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.
Kytril 1 mg film-coated tablets
⚠ 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
Kytril contains the active substance granisetron. This belongs to a group of medicines called '5-HT3 receptor antagonists' or 'anti-emetics'. These tablets are only for use in adults. Kytril is used to prevent or treat nausea and vomiting (feeling and being sick) caused by other medical treatments, such as chemotherapy or radiotherapy for cancer. 2.
What you need to know before you take it
e Kytril
Do not take Kytril tablets
- if you are allergic (hypersensitive) to granisetron or any of the other ingredients of Kytril (listed in section 6: Further information and "Important Information about some of the ingredients Kytril below"). If you are not sure, talk to your doctor, nurse or pharmacist before taking these tablets. Warnings and precautions Talk to your doctor, nurse or pharmacist before using these tablets, especially if you:
- are having problems with your bowel movements because of a blockage 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, ondansetron used like Kytril in the treatment and prevention of nausea and vomiting. Serotonin Syndrome is a rare but potentially life-threatening reaction that can occur with Kytril. It can cause serious changes in how your brain, muscles, and digestive system work. The reaction can occur 1
if you take Kytril alone but is more likely to occur if you take Kytril with certain other medications. 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 Kytril Please tell your doctor, nurse or pharmacist if you are taking or have recently taken or might take any other medicines, including medicines obtained without a prescription. This is because Kytril can affect the way some medicines work. Also some other medicines can affect the way these tablets work. In particular, tell your doctor, nurse or pharmacist if you are taking the following medicines:
- medicines used to treat an irregular heartbeat, other '5-HT3 receptor antagonist' medicines such as dolasetron or ondansetron (see "Warnings and precautions" above)
- phenobarbital, a medicine used to treat epilepsy
- a medicine called ketoconazole used in the treatment of fungal infections
- the antibiotic erythromycin used to treat bacterial infections
- SSRIs (selective serotonin reuptake inhibitors) used to treat depression and/or anxiety including fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram
- SNRIs (serotonin noradrenaline reuptake inhibitors) used to treat depression and/or anxiety including venlafaxine, duloxetine. Pregnancy and breast-feeding You should not take these tablets if you are pregnant, trying to get pregnant or are breast-feeding, unless your doctor has told you to. If you are pregnant or breast-feeding, 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 Kytril has no or negligible effect on your ability to drive or use any tools or machines. Kytril contains Kytril contains lactose (a type of sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. Kytril is essentially 'sodium free' as it contains less than 1 mmol sodium (23 mg) per dose (2 mg). 3.
How to take it
Kytril
Always take this medicine exactly as your doctor has told you. Check with your doctor, nurse or pharmacist if you are not sure. The recommended dose of Kytril 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 2
Your first dose of Kytril will usually be given an hour before your radio- or chemotherapy. The dose will be taken either as: –
one 1 mg tablet twice a day or
–
two 1 mg tablets once a day or
–
one 2 mg tablet once a day
for up to a week after your radio- or chemotherapy. Treatment of feeling or being sick The dose will usually be taken either as: –
one 1 mg tablet twice a day or
–
two 1 mg tablets once a day or
–
one 2 mg tablet once a day.
If you take more Kytril than you should If you think you have taken too many of the tablets talk to your doctor or nurse. The symptoms of overdose include mild headaches. You will be treated depending on your symptoms. If you forget to take Kytril If you think you have forgotten to take your medicine speak to your doctor or nurse. Do not take a double dose to make up for a forgotten tablet. If you stop taking Kytril Do not stop taking your medicine before the treatment is finished. If you do stop taking your medicine, your symptoms may return. If you have any further questions on the use of this medicine, ask your doctor, nurse or pharmacist. 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: may affect more than 1 in 10 people
- headache
- constipation. Your doctor will monitor your condition. Common: may affect up to 1 in 10 people
- problems sleeping (insomnia)
- changes in how your liver is working shown by blood tests 3
•
diarrhoea.
