Ritalin 10mg tablets

Страна: Великобритания

Език: английски

Източник: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активна съставка:

Methylphenidate hydrochloride

Предлага се от:

CST Pharma Ltd

АТС код:

N06BA04

INN (Международно Name):

Methylphenidate hydrochloride

дозиране:

10mg

Лекарствена форма:

Oral tablet

Начин на приложение:

Oral

Клас:

Schedule 2 (CD)

Вид предписание :

Valid as a prescribable product

Каталог на резюме:

BNF: 04040000; GTIN: 5055946805801

Листовка

INFORMATION FOR CHILDREN AND YOUNG PEOPLE WITH ADHD
This info is to help you learn the main things about
your medicine called Ritalin.
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.
•
If you take this medicine more than once a day,
you may have to remember to take it
AT SCHOOL OR
COLLEGE.
You or your mum, dad or carer will need to find out
what the school rules are about this.
•
Do not drink alcohol. Alcohol may make the side
effects of this medicine worse.
•
Girls must tell their doctor straight away if they
think they may be pregnant. We do not know
how this medicine affects unborn babies. If you
are having sex, please talk to your doctor about
contraception.
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.
SOME PEOPLE NEED TO TALK TO THEIR DOCTOR BEFORE THEY
START HAVING THIS MEDICINE
You need to talk to your doctor if:
•
you have epilepsy (fits)

Данни за продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Ritalin
®
10mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredient is Methylphenidate (INN for
α
-Phenyl-2-piperidineacetic acid
methyl ester hydrochloride).
One tablet contains 10mg methylphenidate hydrochloride.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablets.
4.1.
THERAPEUTIC INDICATIONS
_ _
Ritalin is indicated as a 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 DSM criteria or the guidelines in ICD 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.
Methylphenidate treatment is not indicated in all children with this
syndrome and the
decision to use the drug must be based on a very thorough assessment
of the severity
and the chronicity of the child’s symptoms in relation to the
child’s age.
Appropriate educational placement is essential, and psychosocial
intervention is
generally necessary. Where remedial measures alone prove insufficient,
the decision to
prescribe a stimulant must be based on