GRANISETRON

Posology 1 mg twice a day or 2 mg once a day for up to one week following radiotherapy or chemotherapy. The first dose of granisetron should be administered within one hour before the start of therapy. Dexamethasone has been used concomitantly at doses up to 20 mg once a day orally.

Maximum Dose and Duration of Treatment Granisetron is also available as ampoules for intravenous administration. The maximum dose of granisetron administered orally and/or intravenously over 24 hours should not exceed 9 mg. Paediatric population The safety and efficacy of granisetron tablets in children have not yet been established.

No data are available. Older people and renal impairment There are no special precautions required for its use in either elderly patients or those patients with renal impairment. Hepatic Impairment There is no evidence to date for an increased incidence of adverse events in patients with hepatic disorders.

2). Method of administration The tablets should be swallowed whole with water.

Summary of the safety profile The most frequently reported adverse reactions for granisetron are headache and constipation, which may be transient. 5). Tabulated list of adverse reactions The following table of listed adverse reactions is derived from clinical trials and post- marketing data associated with granisetron and other 5-HT3 antagonists.

g. 5). 5). 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. uk/yellowcard.

As granisetron may reduce lower bowel motility, patients with signs of sub-acute intestinal obstruction should be monitored following administration of granisetron. As for other 5-HT3 antagonists, ECG changes including QT interval prolongation have been reported with granisetron.

In patients with pre-existing arrhythmias or cardiac conduction disorders this might lead to clinical consequences. 5). dolasetron, ondansetron) has been reported. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

5). If concomitant treatment with other serotonergic agents is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases. Symptoms of serotonin syndrome may include mental-status changes, autonomic instability, neuromuscular abnormalities, and/or gastrointestinal symptoms.

If serotonin syndrome is suspected, a dose reduction or discontinuation of therapy should be considered depending on the severity of the symptoms. Granisetron is essentially ‘sodium free’ as it contains less than 1 mmol sodium (23 mg) per dose (2 mg).

To be used with caution in children or in patients on a low sodium diet. Paediatric population There is insufficient clinical evidence to recommend administration of these tablets to children.

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