METOCLOPRAMIDE

Posology - - Adult population - The recommended single dose is 10 mg, repeated up to three times daily. 5 mg/kg body weight. 3). 15 mg/kg body weight, repeated up to three times daily. 5 mg/kg body weight. 5 mg 9-18 years 30-60 kg 5 mg 15-18 years over 60 kg 10 mg up to 3 times daily - Elderly patients - In elderly patients a dose reduction should be considered, based on renal and hepatic function and overall frailty.

- - Patients with renal impairment - In patients with end stage renal disease (Creatinine clearance ≤ 15 ml/min), the daily dose should be reduced by 75%. 2). 2). 4). - Duration of administration - The maximum recommended treatment duration is 5 days.

Adverse reactions are listed by System Organ Class.

Frequencies are defined using the following convention:

Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (frequency cannot be estimated from the available data). 3), transient rise in blood pressure Gastrointestinal disorders Common Diarrhoea General disorders and administration site conditions Common Asthenia * Endocrine disorders during prolonged treatment in relation with hyperprolactinaemia (amenorrhoea, galactorrhoea, gynaecomastia).

4). - Drowsiness, decreased level of consciousness, confusion, hallucination. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

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Neurological disorders Extrapyramidal disorders may occur, particularly in children and young adults, and/or when high doses are used. These reactions occur usually at the beginning of the treatment and can occur after a single administration.

Metoclopramide should be discontinued immediately in the event of extrapyramidal symptoms. These effects are generally completely reversible after treatment discontinuation, but may require a symptomatic treatment (benzodiazepines in children and/or anticholinergic anti- Parkinsonian medicinal products in adults).

2 should be respected between each metoclopramide administration, even in case of vomiting and rejection of the dose, in order to avoid overdose. Prolonged treatment with metoclopramide may cause tardive dyskinesia, potentially irreversible, especially in the elderly.

8). Treatment must be discontinued if clinical signs of tardive dyskinesia appear. 8). Metoclopramide should be discontinued immediately in the event of symptoms of neuroleptic malignant syndrome and appropriate treatment should be initiated.

3). Symptoms of Parkinson’s disease may also be exacerbated by metoclopramide. Methaemoglobinaemia Methaemoglobinaemia which could be related to NADH-cytochrome b5 reductase deficiency has been reported. In such cases, metoclopramide should be immediately and permanently discontinued and appropriate measures initiated (such as treatment with methylene blue).

8). Special care should be taken when administering metoclopramide, particularly via the intravenous route to the elderly population, to patients with cardiac conduction disturbances (including QT prolongation), patients with uncorrected electrolyte imbalance, bradycardia and those taking other drugs known to prolong QT interval.

g. hypotension, akathisia). 2). This medicinal product contains methyl-parahydroxybenzoate and propyl- parahydroxybenzoate and may therefore cause allergic reactions (possibly delayed).

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