Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Risperidone
Sun Pharmaceutical Industries Europe B.V.
N05AX08
Risperidone
2mg
Orodispersible tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04020100; GTIN: 5015525186127
1 Package leaflet: Information for the user Risperidone 2mg 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 is and what it is used for 2. What you need to know before you take Risperidone 3. How to take Risperidone 4. Possible side effects 5. How to store Risperidone 6. Contents of the pack and other information _1. WHAT RISPERIDONE IS AND WHAT IT IS USED FOR _ Risperidone belongs to a group of medicines called ‘anti-psychotics’. Risperidone 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 can help alleviate the symptoms of your disease and stop your symptoms from coming back. _2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE RISPERIDONE _ Do not take Risperidone: • If you are allergic to risperidone or any of the other ingredients of this medicine (listed in section 6). 2 If you are Read the complete document
OBJECT 1 RISPERIDONE 2 MG ORODISPERSIBLE TABLETS Summary of Product Characteristics Updated 28-Oct-2016 | Ranbaxy (UK) Limited a Sun Pharmaceutical Company 1. Name of the medicinal product Risperidone 2 mg Orodispersible Tablets 2. Qualitative and quantitative composition Each orodispersible tablet contains 2 mg risperidone. Each tablet also contains 1.126mg aspartame. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Orodispersible tablet Pink coloured, mottled, circular, flat beveled tablets, debossed with 'R' on one side and '2' on the other side. 4. Clinical particulars 4.1 Therapeutic indications Risperidone Orodispersible Tablets is indicated for the treatment of schizophrenia. Risperidone Orodispersible Tablets is indicated for the treatment of moderate to severe manic episodes associated with bipolar disorders. Risperidone Orodispersible Tablets 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 Orodispersible Tablets 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 behaviors 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 Orodispersible Tablets may be given once daily or twice daily. Read the complete document