Granisetron Altan 3 mg/50 ml solution for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Granisetron Altan 3 mg/50 ml solution for infusion

Read the entire leaflet carefully before starting to take this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms, as it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

This medicine contains the active substance 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.

Granisetron Altan is used for the prevention and treatment of nausea and vomiting (feeling of discomfort) caused by certain treatments, such as chemotherapy or radiotherapy in anticancer therapy.

The injectable solution is indicated in adults and children aged 2 years and older.

2. What you need to know before using Granisetrón Altan

Do not use Granisetrón Altan

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

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

Warnings and precautions

Before using this medicine, consult your doctor, nurse, or pharmacist if:

• you have constipation due to intestinal obstruction

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

• you are taking another medicine from the group of “5-HT3 receptor antagonists.” This group includes dolasetron and ondansetron, which, like granisetron, are used for the treatment and prevention of nausea and vomiting.

Serotonin syndrome is an uncommon but potentially life-threatening reaction that may occur with granisetron (see section 4). It may cause serious changes in how your brain, muscles, and digestive system function. The reaction may occur when you take granisetron alone, but is more likely if you take granisetron together with other medicines (particularly fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram, venlafaxine, duloxetine). Make sure to inform your doctor, nurse, or pharmacist about all medicines you are taking.

Other medicines and Granisetrón Altan

Tell your doctor, nurse, or pharmacist if you are using, have recently used, or might need to use any other medicines. This is because Granisetrón Altan may interact with certain medicines. Also, 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, other “5-HT3 receptor antagonist” medicines such as dolasetron or ondansetron (see “Special caution with Granisetrón Altan”)

• 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-norepinephrine 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.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

This medicine is not expected to affect your ability to drive or operate machinery.

Granisetrón Altan contains sodium. This medicine contains 177 mg of sodium (the main component of table/cooking salt) in each 50 ml bag. This corresponds to 8.85% of the maximum daily recommended sodium intake for an adult.

3. How to use Granisetron Altan

The treatment will be administered intravenously.

The infusion will be given by your doctor or nurse. The dose of granisetron varies from patient to patient. It depends on age, body weight, and whether you are taking other medications to prevent or treat nausea and vomiting. Your doctor will decide how much medication you should receive.

Prevention of nausea or vomiting following radiotherapy or chemotherapy

You will be given the injection before radiotherapy or chemotherapy begins. The preventive dose of granisetron for adults is a single dose of 3 mg (1 bag) administered as a 5-minute intravenous infusion before the start of chemotherapy.

Treatment of nausea or vomiting following radiotherapy or chemotherapy

The recommended therapeutic dose of granisetron for established nausea and vomiting in adults is a single dose of 3 mg (1 bag), administered as a 5-minute infusion. If additional doses of granisetron are required, they should be separated by an interval of at least 10 minutes.

The maximum dose of granisetron must not exceed 9 mg within a 24-hour period.

The dose range for both prevention and treatment of chemotherapy- or radiotherapy-induced nausea in adults is 1 to 3 mg. However, for doses different from 3 mg, other formulations containing the same active substance are recommended.

Combination with corticosteroids

The effect of the infusion may be enhanced by using other medications called corticosteroids. This may include 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

This medicine is administered by intravenous infusion as described above, with the dose adjusted according to the child's body weight. Infusions are given before radiotherapy or chemotherapy and last 5 minutes. Children may receive up to 2 doses per day, with a minimum interval of 10 minutes between doses.

Special populations

Elderly patients:

Same dose as in adults

Patients with renal impairment:

Same dose as in adults

If you think that the effect of this medicine is too strong or too weak, tell your doctor or pharmacist.

If you use more Granisetron Altan than you should

Because this infusion is administered by a doctor or nurse, it is unlikely that you will receive more than the correct 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, this medicine can cause adverse effects, although not everyone will experience them. If you notice any of the following adverse effects, you should immediately contact your doctor:

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

Other adverse effects that may occur while taking this medicine are:

Very common: may affect more than 1 in 10 people

? headache
? constipation. Your doctor will monitor your condition.

Common: may affect up to 1 in 10 people

? difficulty falling asleep (insomnia)
? blood tests show changes in liver function
? diarrhoea

Uncommon: may affect up to 1 in 100 people

? skin rashes or an allergic reaction or urticaria. Signs may include red, itchy spots.
? changes in heart rhythm (beat) and changes in the ECG (electrocardiogram).
? abnormal involuntary movements, such as tremors, muscle stiffness, 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 can also report them directly through the National Reporting System: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Granisetron Altan

Keep the container in the outer packaging to protect it from light.

Do not freeze.

Keep out of sight and reach of children.

Do not use the infusion solution after the expiry date stated on the container after "EXP". The expiry date refers to the last day of the month indicated.

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

6. Contents of the pack and other information

Composition of Granisetron Altan

The active substance is granisetron. Each 50 ml bag of infusion solution contains 3 mg of granisetron (as granisetron hydrochloride).

The other components (excipients) are sodium chloride and water for injections.

Appearance of Granisetron Altan and contents of the container

The medicine is presented in bags with a metallic overpouch. The bags contain a sterile, clear, and colourless infusion solution.

They are supplied in packs of 1 or 5 bags.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Altan Pharmaceuticals, S.A.

C/ Cólquide, 6 Portal 2, 1st Floor, Office F, Edificio Prisma

28231 - Las Rozas (Madrid)

Manufacturer

Altan Pharmaceuticals, S.A.

Polígono Industrial de Bernedo s/n

01118 - Bernedo (Álava)

Date of the most recent revision of this summary: February 2026

Detailed information on this medicine 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:

Granisetron Altan bags are ready for immediate administration.

Compatibility with other drugs:

As a general precaution, granisetron should not be mixed in solution with other drugs, except with dexamethasone sodium phosphate.

Mixtures of granisetron hydrochloride and dexamethasone sodium phosphate are compatible at concentrations of 10 to 60 micrograms/ml of granisetron and 80 to 480 micrograms/ml of dexamethasone phosphate.

Such mixtures will have a shelf life of 24 hours.