Kytril

PACKAGE LEAFLET: INFORMATION FOR THE USER

Kytril 1 mg film-coated tablets, 2 mg film-coated tablets

Granisetron
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, nurse, or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, or if you notice any side effects not mentioned in this leaflet, inform your doctor, nurse, or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Kytril is and what it is used for

Kytril contains the active substance granisetron, which belongs to a group of medicines known as
“5-HT₃ receptor antagonists” or “antiemetics”. These tablets should only be used in adults.
Kytril is used to prevent or treat nausea and vomiting caused by treatment with other medicines, such as chemotherapy or radiotherapy for cancer.

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 excipients of Kytril (listed in section 6: “Other information” and “Important information about some of the excipients of Kytril”, listed below).

If in doubt, consult 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 have problems with intestinal movements due to intestinal blockage.
• you have heart problems, are being treated for cancer with a medicine known to damage the heart, or if you have problems with levels of salts such as potassium, sodium or calcium in your body (electrolyte imbalance).
• you are taking other “5-HT receptor antagonist” medicines, which include dolasetron and ondansetron, used like Kytril for the treatment and prevention of nausea and vomiting.

Serotonin syndrome is an uncommon but potentially life-threatening reaction that may occur with granisetron (see section 4). It may cause serious changes in how the brain, muscles and digestive system function. The reaction may occur if you take Kytril alone, but is more likely to occur if you take Kytril together with certain other medicines (particularly fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram, venlafaxine and duloxetine). The risk of serotonin syndrome also increases if you take medicines containing buprenorphine or other opioids. Make sure you inform your doctor, nurse or pharmacist about all the 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 not requiring a prescription. This is because Kytril may affect how some medicines work. Other medicines may also affect how these tablets work.
In particular, inform your doctor or nurse if you are taking, have recently taken, or might take any other medicines:

• medicines used to treat irregular heartbeat other than “5-HT receptor antagonists” such as dolasetron or ondansetron (see “Warnings and precautions” above)
• 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, including fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram
• SNRIs (serotonin and noradrenaline reuptake inhibitors) used to treat depression and/or anxiety, including venlafaxine, duloxetine
• medicines containing buprenorphine or other opioids

Pregnancy and breastfeeding
You must not take these tablets if you are pregnant, trying to become pregnant, or breastfeeding, unless your doctor has specifically prescribed them.
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor, nurse or pharmacist before taking this medicine.
Driving and using machines
Kytril does not affect, or affects only insignificantly, the ability to drive or use tools and machines.
Kytril contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.
Kytril contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose (1 mg; 2 mg), i.e. essentially ‘sodium-free’.

3. How to take Kytril

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your
doctor, nurse, or pharmacist.
The recommended dose of Kytril varies from patient to patient depending on age, weight, and whether
the medicine has been prescribed to prevent or treat nausea and vomiting. Your doctor will calculate the dose you should take.
Prevention of nausea or vomiting
The first dose of Kytril is usually administered one hour before radiotherapy or chemotherapy.
The dose will be:

• one 1 mg tablet twice daily, or
• two 1 mg tablets once daily, or
• one 2 mg tablet once daily

up to one week after radiotherapy or chemotherapy.
Treatment of nausea or vomiting
The usual dose will be:

• 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 too many tablets, contact your doctor or nurse. Symptoms of an
overdose may include mild headache. You will be treated according to your symptoms.
If you forget to take Kytril
If you think you have missed a dose, contact 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 Kytril before your anti-tumour treatment has ended. If you stop taking Kytril,
your symptoms may return.
If you have any questions about the use of this medicine, consult your doctor, nurse, or
pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. If you notice the following problem, contact your doctor immediately:

• allergic reactions (anaphylaxis). Signs may include swelling of the throat, face, lips, and mouth, difficulty breathing or swallowing.
• serotonin syndrome. Signs may include diarrhoea, nausea, vomiting, increased body temperature and blood pressure, excessive sweating, rapid heartbeat, agitation, confusion, hallucinations, shivering, muscle tremors, spasms or stiffness, loss of coordination, and restlessness. This reaction may occur if you take Kytril alone or, more likely, together with certain other medicines (see "Warnings and precautions").

Other side effects that may occur during treatment with this medicine are:
Very common: may affect more than 1 in 10 people

• headache
• constipation. Your doctor will monitor your health status.

Common: may affect up to 1 in 10 people

• difficulty sleeping (insomnia)
• changes in liver function as shown by blood tests
• diarrhoea.

