Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Granisetron 1 mg/ml concentrate for solution for injection or infusion
⚠ This medicine appears to have been discontinued
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.
What it is and what it is used for
FOR Granisetron 1 mg/ml concentrate for solution for injection or infusion contains a medicine called granisetron. This belongs to a group of medicines called '5-HT3 receptor antagonists' or 'antiemetics'. Granisetron is used to prevent or treat nausea (feeling sick) and vomiting (being sick) caused by other medical treatments, such as chemotherapy or radiotherapy for cancer, and by surgery. The solution for injection or infusion is for use in adults, adolescents and children from 2 years of age.
What you need to know before you take it
GRANISETRON Do not use Granisetron
- if you are allergic (hypersensitive) to granisetron or any of the other ingredients of this medicine (listed in section 6). Warnings and precautions Talk to your doctor, nurse or pharmacist before using Granisetron Check with your doctor, nurse or pharmacist before using Granisetron if you:
- have problems with your bowel movements because of a blockade of your gut (intestines)
- have heart problems, are being treated for cancer with a medicine that is known to damage your heart or have problems with levels of salts, such as potassium, sodium or calcium in your body (electrolyte abnormalities)
- are taking other '5-HT3 receptor antagonist' medicines. These include dolasetron and ondansetron used like Granisetron in the treatment and prevention of nausea and vomiting. Serotonin syndrome is an uncommon but potentially lifethreatening reaction that can occur with granisetron (see section 4). The reaction can occur if you take granisetron alone but it is more likely to occur if you take granisetron with certain other medicines (in particular fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram, venlafaxine, duloxetine). Other medicines and Granisetron Please tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other medicines. This is because Granisetron can affect the way some medicines work. Also some other medicines can affect the way this injection or infusion works. In particular, tell your doctor, nurse or pharmacist if you are taking the following medicines:
- medicines used to treat an irregular heartbeat or other '5-HT3 receptor antagonist' medicines such as dolasetron or ondansetron (see 'Warnings and precautions' above)
- phenobarbital, a medicine used to treat epilepsy.
- SSRIs (selective serotonin reuptake inhibitors) used to treat depression and/or anxiety. Examples are fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram.
- SNRIs (serotonin noradrenaline reuptake inhibitors) used to treat depression and/or anxiety. Examples are venlafaxine, duloxetine. Pregnancy and breastfeeding You should not have this injection or infusion if you are pregnant, trying to get pregnant or are breastfeeding, unless your doctor has told you to. If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor, nurse or pharmacist for advice before taking this medicine. Driving and using machines Granisetron is not likely to affect your ability to drive or use any tools or machines. Granisetron contains sodium This medicine contains:
- a maximum of 27.7 mg (or 1.2 mmol) sodium (main component of cooking/table salt) per 1 ml ampoule. This is equivalent to 1.4% of the recommended maximum daily dietary intake of sodium for an adult
- a maximum of 83.1 mg (or 3.6 mmol) sodium (main component of cooking/table salt) per 3 ml ampoule. This is equivalent to 4.2% of the recommended maximum daily dietary intake of sodium for an adult
