RITALIN LA 30 Milligram Prolonged Release Capsules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

METHYLPHENIDATE HYDROCHLORIDE

Available from:

Novartis Pharmaceuticals UK Ltd

ATC code:

N06BA04

INN (International Name):

METHYLPHENIDATE HYDROCHLORIDE

Dosage:

30 Milligram

Pharmaceutical form:

Prolonged Release Capsules

Prescription type:

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

Therapeutic area:

Centrally acting sympathomimetics

Authorization status:

Authorised

Authorization date:

2003-07-11

Patient Information leaflet

Novartis
Confidential
Page 2
Proposed EU WS PIL
RITALIN
®
LA
PACKAGE LEAFLET: INFORMATION FOR THE USER
Ritalin LA, 20 30 40 mg capsules
Methylphenidate
The name of your medicine is Ritalin LA. It contains the active
substance ‘methylphenidate
hydrochloride’. The name ‘methylphenidate’ will also be used in
this leaflet.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD STARTS
TAKING THIS MEDICINE.

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. Do not pass
it on to others. It
may harm them, even if they have the same symptoms.

If any of the side effects gets serious, or if you notice any side
effects not listed in this
leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
What Ritalin LA is and what it is used for
2.
Before you take methylphenidate
3.
How to take Ritalin LA
4.
Possible side effects
5.
How to store Ritalin LA
6.
Further information
1.
WHAT RITALIN LA IS AND WHAT IT IS USED FOR
WHAT IT IS USED FOR
Ritalin LA is used to treat ‘Attention Deficit Hyperactivity
Disorder’ (ADHD).

It is used in children and young people between the ages of 6 and 18,
and in adults.

It is used only after trying treatments which do not involve
medicines, such as counselling
and behavioural therapy and which have been insufficient.
Ritalin LA is not for use as a treatment for ADHD in children under 6
years of age. It is not
known if it is safe or of benefit in children under 6 years of age.
HOW IT WORKS
Ritalin LA 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
Novartis
Confidential
Page 3
Proposed EU WS PIL
RITALIN
®
LA

educational and

social therapy.
Ritalin LA is prescribed only by a specialist in behaviou

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ritalin
®
LA 30mg prolonged-release capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Prolonged-release capsules containing 30mg methylphenidate
hydrochloride.
Excipients with a known effect: sucrose
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release capsules, hard.
White to off-white beads in a yellow opaque hard gelatine capsule,
size 2, with imprinted NVR (cap) and R30 (body) in
tan-coloured ink.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ATTENTION-DEFICIT/HYPERACTIVITY DISORDER (ADHD)
Methylphenidate 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.
Ritalin LA is indicated in the treatment of ADHD in adults as part of
a comprehensive treatment programme.
SPECIAL DIAGNOSTIC CONSIDERATIONS FOR ADHD IN CHILDREN
Treatment must be under the supervision of a specialist in childhood
behavioural disorders. Diagnosis should be made
according to DSM criteria or the guidelines in ICD 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.
Methylphenidate treatment is not indicated in all children with ADHD
and the decision to use t