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 1mg 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 in whom the severity of aggressive or other disruptive behaviours require pharmacologic treatment. Posology and Method of Administration: Schizophrenia: Starting dose of 2mg/day. 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: 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: Conduct disorder in children from 5-18 years: Starting dose of 0.25-0.5 mg depending on patient weight. 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. For oral use diluted with water or orange juice and to be used immediately. This liquid should not be mixed with coffee and 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, patients receiving both psychostimulants and risperidone, neuroleptic malignant syndrome (NMS), worsening of Parkinson’s disease and dementia with Lewy bodies, hyperglycaemia, diabetes mellitus and exacerbation of pre-existing diabetes. 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. Black Triangle notice: Not applicable. Legal Category: POM. The undesirable effects reported for memantine 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; Uncommon: respiratory tract infection, cystitis, eye infection, tonsillitis, onychomycosis, cellulitis localised infection, viral infection, acarodermatitis, neutropenia, white blood cell count decreased, thrombocytopenia, anaemia, haematocrit decreased, eosinophil count increased, hypersensitivity, diabetes mellitus, hyperglycaemia, polydipsia, weight decreased, anorexia, blood cholesterol increased, mania, confusional state, libido decreased, nervousness, nightmare, tardive dyskinesia, cerebral ischaemia, unresponsive to stimuli, loss of consciousness, depressed level of consciousness, convulsion, syncope, psychomotor hyperactivity, balance disorder, coordination abnormal, dizziness postural, disturbance in attention, dysarthria, dysgeusia, hypoaesthesia, paraesthesia, photophobia, dry eye, lacrimation increased, ocular hyperaemia, vertigo, tinnitus, ear pain, atrial fibrillation, atrioventricular block, conduction disorder, electro-cardiogram QT prolonged, bradycardia, electro-cardiogram abnormal, palpitations, hypotension, orthostatic hypotension, flushing, pneumonia aspiration, pulmonary congestion, respiratory tract congestion, rales, wheezing, dysphonia, respiratory disorder, faecal incontinence, faecaloma, gastroenteritis, dysphagia, flatulence, urticaria, pruritus, alopecia, hyperkeratosis, eczema, dry skin, skin discolouration, acne, seborrhoeic dermatitis, skin disorder, skin lesion, blood creatine phosphokinase increased, posture abnormal, joint stiffness, joint swelling muscular weakness, neck pain, pollakiuria, urinary retention, dysuria, erectile dysfunction, ejaculation disorder, amenorrhoea, menstrual disordered, gynaecomastia, galactorrhoea, sexual dysfunction, breast pain, breast discomfort, vaginal discharge, face oedema, chills, body temperature increased, gait abnormal, thirst, chest discomfort, malaise, feeling abnormal, discomfort, transaminases increased, gamma-glutamyltransferase increased, hepatic enzyme increased, procedural pain; Rare: Infection, agranulo-cytosis, anaphylactic reaction, inappropriate antidiuretic hormone secretion, glucose urine present, water intoxication, hypoglycemia, hyper-insulinaemia, blood triglycerides increased, catatonia, somnambulism, sleep related eating disorder, blunted affect, anorgasmia, neuroleptic malignant syndrome, cerebrovascular disorder, diabetic coma, head titubation, glaucoma, eye movement disorder, eye rolling, eyelid margin crusting, floppy iris syndrome (intraoperative), sinus arrhythmia, pulmonary embolism, venous thrombosis, sleep apnoea syndrome, hyperventilation, pancreatitis, intestinal obstruction, swollen tongue, cheilitis, drug eruption, dandruff, rhabdomyolysis, drug withdrawal syndrome neonatal, priapism, menstruation delayed, breast engorgement, breast enlargement, breast discharge, hypothermia, body temperature decreased, peripheral coldness, drug withdrawal syndrome, induration, jaundice; Very rare: diabetic ketoacidosis, ileus, Angioedema; Not Known: Stevens- Johnson syndrome / toxic epidermal necrolysis. Pack Size and NHS Price: 100ml – £9.46. 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: 28 September 2023.