Uncommon: may affect up to 1 in 100 people

• skin rashes or allergic skin reactions or hives (urticaria). Signs may include red, raised, itchy bumps or blisters.
• changes in heart rate (rhythm) and changes seen on ECG (electrical recording of the heart).
• abnormal involuntary movements such as tremor, muscle rigidity, and muscle contractions.

Reporting of side effects
If you get any side effect, including those not listed in this leaflet, talk to your doctor, nurse, or pharmacist. You can also report side effects directly via the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Kytril

Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date stated on the blister pack and carton after "Exp.". The expiry date refers to the last day of the month.
This medicine requires no special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Kytril contains
The active substance is granisetron.
Each film-coated tablet contains 1 mg of granisetron (as hydrochloride).
Each film-coated tablet contains 2 mg of granisetron (as hydrochloride).
The other components are:
Lactose monohydrate
hypromellose
Sodium carboxymethyl starch
microcrystalline cellulose
magnesium stearate,
Coating film:
hypromellose
titanium dioxide (E 171)
macrogol 400
polysorbate 80

Appearance of Kytril and pack sizes
The tablets are biconvex, triangular, white to almost white, with "K1" engraved on one side.
The tablets are biconvex, triangular, white to almost white, with "K2" engraved on one side.
Opaque PVC blisters sealed with an aluminum foil containing 2 or 10 tablets (1 mg) or 1, 5 or 10 tablets (2 mg). Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
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 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, Netherlands, Slovenia, Spain, United Kingdom (Northern Ireland): Kytril
Germany: Kevatril

Other sources of information
More detailed information on this medicinal product is available on the AIFA website:

PATIENT LEAFLET: INFORMATION FOR THE USER

Kytril 1 mg/1 ml solution for injection, 3 mg/3 ml solution for injection

Granisetron
Please read this leaflet carefully before receiving this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, nurse or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, or if you notice any adverse reaction not listed in this leaflet, inform your doctor, nurse or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Kytril is and what it is used for

Kytril contains the active substance granisetron, which belongs to a group of medicines known as
"5-HT receptor antagonists" or "antiemetics".
Kytril is used to prevent or treat nausea and vomiting caused by treatment with other
medicines, such as chemotherapy or radiotherapy for cancer, and by surgical procedures.
The injectable solution is intended for use in adults and children from the age of 2 years.

2. What you need to know before taking Kytril

Do not use Kytril

• if you are allergic (hypersensitive) to granisetron or to any of the excipients in Kytril (listed in section 6: "Other information")

If you have any doubts, consult your doctor, nurse, or pharmacist before receiving the injection.
Warnings and precautions
Consult your doctor, nurse, or pharmacist before using Kytril, especially if:

• you have intestinal motility problems due to intestinal obstruction.
• you have heart problems, are being treated for cancer with a medicine known to damage the heart, or if you have problems with electrolyte levels such as potassium, sodium, or calcium in your body (electrolyte imbalance).
• you are taking other "5-HT receptor antagonist" medicines, including dolasetron and ondansetron, which, like Kytril, are used to treat and prevent nausea and vomiting.

Serotonin syndrome is an uncommon but potentially life-threatening reaction that may occur with granisetron (see section 4). It may cause serious disturbances in how the brain, muscles, and digestive system function. The reaction may occur when taking Kytril alone, but is more likely to occur when Kytril is taken with certain other medicines (particularly fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram, venlafaxine, and 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.
Other medicines and Kytril
Inform your doctor, nurse, or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription. This is because Kytril may affect how some medicines work. Other medicines may also affect how the injection works.
In particular, inform your doctor or nurse if you are taking, have recently taken, or might take any other medicine:

• medicines used to treat irregular heartbeat other than "5-HT receptor antagonists", such as dolasetron or ondansetron (see "Warnings and precautions" above)
• 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, including fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram
• SNRIs (serotonin and noradrenaline reuptake inhibitors) used to treat depression and/or anxiety, including venlafaxine, duloxetine
• medicines containing buprenorphine or other opioids

Pregnancy and breastfeeding
You must not receive this injection if you are pregnant, trying to become pregnant, or breastfeeding, unless your doctor has specifically prescribed it.
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, ask your doctor, nurse, or pharmacist for advice before taking this medicine.
Driving and using machines
It is unlikely that Kytril will affect your ability to drive or operate machinery.
Kytril contains sodium.
This medicine contains less than 1 mmol of sodium (23 mg) per dose (1 mg/1 ml; 3 mg/3 ml), i.e. essentially 'sodium-free'.

3. How to receive Kytril

Kytril will be administered to you by a doctor or nurse. The recommended dose of Kytril varies from patient to patient depending on age, weight, and whether the medicine is being given to prevent or treat nausea and vomiting. Your doctor will calculate the appropriate dose for you.
Kytril can be administered as an intravenous injection (into the vein).

