Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
Methylphenidate hydrochloride
Accord Healthcare Ireland Ltd.
N06BA; N06BA04
Methylphenidate hydrochloride
27 milligram(s)
Prolonged-release tablet
Centrally acting sympathomimetics; methylphenidate
Not marketed
2016-09-16
1 PACKAGE LEAFLET 2 PACKAGE LEAFLET: INFORMATION FOR THE USER DELMOSART PR 18 MG PROLONGED-RELEASE TABLETS DELMOSART PR 27 MG PROLONGED-RELEASE TABLETS DELMOSART PR 36 MG PROLONGED-RELEASE TABLETS DELMOSART PR 54 MG PROLONGED-RELEASE TABLETS Methylphenidate hydrochloride READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD STARTS 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 or your child only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours or your child’s ones. - If you or your child 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 DELMOSART PR IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU OR YOUR CHILD TAKE DELMOSART PR 3. HOW TO TAKE DELMOSART PR 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE DELMOSART PR 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT DELMOSART PR IS AND WHAT IT IS USED FOR WHAT IT IS USED FOR Delmosart PR 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. Delmosart PR is not for use as a treatment for ADHD in children under 6 years of age or for initiation of treatment in adults. When treatment was started at a younger age, it might be appropriate to continue taking Delmosart PR when you become an adult. Your doctor will advise you about this. HOW IT WORKS Delmosart PR 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 progra Lugege kogu dokumenti
Health Products Regulatory Authority 01 December 2019 CRN009CY9 Page 1 of 15 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Delmosart PR 27 mg prolonged-release tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each prolonged-release tablet contains 27 mg of methylphenidate hydrochloride equivalent to 23.3 mg of methylphenidate. Excipient with known effect: contains 184.5 mg of lactose (as monohydrate). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged-release tablet. 27 mg Tablet: Capsule-shaped, biconvex, grey tablet, 6.7 mm x 12.0 mm, with "2393" printed on one side in black ink. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Attention-Deficit/HyperactivityDisorder(ADHD) Delmosart PR 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-IV criteria or the guidelines in ICD-10 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. Delmosart PR treatment is not indicated in all children with ADHD and the decision to use the medicinal product must be based Lugege kogu dokumenti