Granisetron 1 mg/ml concentrate for solution for injection or infusion

• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness 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.

Active substance: Granisetron hydrochloride

1. What Granisetron is and what it is used for
2. What you need to know before you are given Granisetron
3. How Granisetron will be given
4. Possible side effects
5. How to store Granisetron
6. Contents of the pack and other information

• if you are allergic (hypersensitive) to granisetron or any of the other ingredients of this medicine (listed in section 6).

Talk to your doctor, nurse or pharmacist before using Granisetron

Check with your doctor, nurse or pharmacist before using Granisetron if you:

• have problems with your bowel movements because of a blockade 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 and ondansetron used like Granisetron in the treatment and prevention of nausea and vomiting.

Serotonin syndrome is an uncommon but potentially life-threatening reaction that can occur with granisetron (see section 4). The reaction can occur if you take granisetron alone but it is more likely to occur if you take granisetron with certain other medicines (in particular fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram, venlafaxine, duloxetine).

Please tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other medicines. This is because Granisetron can affect the way some medicines work. Also some other medicines can affect the way this injection or infusion works.

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

• medicines used to treat an irregular heartbeat or other ‘5-HT₃ receptor antagonist’ medicines such as dolasetron or ondansetron (see ‘Warnings and precautions’ above)
• phenobarbital, a medicine used to treat epilepsy.
• SSRIs (selective serotonin reuptake inhibitors) used to treat depression and/or anxiety. Examples are fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram.
• SNRIs (serotonin noradrenaline reuptake inhibitors) used to treat depression and/or anxiety. Examples are venlafaxine, duloxetine.

You should not have this injection or infusion if you are pregnant, trying to get pregnant or are 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 taking this medicine.

Granisetron is not likely to affect your ability to drive or use any tools or machines.

This medicine contains:

• a maximum of 27.7 mg (or 1.2 mmol) sodium (main component of cooking/table salt) per 1 ml ampoule. This is equivalent to 1.4% of the recommended maximum daily dietary intake of sodium for an adult
• a maximum of 83.1 mg (or 3.6 mmol) sodium (main component of cooking/table salt) per 3 ml ampoule. This is equivalent to 4.2% of the recommended maximum daily dietary intake of sodium for an adult

The usual doses are:

Prevention of feeling or being sick following radio- or chemotherapy

You will be given the injection or infusion before your radio- or chemotherapy starts. The injection or infusion into your veins will take between 30 seconds (injection) and 5 minutes (infusion) and the dose will usually be between 1 and 3 mg. The medicine may be diluted before it is injected.

Treatment of feeling or being sick following radio- or chemotherapy

The injection or infusion will take between 30 seconds (injection) and 5 minutes (infusion) and the dose will usually be between 1 and 3 mg. The medicine may be diluted before it is injected or infused into your veins. You may be given more injections or infusions to stop your sickness after the first dose. There will be at least 10 minutes between each dose. The most Granisetron you will be given is 9 mg a day.

Combination with steroids

The effect of the injection or infusion may be improved by the use of medicines called adrenocortical steroids. The steroid will be given either as a dose between 8 and 20 mg dexamethasone before your radio- or chemotherapy or as 250 mg methyl-prednisolone, which will be given both before and after your radio- or chemotherapy.

Use in children in the prevention or treatment of feeling or being sick following chemotherapy

Children will be given Granisetron by infusions into a vein as described above with the dose depending on the child’s weight. The infusions will be diluted and be given before chemotherapy and will take 5 minutes. Children will be given a maximum of 2 doses a day, at least 10 minutes apart.

Treatment of feeling or being sick following surgery

The injection into your veins will take between 30 seconds and 5 minutes and the dose will usually be 1 mg. The most Granisetron you will be given is 3 mg a day.

Children should not be given this injection to treat sickness or the feeling of sickness after surgery.

Because the injection or infusion will be given to you by a doctor or nurse, it is unlikely that you will be given too much. However, if you are worried talk to your doctor or nurse. Symptoms of overdose include mild headaches. You will be treated depending on your symptoms.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme – website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

The active substance is granisetron hydrochloride.

Each 1 ml ampoule contains a total content of 1 mg granisetron as the hydrochloride in 1 ml of a sterile solution.

Each 3 ml ampoule contains a total content of 3 mg granisetron as the hydrochloride in 3 ml of a sterile solution.

The other ingredients are sodium chloride, citric acid monohydrate, sodium hydroxide and water for injections.

Granisetron is a clear, colourless concentrate for solution for injection or infusion.

Pack size:

Granisetron is available in packs of five or ten ampoules filled with 1 ml or 3 ml of the solution.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Manufacturer:

This medicinal product is authorised in the Member States of the EEA under the following names:

DE Granisetron-hameln 1 mg/ml

DK Granisetron Hameln 1 mg/ml

FI Granisetron Hameln 1 mg/ml

NL Granisetron-hameln 1 mg/ml

PT Granissetrom Hameln 1 mg/ml

SE Granisetron Hameln 1 mg/ml

UK Granisetron 1 mg/ml