Kytril 1 mg film-coated tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Kytril 1 mg film-coated tablets
Granisetron
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse reactions, consult your doctor, nurse or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.
Contents of the leaflet
- What Kytril is and what it is used for
- What you need to know before taking Kytril
- How to take Kytril
- Possible side effects
- How to store Kytril
- Contents of the pack and other information
1. What Kytril is and what it is used for
Kytril contains the active substance granisetron. It belongs to a group of medicines called serotonin 5-HT3 receptor antagonists, or antiemetics, which means they prevent or stop nausea and vomiting. These tablets are indicated only for use in adults.
Kytril is indicated for the prevention and treatment of nausea and vomiting (feeling of discomfort) caused by certain treatments, such as chemotherapy or radiotherapy in anticancer therapy.
2. What you need to know before taking Kytril
Do not take Kytril tablets
? if you are allergic (hypersensitive) to granisetron or to any of the other components of Kytril (listed in section 6: Further information and the section on Important information about some of the components of Kytril).
If you are unsure, consult your doctor, nurse, or pharmacist before taking these tablets.
Warnings and precautions
Talk to your doctor or pharmacist before starting to take these tablets, especially if you:
? have constipation due to intestinal obstruction
? have heart problems, are receiving anticancer medicines that may be harmful to your heart, and/or suffer from electrolyte imbalances such as low levels of potassium, sodium, or calcium (electrolyte disturbances).
? are taking another medicine from the group of “5-HT3 receptor antagonists.” This group includes dolasetron and ondansetron, which, like Kytril, are used for the prevention and treatment of nausea and vomiting.
Serotonin syndrome is an uncommon but potentially life-threatening reaction that may occur with granisetron (see section 4). It can cause serious changes in how your brain, muscles, and digestive system function. The reaction may occur if you take granisetron alone, but it is more likely to occur if you take granisetron with other medicines (particularly fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram, venlafaxine, duloxetine). The risk of serotonin syndrome also increases if you are taking medicines containing buprenorphine or other opioids. Make sure to inform your doctor, nurse, or pharmacist about all medicines you are taking.
Children
Children must not take these tablets.
Other medicines and Kytril
Tell your doctor, nurse, or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription. This is because Kytril may interact with certain medicines. Likewise, some medicines may interact with these tablets.
Inform your doctor, nurse, or pharmacist if you are taking or may have taken other medicines:
? medicines used to treat irregular heartbeats, other “5-HT3 receptor antagonist” medicines such as dolasetron or ondansetron (see “Warnings and precautions”).
? phenobarbital, a medicine used to treat epilepsy
? ketoconazole, a medicine used to treat fungal infections
? erythromycin, an antibiotic used to treat bacterial infections
? SSRIs (selective serotonin reuptake inhibitors) used to treat depression and/or anxiety. For example: fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram
? SNRIs (serotonin and noradrenaline reuptake inhibitors) used to treat depression and/or anxiety. For example: venlafaxine, duloxetine.
- Medicines containing buprenorphine or other opioids.
Pregnancy and breastfeeding
Do not take these tablets if you are pregnant, trying to become pregnant, or breastfeeding, unless your doctor has instructed you to do so.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor, nurse, or pharmacist before using this medicine.
Driving and using machines
The effect of Kytril on the ability to drive and use machines is negligible or none.
Contents of Kytril
Kytril contains lactose (a type of sugar). If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.
Kytril contains less than 23 mg (1 mmol) of sodium per dose (1 mg), therefore it is considered essentially “sodium-free.”
3. How to take Kytril
Follow exactly the instructions given by your doctor for administering this medicine. If in doubt, please consult your doctor, nurse, or pharmacist again.
The recommended dose of Kytril varies from patient to patient. It depends on age, weight, and whether you are taking other medicines to prevent or treat nausea and vomiting. Your doctor will decide how much you should take.
