Pays: Royaume-Uni
Langue: anglais
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Risperidone
Wockhardt UK Ltd
N05AX08
Risperidone
1mg/1ml
Oral solution
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04020100; GTIN: 5012727905686
pg 1/2 _1st fold_ _(37.125mm)_ _2nd fold_ _(37.125mm)_ _3rd fold_ _(37.125mm)_ _4th fold_ _(37.125mm)_ _5th fold_ _(37.125mm)_ _6th fold_ _(37.125mm)_ _7th fold_ _(37.125mm)_ _8th fold_ _(37.125mm)_ NEUTRAL CODE NOT REQUIRED ON THE LEAFLET ARTWORKS PACKAGE LEAFLET: INFORMATION FOR THE PATIENT RISPERIDONE 1MG/ML ORAL SOLUTION RISPERIDONE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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, nurse 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Risperidone Oral Solution is and what it is used for 2. What you need to know before you take Risperidone Oral Solution 3. How to take Risperidone Oral Solution 4. Possible side effects 5. How to store Risperidone Oral Solution 6. Contents of the pack and other information 1. WHAT RISPERIDONE ORAL SOLUTION IS AND WHAT IT IS USED FOR Risperidone Oral Solution belongs to a group of medicines called ‘anti-psychotics’. Risperidone Oral Solution 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 six 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 six weeks) of long-term aggression in intellectually disabled children (at least five years of Lire le document complet
OBJECT 1 RISPERIDONE 1MG/ML ORAL SOLUTION Summary of Product Characteristics Updated 31-Aug-2017 | Wockhardt UK Ltd 1. Name of the medicinal product Risperidone 1mg/ml Oral Solution 2. Qualitative and quantitative composition Each ml of solution contains 1mg of risperidone. Excipient with known effect: sodium methylparaben (E219) 1.8mg/ml. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Oral solution The solution is clear and colourless. 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 five 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. 4.2 Posology and method of administration Posology Schizophrenia: _Adults_ Risperidone Oral Solution 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 w Lire le document complet