KYTRIL 1 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Kytril1mg film-coated tablets

Granisetron

<Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Kytril and what is it used for
2. What you need to know before you take Kytril
3. How to take Kytril
4. Possible side effects
5. Storage of Kytril
6. Contents of the pack and other information

1. What is Kytril and what is it used for

Kytril contains the active substance granisetron. This belongs to a group of medicines called serotonin receptor antagonists, 5-HT3, or antiemetics, which means they prevent or stop nausea and vomiting. These tablets are only for use in adults.

Kytril is used to prevent and treat nausea and vomiting (feeling sick) caused by certain treatments, such as chemotherapy or radiotherapy in cancer therapy.

2. What you need to know before you take 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 the section on Important information about some of the ingredients of Kytril).

If you are not sure, consult your doctor, nurse or pharmacist before taking these tablets.

Warnings and precautions

Consult your doctor or pharmacist before starting to take these tablets, especially if you:

have problems with constipation due to intestinal obstruction

have heart problems, are receiving anticancer medicines that can be harmful to your heart and/or have some disorder of the levels of salts such as potassium, sodium or calcium (electrolyte disturbances).

are taking another medicine from the group of “5-HT3 receptor antagonists”. This group includes dolasetron and ondansetron, used like Kytril, for the treatment and prevention of nausea and vomiting.

Serotonin Syndrome is a rare but potentially life-threatening reaction that can occur with granisetron (see section 4). It can cause serious changes in how your brain, muscles, and digestive system work. The reaction can occur if you take granisetron alone,butit is more likely to occur if you take granisetron with other medicines (in particular fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram, venlafaxine, duloxetine). The risk of serotonin syndrome also increases if you are taking medicines that contain buprenorphine or other opioids. Make sure to tell your doctor, nurse or pharmacist about all the medicines you are taking.

Children

Children should not take these tablets.

Other medicines and Kytril

Tell your doctor, nurse or pharmacist if you are using or have recently used or might take other medicines, even those bought without a prescription. This is because Kytril can interact with some medicines. Also, some medicines can interact with these tablets.

Tell your doctor, nurse or pharmacist if you are taking or might take other medicines:

medicines used to treat irregular heartbeats, other “5-HT3 receptor antagonists” 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 that contain buprenorphine or other opioids.

Pregnancy and breastfeeding

Do not take these tablets if you are pregnant, trying to become 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

The effect of Kytril on the ability to drive and use machines is negligible or non-existent.

Kytril contains

Kytril contains lactose (a type of sugar). If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Kytril contains less than 23 mg (1mmol) of sodium per dose (1mg), so it is essentially “sodium-free”.

3. How to take Kytril

Follow exactly the administration instructions of this medicine given by your doctor. In case of doubt, consult your doctor, nurse or pharmacist again

The recommended dose of Kytril varies from one patient to another. This 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 sick)

The first dose of Kytril will usually be given one hour before your radio or chemotherapy. The dose should be taken 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 maximum of one week after your radio or chemotherapy.

Treatment of nausea or vomiting (feeling sick)

The dose will usually be:

• 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 more tablets than you should, tell your doctor or nurse. You can also call the Toxicology Information Service on 91 562 04 20, stating the medicine and the amount taken.

Among the symptoms of overdose are included a mild headache (cephalea). You will be treated according to your symptoms.

If you forget to take Kytril

If you think you have forgotten to take 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 your medicine before you have finished the treatment. If you stop the treatment, your symptoms may come back.

If you have any other questions about 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 any of the following side effects, you should see your doctor immediately:

• allergic reactions (anaphylaxis). The signs can include swelling of the throat, or your face, lips and mouth becoming swollen, and difficulty breathing or swallowing
• Serotonin Syndrome. The signs can include diarrhea, nausea, vomiting, high temperature and blood pressure, excessive sweating and rapid heartbeat, agitation, confusion, hallucination, shivering, muscle tremors, shaking or stiffness, loss of coordination and restlessness. This reaction can occur if you take Kytril alone or, more likely, with other medicines (see “Warnings and precautions”)

Other side 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 sleeping (insomnia)

blood tests show changes in liver function

diarrhea

Uncommon, may affect up to 1 in 100 people

skin rash or an allergic reaction or hives. The signs can include red spots that itch.

changes in heartbeats (rhythm) and changes in the ECG (electrocardiogram)

abnormal involuntary movements, such as tremors, muscle stiffness and muscle contractions

• Serotonin Syndrome. The signs can include diarrhea, nausea, vomiting, fever and high blood pressure, excessive sweating and rapid heartbeat, agitation, confusion, hallucinations, shivering, muscle spasms, shaking or stiffness, loss of coordination and restlessness.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for human use medicines, https://www.notificaRAM.es. By reporting side 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 which is stated on the blister and carton after “EXP”. The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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 ingredients 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 bear the inscription “K1” on one side. They are supplied in opaque PVC/Aluminum blister packs containing 2 or 10 tablets per pack.

Not all pack sizes may be marketed.

Other presentations:

Kytril 3 mg/3 ml solution for injection (for hospital use)

Kytril 1 mg/1 ml solution for injection (for hospital use)

Marketing authorisation holder and manufacturer

Marketing authorisation 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

Or

Waymade Plc

Sovereign House

Miles Gray Road

Basildon

Essex SS14 3FR

United Kingdom

This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Austria, Belgium, Czech Republic, Estonia, Finland, France, Ireland, Italy, Latvia, Netherlands, Slovakia, Slovenia, Spain, United Kingdom (Northern Ireland): Kytril

Germany: Kevatril

Date of last revision of this leaflet: March 2025

Other sources of information

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/