Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Granisetron hydrochloride may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
for
Granisetron belongs to a group of medicines known as '5-HT3 receptor antagonists' or anti-emetics or anti-sickness medicines. These tablets are only for use in adults. It is used to prevent or treat nausea (feeling sick) and vomiting (being sick) caused by other medical treatments, such as chemotherapy or radiation treatment for cancer.
2.
e Granisetron
Do not take granisetron
reaction can occur if you take granisetron alone but is more likely to occur if you take granisetron with certain other medicines (in particular fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram, venlafaxine, duloxetine). Be sure to tell your doctor, nurse or pharmacist all the medicines you are taking. Children Children should not take these tablets. Other medicines and granisetron Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is because granisetron can affect the way some medicines work. Also some other medicines can affect the way these tablets work. In particular, tell your doctor or pharmacist if you are taking the following medicines:
Granisetron
Always take Granisetron exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Swallow the tablets with a glass of water. The recommended dose of granisetron varies from one patient to another. It depends on your age, weight, and whether you are being given the medicine to prevent, or treat, nausea and vomiting. The doctor will work out how much to give you. Prevention of feeling or being sick Your first dose of granisetron will usually be given an hour before your radio- or chemotherapy. The dose will be either one or two 1 mg tablets or one 2 mg tablet once a day for up to a week after your radio- or chemotherapy. 2
Treatment of feeling or being sick The dose will usually be either one or two 1 mg tablets or one 2 mg tablet once a day, but your doctor may decide to increase your dose to upto nine 1 mg tablets a day. Your doctor may also give you another medicine called dexamethasone to take as well. Children Granisetron is not suitable for children. If you take more Granisetron than you should
Contact your doctor or go to the nearest hospital casualty department immediately. Take the container and any remaining tablets with you. The symptoms of overdose include mild headaches. You will be treated depending on your symptoms.
If you forget to take Granisetron If you think you have forgotten to take your medicine speak to your doctor or nurse. Do not take two doses together to make up for the one you have missed. If you stop taking Granisetron
Do not stop taking your medicine before the treatment is finished. If you do stop taking your medicine, your symptoms may return. Speak to your doctor first if you wish to stop taking this medicine. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4.
Like all medicines, this medicine can cause side effects, although not everybody gets them. If you notice the following problem you must see a doctor straight away: •
Allergic reactions (anaphylaxis). The signs may include swelling of the throat, face, lips and mouth, difficulty in breathing or swallowing.
Other side effects that may be experienced while taking this medicine are: Very common: may affect more than 1 in 10 people
3
Reporting of side effects If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine. 5.
Granisetron
Keep this medicine out of the sight and reach of children. Do not use Granisetron after the expiry date which is stated on the carton or label after EXP. The expiry date refers to the last day of that month. Do not store above 30°C. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. 6.
What Granisetron contains
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Granisetron 1 mg film-coated tablets comes as tablet containing 1mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Granisetron 1 mg film-coated tablets is granisetron hydrochloride.
Medicines with the same active substance, strength and form include: Kytril 1 mg film-coated tablets. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Granisetron 1 mg film-coated tablets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Granisetron tablets are indicated in adults for the prevention and treatment of acute nausea and vomiting associated with chemotherapy and radiotherapy.
Granisetron tablets are indicated in adults for prevention of delayed nausea and vomiting associated with chemotherapy and radiotherapy.
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.
Granisetron is contra-indicated in patients hypersensitive to the active substance or to any of the excipients listed in section 6.1.
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. Therefore caution should be exercised in patients with cardiac co-morbidities, on cardiotoxic chemotherapy and/or with concomitant electrolyte abnormalities (see section 4.5).
Cross-sensitivity between 5-HT3 antagonists (e.g.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.
Serotonin Syndrome
Concomitant administration of granisetron and buprenorphine/opioids may result in serotonin syndrome, a potentially life threatening condition (see section 4.5).
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.
As for other 5-HT3 antagonists, cases of ECG modifications including QT prolongation have been reported with granisetron. In patients concurrently treated with medicinal products known to prolong QT interval and/or which are arrhythmogenic, this may lead to clinical consequences (see section 4.4).
In studies in healthy subjects, no evidence of any interaction has been indicated between granisetron and benzodiazepines (lorazepam), neuroleptics (haloperidol) or anti-ulcer medicinal products (cimetidine). Additionally, granisetron has not shown any apparent medicinal product interaction with emetogenic cancer chemotherapies.
No specific interaction studies have been conducted in anaesthetised patients.
Granisetron should be used cautiously when co-administered with:
- Buprenorphine/opioids as the risk of serotonin syndrome, a potentially life-threatening condition, is increased (see section 4.4).
Pregnancy
There is limited amount of data from the use of granisetron in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). As a precautionary measure, it is preferable to avoid the use of granisetron during pregnancy.
Breast-feeding
It is unknown whether granisetron or its metabolites are excreted in human milk. As a precautionary measure, breast-feeding should not be advised during treatment with granisetron.
Fertility
In rats, granisetron had no harmful effects on reproductive performance or fertility.
Granisetron has no or negligible influence on the ability to drive and use machines.
Summary of the safety profile
The most frequently reported adverse reactions for granisetron are headache and constipation, which may be transient. ECG changes including QT prolongation have been reported with granisetron (see sections 4.4 and 4.5).
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.
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. anaphylaxis, urticaria
Psychiatric disorders
Common
Insomnia
Nervous system disorders
Very common
Headache
Uncommon
Extrapyramidal Reactions
Uncommon
Serotonin Syndrome (see also sections 4.4 and 4.5)
Cardiac disorders
Uncommon
QT prolongation
Gastrointestinal disorders
Very common
Constipation
Common
Diarrhoea
Hepatobiliary disorders
Common
Elevated hepatic transaminases*
Skin and subcutaneous tissue disorders
Uncommon
Rash
*Occurred at a similar frequency in patients receiving comparator therapy
Description of selected adverse reactions
As for other 5-HT3 antagonists, ECG changes including QT prolongation have been reported with granisetron (see sections 4.4 and 4.5).
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 (see sections 4.4 and 4.5).
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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
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.
Ask anything about Granisetron 1 mg film-coated tablets. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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