GRANISETRON NORMON 1 mg/1 ml INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

Granisetron NORMON 1mg/ 1 ml injectable solution EFG

Granisetron

Read all of this leaflet carefully before you start using this medicine.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor 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 experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack:

1. What Granisetron Normon is and what it is used for
2. Before using Granisetron Normon
3. How to use Granisetron Normon
4. Possible side effects
5. Storage of Granisetron Normon
6. Further information

1. What Granisetron Normon is and what it is used for

Granisetron Normon contains a medicine called granisetron. This belongs to a group of medicines called serotonin receptor antagonists, 5-HT3, or antiemetics, which prevent or stop nausea and vomiting.

Granisetron Normon is used to prevent and treat nausea and vomiting (feeling sick) caused by certain treatments, such as chemotherapy or radiotherapy in cancer therapy, as well as to treat and prevent nausea and vomiting after surgery.

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

2. Before using Granisetron Normon

Do not use Granisetron Normon

? if you are allergic (hypersensitive) to granisetron or any of the other ingredients of Granisetron Normon (see section 6: Further information).

If you are not sure, consult your doctor, nurse or pharmacist before receiving the injection.

Warnings and precautions

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

Before using Granisetron Normon, check with your doctor, nurse or pharmacist if:

? you have problems with constipation due to intestinal obstruction

? you have heart problems, are receiving anticancer medicines that can be harmful to your heart and/or have any disorder of the levels of salts such as potassium, sodium or calcium (electrolyte disturbances)

? you are using another medicine from the group of “5-HT3 receptor antagonists”. This group includes dolasetron and ondansetron, used, like Granisetron Normon, for the treatment and prevention of nausea and vomiting

Using Granisetron Normon with other medicines

Tell your doctor, pharmacist or nurse if you are using, have recently used or might use any other medicines, including those obtained without a prescription. This is because Granisetron Normon may interact with some medicines. Also, some medicines may interact with this injection.

Tell your doctor, nurse or pharmacist if you are using any of the following medicines:

? medicines used to treat irregular heartbeats, other “5-HT3 receptor antagonists” such as dolasetron or ondansetron (see “Take special care with Granisetron Normon”)

? 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. For example: fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram

? SNRIs (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.

Consult your doctor, nurse or pharmacist before using any medicine.

Driving and using machines

Granisetron Normon is not expected to affect your ability to drive or use machines.

Important information about some of the ingredients of Granisetron Normon

This medicine contains less than 23 mg (1 mmol) of sodium per ampoule, so it is considered essentially “sodium-free”.

3. How to use Granisetron Normon

The injection will be given to you by your doctor or nurse. The dose of Granisetron Normon varies from one patient to another. It depends on age, weight and whether you are using other medicines to prevent or treat nausea and vomiting. Your doctor will decide how much to give you.

Granisetron Normon can be given as an injection into the veins (intravenously).

Prevention of nausea or vomiting after radiotherapy or chemotherapy

You will be given the injection before you start radiotherapy or chemotherapy. The injection into the veins (intravenously) will last between 30 seconds to 5 minutes and the usual dose is between 1 and 3 mg. The medicine can be diluted before injection.

Treatment of nausea or vomiting after radiotherapy or chemotherapy

The injection will last between 30 seconds to 5 minutes and the usual dose is between 1 and 3 mg. The medicine can be diluted before injection into the veins (intravenously). To stop the discomfort, you may receive more injections after the first dose. There must be at least 10 minutes between each dose. The maximum dose of Granisetron Normon will be 9 mg per day.

Combination with corticosteroids

The effect of the injection may be increased with the use of other medicines, called corticosteroids. It can be 8-20 mg of dexamethasone, given before the start of radiotherapy or chemotherapy treatment, or 250 mg of methylprednisolone, given before the start of chemotherapy and again immediately after finishing it.

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

Granisetron Normon is given by injection into the veins (intravenously), as described above, and the dose must be adjusted according to the child's weight. The injections are diluted and given before radiotherapy or chemotherapy and last 5 minutes. Children may receive a maximum of 2 doses per day, with at least 10 minutes between each dose.

Treatment of nausea or vomiting after an operation

The injection into the veins (intravenously) will last between 30 seconds and 5 minutes and the usual dose is 1 mg. The maximum dose of Granisetron Normon is 3 mg per day.

Use in children for the prevention or treatment of nausea or vomiting after an operation

This injection should not be given for the treatment of nausea or discomfort after an operation.

If you use more Granisetron Normon than you should

Because this injection is given by a doctor or nurse, it is unlikely that you will receive more than the dose you should. However, if you are concerned, consult your doctor or nurse. Symptoms of overdose include a mild headache (cephalalgia). You will be treated according to your symptoms.

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

4. Possible side effects

Like all medicines, Granisetron Normon can cause side effects, although not everybody gets them. If you notice any of the following side effects, you should see your doctor immediately:

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

Other side effects that may occur while using this medicine are:

Very common: affects more than 1 in 10 patients

? headache

? constipation. Your doctor will monitor your condition

Common: affects between 1 and 10 in 100 patients

? difficulty sleeping (insomnia)

? changes in liver function shown by blood tests

? diarrhea

Uncommon: affects between 1 and 10 in 1,000 patients

• skin rashes or an allergic reaction or hives. The signs can include red spots that itch
• changes in heart rhythm and changes in the ECG (electrocardiogram)
• abnormal involuntary movements, such as tremors, muscle stiffness and muscle contractions
• Serotonin syndrome. The signs can include diarrhea, nausea, vomiting, fever and high blood pressure, excessive sweating and rapid heartbeat, agitation, confusion, hallucinations, chills, muscle spasms, tremors or stiffness, loss of coordination and restlessness.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist or nurse, even if they are not listed in this leaflet. You can also report them directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) through the website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Granisetron Normon

Keep the container in the outer packaging to protect it from light. Do not freeze.

Keep out of the reach and sight of children.

Do not use the injectable solution after the expiry date stated on the container after “EXP”. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Further information

Composition of Granisetron Normon

The active substance is granisetron.

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

The other ingredients (excipients) are sodium chloride, citric acid monohydrate, sodium hydroxide or hydrochloric acid (for pH adjustment) and water for injection.

Appearance of Granisetron Normon and container contents

Granisetron Normon 1 mg/1 ml is presented in colorless glass ampoules, with a capacity sufficient to contain 1 ml. The ampoules contain a sterile, clear, colorless or slightly yellowish solution.

They are supplied in packs of 5 ampoules or clinical packs of 50 ampoules.

Marketing authorization holder and manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760

Tres Cantos – Madrid (Spain)

This leaflet was approved inMarch 2017

“Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es”

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This information is intended only for healthcare professionals:

Preparation of the dilution:

Adults:1 ml should be withdrawn from the ampoule and diluted with 5 ml of sodium chloride 0.9%. No other diluents should be used.

Children: to prepare the dose of 40 micrograms/kg, the appropriate dose should be withdrawn and diluted with the infusion solution to a total volume of 10 to 30 ml. Any of the following solutions can be used: sodium chloride 0.9%, sodium chloride 0.18% with glucose 4%, glucose 5%, Hartmann solution, sodium lactate and mannitol 10%. No other diluents should be used.

Granisetron Normon dilutions should be prepared at the time of administration. The solution should be used immediately after dilution. However, Granisetron Normon remains stable for 24 hours in the above-mentioned solutions when stored at 25 ºC with normal indoor lighting (natural daylight supplemented with fluorescent lighting).