Ritalin 10mg Tablets

Țară: Malta

Limbă: engleză

Sursă: Medicines Authority

Ingredient activ:

METHYLPHENIDATE HYDROCHLORIDE

Disponibil de la:

Novartis Ireland Limited Vista Building, Elm Park, Merrion Road, Ballsbridge, Dublin 4,, Ireland

Codul ATC:

N06BA04

INN (nume internaţional):

METHYLPHENIDATE HYDROCHLORIDE 10 mg

Forma farmaceutică:

TABLET

Compoziție:

METHYLPHENIDATE HYDROCHLORIDE 10 mg

Tip de prescriptie medicala:

POM

Zonă Terapeutică:

PSYCHOANALEPTICS

Statutul autorizaţiei:

Authorised

Data de autorizare:

2006-11-10

Prospect

PACKAGE LEAFLET: INFORMATION FOR THE USER
RITALIN
® 10 MG TABLETS
methylphenidate
The name of your medicine is Ritalin, it contains the active substance
‘methylphenidate
hydrochloride’. The name ‘methylphenidate’ will also be used in
this leaflet.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This
includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Ritalin is and what it is used for
2. What you need to know before you take Ritalin
3. How to take Ritalin
4. Possible side effects
5. How to store Ritalin
6. Contents of the pack and other information
1.
WHAT RITALIN IS AND WHAT IT IS USED FOR
Ritalin is used to treat ‘Attention Deficit Hyperactivity
Disorder’ (ADHD).
•
It is used in children and young people between the ages of 6 and 18.
•
It is used only after trying treatments which do not involve
medicines. Such as counselling and
behavioural therapy.
Methylphenidate is used to treat attention deficit hyperactivity
disorder (ADHD) in adolescents
and children 6 years of age and over when other non pharmaceutical
measures alone have proven
insufficient.
Methyphenidate should be used together with other forms of treatment,
as part of a comprehensive
treatment programme. A comprehensive treatment programme typically
includes psychological,
educational and social measures as well as pharmacotherapy and is
aimed at stabilising children
with ADHD with symptoms that may include chronic history of short
attention span,
distractibility, emotional lability, impulsivity, moderate to severe
hyperactivity, minor neurological
signs and abnormal ele

Caracteristicilor produsului

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
RITALIN 10 mg Tablets.
2
QUALITATIVE AND QUANTITLATIVE COMPOSITION
Ritalin tablet contains 10 mg methylphenidate hydrochloride.
Excipient(s) with known effect
Each tablet contains 40 mg lactose monohydrate and 48 mg wheat starch.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Ritalin: Immediate-release tablet, divisible.
The tablet can be divided into equal doses.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ATTENTION-DEFICIT/HYPERACTIVITY DISORDER (ADHD)
Methylphenidate 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 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 symptoms.
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 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
inter