Uncommon: may affect up to 1 in 100 people
- skin rashes or an allergic skin reaction or "nettle-rash" or "hives" (urticaria). The signs may include red, raised itchy bumps
- changes in the heartbeat (rhythm) and changes seen on ECG readings (electrical recordings of the heart)
- abnormal involuntary movements, such as shaking, muscle rigidity and muscle contractions
- Serotonin Syndrome. The signs may include fever, sweating, shivering, diarrhoea, nausea, vomiting, muscle shakes, jerks, twitches or stiffness, overactive reflexes, loss of coordination, fast heartbeat, changes in blood pressure,confusion, agitation, restlessness, hallucinations, mood changes, unconsciousness and coma. 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. By reporting side effects you can help provide more information on the safety of this medicine. 5.
How to store it
Kytril
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. The expiry date refers to the last day of that month. This medicinal product does not require any special storage conditions. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment. 6.
Contents of the pack and other information
What Kytril contains The active substance is granisetron. Each 1 mg film-coated tablet contains 1 mg granisetron (as the hydrochloride). Each 2 mg film-coated tablet contains 2 mg granisetron (as the hydrochloride). The other ingredients are: Lactose monohydrate Hypromellose Sodium starch glycolate Cellulose, microcrystalline Magnesium stearate Film-coat: Hypromellose Titanium dioxide (E171) Macrogol 400 Polysorbate 80 What Kytril looks like and contents of the pack 4
The tablets are white to almost white triangular biconvex tablets imprinted with K1 on one side. The tablets are white to almost white triangular biconvex tablets imprinted with K2 on one side. Opaque PVC blisters sealed with an aluminium foil containing 2 or 10 tablets (1 mg) or 1, 5 or 10 tablets (2 mg). Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Atnahs Pharma UK Limited Sovereign House, Miles Gray Road Basildon, Essex, SS14 3FR United Kingdom Manufacturer
IL CSM Clinical Supplies Management Marie-Curie-Strasse 8 Lörrach Baden-Württemberg 79539, Germany This leaflet was last revised in November 2021
5
Frequently asked questions about Kytril 1 mg film-coated tablets
How do I take Kytril 1 mg film-coated tablets?
Kytril 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.
What is the active substance in Kytril 1 mg film-coated tablets?
The active substance in Kytril 1 mg film-coated tablets is granisetron hydrochloride.
Are there equivalent medicines to Kytril 1 mg film-coated tablets?
Medicines with the same active substance, strength and form include: Granisetron 1 mg film-coated tablets. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Kytril 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.
Can I get Kytril 1 mg film-coated tablets 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
Kytril film-coated tablets are indicated in adults for the prevention and treatment of acute nausea and vomiting associated with chemotherapy and radiotherapy.
Kytril film-coated tablets are indicated in adults for prevention of delayed nausea and vomiting associated with chemotherapy and radiotherapy.
4.2. Posology and method of administration
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. 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.
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. dolasteron, ondansetron) has been reported.
Patients with rare hereditary problems of galactose intolerance, lactase deficiency or glucose-galactose malabsorption should not take this medicine.
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.
Kytril is essentially 'sodium free' as it contains less than 1 mmol sodium (23 mg) per dose (2 mg).
Paediatric population
There is insufficient clinical evidence to recommend administration of these tablets to children.
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 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, breast-feeding should not be advised during treatment with Kytril.
Fertility
In rats, granisetron had no harmful effects on reproductive performance or fertility.
4.7. Effects on ability to drive and use machines
Kytril has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
Summary of the safety profile
The most frequently reported adverse reactions for Kytril are headache and constipation, which may be transient. ECG changes including QT prolongation have been reported with Kytril (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 Kytril 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 Kytril 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 website: www.mhra.gov.uk/yellowcard.
4.9. Overdose
There is no specific antidote for Kytril. In the case of overdose with the tablets, symptomatic treatment should be given. Doses of up to 38.5 mg of Kytril as a single injection have been reported, with symptoms of mild headache but no other reported sequelae.
💬 Ask about this leaflet
Ask anything about Kytril 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.