GRANISETRON Film-coated tablet Ref.[8215] Active ingredients: 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. On the basis of its kinetics, whilst no dosage adjustment is necessary, granisetron should be used with a certain amount of caution in this patient group (see section 5.2).

Method of administration

The tablets should be swallowed whole with water.

There is no specific antidote for granisetron. In the case of overdose with the tablets, symptomatic treatment should be given. Doses of up to 38.5 mgof granisetron as a single injection have been reported, with symptoms of mild headache but no other reported sequelae.

36 months.

This product does not require any special storage conditions.

PVC/PVDC aluminium foil opaque blisters in a cardboard carton and HDPE bottle with PE cap containing 1,2,4,5,6,7,10,14,20,28,30,50,90,100,150,200,250 and 500 tablets.

Not all pack sizes may be marketed.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.