Package Insert: Information for the User

Kytril1mg Film-Coated Tablets

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 for you only, and you must not give it 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 taking Kytril

3. How to take Kytril

4. Possible side effects

5. Storage of Kytril

6. Contents of the pack and additional information

Kytril contains the active ingredient granisetron. This belongs to a group of medicines called 5-HT3receptor antagonists, or antiemetics, which prevent or prevent nausea and vomiting. These tablets are only indicated for adults.

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.

Do not take Kytril tablets

?if you are allergic (hypersensitive) to granisetron or to any of the other ingredients of Kytril (listed in section 6: Additional information and the section on Important information about some of the ingredients of Kytril).

If you are unsure, consult your doctor, nurse or pharmacist before taking these tablets.

Warnings and precautions

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

?have bowel obstruction

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

?are taking another medication from the group of “5-HT3receptor antagonists”. Within this group are 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 mayoccur if you take granisetron alone,butis more likely to occur if you take granisetron with other medications (particularly fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram, venlafaxine, duloxetine). Make sure to inform your doctor, nurse or pharmacist of all the medications you are taking.

Children

Children should not take these tablets.

Other medicines and Kytril

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

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

?medicines used to treat irregular heartbeats, other “5-HT3receptor 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

?ISRS (selective serotonin reuptake inhibitors) used to treat depression and/or anxiety. For example: fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram

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

Pregnancy and breastfeeding

Do not take these tablets 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 are planning to become pregnant, consult your doctor, nurse or pharmacist before using this medicine.

Driving and operating machinery

The effect of Kytril on your ability to drive and operate machinery is negligible or insignificant.

Content of Kytril

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

Kytril contains less than 23 mg (1mmol) of sodium per dose (2mg), so it is considered essentially“sodium-free“.

Follow exactly the administration instructions for this medication as indicated 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 medications 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 will be given generally one hour before your radiation 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 one week after your radiation or chemotherapy

Treatment of Nausea or Vomiting (Feeling Unwell)

The dose will generally 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, inform your doctor or nurse. You can also call theToxicology Information Service at phone 91 562 04 20, indicating the medication and the amount ingested.

Common symptoms of overdose include a mild headache. You will be treated according to your symptoms.

If You Forget to Take Kytril

If you think you have forgotten to take your medication, ask your doctor or nurse.

Do not take a double dose to make up for the missed dose.

If You Interrupt Treatment with Kytril

Do not stop taking your medication before completing the treatment. If you interrupt the treatment, your symptoms may return.

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 visit your doctor immediately:

?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, may affect more than 1 in 10 people

?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 patches that itch.

?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, and 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 with your doctor or pharmacist, even if it is a possible adverse effect that does not appear 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 blister and packaging after “CAD”. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE point of your pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Composition of Kytril

The active ingredient 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 in color, and carry the inscription “K1” on one of their faces. They are supplied in PVC/Aluminum opaque blisters containing 2 or 10 tablets per pack.

Not all pack sizes may be marketed.

Other presentations:

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

Kytril 1 mg/1 ml injectable solution (hospital use)

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Atnahs Pharma Netherlands B.V.

Copenhagen Towers

Ørestads Boulevard 108, 5.tv

DK-2300 København S

Denmark

Responsible manufacturer

IL CSM Clinical Supplies Management

Marie-Curie-Strasse 8

Lörrach

Baden-Württemberg

79539, Germany

O

Waymade Plc

Sovereign House

Miles Gray Road

Basildon

Essex SS14 3FR

United Kingdom

This medicine 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 medicine is available on the website of the Spanish Agency of Medicines and Medical Products (AEMPS)http://www.aemps.gob.es/