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 including acute migraine induced nausea and vomiting. Metoclopramide can be used in combination 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. For 1-3 years of age (10-14 kg body weight)1 mg (1 ml) up to 3 times daily, for 3-5 years of age (15-19 kg body weight) 2 mg (2 ml) up to 3 times daily, for 5-9 years of age (20-29 kg body weight) 2.5 mg (2.5 ml) up to 3 times daily, for 9- years of age (30-60 kg body weight) 5 mg (5 ml) up to 3 times daily and for 15-18 years of age ( over 60 kg body weight) 10 mg (10 ml) up to 3 times daily, The maximum duration is 5 days for prevention of delayed chemotherapy induced nausea and vomiting.  A minimal interval of 6 hours between two administrations is to be respected, even in case of vomiting or rejection of the dose. Special Population: Elderly patients: a dose reduction should be considered based on renal and hepatic function and overall frailty.  In patients with end stage renal disease (Creatinine clearance ≤ 15 ml/min), the daily dose should be reduced by 75% and with moderate to severe renal impairment (Creatinine clearance ≤ 15 ml/min), the dose should be reduced by 50%. In patients with severe hepatic impairment, the dose should be reduced by 50%. Metoclopramide is contraindicated in children aged less than 1 year. 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 to exclude the possibility of an underlying disorder, i.e. cerebral irritation. Care should be exercised when using in patients with a history of atopy (including asthma) 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, particularly in children and and young adults, and/or when high doses are used. Metoclopramide should be discontinued immediately in the event of extrapyramidal symptoms. These effects are generally completely reversible after treatment discontinuation but may require symptomatic treatment. 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. Neuroleptic malignant syndrome has been reported with metoclopramide in combination with neuroleptics as well as with metoclopramide monotherapy. 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 immediately and permanently discontinued and appropriate measures initiated (such as treatment with methylene blue). There have been reports of serious cardiovascular undesirable effects including cases of circulatory collapse, severe bradycardia, cardiac arrest and QT prolongation following administration of metoclopramide by injection, particularly via the intravenous route.  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. The content of sorbitol in medicinal products for oral use may affect the bioavailability of other medicinal products for oral use administered concomitantly. Patients with hereditary fructose intolerance (HFI) should not take/be given this medicinal product. This medicine contains 259mg propylene glycol (E1520) in each 5ml. Co-administration with any substrate for alcohol dehydrogenase such as ethanol may induce adverse effects in children less than 5 years old. While propylene glycol has not been shown to cause reproductive or development toxicity in animals or humans, it may reach the foetus and was found in milk. As a consequence, administration of propylene glycol to pregnant or lactating patients should be considered on a case-by-case basis. Medical monitoring is required in patients with impaired renal or hepatic functions because various adverse events attributed to propylene glycol have been reported such as renal dysfunction (acute tubular necrosis), acute renal failure and liver dysfunction. Any warning from the MC, CHM CSM or MHRA. No. Black Triangle notice: Not applicable. A list of very common, common adverse reactions and serious reactions are presented below : Methaemoglobinaemia, which could be related to NADH cytochrome b5 r deficiency, particularly in neonates; Sulfhaemoglobinaemia, mainly with concomitant administration of high doses of sulfur-releasing medicinal products. Bradycardia, particularly with intravenous formulation. Cardiac arrest, occurring shortly after injectable use, and which can be subsequent to bradycardia; Asystole; Atrioventricular block; Sinus arrest particularly with intravenous formulation; Electrocardiogram QT prolonged; Torsade de Pointes. Amenorrhoea; Hyperprolactinaemia, Galactorrhoea, Gynaecomastia. Diarrhoea, constipation, nausea, unusual dryness of mouth. Asthenia, Oedema (including face oedema). Hypersensitivity, Anaphylactic reaction (including anaphylactic shock particularly with intravenous formulation). Somnolence, 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, Dystonia (including visual disturbances and oculogyric crisis); Dyskinesia; Depressed level of consciousness, Convulsion especially in epileptic patients; Dizziness; Headache, Tardive dyskinesia which may be persistent, during or after prolonged treatment, particularly in elderly patients; Neuroleptic malignant syndrome Depression; Restlessness, Hallucination, Confusional state; Trouble sleeping; Unusual irritability, Dyspnoea, Skin rash: A small number of skin reactions such as urticaria and pruritus, Hypotension; particularly with intravenous formulation. Shock, Syncope after injectable use, Acute hypertension in patients with phaeochromocytoma. Transient increase in blood pressure. Endocrine disorders during prolonged treatment in relation with hyperprolactinaemia (amenorrhoea, galactorrhoea, gynaecomastia). The following reactions, sometimes associated, occur more frequently when high doses are used: – Extrapyramidal symptoms: acute dystonia and dyskinesia, parkinsonian syndrome, akathisia, even following administration of a single dose of the medicinal product, particularly in children and young adults. Drowsiness, decreased level of consciousness, confusion, hallucination. Very common adverse reaction: somnolence Common adverse s: 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. Serious adverse reactions: methaemoglobinaemia, which could be related to NADH cytochrome b5 reductase deficiency – particularly in neonates, sulfhaemoglobinaemia – mainly with concomitant administration of high doses of sulfur-releasing medicinal products, endocrine disorders during prolonged treatment in relation with hyperprolactinaemia (amenorrhoea, galactorrhoea, gynaecomastia), oedema including face oedema, hypersensitivity, dystonia (including visual disturbances and oculogyric crisis); dyskinesia; depressed level of consciousness, convulsion especially in epileptic patients, tardive dyskinesia which may be persistent, during or after prolonged treatment, particularly in elderly patients, neuroleptic malignant syndrome, hallucination, confusional state, dyspnoea, shock, acute hypertension in patients with phaeochromocytoma, transient increase in blood pressure. Serious reactions sometimes more frequently associated with high doses: extrapyramidal symptoms: acute dystonia and dyskinesia, parkinsonian syndrome, akathisia, even following administration of a single dose of the medicinal product, particularly in children and young adults, drowsiness, decreased level of consciousness, confusion, hallucination. Please refer to summary of product characteristic for more details on adverse events. Pack Size and NHS Price: 150ml – £15.50. Legal category: POM. 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 revision: 16OCT2025