Risperidone Abbreviated Prescribing Information

Abbreviated Prescribing Information: Risperidone 1mg/ml Oral Solution. Consult Summary of Product Characteristics before prescribing. Presentation: A clear colourless solution containing 1 mg risperidone per ml. Therapeutic Indications: Schizophrenia. Moderate to severe manic episodes associated with bipolar disorders. Short-term treatment of persistent aggression in patients with moderate to severe Alzheimer’s dementia unresponsive to non-pharmacological approaches & when there is a risk of harm to self or others. Short-term treatment 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 requires pharmacologic treatment. Posology and Method of Administration: Schizophrenia: Adults: Starting dose of 2mg/day. The dosage may be increased on the second day to 4 mg. Typical dose 4-6 mg/day. Elderly: Starting dose of 0.5mg twice daily, which can be titrated to 1-2 mg twice daily. Manic episodes in bipolar disorder: Adults: Starting on a 2mg once daily dose, adjusted to dose range of 1-6 mg once per day. Elderly: Starting dose of 0.5mg twice daily, individually adjusted to 1-2 mg twice daily. Aggression in Alzheimer’s dementia: Starting dose of 0.25mg twice daily, individually adjusted to optimum dose of 0.5mg twice daily, up to 1mg in some patients for up to 6 weeks. Paediatric population: Schizophrenia, Manic episodes in bipolar disorder: Not recommended for use in children below age 18. Conduct disorder in children from 5-18 years: Children >50kg: Starting dose of 0.5 mg daily is recommended. The optimum dose is 1 mg once daily for most patients. Some patients, however, may benefit from 0.5 mg once daily while others may require 1.5 mg once daily. Children <50kg: Starting dose of 0.25mg daily is recommended. The optimum dose is 0.5 mg once daily for most patients. Some patients may benefit from 0.25 mg once daily while others may require 0.75 mg once daily. Not recommended in children less than 5 years of age. Patients with hepatic and renal impairment: Irrespective of the indication, starting and consecutive dosing should be halved, and dose titration should be slower. Upon discontinuation, gradual withdrawal is advised, as acute withdrawal symptoms, including nausea, vomiting, sweating, and insomnia have very rarely been reported. Recurrence of psychotic symptoms may also occur, and the emergence of involuntary movement disorders (such as akathisia, dystonia and dyskinesia) has been reported. When medically appropriate, gradual discontinuation of the previous treatment while Risperidone therapy is initiated is recommended. For oral use, dilute with water or orange juice and administer immediately. This liquid should not be mixed with coffee or tea. Contra-indications: Hypersensitivity to the active substance or to any of the excipients. Special Warnings and Precautions for use: Elderly patients with dementia: increased risk of mortality with atypical antipsychotics & increased risk of mortality with concomitant use of furosemide. Increased risk of cerebrovascular adverse events, orthostatic hypotension, leukopenia, neutropenia and agranulocytosis, tardive dyskinesia/extrapyramidal symptoms, neuroleptic malignant syndrome (NMS), worsening of Parkinson’s disease and dementia with Lewy bodies, hyperglycaemia, diabetes mellitus and exacerbation of pre-existing diabetes have been reported. Caution should be exercised with increased risk of weight gain, hyperprolactinaemia, known cardiovascular disease & QT prolongation, a history of seizures and in patients with renal & hepatic impairment, priapism, disruption of body temperature regulation, antiemetic effect, venous thromboembolism, intraoperative floppy iris syndrome. Close monitoring of use in the paediatric population is recommended. Any warning from the MC, CHM CSM or MHRA. No. Black Triangle notice: Not applicable. l The undesirable effects reported for risperidone are: Very common: insomnia, sedation/somnolence, Parkinsonism, and headache. Common: pneumonia, bronchitis, upper respiratory tract infection, sinusitis, urinary tract infection, ear infection, influenza, hyperprolactinaemia, weight increased, increased appetite, decreased appetite, sleep disorder, agitation, depression, anxiety, akathisia, dystonia, dizziness, dyskinesia, tremor, vision blurred, conjunctivitis, tachycardia, hypertension, dyspnoea, pharyngolaryngeal pain, cough, epistaxis, nasal congestion, abdominal pain, abdominal discomfort, vomiting, nausea, constipation, diarrhoea, dyspepsia, dry mouth, toothache, rash, erythema, muscle spasms, musculoskeletal pain, back pain, arthralgia, urinary incontinence, oedema, pyrexia, chest pain, asthenia, fatigue, pain, and fall; Serious undesirable effects include: cellulitis localised infection, neutropenia, white blood cell count decreased, thrombocytopenia, anaemia, hypersensitivity, diabetes mellitus, hyperglycaemia, weight decreased, anorexia, mania, confusional state, tardive dyskinesia, cerebral ischaemia, unresponsive to stimuli, loss of consciousness, depressed level of consciousness, convulsion, syncope, balance disorder, coordination abnormal, dizziness postural, dysarthria, atrial fibrillation, atrioventricular block, conduction disorder, electro-cardiogram QT prolonged, bradycardia, electro-cardiogram abnormal, palpitations, hypotension, orthostatic hypotension, pneumonia aspiration, pulmonary congestion, respiratory tract congestion, urticaria, pruritus, blood creatine phosphokinase increased, urinary retention, dysuria, face oedema, chills, body temperature increased, chest discomfort, transaminases increased, gamma-glutamyltransferase increased, hepatic enzyme increased, Infection, agranulo-cytosis, anaphylactic reaction, inappropriate antidiuretic hormone secretion, water intoxication, hypoglycemia, hyper-insulinaemia, catatonia, neuroleptic malignant syndrome, cerebrovascular disorder, diabetic coma, head titubation, glaucoma, eye movement disorder, eye rolling, floppy iris syndrome (intraoperative), sinus arrhythmia, pulmonary embolism, venous thrombosis, sleep apnoea syndrome, hyperventilation, pancreatitis, intestinal obstruction, swollen tongue, drug eruption, rhabdomyolysis, drug withdrawal syndrome neonatal, priapism, hypothermia, body temperature decreased, drug withdrawal syndrome, jaundice, diabetic ketoacidosis, ileus, angioedema, Stevens- Johnson syndrome/toxic epidermal necrolysis. Please refer to the SPC for full details of undesirable effects. Pack Size and NHS Price: 100ml – £9.46. Legal category: POM. Marketing authorisation number: PL00427/0239. Marketing Authorisation Holder: Rosemont Pharmaceuticals Ltd, Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK. Date of Preparation: 20-Oct-2025.