Concerta XL 27mg tablets

Země: Velká Británie

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivní složka:

Methylphenidate hydrochloride

Dostupné s:

Janssen-Cilag Ltd

ATC kód:

N06BA04

INN (Mezinárodní Name):

Methylphenidate hydrochloride

Dávkování:

27mg

Léková forma:

Modified-release tablet

Podání:

Oral

Třída:

Schedule 2 (CD)

Druh předpisu:

Caution - AMP level prescribing advised

Přehled produktů:

BNF: 04040000; GTIN: 5012674901212

Informace pro uživatele

This info is to help you learn the main things about your medicine
called Concerta XL.
If you don’t enjoy reading, someone like your mum, dad or carer
(sometimes called ‘your guardian’) can read it to
you and answer any questions.
It may help if you read small bits at a time.
WHY HAVE I BEEN GIVEN THIS MEDICINE?
This medicine can help children and young people with ‘ADHD’.
•
ADHD can make you:
- run about too much
- not be able to pay attention
- act quickly without thinking about what will happen next
(impulsive).
•
It affects learning, making friends and how you think about yourself.
It is not your fault.
WHILE YOU ARE TAKING THIS MEDICINE
•
as well as taking this medicine you will also get help with ways to
cope with your ADHD such as talking to
ADHD specialists.
•
this medicine should help you. But it does not cure ADHD.
•
you will need to go to your doctor several times a year for check ups.
This is to make sure the medicine is
working and that you are growing and developing OK.
•
if you take the medicine for more than one year, your doctor may stop
your medicine to see if it is still
needed. This will probably happen in a school holiday.
•
do not drink alcohol. Alcohol may make the side effects of this
medicine worse.
•
if you are having sex, please talk to your doctor about contraception.
Girls must tell their doctor straight
away if they think they may be pregnant. We do not know how this
medicine affects unborn babies.
SOME PEOPLE CANNOT HAVE THIS MEDICINE
You cannot have this medicine if:
•
you have a problem with your heart
•
you feel very unhappy, depressed or have a mental illness.

PACKAGE LEAFLET: INFORMATION FOR THE USER
CONCERTA
® XL 27 MG PROLONGED RELEASE TABLETS
Methylphenidate hydrochloride
The name of your medicine is Concerta XL 27mg Prolonged release
tablets. However they will be referred to
as Concerta XL throughout this leaflet. Concerta XL contains the
active substance ‘methylphenidate
hydrochloride’. The name ‘methylphenidate’ will also be used

Charakteristika produktu

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