Kytril 1 mg film-coated tablets

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, nurse or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms 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.

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

• if you are allergic (hypersensitive) to granisetron or any of the other ingredients of Kytril (listed in section 6: Further information and “Important Information about some of the ingredients Kytril below”.

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

Talk to your doctor, nurse or pharmacist before using these tablets, especially if you:

• are having problems with your bowel movements because of a blockage of your gut (intestines)
• have heart problems, are being treated for cancer with a medicine that is known to damage your heart or have problems with levels of salts, such as potassium, sodium or calcium, in your body (electrolyte abnormalities)
• are taking other ‘5-HT₃ receptor antagonist’ medicines. These include dolasetron, ondansetron used like Kytril in the treatment and prevention of nausea and vomiting.

Serotonin Syndrome is a rare but potentially life-threatening reaction that can occur with Kytril. It can cause serious changes in how your brain, muscles, and digestive system work. The reaction can occur if you take Kytril alone but is more likely to occur if you take Kytril with certain other medications. Be sure to tell your doctor, nurse or pharmacist all the medicines you are taking.

Children should not take these tablets.

Please tell your doctor, nurse or pharmacist if you are taking or have recently taken or might take any other medicines, including medicines obtained without a prescription. This is because Kytril can affect the way some medicines work. Also some other medicines can affect the way these tablets work.

In particular, tell your doctor, nurse or pharmacist if you are taking the following medicines:

• medicines used to treat an irregular heartbeat, other ‘5-HT₃ receptor antagonist’ medicines such as dolasetron or ondansetron (see “Warnings and precautions” above)
• phenobarbital, a medicine used to treat epilepsy
• a medicine called ketoconazole used in the treatment of fungal infections
• the antibiotic erythromycin 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 noradrenaline reuptake inhibitors) used to treat depression and/or anxiety including venlafaxine, duloxetine.

You should not take these tablets if you are pregnant, trying to get pregnant or are breast-feeding, unless your doctor has told you to.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor, nurse or pharmacist for advice before taking this medicine.

Kytril has no or negligible effect on your ability to drive or use any tools or machines.

Kytril contains lactose (a type of sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Kytril is essentially ‘sodium free’ as it contains less than 1 mmol sodium (23 mg) per dose (2 mg).

Your first dose of Kytril will usually be given an hour before your radio- or chemotherapy. The dose will be taken either 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 week after your radio- or chemotherapy.

The dose will usually be taken either as:

• 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 think you have taken too many of the tablets talk to your doctor or nurse. The symptoms of overdose include mild headaches. You will be treated depending on your symptoms.

If you think you have forgotten to take your medicine speak to your doctor or nurse.

Do not take a double dose to make up for a forgotten tablet.

Do not stop taking your medicine before the treatment is finished. If you do stop taking your medicine, your symptoms may return.

If you get 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 Yellow Card Scheme at www.mhra.gov.uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

The active substance is granisetron.

Each 1 mg film-coated tablet contains 1 mg granisetron (as the hydrochloride).

Each 2 mg film-coated tablet contains 2 mg granisetron (as the hydrochloride).

The other ingredients are:

Lactose monohydrate

Hypromellose

Sodium starch glycolate

Cellulose, microcrystalline

Magnesium stearate

Film-coat:

Hypromellose

Titanium dioxide (E171)

Macrogol 400

Polysorbate 80

The tablets are white to almost white triangular biconvex tablets imprinted with K1 on one side.

The tablets are white to almost white triangular biconvex tablets imprinted with K2 on one side.

Opaque PVC blisters sealed with an aluminium foil containing 2 or 10 tablets (1 mg) or 1, 5 or 10 tablets (2 mg). Not all pack sizes may be marketed.

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