Prevention of nausea or vomiting following radiotherapy or chemotherapy
The injection will be given before your radiotherapy or chemotherapy begins. The intravenous injection will take from 30 seconds to 5 minutes, and the dose will normally range between 1 and 3 mg. The medicine may be diluted before injection.

Treatment of nausea or vomiting following radiotherapy or chemotherapy
The injection will take from 30 seconds to 5 minutes, and the dose will normally range between 1 and 3 mg. The medicine may be diluted before intravenous injection. You may receive additional injections to control nausea or vomiting after the first dose. At least 10 minutes should elapse between injections. The maximum daily dose of Kytril administered will be 9 mg.

Combination with corticosteroids
The effect of the injection may be enhanced by using medicines called adrenocorticosteroids. The corticosteroid will be administered at a dose between 8 and 20 mg of dexamethasone before radiotherapy or chemotherapy, or as 250 mg of methylprednisolone, administered before and after radiotherapy or chemotherapy.

Use in children for prevention or treatment of nausea or vomiting following radiotherapy or chemotherapy
In children, Kytril will be administered by intravenous injection as described above, and the dose will depend on the child's weight. The injections will be diluted and administered over 5 minutes before radiotherapy or chemotherapy. Children may receive up to a maximum of 2 doses per day, with at least 10 minutes between doses.

Treatment of nausea or vomiting following surgery
The intravenous injection will take from 30 seconds to 5 minutes, and the dose will usually be 1 mg. The maximum daily dose of Kytril administered will be 3 mg.

Use in children for prevention or treatment of nausea or vomiting following surgery
This injection should not be administered to children to treat nausea or vomiting following surgery.

If you receive too much Kytril
Since the injection is administered by a doctor or nurse, it is unlikely that you will receive too much. However, if you are concerned, speak to your doctor or nurse. Symptoms of overdose may include mild headache. Treatment will be provided based on symptoms.

If you have any doubts about the use of this medicine, consult your doctor, nurse, or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. If you notice the following problem, contact your doctor immediately:

• allergic reactions (anaphylaxis). Signs may include swelling of the throat, face, lips and mouth, difficulty breathing or swallowing.
• serotonin syndrome. Signs may include diarrhoea, nausea, vomiting, increased body temperature and blood pressure, excessive sweating, rapid heartbeat, agitation, confusion, hallucinations, shivering, muscle tremors, spasms or stiffness, loss of coordination and restlessness. This reaction may occur if you take Kytril alone or, more likely, together with certain other medicines (see "Warnings and precautions").

Other side effects that may occur during treatment with this medicine are:
Very common: may affect more than 1 in 10 people

• headache
• constipation. Your doctor will monitor your health status.

Common: may affect up to 1 in 10 people

• difficulty sleeping (insomnia)
• changes in liver function as shown by blood tests
• diarrhoea.

Uncommon: may affect up to 1 in 100 people

• skin rash or an allergic skin reaction or hives (urticaria). Signs may include red, raised, itchy blisters.
• changes in heart rate (rhythm) and changes observed on ECG (electrical recording of the heart).
• abnormal involuntary movements such as tremor, muscle rigidity and muscle contractions.

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor, nurse or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Kytril

Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date stated on the carton and/or vial after "Exp.". The expiry date refers to the last day of the month.
Store the container in the outer packaging to protect the medicine from light.
After dilution, the diluted solution should be stored at 2°C – 8°C and used within 24 hours of dilution.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Kytril contains
The active substance is granisetron.
Each ml of injectable solution contains 1 mg of granisetron (as hydrochloride).
Each ml of injectable solution contains 1 mg of granisetron (as hydrochloride).
The other components are sodium chloride, water for injections, citric acid monohydrate,
hydrochloric acid and sodium hydroxide for pH adjustment (acidity correction).

Appearance of Kytril and contents of the pack
Kytril solution is a clear, colourless liquid contained in colourless glass vials with a nominal volume of 1 and 3 ml.
Each pack may contain either 1 or 5 vials.
Not all pack sizes may be marketed.
Each ml of Kytril solution contains 1 mg of granisetron (as hydrochloride).
Each 1 ml vial contains 1 mg of granisetron (as hydrochloride).
Each 3 ml vial contains 3 mg of granisetron (as hydrochloride).

Dilution preparation
For single use only. Dilute before use.
The product must be diluted before administration, whether by injection or infusion.

Marketing Authorisation Holder and Manufacturer
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 medicinal product 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, Netherlands, Slovenia, Spain,
United Kingdom: Kytril
Germany: Kevatril

Other sources of information
More detailed information on this medicinal product is available on the AIFA website.