Pajjiż: Malta
Lingwa: Ingliż
Sors: Malta Medicines Authority
METHYLPHENIDATE HYDROCHLORIDE
Sandoz Pharmaceuticals d.d. Verovškova Ulica 57, SI-1000 Ljubljana, Slovenia
N06BA04
METHYLPHENIDATE HYDROCHLORIDE 14 mg
PROLONGED-RELEASE TABLET
METHYLPHENIDATE HYDROCHLORIDE 14 mg
POM
PSYCHOANALEPTICS
Withdrawn
2014-11-12
Page 1 of 10 1.3.1.3 PACKAGE LEAFLET PACKAGE LEAFLET: INFORMATION FOR THE USER MATORIDE XL, 18 MG, PROLONGED-RELEASE TABLETS MATORIDE XL, 36 MG, PROLONGED-RELEASE TABLETS MATORIDE XL, 54 MG, PROLONGED-RELEASE TABLETS methylphenidate hydrochloride 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 Matoride XL is and what it is used for 2. What you need to know before you take Matoride XL 3. How to take Matoride XL 4. Possible side effects 5. How to store Matoride XL 6. Contents of the pack and other information 1. WHAT MATORIDE XL IS AND WHAT IT IS USED FOR_ _ WHAT IT IS USED FOR Methylphenidate is used to treat ‘Attention Deficit Hyperactivity Disorder’ (ADHD). It is used in children, 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 not for use as a treatment for ADHD in children under 6 years of age or in adults. When treatment was started at a younger age, it might be appropriate to continue taking Matoride XL when you become an adult. Your doctor will advise you about this. HOW IT WORKS Methylphenidate 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 It is prescribed only by doctors who have ex Aqra d-dokument sħiħ
Page 1 of 21 1.3.1.1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Matoride XL , 18 mg, prolonged-release tablets Matoride XL , 36 mg, prolonged-release tablets Matoride XL , 54 mg, prolonged-release tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Matoride XL 18 mg, prolonged-release tablets: Each tablet contains 18 mg of methylphenidate hydrochloride. Excipient(s) with known effect: contains 6.31 mg of lactose monohydrate. Matoride XL , 36 mg, prolonged-release tablets: Each tablet contains 36 mg of methylphenidate hydrochloride. Excipient(s) with known effect: contains 8.43 mg of lactose monohydrate. Matoride XL , 54 mg, prolonged-release tablets: Each tablet contains 54 mg of methylphenidate hydrochloride. Excipient(s) with known effect: contains 6.76 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Prolonged-release tablet. Matoride XL , 18 mg, prolonged-release tablets: Light yellow film-coated tablet of round shape (diameter 8 mm) with a delivery orifice (visible round small hole) on one side. Matoride XL , 36 mg, prolonged-release tablets: White film-coated tablet of round shape (diameter 10 mm) with a delivery orifice (visible round small hole) on one side. Matoride XL , 54 mg, prolonged-release tablets: Red film-coated tablet of round shape (diameter 10 mm) with a delivery orifice (visible round small hole) on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Page 2 of 21 Attention-Deficit/Hyperactivity Disorder (ADHD) Methylphenidate prolonged-release tablets 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 5 criteria or the guidelines in ICD-10 and should be based on a complete history and evaluation of the patient. Diagnosis cannot Aqra d-dokument sħiħ