Land: Storbritannien
Sprog: engelsk
Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Risperidone
Kent Pharma (UK) Ltd
N05AX08
Risperidone
4mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04020100
1952, 1953, 1954, 1955 04.01.19[22] PATIENT INFORMATION LEAFLET RISPERDAL ® 1MG TABLETS RISPERIDONE 1MG TABLETS RISPERDAL ® 2MG TABLETS RISPERIDONE 2MG TABLETS RISPERDAL ® 3MG TABLETS RISPERIDONE 3MG TABLETS RISPERDAL ® 4MG TABLETS RISPERIDONE 4MG 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. This medicine is available using any one of the above names but will be referred to as Risperdal throughout this leaflet. Risperdal Tablets are also available in other strengths. 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 years of age) and adolescents with condu Læs hele dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Risperidone 4mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 4 mg risperidone Excipient(s) with known effect: Each film-coated tablet contains 199.5mg lactose (as lactose monohydrate). 3 PHARMACEUTICAL FORM Film-coated tablet Green, oval film-coated tablets with breaking notch and embossed with “4” on one side. The tablet can be divided into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Risperidone is indicated for the treatment of schizophrenia. Risperidone is indicated for the treatment of moderate to severe manic episodes associated with bipolar disorders. Risperidone 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. Risperidone 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 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. 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 adolescents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Schizophrenia _Adults _ Risperidone may be given once daily or twice daily. Patients should start with 2 mg/day risperidone. The dosage may be increased on the second day to 4 mg. Subsequently, the dosage can be maintained unchanged, or further individualised, if needed. Most patients will benefit fr Læs hele dokumentet