Prospect: information for the user

Granisetrón NORMON 1mg/ 1 ml injectable solution EFG

Granisetrón

Read this prospect carefully before starting to use the medication.

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medication has been prescribed to you and should not be given to other people, even if they have the same symptoms, as it may harm them.

-If you consider that any of the adverse effects you are experiencing is severe or if you notice any adverse effect not mentioned in this prospect, inform your doctor or pharmacist.

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

2.Before using Granisetrón Normon

3.How to use Granisetrón Normon

4.Possible adverse effects

5.Storage of Granisetrón Normon

6.Additional information

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

Granisetrón Normon 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 Granisetrón Normon

?if you are allergic (hypersensitive) to granisetron or to any of the other components of Granisetrón Normon (see section 6: Additional information).

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

Warnings and precautions

The serotonin syndrome is a rare but potentially fatal 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 (particularly fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram, venlafaxine, duloxetine).

Before using Granisetrón Normon, consult your doctor, nurse or pharmacist if:

?you have bowel obstruction causing constipation

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

?you are using another medicine from the group of "5-HT3 receptor antagonists". Within this group are dolasetron and ondansetron used, like Granisetrón Normon, for the treatment and prevention of nausea and vomiting

Use of Granisetrón Normon with other medicines

Inform your doctor, pharmacist or nurse if you are using, have used recently or may need to use any other medicine, including those obtained without a prescription. This is because Granisetrón Normon may interact with some medicines. Some medicines may also interact with this injection.

Inform 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 "Be careful with Granisetrón 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 (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.

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

Driving and operating machinery

Granisetrón Normon is not expected to affect your ability to drive or operate machinery.

Important information about some of the components of Granisetrón Normon

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

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

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

Prevention of nausea or vomiting after radiation or chemotherapy

The injection will be administered before the start of radiation 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 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 discomfort, you may receive additional injections after the first dose. At least 10 minutes must pass between each injection. The maximum dose of Granisetrón Normon 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 or chemotherapy treatment, or 250 mg of methylprednisolone before the start and again immediately after the end of chemotherapy treatment.

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

Granisetrón Normon is administered by intravenous injection, as previously described, with the dose adjusted according to the child's weight. The injections are diluted and administered before radiation or chemotherapy, lasting 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 Granisetrón Normon 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 Granisetrón Normon 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 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, Granisetrón Normon may produce adverse effects, although not everyone will experience them. If you observe any of the following adverse effects, you must immediately consult your doctor:

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

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

Very frequent: affect more than one in 10 patients

?headache

?constipation. Your doctor will monitor your condition

Frequent: affect between 1 and 10 in 100 patients

?difficulty falling asleep (insomnia)

?through blood tests, changes in liver function are shown

?diarrhea

Rare: affect between 1 and 10 in 1,000 patients

• 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, and high blood pressure, excessive sweating, and rapid heart rate, agitation, confusion, hallucinations, chills, muscle spasms, convulsions, or rigidity, loss of coordination, and restlessness.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, 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 for 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.

Store the packaging 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 expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

Composition of Granisetrón Normon

The active principle is granisetron.

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

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

Appearance of Granisetrón Normon and contents of the package

Granisetrón Normon 1 mg/1 ml is presented in colourless glass vials, of a sufficient capacity to contain 1 ml. The vials contain a sterile, transparent, colourless or slightly yellowish solution.

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

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760

Tres Cantos – Madrid (Spain)

This leaflet has been approved inMarch 2017

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

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This information is intended solely for doctors or healthcare professionals:

Preparation of the dilution:

Adults:1 ml should be removed from the vial and diluted with 5 ml of sodium chloride 0.9%. Other diluents should not be used.

Children:to prepare the dose of 40 micrograms/kg, the appropriate dose should be extracted 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's solution, sodium lactate and mannitol 10%. Other diluents should not be used.

The dilutions ofGranisetrón Normonshould be prepared at the time of administration. The solution should be used immediately after dilution. However,Granisetrón Normonremains stable for 24 hours in the aforementioned solutions when stored at 25 °C with normal interior lighting (natural daylight supplemented with fluorescent light).