Land: Sverige
Sprog: svensk
Kilde: Läkemedelsverket (Medical Products Agency)
metylfenidathydroklorid
Viatris Limited
N06BA04
methylphenidate hydrochloride
20 mg
Tablett
metylfenidathydroklorid 20 mg Aktiv substans
Receptbelagt
Förpacknings: Blister, 20 tabletter; Blister, 60 tabletter; Blister, 30 tabletter
Godkänd
2016-04-14
Page 1 of 11 PACKAGE LEAFLET Page 2 of 11 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT MEDANEF 5 MG TABLETS MEDANEF 10 MG TABLETS MEDANEF 20 MG 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 childs. - 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 Medanef is and what it is used for 2. What you need to know before you or your child takes Medanef 3. How to take Medanef 4. Possible side effects 5. How to store Medanef 6. Contents of the pack and other information 1. WHAT MEDANEF IS AND WHAT IT IS USED FOR Medanef contains the active substance methylphenidate. MEDANEF 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 Medanef 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 Medanef improves the activity of certain parts of the brain which are underactive. 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 MEDANEF MUST ONLY BE INITIATED BY, AND USED UNDER THE SUPERVISION OF, A SPECIALIST IN CHILDHOOD/AND OR ADOLESCENT BEHAVIOURAL DISORDERS. Although there Læs hele dokumentet
Page 1 of 17 SUMMARY OF PRODUCT CHARACTERISTICS Page 2 of 17 1. NAME OF THE MEDICINAL PRODUCT Medanef 5 mg Tablets Medanef 10 mg Tablets Medanef 20 mg Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5 mg methylphenidate hydrochloride. Each tablet contains 10 mg methylphenidate hydrochloride. Each tablet contains 20 mg methylphenidate hydrochloride. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. White, round, flat tablet marked with “RU” on one side and “5” on the other side, approximately 6 mm in diameter. White, round, flat, scored tablet marked with “RU 10” on one side, approximately 7 mm in diameter. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. White, round, flat, scored tablet marked with “RU 20” on one side, approximately 9 mm in diameter. The score line is only to facilitate breaking for ease of swallowing and not to divide 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-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 sym Læs hele dokumentet