Concerta XL 18 mg prolonged-release tablets

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Methylphenidate hydrochloride; Methylphenidate hydrochloride; Methylphenidate hydrochloride

Tilgjengelig fra:

Janssen Sciences Ireland UC

ATC-kode:

N06BA; N06BA04

INN (International Name):

Methylphenidate hydrochloride; Methylphenidate hydrochloride; Methylphenidate hydrochloride

Dosering :

18 milligram(s)

Legemiddelform:

Prolonged-release tablet

Terapeutisk område:

Centrally acting sympathomimetics; methylphenidate

Autorisasjon status:

Marketed

Autorisasjon dato:

2002-11-22

Informasjon til brukeren

PACKAGE LEAFLET: INFORMATION FOR THE USER
CONCERTA® XL 18 MG PROLONGED RELEASE TABLETS
CONCERTA® XL 36 MG PROLONGED RELEASE TABLETS
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 medicine has been prescribed for you only. Do not pass it on to
others.

Preparatomtale

Health Products Regulatory Authority
15 November 2022
CRN00D6CR
Page 1 of 19
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
Each tablet contains 6.5 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 and adults when remedial
measures alone prove insufficient.
TREATMENT MUST BE INITIATED AND SUPERVISED BY A PHYSICIAN SPECIALISED
IN THE TREATMENT OF ADHD SUCH AS AN EXPERT
PAEDIATRICIAN, A CHILD AND ADOLESCENT PSYCHIATRIST OR AN ADULT
PSYCHIATRIST.
Special Diagnostic Considerations for ADHD in children
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. Third-party corroboration is desirable
and 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.
Me