Concerta XL 18 mg prolonged-release tablets
Country: United Kingdom
Language: English
Source: myHealthbox
Patient Information leaflet
(PIL)
20-04-2024
Summary of Product characteristics
(SPC)
20-04-2024
Active ingredient:
Methylphenidate hydrochloride
Available from:
Janssen-Cilag Ltd
ATC code:
N06BA04
INN (International Name):
Methylphenidate hydrochloride
Dosage:
18 mg
Pharmaceutical form:
Prolonged-release tablet
Administration route:
Oral use
Units in package:
28 or 30 prolonged-release tablets
Prescription type:
POM - Prescription Only Medicine
Manufactured by:
Janssen Pharmaceutica NV
Therapeutic group:
Centrally acting sympathomimetics
Therapeutic indications:
It 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.
Authorization status:
Authorised
Authorization date:
2002-02-19
Patient Information leaflet
TO
P
PACK
AGE L
EA
FL ET:
INF
ORMATION F
OR THE USER
CONCER
TA
®
XL 18 MG
PR
OLONGED R
ELEASE
TABLETS
CONCER
TA
®
XL 36 MG
PR
OLONGED R
ELEASE
TABLETS
CONCER
TA
®
XL 54 MG
PR
OLONGED R
ELEASE
TABLETS
Meth
ylphenidate h
ydr
ochloride
The name of y
our medicine is Concer
ta XL, it contains the activ
e substance
‘meth
ylphenidate h
ydr
ochloride’. The name
‘meth
ylphenidate’ will also be used in this lea
fl et.
IMPORTANT THINGS YOU NEED TO KNOW ABOUT
YOUR MEDICINE
THIS MEDICINE IS USED TO TR
EAT ADHD
• The full name f
or ADHD is
‘A
ttention De
fi cit Hyper
activity Disor
der’.
• The medicine helps with y
our br
ain activity
. It can help impr
ov
e y
our
attention, help y
ou concentr
ate
, and mak
e y
ou less impulsiv
e.
• Y
ou need to ha
ve other tr
eatments f
or ADHD as w
ell as this medicine
.
R
ead Section 1 f
or mor
e inf
ormation.
BE
FOR
E Y
OU TAK
E THIS MEDICINE
, TALK TO Y
OUR DOCTOR IF:
• Y
ou ha
ve hear
t, cir
culation, or mental health pr
oblems - y
ou ma
y not be
able to tak
e this medicine
.
• Y
ou ar
e taking an
y other medicines - this is because meth
ylphenidate can
aff
ect ho
w other medicines w
ork.
R
ead Section 2 f
or mor
e inf
ormation.
WHILE TAKING THIS MEDICINE:
• See y
our doctor r
egularly
. This is because y
our doctor will w
ant to check
ho
w the medicine is w
orking.
• Do not stop taking the medicine without
fi rst talking to y
our doctor
.
• Y
our doctor ma
y stop y
our medicine to see if it is still needed, if y
ou tak
e
it f
or mor
e than a y
ear
.
• The most common side e
ff ects ar
e f
eeling ner
vous
, not being able to
sleep or ha
ving a headache
.
R
ead Sections 3 and 4 f
or mor
e inf
ormation.
TALK TO Y
OUR DOCTOR STR
AIGHT A
W
AY IF AN
Y OF THE F
OLLO
WING
HAPPEN:
• Y
our mood and ho
w y
ou f
eel changes
.
• Y
ou f
eel an
y pr
oblems with y
our hear
t.
R
ead Section 4 f
or mor
e inf
ormation.
THE R
EST OF THIS LEA
FL ET INCLUDES MOR
E DETAIL AND OTHER IMPOR
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Summary of Product characteristics
Concerta XL 18 mg prolongedrelease tablets.
Summary of Product Characteristics Updated 16Jun2015 | JanssenCilag Ltd
1. Name of the medicinal product
Concerta XL 18 mg prolongedrelease tablets.
2. Qualitative and quantitative composition
One prolongedrelease 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
Prolongedrelease tablet.
Capsuleshaped yellow tablet with “alza 18” printed on one side in black ink.
4. Clinical particulars
4.1 Therapeutic indications
AttentionDeficit/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
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