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Metoclopramide Abbreviated Prescribing Information

Abbreviated Prescribing Information: Metoclopramide Hydrochloride 5mg/5ml Oral Solution Consult Summary of Product Characteristics before prescribing. Presentation: Oral solution. Each 5ml of oral solution contains metoclopramide hydrochloride monohydrate, equivalent to 5mg metoclopramide hydrochloride. Therapeutic Indications: Adult population: Prevention of delayed chemotherapy induced nausea and vomiting. Prevention of radiotherapy induced nausea and vomiting. Symptomatic treatment of nausea and vomiting. Metoclopramide can be used with oral analgesics to improve the absorption of analgesics in acute migraine. Paediatric population: Metoclopramide is indicated in children (aged 1-18 years) for prevention of delayed chemotherapy induced nausea and vomiting as a second line option. Posology and method of administration: For oral use. Suitable for administration via nasogastric (NG) or percutaneous endoscopic gastrostomy (PEG) tubes. All indications (adult patients): The recommended single dose is 10 mg, repeated up to three times daily. The maximum recommended daily dose is 30 mg or 0.5 mg/kg body weight. The maximum recommended treatment duration is 5 days. Paediatric population (1 – 18 years): Prevention of delayed chemotherapy induced nausea and vomiting, 0.1 to 0.15 mg/kg body weight, repeated up to three times daily by oral route. The maximum dose in 24 hours is 0.5 mg/kg body weight. Special Population: Elderly patients: a dose reduction should be considered. In patients with end stage renal disease the daily dose should be reduced by 75% and with moderate to severe renal impairment, the dose should be reduced by 50%. In patients with severe hepatic impairment, the dose should be reduced by 50%. Contra-indications: hypersensitivity to metoclopramide hydrochloride or any of the excipients, hypersensitivity to procaine and procainamide, use during the first three to four days following operations such as pyloroplasty or gut anastomosis, gastrointestinal haemorrhage, mechanical obstruction or gastro-intestinal perforation, confirmed or suspected pheochromocytoma, history of neuroleptic or metoclopramide-induced tardive dyskinesia, epilepsy, Parkinson’s disease, combination with levodopa or dopaminergic agonists, known history of methaemoglobinaemia with metoclopramide, or of NADH cytochrome-b5 deficiency, and use in children less than 1 year of age. Special Warnings and Precautions for use: If vomiting persists, the patient must be re-assessed. Care should be exercised when using in patients with a history of atopy or porphyria. Patients receiving this drug for delayed gastric emptying should be reviewed at an early stage for response to treatment. May cause elevation of serum prolactin levels. Extrapyramidal disorders may occur and metoclopramide should be discontinued immediately. These effects are generally completely reversible after treatment discontinuation. Give at least 6 hours between doses. Prolonged treatment may cause tardive dyskinesia, potentially irreversible, especially in the elderly. Treatment should not exceed 3 months. Treatment must be discontinued if signs of tardive dyskinesia appear. Should be discontinued immediately in the event of symptoms of neuroleptic malignant syndrome. Special care should be exercised in patients with underlying neurological conditions and in patients being treated with other centrally-acting drugs.Symptoms of Parkinson’s disease may also be exacerbated. In cases of methaemoglobinemia, metoclopramide should be immediatelyand permanently discontinued. Special care should be taken when administering to the elderly population, to patients with cardiac conduction disturbances, patients with uncorrected electrolyte imbalance, bradycardia and those taking other drugs known to prolong QT interval. In patients with renal impairment or with severe hepatic impairment, a dose reduction is recommended. The additive effect of concomitantly administered products containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account. Patients with hereditary fructose intolerance (HFI) should not take/be given this medicinal product. Co-administration with any substrate for alcohol dehydrogenase such as ethanol may induce adverse effects in children less than 5 years old. Any warning from the MC, CHM CSM or MHRA. No. Black Triangle notice: Not applicable. Legal Category: POM. A list of very common and common adverse reactions are presented below and refer the SmPC for other reactionsVery commonSomnolence. Common: Diarrhoea, Asthenia, Extrapyramidal disorders (particularly in children and young adults and/or when the recommended dose is exceeded, even following administration of a single dose of the drug); Parkinsonism, Akathisia, Depression, Restlessness, and Hypotension; particularly with intravenous formulation. Pack Size and NHS Price: 150ml – £15.50. Marketing authorisation number: PL 00427/0117. Marketing Authorisation Holder: Rosemont Pharmaceuticals Ltd, Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK. Date of Preparation: December 2022

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