Quốc gia: Malta
Ngôn ngữ: Tiếng Anh
Nguồn: Medicines Authority
RISPERIDONE
Mylan S.A.S. 117 Allee des Parcs, 69800 Saint Priest, France
N05AX08
RISPERIDONE
ORODISPERSIBLE TABLET
RISPERIDONE 4 milligram(s)
POM
PSYCHOLEPTICS
Authorised
2012-07-13
PACKAGE LEAFLET PACKAGE LEAFLET: INFORMATION FOR THE PATIENT RISPERIDONE MYLAN 0.5 MG ORODISPERSIBLE TABLETS RISPERIDONE MYLAN 1 MG ORODISPERSIBLE TABLETS RISPERIDONE MYLAN 2 MG ORODISPERSIBLE TABLETS RISPERIDONE MYLAN 3MG ORODISPERSIBLE TABLETS RISPERIDONE MYLAN 4 MG ORODISPERSIBLE TABLETS risperidone 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 Risperidone Mylan is and what it is used for 2. What you need to know before you take Risperidone Mylan 3. How to take Risperidone Mylan 4. Possible side effects 5. How to store Risperidone Mylan 6. Contents of the pack and other information. 1. WHAT RISPERIDONE MYLAN IS AND WHAT IT IS USED FOR This medicine belongs to a group of medicines called ‘anti-psychotics’. Risperidone Mylan is used to treat the following: Schizophrenia, where you may see, hear or feel things that are not there, believe things that are not true or feel unusually suspicious, or confused Mania, where you may feel very excited, elated, agitated, enthusiastic or hyperactive Mania occurs in an illness called “bipolar disorder” Short-term treatment (up to 6 weeks) of long-term aggression in people with Alzheimer’s dementia, who harm themselves or others. Alternative (non-drug) treatments should have been used previously Short-term treatment (up to 6 weeks) of long-term aggression in intellectually disabled children (at least 5 years of age) and adolescents with conduct disorder. Risperidone Mylan can hel Đọc toàn bộ tài liệu
1/9 PUBLIC ASSESSMENT REPORT SCIENTIFIC DISCUSSION RISPERIDONE MYLAN 0.5MG, 1MG, 2MG, 3MG, 4MG ORODISPERSIBLE TABLETS RISPERIDONE MT/H/0145/001-005/DC THIS MODULE REFLECTS THE SCIENTIFIC DISCUSSION FOR THE APPROVAL OF RISPERIDONE MYLAN 0.5MG, 1MG, 2MG, 3MG AND 4MG ORODISPERSIBLE TABLETS. THE PROCEDURE WAS FINALISED ON 22/05/2012 ON DAY 210. FOR INFORMATION ON CHANGES AFTER THIS DATE PLEASE REFER TO THE MODULE ‘UPDATE’. 2/9 I. INTRODUCTION _ _ Based on the review of the quality, safety and efficacy data, the Member States have granted a marketing authorisation for Risperidone Mylan 0.5mg, 1mg, 2mg, 3mg and 4mg Orodispersible tablets, from Mylan _._ The product is indicated in: - Treatment of schizophrenia. - Treatment of moderate to severe manic episodes associated with bipolar disorders. - Short-term treatment (up to 6 weeks) of persistent aggression in patients with moderate to severe Alzheimer’s dementia unresponsive to non-pharmacological approaches and when there is a risk of harm to themself or others. - Short-term symptomatic treatment (up to 6 weeks) of persistent aggression in conduct disorder in children from the age of 5 years and adolescents with sub-average intellectual functioning or mental retardation diagnosed according to DSM-IV criteria in whom the severity of aggressive or other disruptive behaviours require pharmacologic treatment. A comprehensive description of the indications and posology is given in the SmPC. _ _ _ _ This decentralised procedure concerns a generic application claiming essential similarity with the reference product RISPERDAL 1 mg, 2 mg, 3 mg & 4 mg film-coated tablets by Janssen-Cilag Ltd, registered since 1992 in UK. _ _ The marketing authorisation has been granted pursuant to Article 10 of Directive 2001/83/EC. _ _ _ _ II. QUALITY ASPECTS _II.1_ _ _ _INTRODUCTION _ Pharmaceutical form: Orodispersible tablet _ _ _ _ Formulation Active Ingredient: Risperidone Excipients Polacrilex resin Crospovidone Silica, colloidal anhydrous Cellulose, microcrystalline (E460) Guar gu Đọc toàn bộ tài liệu