Země: Velká Británie
Jazyk: angličtina
Zdroj: myHealthbox
Risperidone
Janssen-Cilag Ltd
N05AX08
Risperidone
4 mg
Tablets
Oral use
packs containing 10, 20, 30, 50, 60, or 100 tablets
POM
Janssen-Cilag Ltd
Other antipsychotic
It is indicated for the treatment of schizophrenia; for the treatment of moderate to severe manic episodes associated with bipolar disorders; in patients with moderate to severe Alzheimer's dementia; forf persistent aggression in conduct disorder in children from the age of 5 years and adolescents with subaverage intellectual functioning or mental retardation
Authorised
2015-06-14
1 PACKAGE LEAFLET: INFORMATION FOR THE USER RISPERDAL 0.5, 1, 2, 3, 4 AND 6 MG FILM-COATED TABLETS RISPERDAL QUICKLET : 0.5, 1, 2, 3 AND 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 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 Přečtěte si celý dokument
Risperdal 4mg Filmcoated Tablets Summary of Product Characteristics Updated 23Jun2015 | JanssenCilag Ltd 1. Name of the medicinal product RISPERDAL 4mg filmcoated tablets 2. Qualitative and quantitative composition Each filmcoated tablet contains 4mg of risperidone Excipients with known effect: Each 4 mg filmcoated tablet contains 260 mg lactose monohydrate For the full list of excipients, see section 6.1. 3. Pharmaceutical form Filmcoated tablet • 4 mg risperidone as green halfscored oblong biconvex tablets The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. Filmcoated tablets are etched on one side with RIS 4. Additionally JANSSEN may be etched on the other side. 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 shortterm treatment (up to 6 weeks) of persistent aggression in patients with moderate to severe Alzheimer's dementia unresponsive to nonpharmacological approaches and when there is a risk of harm to self or others. RISPERDAL is indicated for the shortterm 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 DSMIV 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 speci Přečtěte si celý dokument