País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
Risperidone
Janssen-Cilag Ltd
N05AX08
Risperidone
1 milligram(s)/millilitre
Oral solution
Product subject to prescription which may not be renewed (A)
risperidone
Marketed
1996-12-13
1 PACKAGE LEAFLET: INFORMATION FOR THE USER RISPERDAL 1 MG/ML ORAL SOLUTION 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 ‘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 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 Llegiu el document complet
Health Products Regulatory Authority 10 October 2018 CRN008P0Z Page 1 of 28 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT RISPERDAL 1 mg/ml oral solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml oral solution contains 1 mg of risperidone Excipients with known effect 1 ml oral solution contains 2 mg benzoic acid (E 210). For the full list of excipients, see section 6.1. 1 ml oral solution contains 1 mg of risperidone 3 PHARMACEUTICAL FORM Oral Solution The solution is clear and colourless. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS RISPERDAL is indicated for thetreatment 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 adolescents. Health Products Regulatory Authority 10 October 2018 CRN008P0Z Page 2 of 28 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Schizophrenia_ _Adults_ RISPERDAL 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. Su Llegiu el document complet