Prevention of feeling or being sick following radio- or chemotherapy You will be given the injection or infusion before your radio- or chemotherapy starts. The injection or infusion into your veins will take between 30 seconds (injection) and 5 minutes (infusion) and the dose will usually be between 1 and 3 mg. The medicine may be diluted before it is injected. Treatment of feeling or being sick following radio- or chemotherapy The injection or infusion will take between 30 seconds (injection) and 5 minutes (infusion) and the dose will usually be between 1 and 3 mg. The medicine may be diluted before it is injected or infused into your veins. You may be given more injections or infusions to stop your sickness after the first dose. There will be at least 10 minutes between each dose. The most Granisetron you will be given is 9 mg a day. Combination with steroids The effect of the injection or infusion may be improved by the use of medicines called adrenocortical steroids. The steroid will be given either as a dose between 8 and 20 mg dexamethasone before your radio- or chemotherapy or as 250 mg methyl-prednisolone, which will be given both before and after your radio- or chemotherapy. Use in children in the prevention or treatment of feeling or being sick following chemotherapy Children will be given Granisetron by infusions into a vein as described above with the dose depending on the child's weight. The infusions will be diluted and be given before chemotherapy and will take 5 minutes. Children will be given a maximum of 2 doses a day, at least 10 minutes apart. Treatment of feeling or being sick following surgery The injection into your veins will take between 30 seconds and 5 minutes and the dose will usually be 1 mg. The most Granisetron you will be given is 3 mg a day. Use in children in the prevention or treatment of feeling or being sick following surgery Children should not be given this injection to treat sickness or the feeling of sickness after surgery. If you are given more Granisetron than you should Because the injection or infusion will be given to you by a doctor or nurse, it is unlikely that you will be given too much. However, if you are worried talk to your doctor or nurse. Symptoms of overdose include mild headaches. You will be treated depending on your symptoms. If you have any further questions on the use of this medicine, ask your doctor, nurse or pharmacist. For information intended for healthcare professionals please see accordant section below. 4. POSSIBLE SIDE EFFECTS 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 (affects more than 1 user in 10):
- Headache
- Constipation. Your doctor will monitor your condition. Common (affects up to 1 in 10 users):
- Difficulty in sleeping (insomnia)
- Diarrhoea
- Changes in how your liver is working shown by blood tests Uncommon (affects up to 1 in 100 users):
- Skin rashes or an allergic skin reaction or "nettlerash" or "hives" (urticaria). The signs may include red, raised itchy bumps.
- Abnormal involuntary movements, such as shaking, muscle rigidity and muscle contractions
- Changes in the heartbeat (rhythm) and changes seen on ECG readings (electrical recordings of the heart)
—–—————————————————————————————————————The following information is intended for healthcare professionals only: PREPARATION GUIDE FOR:
Granisetron 1 mg/ml concentrate for solution for injection or infusion It is important that you read the entire contents of this guide prior to the preparation of this medicinal product. 1. PRESENTATION Granisetron is supplied as a concentrate for solution for intravenous injection or infusion in colourless glass ampoules with a volume of 1 ml or 3 ml containing a sterile, clear colourless solution. 2. PREPARATION FOR ADMINISTRATION
THE
INTRAVENOUS
In adults: Granisetron can be administered as an intravenous bolus over not less than 30 seconds diluted with infusion fluid.
The contents of a 1 ml ampoule can be diluted to a volume of 5 ml; the contents of a 3 ml ampoule can be diluted to a volume of 15 ml. Granisetron can also be diluted in 20 to 50 ml infusion fluid and then given over 5 minutes as an intravenous infusion. In children: Granisetron should be diluted to a total volume of 10 ml to 30 ml and administered by intravenous infusion over 5 minutes. Granisetron is compatible with the following solutions: 0.9% w/v sodium chloride injection 0.18% w/v sodium chloride and 4% glucose injection 5% w/v glucose injection
- Serotonin Syndrome. The signs may include diarrhoea, nausea, vomiting, high temperature and blood pressure, excessive sweating and rapid heartbeat, agitation, confusion, hallucination, shivering, muscles shakes, jerks or stiffness, loss of coordination and restlessness. Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme – website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting
Possible side effects
you can help provide more information on the safety of this medicine.
