MAXOLON SR

Posology:

Adults The recommended single dose is 15 mg, repeated up to twice daily. 5mg/kg body weight. The maximum recommended treatment duration is 5 days. 15 mg/kg body weight, repeated up to three times daily by oral route. 5 mg/kg body weight.

5 mg Up to 3 times daily 9-18 years 30-60 kg 5 mg Up to 3 times daily 15-18 years Over 60kg 10 mg Up to 3 times daily The maximum treatment duration is 5 days for prevention of delayed chemotherapy induced nausea and vomiting (CINV).

Capsules are not suitable for use in children weighing less than 61 kg. Other pharmaceutical forms/strengths may be more appropriate for administration to this population. 3). Special population Elderly In elderly patients a dose reduction should be considered, based on renal and hepatic function and overall frailty.

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).

Adverse reactions listed by System Organ Class.

Frequencies are defined using the following convention:

Very common (>1/10), Common (>1/100to <1/10), Uncommon (>1/1,000to <1/100), Rare (>1/10,000to <1/1,000), Very rare (<1/10,000), not known (cannot be estimated from the available data). 3) Transient increase 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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g. cerebral irritation. 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. Metoclopramide may cause elevation of serum prolactin levels. Patients with rare hereditary problems of fructose intolerance, glucose- galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

Care should be exercised when using Maxolon in patients with a history of atopy (including asthma) or porphyria. Methaemoglobinemia Methemoglobinemia 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.

1 ‘Maxolon’ should not be used during the first three to four days following operations such as pyloroplasty or gut anastomosis as vigorous muscular contractions may not help healing. 5) - Known history of methaemoglobinaemia with metoclopramide or of NADH cytochrome-b5 deficiency.

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