Страна: Ирландия
Език: английски
Източник: HPRA (Health Products Regulatory Authority)
METHYLPHENIDATE HYDROCHLORIDE
Novartis Pharmaceuticals UK Ltd
N06BA04
METHYLPHENIDATE HYDROCHLORIDE
20 Milligram
Prolonged Release Capsules
Product subject to prescription which may not be renewed (A)
Centrally acting sympathomimetics
Authorised
2003-07-11
Novartis Confidential Page 2 Proposed EU WS PIL RITALIN ® LA PACKAGE LEAFLET: INFORMATION FOR THE USER Ritalin LA, 20 30 40 mg capsules Methylphenidate The name of your medicine is Ritalin LA. 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 OR YOUR CHILD STARTS TAKING THIS MEDICINE. 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 or your child. Do not pass it on to others. It may harm them, even if they have the same symptoms. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Ritalin LA is and what it is used for 2. Before you take methylphenidate 3. How to take Ritalin LA 4. Possible side effects 5. How to store Ritalin LA 6. Further information 1. WHAT RITALIN LA IS AND WHAT IT IS USED FOR WHAT IT IS USED FOR Ritalin LA is used to treat ‘Attention Deficit Hyperactivity Disorder’ (ADHD). It is used in children and young people between the ages of 6 and 18, and in adults. It is used only after trying treatments which do not involve medicines, such as counselling and behavioural therapy and which have been insufficient. Ritalin LA is not for use as a treatment for ADHD in children under 6 years of age. It is not known if it is safe or of benefit in children under 6 years of age. HOW IT WORKS Ritalin LA improves the activity of certain parts of the brain which are under-active. The medicine can help improve attention (attention span), concentration and reduce impulsive behaviour. The medicine is given as part of a treatment programme, which usually includes: psychological Novartis Confidential Page 3 Proposed EU WS PIL RITALIN ® LA educational and social therapy. Ritalin LA is prescribed only by a specialist in behaviou Прочетете целия документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ritalin ® LA 20mg prolonged-release capsules. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Prolonged-release capsules containing 20mg methylphenidate hydrochloride. Excipients with a known effect: sucrose For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged-release capsules, hard White to off-white beads in a white opaque hard gelatin capsule, size 2, with imprint NVR (cap) and R20 (body) in tan- coloured ink. 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. Ritalin LA is indicated in the treatment of ADHD in adults as part of a comprehensive treatment programme. SPECIAL DIAGNOSTIC CONSIDERATIONS FOR ADHD IN CHILDREN 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 ADHD and the decision to use the Прочетете целия документ