Χώρα: Ηνωμένο Βασίλειο
Γλώσσα: Αγγλικά
Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)
Risperidone
Consilient Health Ltd
N05AX08
Risperidone
2mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04020100; GTIN: 3838989543891
Package leaflet: Information for the user Risperdal ® 2mg tablets (risperidone) 1 What Risperdal is and what it is used for Risperdal belongs to a group of medicines called ‘antipsychotics’. 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 conduct disorder. Risperdal can help alleviate the symptoms of your disease and stop your symptoms from coming back. 2 What you need to know before you take Risperdal Do not take Risperdal If you are allergic (hypersensitive) to risperidone or any of the other ingredients of this medicine (listed in section 6). If you are not sure if the above applies to you, talk to your doctor or pharmacist before using Risperdal. Warnings and precautions Talk to your doctor or pharmacist before taking Risperdal if: You have a heart problem. Examples include an irregular heart rhythm or if you are prone to low blood pressure or if you are using medicines for your blood pressure. Risperdal may cause low blood pressure. Your dose may need to be adjusted You know of any factors which would favour you having a stroke, such as high blood pressure, cardiovascular disorder or blood vessel problems in the brain You have ever experienced involuntary movements of the tongue, mouth and face You have ever had a condition whose symptoms include high temperature, muscle stiffness, sweating or a lowered level of consciousness (also known as Neurolept Διαβάστε το πλήρες έγγραφο
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Risperidone 2mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 2 mg risperidone Excipient(s) with known effect: Each film-coated tablet contains 99.75 mg lactose (as lactose monohydrate). 3 PHARMACEUTICAL FORM Film-coated tablet Apricot, oval film-coated tablets with breaking notch and embossed with “2” 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 Διαβάστε το πλήρες έγγραφο