Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
Methylphenidate hydrochloride
Medice Arzneimittel Putter GmbH & Co. K.G
N06BA; N06BA04
Methylphenidate hydrochloride
5 milligram(s)
Tablet
Product subject to prescription which may not be renewed (A)
Centrally acting sympathomimetics; methylphenidate
Marketed
2011-02-25
PACKAGE LEAFLET: INFORMATION FOR THE USER MEDIKINET_ _ 5 MG tablets MEDIKINET_ _10 MG tablets MEDIKINET_ _20 MG tablets Methylphenidate hydrochloride READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD 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 or your child. Do not pass it on to others. It may harm them, even if their symptoms 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 MEDIKINET is and what it is used for 2. What you need to know before you or your child takes MEDIKINET 3. How to take MEDIKINET 4. Possible side effects 5. How to store MEDIKINET 6. Contents of the pack and other information 1. WHAT MEDIKINET IS AND WHAT IT IS USED FOR WHAT IT IS USED FOR MEDIKINET 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. MEDIKINET is not for use as a treatment for ADHD in children under 6 years of age or in adults. It is not known if it is safe or of benefit in these people. HOW IT WORKS MEDIKINET 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 • educational and • social therapy. MEDIKINET treatment must only be initiated by, and used under the supervision of, a specialist in childhood and/or adolescent behavioural disorders. Although there is no cure for ADHD, it can be managed using treatment programmes. ABO Preberite celoten dokument
Health Products Regulatory Authority 07 November 2022 CRN00D5MD Page 1 of 12 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Medikinet 5 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5 mg methylphenidate hydrochloride, equivalent to 4.35 mg methylphenidate. Excipient with known effect: 42.28 mg lactose/tablet For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. White, round tablet with a break score on both sides and notches at the edges embossed with ”S” on both halves. The tablet can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ATTENTION-DEFICIT/HYPERACTIVITY DISORDER (ADHD) Medikinet 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 initiated under the supervision of a specialist in childhood behaviour disorders. Diagnosis should be made according to current DSM 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 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 medicinal product must be based on a very thorough assessme Preberite celoten dokument