Granisetron Normon 1 mg/1 ml solution for injection EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Granisetron NORMON 1 mg/1 ml solution for injection EFG
Granisetron
Read the entire leaflet carefully before you start using this medicine.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you and must not be given to other people, even if they have the same symptoms as you, as it could harm them.
- If you consider any of the side effects you experience to be severe, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.
Leaflet contents:
- What Granisetron Normon is and what it is used for
- Before you use Granisetron Normon
- How to use Granisetron Normon
- Possible side effects
- How to store Granisetron Normon
- Further information
1. What Granisetrón Normon is and what it is used for
Granisetrón Normon contains a medicine called granisetron. It belongs to a group of medicines known as serotonin 5-HT3 receptor antagonists, or antiemetics, which means they prevent or reduce 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 radiotherapy in anticancer therapy, as well as for the treatment and prevention of postoperative nausea and vomiting.
The injectable solution is indicated in adults and children aged 2 years and older.
2. Before using Granisetron Normon
Do not use Granisetron Normon
• if you are allergic (hypersensitive) to granisetron or to 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 an uncommon but potentially life-threatening reaction that may occur with granisetron (see section 4). The reaction may occur when you use granisetron alone, but it is more likely to occur if you use granisetron together with other medicines (particularly fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram, venlafaxine, duloxetine).
Before using Granisetron Normon, consult with your doctor, nurse or pharmacist if:
• you have constipation due to intestinal obstruction
• you have heart problems, are receiving anticancer medicines that may harm your heart and/or suffer from electrolyte imbalances such as low levels of potassium, sodium or calcium
• you are taking another medicine from the group of “5-HT3 receptor antagonists”. This group includes dolasetron and ondansetron, which, like Granisetron Normon, are used for the prevention and treatment of nausea and vomiting
Use of Granisetron Normon with other medicines
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might need to take any other medicines, including those obtained without a prescription. This is because Granisetron Normon may interact with certain medicines. Likewise, some medicines may interact with this injection.
Inform your doctor, nurse or pharmacist if you are taking any of the following medicines:
• medicines used to treat irregular heartbeats, or other “5-HT3 receptor antagonist” medicines 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 instructed you to do so.
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 operate machinery.
Important information about some of the ingredients of Granisetron Normon
This medicine contains less than 23 mg (1 mmol) of sodium per ampoule and is therefore essentially “sodium-free”.
3. How to use Granisetron Normon
Granisetron Normon will be administered to you by your doctor or nurse. The dose of Granisetron Normon varies from patient to patient. It depends on age, body weight, and whether you are taking other medicines to prevent or treat nausea and vomiting. Your doctor will decide how much you should be given.
Granisetron Normon can be given as an injection into the veins (intravenous route).
Prevention of nausea or vomiting following radiotherapy or chemotherapy
The injection will be given before radiotherapy or chemotherapy begins. The intravenous injection will last between 30 seconds and 5 minutes, and the usual dose ranges from 1 to 3 mg. The medicine may be diluted before injection.
Treatment of nausea or vomiting following radiotherapy or chemotherapy
The intravenous injection lasts between 30 seconds and 5 minutes, and the usual dose is between 1 and 3 mg. The medicine may be diluted before intravenous injection. To control discomfort, additional injections may be given after the first dose, with at least 10 minutes between each. The maximum daily dose of Granisetron Normon is 9 mg.
Combination with corticosteroids
The effect of the injection may be enhanced by using other medicines called corticosteroids. This may be 8–20 mg of dexamethasone, administered before the start of radiotherapy or chemotherapy, or 250 mg of methylprednisolone, administered before the start of chemotherapy and again immediately after its completion.
Use in children for prevention or treatment of nausea or vomiting following radiotherapy or chemotherapy
Granisetron Normon is administered by intravenous injection as described above, with the dose adjusted according to the child's body weight. The injections are diluted and administered before radiotherapy or chemotherapy and last 5 minutes. Children may receive up to 2 doses per day, with at least 10 minutes between doses.
Treatment of nausea or vomiting following surgery
The intravenous injection lasts between 30 seconds and 5 minutes, and the usual dose is 1 mg. The maximum daily dose of Granisetron Normon is 3 mg.
Use in children for prevention or treatment of nausea or vomiting following surgery
This injection must not be administered for the treatment of nausea or feeling unwell after surgery.
If you use more Granisetron Normon than you should
Since this injection is administered by a doctor or nurse, it is unlikely that you will receive more than the prescribed dose. However, if you are concerned, consult your doctor or nurse. Symptoms of overdose may include 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 adverse effects
Like all medicines, Granisetrón Normon may produce adverse effects, although not everyone experiences them. If you notice any of the following adverse effects, you should immediately consult your doctor:
? allergic reactions (anaphylaxis). Signs may include throat swelling or swelling of the face, lips, and mouth; and difficulty breathing or swallowing
Other adverse effects that may occur while using this medicine are:
Very common: affect more than 1 in 10 patients
? headache
? constipation. Your doctor will monitor your condition
Common: affect between 1 and 10 in every 100 patients
? difficulty falling asleep (insomnia)
? blood tests show changes in liver function
? diarrhoea
Uncommon: affect between 1 and 10 in every 1,000 patients
- skin rashes or an allergic reaction or urticaria. Signs may include red, itchy spots
- changes in heart rhythm (rhythm) and changes in the ECG (electrocardiogram)
- abnormal involuntary movements, such as tremors, muscle rigidity, and muscle contractions
- Serotonin Syndrome. Signs may include diarrhoea, nausea, vomiting, high fever and high blood pressure, excessive sweating and rapid heart rate, agitation, confusion, hallucinations, chills, muscle spasms, jerking or rigidity, loss of coordination, and restlessness.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 packaging after "EXP". The expiry date refers to the last day of the month indicated.
Medicines should not be disposed of via wastewater drains or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Additional 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 components (excipients) are sodium chloride, citric acid monohydrate, sodium hydroxide or hydrochloric acid (for pH adjustment), and water for injection.
Appearance of Granisetron Normon and contents of the container
Granisetron Normon 1 mg/1 ml is presented in colorless glass ampoules with sufficient capacity to contain 1 ml. The ampoules contain a sterile, clear, colourless or slightly yellowish solution.
It is supplied in packs of 5 ampoules or clinical packs of 50 ampoules.
Marketing Authorisation Holder and Manufacturer
LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760
Tres Cantos – Madrid (Spain)
This leaflet was last approved in: March 2017
“Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es ”
This information is intended for healthcare professionals only:
Preparation of dilution:
Adults: Withdraw 1 ml from the ampoule and dilute with 5 ml of 0.9% sodium chloride. Other diluents must not be used.
Children: To prepare the dose of 40 micrograms/kg, withdraw the appropriate dose and dilute it with infusion solution to a total volume of 10 to 30 ml. Any of the following solutions may be used: 0.9% sodium chloride, 0.18% sodium chloride with 4% glucose, 5% glucose, Hartmann’s solution, sodium lactate, or 10% mannitol. Other diluents must not be used.
Dilutions of Granisetron Normon 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°C under normal indoor lighting (natural daylight supplemented with fluorescent light).