Prevention of nausea or vomiting (feeling unwell)
The first dose of Kytril is usually given one hour before your radiotherapy or chemotherapy. The dose should be taken as:
- one 1 mg tablet twice daily, or
- two 1 mg tablets once daily, or
- one 2 mg tablet once daily,
up to a maximum of one week after your radiotherapy or chemotherapy.
Treatment of nausea or vomiting (feeling unwell)
The usual dose is:
- one 1 mg tablet twice daily, or
- two 1 mg tablets once daily, or
- one 2 mg tablet once daily.
If you take more Kytril than you should
If you think you have taken more tablets than you should, inform your doctor or nurse. You may also call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.
Symptoms of overdose may include mild headache (cephalalgia). You will be treated according to your symptoms.
If you forget to take Kytril
If you think you have missed a dose of your medicine, ask your doctor or nurse.
Do not take a double dose to make up for forgotten doses.
If you stop taking Kytril
Do not stop taking this medicine before completing the prescribed course. If you interrupt treatment, your symptoms may return.
If you have any further questions about the use of this medicine, ask your doctor, nurse, or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone experiences them. If you notice any of the following adverse effects, you should immediately consult your doctor:
- allergic reactions (anaphylaxis). Signs may include throat swelling, or swelling of the face, lips, and mouth, and difficulty breathing or swallowing
- Serotonin syndrome. Signs may include diarrhea, nausea, vomiting, high temperature and blood pressure, excessive sweating, rapid heartbeat, agitation, confusion, hallucinations, chills, muscle tremors, jerking or stiffness, loss of coordination, and restlessness. This reaction may occur when taking Kytril alone, but is more likely when taken with other medicines (see “Warnings and precautions”)
Other adverse effects that may occur 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
• difficulty falling asleep (insomnia)
• blood tests show changes in liver function
• diarrhea
Uncommon: may affect up to 1 in 100 people
• skin rashes or an allergic reaction or urticaria. Signs may include itchy red spots.
• changes in heart rhythm (rhythm) and changes in ECG (electrocardiogram)
• abnormal involuntary movements, such as tremors, muscle stiffness, and muscle contractions
• Serotonin syndrome. Signs may include diarrhea, nausea, vomiting, high fever and blood pressure, excessive sweating, and rapid heartbeat, agitation, confusion, hallucinations, chills, muscle spasms, jerking or stiffness, loss of coordination, and restlessness.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Kytril
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and carton following “EXP“. The expiry date refers to the last day of the month indicated.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be handed over to the SIGRE point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Kytril
The active substance is granisetron.
Each film-coated tablet contains 1 mg of granisetron (as granisetron hydrochloride).
The other components are:
Lactose monohydrate
Hypromellose
Sodium starch glycolate
Microcrystalline cellulose
Magnesium stearate
Tablet coating:
Hypromellose
Titanium dioxide (E171)
Macrogol 400
Polysorbate 80
Appearance of Kytril and contents of the pack
The tablets are biconvex triangular, white to almost white, and are marked with the inscription “K1” on one side. They are supplied in PVC/aluminum blisters containing 2 or 10 tablets per pack.
Not all pack sizes may be marketed.
Other presentations:
Kytril 3 mg/3 ml injectable solution (for hospital use)
Kytril 1 mg/1 ml injectable solution (for hospital use)
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Atnahs Pharma Netherlands B.V.
Copenhagen Towers
Ørestads Boulevard 108, 5.tv
DK-2300 København S
Denmark
Manufacturer
IL CSM Clinical Supplies Management
Marie-Curie-Strasse 8
Lörrach
Baden-Württemberg
79539, Germany
This medicinal product is authorized in the European Economic Area (EEA) Member States and in the United Kingdom (Northern Ireland) under the following names:
Austria, Belgium, Czech Republic, Estonia, Finland, France, Ireland, Italy, Netherlands, Slovenia, Spain, United Kingdom (Northern Ireland): Kytril
Germany: Kevatril
Date of the most recent review of this leaflet: March 2025
Other sources of information
Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/