Concerta XL 27mg tablets

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv ingrediens:

Methylphenidate hydrochloride

Tilgjengelig fra:

CST Pharma Ltd

ATC-kode:

N06BA04

INN (International Name):

Methylphenidate hydrochloride

Dosering :

27mg

Legemiddelform:

Modified-release tablet

Administreringsrute:

Oral

Klasse:

Schedule 2 (CD)

Resept typen:

Caution - AMP level prescribing advised

Produkt oppsummering:

BNF: 04040000; GTIN: 5055946806600

Informasjon til brukeren

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
CONCERTA
® XL 27MG TABLETS
(methylphenidate hydrochloride)
The name of your medicine is Concerta XL 27mg. However, it
will be referred to as Concerta XL throughout this leaflet.
This medicine contains the active substance ‘methylphenidate
hydrochloride’. The name ‘methylphenidate’ will also be used
in this leaflet. This product is also available in other
strengths.
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 affect 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 effects 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
FOLLOWING 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
EFFECTIVE 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.
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Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Concerta XL 27 mg prolonged-release tablets.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
One prolonged-release tablet contains 27 mg of methylphenidate
hydrochloride.
Excipients with known effect: contains 4.94 mg of lactose.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Prolonged-release tablet.
Capsule-shaped grey tablet with “alza 27” 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 child’s age.
Appropriate educational placement is essential, and psychosocial