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Sulpiride Abbreviated Prescribing Information

Abbreviated Prescribing Information: Sulpiride Rosemont 200mg/5ml Oral Solution Consult Summary of Product Characteristics before prescribing. Presentation: A colourless to slightly yellow oral solution containing 200mg/5ml Sulpiride. Therapeutic Indications: Acute and chronic schizophrenia. Posology and Method of AdministrationAdults: A starting dose of 400mg to 800mg daily, given in two divided doses. Maximum dose 1200mg twice daily. Elderly: The same dose ranges may be required in the elderly, but should be reduced if there is evidence of renal impairment. Paediatric population: Not recommended in children under 14 years. Contra-indications: Phaeochromocytoma. Acute porphyria. Hypersensitivity to the active substance or to any of the excipients. Severe renal, haematological or hepatic disease. Alcoholic intoxication and other disorders which depress CNS function. Concomitant prolactin-dependant tumours. Association with levodopa or antiparkinsonian drugs. Bone marrow suppression. Excipient warnings: The product contains liquid maltitol and parahydroxybenzoates. Drug interactions: Associations not recommended: Alcohol, QT prolonging drugs and drugs causing electrolyte imbalance, dopaminergics, pramipexole, ropinirole. Bradycardia-inducing medications, medications which induce electrolyte imbalance, in particular those causing hypokalaemia, class Ia antiarrhythmic agents, class III antiarrhythmic agents, pimozide, haloperidol, methadone, imipramine, lithium, cisapride, thioridazine, IV erythromycin, halofantrine, pentamidine. Associations to be taken into account: Anaesthetics, analgesics, antidepressants, antiepileptics. Antihypertensives and CNS depressants or stimulants, sucralfate, antacids, lithium, sympathomimetics. Special Warnings and Precautions for use: Increased motor agitation: (extrapyramidal reactions, neuroleptic malignant syndrome, postural hypotension, sedation and extrapyramidal effects in elderly, acute withdrawal symptoms), increased mortality in elderly people with dementia, venous thromboembolism, breast cancer. Precaution with: Parkinson’s disease, epilepsy, glaucoma, ileus, congenital digestive stenosis, urine retention or prostate hyperplasia, prolongation of the QT interval, stroke. Fertility, Pregnancy and Lactation: Sulpiride should not be used during pregnancy and breastfeeding. If sulpiride is used during pregnancy, neonate should be carefully monitored. Effects on Ability to Drive and Use Machines: Patients should be advised not to drive or operate machinery if they experience symptoms of slowing of reaction time, drowsiness or loss of concentration. Undesirable Effects: Common: hyperprolactinaemia, insomnia, sedation or drowsiness, extrapyramidal disorder, Parkinsonism, tremor, akathisia, constipation, hepatic enzyme increased, maculo-papular rash, breast pain, galactorrhoea, weight gain. Uncommon: leukopenia, hypertonia, dyskinesia, dystonia, orthostatic hypotension, salivary hypersecretion, breast enlargement, amenorrhoea, orgasm abnormal, erectile dysfunction. Rare: oculogyric crisis, ventricular arrhythmia, ventricular fibrillation, ventricular tachycardia. Not known: neutropenia, agranulocytosis, haemolytic anaemia, thrombocytopenic purpura, anaphylactic reactions; urticaria, dyspnoea, hypotension and anaphylactic shock, blurred vision, corneal and lens opacities, deposition of pigment in the eyes, confusion, depression, agitation, neuroleptic malignant syndrome, hypokinesia, tardive dyskinesia, convulsion, hyponatraemia, syndrome of inappropriate antidiuretic hormone secretion (SIADH), hyperglycaemia, hypothermia, hyperthermia, electrocardiogram QT prolonged, cardiac arrest, torsade de pointes, sudden death, venous embolism, pulmonary embolism, deep vein thrombosis, pneumonia aspiration, nasal congestion, dry mouth, jaundice, hepatitis, contact sensitivity, exfoliative dermatitis, pigmentation of the skin, photosensitivity and skin rashes, torticollis, trismus, extrapyramidal symptoms, drug withdrawal syndrome neonatal, difficulties with micturition, gynaecomastia, ejaculatory dysfunction. Overdose: The duration of intoxication is generally short, the symptoms disappearing within a few hours. Comas which have occurred after large doses have lasted up to four days. There are no specific complications from overdose. Sulpiride is partly removed by haemodialysis. There is no specific antidote to sulpiride. Treatment is symptomatic. Appropriate supportive measures of vital functions and cardiac monitoring. Shelf Life and storage: 36 months. 3 months – opened. Do not store above 25°C. Legal Category: POM Pack Size and NHS Price: 150ml – £140.00. Marketing Authorisation Number: PL 00427/0129 Marketing Authorisation Holder: Rosemont Pharmaceuticals Ltd, Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK. Date of Preparation: September-2019

Adverse Drug Events

Information about adverse event reporting can be found at www.mhra.gov.uk/yellowcard
Adverse events should also be reported to Rosemont Pharmaceuticals Ltd on 0113 244 1400