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 film coated tablets should be administered within 1 hour before the start of therapy. Dexamethasone has been used concomitantly at doses up to 20 mg once a day orally.

Paediatric population The safety and efficacy of granisetron tablets in children have not yet been established. No data are available. Elderly and renal impairment There are no special precautions required for its use in either elderly patients or those patients with renal or hepatic 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 Film-coated Tablets 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 Film-coated Tablets 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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

As granisetron may reduce lower bowel motility, patients with signs of sub-acute intestinal obstruction should be monitored following its administration. 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). g. dolasteron, ondansetron) has been reported. Patients with rare hereditary problems of galactose intolerance, lactase deficiency or glucose-galactose malabsorption should not take this medicine.

There have been reports of serotonin syndrome with the use of 5-HT3 antagonists either alone, but mostly in combination with other serotonergic drugs (including selective serotonin reuptake inhibitors (SSRIs), and serotonin noradrenaline reuptake inhibitors (SNRIs).

Appropriate observation of patients for serotonin syndrome-like symptoms is advised. Granisetron Film-coated Tablets are essentially ‘sodium free’ as they contain less than 1 mmol sodium (23 mg) per daily dose of 2 mg (when taken as two 1 mg tablets, or individually as one 2 mg tablet).

Paediatric population There is insufficient clinical evidence to recommend administration of these tablets to children.

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