How to store it
GRANISETRON Keep this medicine out of the sight and reach of children. This product does not require any special temperature storage conditions. Keep the ampoules in the outer carton in order to protect from light. Do not use this medicine after the expiry date which is stated on the ampoule label and the outer carton after "EXP.". The expiry date refers to the last day of that month. Do not use this medicine if you notice the solution is not clear or free from particles. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment. 6. CONTENTS OF INFORMATION
THE
PACK
AND
OTHER
What Granisetron contains The active substance is granisetron hydrochloride. Each 1 ml ampoule contains a total content of 1 mg granisetron as the hydrochloride in 1 ml of a sterile solution. Each 3 ml ampoule contains a total content of 3 mg granisetron as the hydrochloride in 3 ml of a sterile solution. The other ingredients are sodium chloride, citric acid monohydrate, sodium hydroxide and water for injections. What Granisetron looks like and contents of the pack Granisetron is a clear, colourless concentrate for solution for injection or infusion. Pack size: Granisetron is available in packs of five or ten ampoules filled with 1 ml or 3 ml of the solution. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: hameln pharma ltd Nexus, Gloucester Business Park Gloucester, GL3 4AG, United Kingdom Manufacturer: Siegfried Hameln GmbH Langes Feld 13 31789 Hameln, Germany hameln rds s.r.o. Horná 36, 90001 Modra, Slovakia This medicinal product is authorised in the Member States of the EEA under the following names: DE
Granisetron-hameln 1 mg/ml
DK
Granisetron Hameln 1 mg/ml
FI
Granisetron Hameln 1 mg/ml
NL
Granisetron-hameln 1 mg/ml
PT
Granissetrom Hameln 1 mg/ml
SE
Granisetron Hameln 1 mg/ml
UK
Granisetron 1 mg/ml
This leaflet was last revised in 03/2026 46170/12/26
—–—————————————————————————————————————Hartmann's solution 1.87% w/v sodium lactate injection 10% mannitol injection 1.4% w/v sodium hydrogen carbonate injection 2.74% w/v sodium hydrogen carbonate injection 4.2% w/v sodium hydrogen carbonate injection If required, Granisetron should only be diluted with one of these infusion fluids. Granisetron must not be mixed with any other medicinal products. For single use only. The product should be used immediately after opening the ampoule. Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C in normal indoor illumination protected from direct sunlight. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally
not be longer than 24 hours at 2 -8°C, unless dilution has taken place in controlled and validated aseptic conditions. This product does not require any special temperature storage conditions. Keep the ampoules in the outer carton in order to protect from light. Any unused product or waste material should be disposed of in accordance with local requirements.
Contents of the pack and other information
The injection or infusion will be given to you by a doctor or nurse. The 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. Granisetron can be given as an injection or infusion into the veins (intravenous). Dosage The usual doses are:
Frequently asked questions about Granisetron 1 mg/ml concentrate for solution for injection or infusion
How do I take Granisetron 1 mg/ml concentrate for solution for injection or infusion?
Granisetron 1 mg/ml concentrate for solution for injection or infusion comes as injection containing 1mg/ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Granisetron 1 mg/ml concentrate for solution for injection or infusion?
The active substance in Granisetron 1 mg/ml concentrate for solution for injection or infusion is granisetron hydrochloride.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Granisetron 1 mg/ml concentrate for solution for injection or infusion, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Granisetron 1 mg/ml concentrate for solution for injection or infusion without a prescription?
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.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: granisetron hydrochloride
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Granisetron is indicated in adults for the prevention and treatment of
- acute nausea and vomiting associated with chemotherapy and radiotherapy.
- post-operative nausea and vomiting.
Granisetron is indicated for the prevention of delayed nausea and vomiting associated with chemotherapy and radiotherapy.
Granisetron is indicated in children aged 2 years and above for the prevention and treatment of acute nausea and vomiting associated with chemotherapy.
4.2. Posology and method of administration
Posology
Chemo- and radiotherapy-induced nausea and vomiting (CINV and RINV)
Prevention (acute and delayed nausea and vomiting)
A dose of 1 – 3 mg (10 – 40 µg/kg) of Granisetron should be administered either as a slow intravenous injection or as a diluted intravenous infusion 5 minutes prior to the start of chemotherapy or radiotherapy. The solution should be diluted to 5 ml per mg.
Treatment (acute nausea and vomiting)
A dose of 1 – 3 mg (10 – 40 µg/kg) of Granisetron should be administered either as a slow intravenous injection or as a diluted intravenous infusion and administered over 5 minutes. The solution should be diluted to 5 ml per mg. Further maintenance doses of Granisetron may be administered at least 10 minutes apart. The maximum dose to be administered over 24 hours should not exceed 9 mg.
