KYTRIL 1mg/1ml INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

Kytril 1mg/1ml injectable solution

Granisetron

Read all of this 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 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 symptoms are the same as yours.
• If you experience 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 package leaflet

1. What is Kytril and what is it used for
2. What you need to know before you use Kytril
3. How to use 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.

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

The injectable solution is indicated for adults and children aged 2 years and older.

2. What you need to know before taking Kytril

Do not use Kytril

? if you are allergic (hypersensitive) to granisetron or any of the other ingredients of Kytril (listed in section 6: Further information).

If you are not sure, talk to your doctor, nurse or pharmacist before receiving the injection.

Warnings and precautions

Talk to your doctor, nurse or pharmacist before starting to use Kytril, 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 salt levels 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.

Other medicines and Kytril

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

Tell your doctor or 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 norepinephrine 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 receive this injection if you are pregnant, trying to become pregnant, or 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 using this medicine.

Driving and using machines

Kytril is not expected to affect your ability to drive or use machines.

Kytril contains

Kytril contains less than 1 mmol of sodium (23 mg) per dose (1mg/1ml), i.e., essentially sodium-free.

3. How to use Kytril

The injection will be given to you by your doctor or nurse. The recommended dose of Kytril varies from one patient to another. 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 to give you.

Kytril can be given as an injection into the veins (intravenously).

Prevention of nausea or vomiting after radiotherapy or chemotherapy

You will be given the injection before you start radiotherapy or chemotherapy. The injection into the veins (intravenously) will take between 30 seconds and 5 minutes, and the usual dose is between 1 and 3 mg. The medicine may be diluted before injection.

Treatment of nausea or vomiting after radiotherapy or chemotherapy

The injection will take between 30 seconds and 5 minutes, and the usual dose is between 1 and 3 mg. The medicine may be diluted before injection into the veins (intravenously). To stop the feeling of sickness, you may receive more injections after the first dose. There must be at least 10 minutes between each dose. The maximum dose of Kytril will be 9 mg per day.

Combination with corticosteroids

The effect of the injection may be increased by the use of other medicines, called corticosteroids. This may be 8-20 mg of dexamethasone, given before the start of radiotherapy or chemotherapy, or 250 mg of methylprednisolone given before the start of chemotherapy and again immediately after finishing it.

Use in children for the prevention or treatment of nausea or vomiting after radiotherapy or chemotherapy

Kytril is given by injection into the veins (intravenously) as described above, with the dose adjusted according to the child's weight. The injections are diluted and given before radiotherapy or chemotherapy and take 5 minutes. Children may receive a maximum of 2 doses per day, with at least 10 minutes between each dose.

Treatment of nausea or vomiting after an operation

The injection into the veins (intravenously) will take between 30 seconds and 5 minutes, and the usual dose is 1 mg. The maximum dose of Kytril is 3 mg per day.

Use in children for the prevention or treatment of nausea or vomiting after an operation

This injection should not be given for the treatment of nausea or feeling sick after an operation.

If you use more Kytril than you should

Because this injection is given by a doctor or nurse, it is unlikely that you will receive more than you should. However, if you are worried, talk to your doctor or nurse. Symptoms of overdose include a mild headache. You will be treated according to your symptoms.

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 any of the following side effects, you should see your doctor immediately:

? Allergic reactions (anaphylaxis). The signs may include swelling of the throat, or your face, lips, and mouth becoming swollen, and difficulty breathing or swallowing.

• Serotonin Syndrome. The signs may 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)

? changes in liver function shown by blood tests

? diarrhea

Uncommon: may affect up to 1 in 100 people

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

? changes in heart rhythm and changes in the ECG (electrocardiogram).

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

Reporting of side effects

If you experience 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 Spanish Medicines Surveillance System for human use, Appendix V. 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 pack and/or ampoule after "EXP". The expiry date is the last day of the month shown.

Kytril should be stored below 30°C to protect it from light.

After dilution, the diluted solution should be stored between 2°C and 8°C and used within 24 hours after dilution.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Kytril contains

The active substance is granisetron.

Each 1 ml of injectable solution contains 1 mg of granisetron (as hydrochloride).

The other ingredients are sodium chloride, water for injections, citric acid monohydrate, hydrochloric acid, and sodium hydroxideto adjust the pH (acidity).

Appearance of Kytril and pack contents

Kytril solution is a clear, colorless liquid, in transparent glass ampoules containing 1 ml of nominal volume. Each pack contains 1 or 5 ampoules. Not all pack sizes may be marketed.

Each 1 ml of Kytril solution contains 1 mg of granisetron (as hydrochloride).

Each 1 ml ampoule contains 1 mg of granisetron (as hydrochloride).

Preparation of the dilution

For single use. Dilute before use. The medicine requires dilution before administration by injection or infusion.

Other presentations:

Kytril 3 mg/3 ml injectable solution (hospital use)

Kytril 1 mg tablets (hospital diagnosis)

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:

Cenexi

52, rue M. et J. Gaucher

94120 Fontenay-sous-Bois

France

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/