GRANISETRON

Posology The dose of Granisetron is one 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 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.

Special patient groups:

Older people 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.

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 cinical trials and post- marketing data associated with granisetron and other 5-HT3 antagonists.

Frequency categories are as follows:

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) Immune system disorders Uncommon Hypersensitivity reactions e . g . 5). As with other 5-HT3 antagonists, cases of serotonin syndrome (including altered mental status, autonomic dysfunction and neuromuscular abnormalities) have been reported following the concomitant use of Granisetron and other serotonergic drugs.

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. 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. This medicinal product contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially “sodium free”. Paediatric population There is insufficient clinical evidence to recommend administration of these tablets to children.

1.