Combination with adrenocortical steroid
The efficacy of parenteral granisetron may be enhanced by an additional intravenous dose of an adrenocortical steroid e.g. by 8 - 20 mg dexamethasone administered before the start of the cytostatic therapy or by 250 mg methyl-prednisolone administered prior to the start and shortly after the end of the chemotherapy.
Paediatric population
The safety and efficacy of granisetron in children aged 2 years and above has been well established for the prevention and treatment (control) of acute nausea and vomiting associated with chemotherapy. A dose of 10 – 40 µg/kg body weight (up to 3 mg) should be administered as an IV infusion, diluted in 10 - 30 ml infusion fluid and administered over 5 minutes prior to the start of chemotherapy. One additional dose may be administered within a 24 hour-period if required. This additional dose should not be administered until at least 10 minutes after the initial infusion.
Post-operative nausea and vomiting (PONV)
A dose of 1 mg (10 µg/kg) of Granisetron should be administered by slow intravenous injection. The maximum dose of Granisetron to be administered over 24 hours should not exceed 3 mg.
For the prevention of PONV, administration should be completed prior to induction of anaesthesia.
Paediatric population
Currently available data are described in section 5.1, but no recommendation on a posology can be made. There is insufficient clinical evidence to recommend administration of the solution for injection to children in prevention and treatment of post-operative nausea and vomiting.
Special populations
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. 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
Administration may be as either a slow intravenous injection (over 30 seconds) or as an intravenous infusion diluted in 20 - 50 ml infusion fluid and administered over 5 minutes.
For instructions on dilution of the medicinal product before administration, see section 6.6.
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
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. 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.
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). Appropriate observation of patients for serotonin syndrome-like symptoms is advised.
This medicine contains:
• a maximum of 27.7 mg (or 1.2 mmol) sodium per 1 ml ampoule, equivalent to 1.4% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
• a maximum of 83.1 mg (or 3.6 mmol) sodium per 3 ml ampoule, equivalent to 4.2% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
4.5. Interaction with other medicinal products and other forms of interaction
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 humans, hepatic enzyme induction with phenobarbital resulted in an increase in total plasma clearance of granisetron of approximately 25%.
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.
Serotonergic medicinal products (e.g. SSRIs and SNRIs)
There have been reports of serotonin syndrome following concomitant use of 5-HT3 antagonists and other serotonergic medicinal products (including SSRIs and SNRIs) (see section 4.4).
4.6. Fertility, pregnancy and lactation
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.
Breastfeeding
It is unknown whether granisetron or its metabolites are excreted in human milk. As a precautionary measure, breastfeeding should not be advised during treatment with Granisetron.
Fertility
In rats, granisetron had no harmful effects on reproductive performance or fertility
4.7. Effects on ability to drive and use machines
Granisetron has no or negligible influence on the ability to drive or to use machines.
4.8. Undesirable effects
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 summary 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)
System organ class
Frequency
Immune system disorders
Uncommon
Hypersensitivity reactions e.g. anaphylaxis, urticaria
Psychiatric disorders
Common
Insomnia
Nervous system disorders
Very Common
Headache
Uncommon
Extrapyramidal reactions, Serotonin syndrome
Cardiac disorders
Uncommon
QT interval prolonged
Gastrointestinal disorders
Very common
Constipation
Common
Diarrhoea
Hepatobiliary disorders
Common
Transaminases increased*
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).
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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
There is no specific antidote for granisetron. In the case of overdose with the injection or infusion, symptomatic treatment should be given. Doses of up to 38.5 mg of granisetron as a single injection have been reported, with symptoms of mild headache but no other reported sequelae.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
- GRANISETRON KABI 1 mg/ml prescriptionGRANISETRONUM · injection / infusion
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.
- SancusoGranisetronum · skin / topical
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Granisetron 1 mg/ml concentrate for solution for injection or infusion. 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.