KYTRIL

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 Kytril 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. 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 Kytril 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 Kytril 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 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. Serotonin Syndrome 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).

Concomitant administration of granisetron and buprenorphine/opioids may result in serotonin syndrome, a potentially life-threatening condition. Symptoms of serotonin syndrome, a potentially life-threatening condition, may include a mental-status changes, autonomic instability, neuromuscular abnormalities, and/or gastrointestinal symptoms.

Appropriate observation of patients for serotonin syndrome-like symptoms is advised. Paediatric population There is insufficient clinical evidence to recommend administration of these tablets to children. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Kytril is essentially ‘sodium free’ as it contains less than 1 mmol sodium (23 mg) per dose (1 mg).

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