 the current DSM criteria or ICD guidelines 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 symptoms.
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.
Metidate XL treatment is not indicated in all children with ADHD and
the decision to use the drug must be based on a
very thorough assessment of the severity and chronicity of the child's
symptoms in relation to the child's age.
Appropriate e