Concerta XL 18 mg prolonged-release tablets

Valsts: Lielbritānija

Valoda: angļu

Klimata pārmaiņas: myHealthbox

Aktīvā sastāvdaļa:

Methylphenidate hydrochloride

Pieejams no:

Janssen-Cilag Ltd

ATĶ kods:

N06BA04

SNN (starptautisko nepatentēto nosaukumu):

Methylphenidate hydrochloride

Deva:

18 mg

Zāļu forma:

Prolonged-release tablet

Ievadīšanas:

Oral use

Vienības iepakojumā:

28 or 30 prolonged-release tablets

Receptes veids:

POM - Prescription Only Medicine

Ražojis:

Janssen Pharmaceutica NV

Ārstniecības grupa:

Centrally acting sympathomimetics

Ārstēšanas norādes:

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.

Autorizācija statuss:

Authorised

Autorizācija datums:

2002-02-19

Lietošanas instrukcija

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

Produkta apraksts

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