Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
RISPERIDONE
B & S Healthcare
N05AX08
RISPERIDONE
1 Milligram
Film Coated Tablet
Product subject to prescription which may not be renewed (A)
Other antipsychotics
Authorised
2009-11-20
PACKAGE LEAFLET: INFORMATION FOR THE USER RISPERDAL ® 1MG FILM-COATED 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. The name of your medicine is Risperdal 1mg film-coated tablets but will be referred to as Risperdal throughout this leaflet. WHAT IS IN THIS LEAFLET: 1. What Risperdal is and what it is used for 2. What you need to know before you take Risperdal 3. How to take Risperdal 4. Possible side effects 5. How to store Risperdal 6. Contents of the pack and other information 1. WHAT RISPERDAL IS AND WHAT IT IS USED FOR Risperdal belongs to a group of medicines called ‘anti-psychotics’. Risperdal 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 Baca dokumen lengkap
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Risperdal 1mg Film-Coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 1mg risperidone. Excipients: Also contains lactose For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Film-coated tablet _Product sourced from Spain:_ Each 1mg film-coated tablet is white, oblong, plain on one side and scored on the other side, with ‘RIS’ and ‘1’ either side of the score line. The score line serves to facilitate the breaking of the tablet to swallow better, and not to divide into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS RISPERDAL is indicated for the treatment of schizophrenia. RISPERDAL is indicated for the treatment of moderate to severe manic episodes associated with bipolar disorders. RISPERDAL is indicated for the 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 self or others. RISPERDAL is indicated for the 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 subaverage intellectual functioning or mental retardation diagnosed according to DSM-IV criteria, in whom the severity of aggressive or other disruptive behaviours require pharmacologic treatment. Pharmacological treatment should be an integral part of a more comprehensive treatment programme, including psychosocial and educational intervention. It is recommended that risperidone be prescribed by a specialist in child neurology and child and adolescent psychiatry or physicians well familiar with the treatment of conduct disorder of children and Baca dokumen lengkap