Package Insert: Information for the User

Kytril 1mg/1ml Injectable Solution

Granisetron

Read this package insert carefully before you start taking this medicine, because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, nurse, or pharmacist, even if they are not listed in this package insert. See section 4.

1. What is Kytril and how is it used

2. What you need to know before using Kytril

3. How to use Kytril

4. Possible side effects

5. Storage of Kytril

6. Contents of the package and additional information

Kytril contains the active ingredient granisetron. This belongs to a group of medicines called 5-HT3 receptor antagonists, or antiemetics, which prevent or avoid nausea and vomiting.3

Kytril is indicated for the prevention and treatment of nausea and vomiting (feeling of discomfort) caused by certain treatments, such as chemotherapy or radiation therapy in cancer therapy, as well as for treating and preventing postoperative nausea and vomiting.

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

No use Kytril

?If you are allergic (hypersensitive) to granisetron or any of the other components of Kytril (listed in section 6: Additional Information).

If you are unsure, consult your doctor, nurse, or pharmacist before receiving the injection.

Warnings and Precautions

Consult your doctor, nurse, or pharmacist before starting to use Kytril, especially if you:

?have bowel obstruction problems

?have heart problems, are receiving chemotherapy medications that may be harmful to your heart, and/or suffer from electrolyte imbalances such as potassium, sodium, or calcium (electrolyte disturbances).

?are taking another medication 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.

The Serotonin Syndrome is a rare but potentially fatal reaction that can occur with granisetron (see section 4). It can cause severe changes in how your brain, muscles, and digestive system function. The reaction can occur if you take granisetron alone, but it is more likely to occur if you take granisetron with other medications (particularly fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram, venlafaxine, duloxetine). Make sure to tell your doctor, nurse, or pharmacist all the medications you are taking.

Other Medications and Kytril

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

Inform your doctor or nurse or pharmacist if you are taking or might have taken other medications:

?medications used to treat irregular heartbeats, other “5-HT3 receptor antagonist” medications such as dolasetron or ondansetron (see “Warnings and Precautions”).

?phenobarbital, a medication used to treat epilepsy

?ketoconazole, a medication 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 (selective serotonin and noradrenaline reuptake inhibitors) used to treat depression and/or anxiety. For example: venlafaxine, duloxetine

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, or think you might be pregnant, or plan to become pregnant, consult your doctor, nurse, or pharmacist before using this medication.

Driving and Operating Machines

No adverse effects on your ability to drive or operate machinery are expected from Kytril.

Contents of Kytril

Kytril contains sodium

The injection will be administered by your doctor or nurse. The recommended dose of Kytril varies from patient to patient. This depends on age, weight, and whether you are taking other medications to prevent or treat nausea and vomiting. Your doctor will decide how much to administer.

Kytril can be administered as an injection into a vein (intravenous).

Prevention of nausea or vomiting after radiation therapy or chemotherapy

The injection will be administered before the start of radiation therapy or chemotherapy. The intravenous injection will last between 30 seconds to 5 minutes, and the usual dose is between 1 and 3 mg. The medication can be diluted before injection.

Treatment of nausea or vomiting after radiation therapy or chemotherapy

The injection will last between 30 seconds to 5 minutes, and the usual dose is between 1 and 3 mg. The medication can be diluted before intravenous injection. To stop the discomfort, you may receive additional injections after the first dose. At least 10 minutes should pass between each injection. The maximum dose of Kytril will be 9 mg per day.

Combination with corticosteroids

The effect of the injection can be increased with the use of other medications, known as corticosteroids. You may receive 8-20 mg of dexamethasone before the start of radiation therapy or chemotherapy, or 250 mg of methylprednisolone before the start of chemotherapy and again immediately after it ends.

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

Kytril is administered by intravenous injection as described above, with the dose adjusted according to the child's weight. The injections are diluted and administered before radiation therapy or chemotherapy and last 5 minutes. Children may receive a maximum of 2 doses per day, with at least 10 minutes passing between each dose.

Treatment of nausea or vomiting after surgery

The intravenous injection will last 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 surgery

This injection should not be administered for the treatment of nausea or discomfort after surgery.

If you use more Kytril than you should

Since this injection is administered by a doctor or nurse, it is unlikely that you will receive more doses than you should. However, if you are concerned, consult your doctor or nurse. Symptoms of overdose may include a mild headache (cephalgia). You will be treated according to your symptoms.

If you have any other questions about the use of this medication, ask your doctor, nurse, or pharmacist.

Like all medications, this medication may produce adverse effects, although not everyone will experience them. If you observe any of the following adverse effects, you must seek immediate medical attention:

?allergic reactions (anaphylaxis). The signs may include throat inflammation, swelling of the face, lips, and mouth, and difficulty breathing or swallowing.

Other adverse effects that may occur while taking this medication are:

Very frequent: affect more than one in ten

?headache

?constipation. Your doctor will monitor your condition.

Frequent: may affect up to 1 in 10 people

?difficulty falling asleep (insomnia)

?through blood tests, changes in liver function are shown

?diarrhea

Rare: may affect up to 1 in 100 people

?skin eruptions or an allergic reaction or urticaria. The signs may include red itchy patches.

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

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

• Serotonin Syndrome. The signs may include diarrhea, nausea, vomiting, fever, high blood pressure, excessive sweating, and rapid heart rate, agitation, confusion, hallucinations, chills, muscle spasms, twitching or stiffness, loss of coordination, and restlessness.

Reporting 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 prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use, https://www.notificaRAM.es.By reporting adverse effects, you can contribute to providing more information on the safety of this medication

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging and/or ampule after “CAD”. The expiration date is the last day of the month indicated.

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.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. In this way, you will help protect the environment.

Composition of Kytril

The active ingredient is granisetron.

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

The other components are sodium chloride, water for injection, citric acid monohydrate, hydrochloric acid, andsodium hydroxideto adjust the pH (acidity)

Appearance of Kytril and contents of the packaging

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

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

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

Preparation of the dilution

For single use. Dilute before use. The medication requires dilution before administration both as an injectable and as an infusion.

Other presentations:

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

Kytril 1 mg tablets (hospital diagnosis)

Marketing authorization holder and manufacturer

Marketing authorization holder:

Atnahs Pharma Netherlands B.V.

Copenhagen Towers

Ørestads Boulevard 108, 5th floor

DK-2300 København S

Denmark

Manufacturer:

Cenexi

52, rue M. et J. Gaucher

94120 Fontenay-sous-Bois

France

This medication is authorized in the member states of the European Economic Area with the following names:

Austria, Belgium, Czech Republic, Estonia, Finland, France, Ireland, Italy, Latvia, Netherlands, Slovak Republic, Slovenia, Spain, United Kingdom: Kytril

Germany: Kevatril

Last review date of this leaflet: April 2017

Other sources of information

The detailed information on this medication is available on the website of the Spanish Agency of Medicines andMedical Products (AEMPS)http://www.aemps.gob.es/