Ritalin LA 40mg prolonged-release capsules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Methylphenidate hydrochloride

Available from:

Novartis Ireland Limited

ATC code:

N06BA; N06BA04

INN (International Name):

Methylphenidate hydrochloride

Dosage:

40 milligram(s)

Pharmaceutical form:

Prolonged-release capsule, hard

Prescription type:

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

Therapeutic area:

Centrally acting sympathomimetics; methylphenidate

Authorization status:

Marketed

Authorization date:

2003-07-11

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
RITALIN® LA, 20 30 40 MG PROLONGED-RELEASE 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
• educational and
• social therapy.
Ritalin LA is prescribed only by a specialist in behavioural
disorders. This specialist will follow up
your further treatment. A thorough examination is necessary. I

Summary of Product characteristics

Health Products Regulatory Authority
06 May 2021
CRN00C2K9
Page 1 of 17
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ritalin LA 40mg prolonged-release capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Prolonged-release capsules containing 40 mg, methylphenidate
hydrochloride.
Excipients with a known effect: each hard capsule contains 225.89 of
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 light brown opaque hard gelatine
capsule, size 1, with imprint NVR (cap) and R40 (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