Concerta XL 18 mg prolonged-release tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Methylphenidate hydrochloride

Available from:

Janssen-Cilag Ltd

ATC code:

N06BA; N06BA04

INN (International Name):

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:

Marketed

Authorization date:

2002-11-22

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
CONCERTA
®
XL 18 MG
PROLONGED RELEASE
T
ABLETS
CONCERTA
®
XL 36 MG
PROLONGED RELEASE
T
ABLETS
CONCERTA
®
XL 54 MG
PROLONGED RELEASE
T
ABLETS
Methylphenidate hydrochloride
The name of your medicine is Concerta XL, it contains the active
substance
‘methylphenidate hydrochloride’. The name ‘methylphenidate’
will also be used in this leaflet.
IMPORTANT
THINGS YOU NEED TO KNOW
ABOUT
YOUR
MEDICINE
THIS MEDICINE IS USED TO TREAT
ADHD
• The full name for ADHD is ‘Attention Deficit Hyperactivity
Disorder’.
• The medicine helps with your brain activity. It can help improve
your
attention, help you concentrate, and make you less impulsive.
• You need to have other treatments for ADHD as well as this
medicine.
Read Section 1 for more information.
BEFORE YOU TAKE THIS MEDICINE, TALK TO YOUR DOCTOR IF:
• You have heart, circulation, or mental health problems - you may
not be
able to take this medicine.
• You are taking any other medicines - this is because
methylphenidate can
a
ff
ect
how other medicines work.
Read Section 2 for more information.
WHILE TAKING THIS
MEDICINE:
• See your doctor regularly. This is because your doctor will want
to check
how the medicine is working.
• Do not stop taking the medicine without first talking to your
doctor.
• Your doctor may stop your medicine to see if it is still needed,
if you take
it for more than a year.
• The most common side
e
ff
ects
are feeling nervous, not being able to
sleep or having a headache.
Read Sections 3 and 4 for more information.
TALK TO YOUR DOCTOR STRAIGHT AWAY IF ANY OF THE F
OLLOWING
HAPPEN:
• Your mood and how you feel changes.
• You feel any problems with your heart.
Read Section 4 for more information.
THE REST OF THIS LEAFLET INCLUDES MORE DETAIL AND OTHER IMPORTANT
INFORMATION ON THE SAFE AND E
ff
ECTIVE USE OF THIS MEDICINE.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This

Summary of Product characteristics

Health Products Regulatory Authority
27 February 2019
CRN008LF8
Page 1 of 17
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Concerta XL 18 mg prolonged-release tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One prolonged-release tablet contains 18 mg of methylphenidate
hydrochloride.
Excipients with known effect: contains 6.49 mg of lactose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release tablet.
Capsule-shaped, yellow tablets with “alza 18” printed on one side
in black ink.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Attention-Deficit/Hyperactivity Disorder (ADHD)
Concerta 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 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.
Concerta 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