GRANISETRON ALTAN 3 mg/50 ml SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the User

Granisetron Altan 3mg/50 ml solution for infusion

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• 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 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 experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Granisetron Altan is and what it is used for
2. What you need to know before you use Granisetron Altan
3. How to use Granisetron Altan
4. Possible side effects
5. Storage of Granisetron Altan
6. Contents of the pack and further 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 called serotonin receptor antagonists, 5-HT3, or antiemetics, which prevent or stop nausea and vomiting.

Granisetron Altan is used to prevent and treat nausea and vomiting (feeling sick) caused by certain treatments, such as chemotherapy or radiotherapy in anticancer therapy.

2. What you need to know before you use Granisetron Altan

Do not use Granisetron Altan

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

Warnings and precautions

Before using this medicine, 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 may be harmful to your heart, and/or have some disorder of salt levels such as potassium, sodium, or calcium (electrolyte disturbances).

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

Serotonin syndrome is a rare 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 other medicines (in particular, fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram, venlafaxine, duloxetine).

Other medicines and Granisetron Altan

Tell your doctor, nurse, or pharmacist if you are using or have recently used or might have to use any other medicines.

Tell your doctor, nurse, or pharmacist if you are taking 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 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 and norepinephrine reuptake inhibitors) used to treat depression and/or anxiety. For example: venlafaxine, duloxetine

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

This medicine is not expected to affect your ability to drive or use machines.

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

3. How to use Granisetron Altan

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

The treatment will be administered intravenously.

The infusion will be administered by your doctor or nurse. The dose of granisetron varies from patient to patient. It depends on age, weight, and whether you are taking other medicines to prevent or treat nausea and vomiting. The doctor will decide how much medicine to administer.

Prevention of nausea or vomiting after radiotherapy or chemotherapy

The preventive dose of granisetron for adults is a single dose of 3 mg (1 bag) administered as an intravenous infusion over 5 minutes before the start of chemotherapy treatment.

Treatment of nausea or vomiting after 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 an infusion over 5 minutes. If additional doses of granisetron are required, they should be separated by an interval of at least 10 minutes.

The maximum dose of granisetron should not exceed 9 mg in a 24-hour period.

Combination with corticosteroids

The effect of the infusion may be increased with the use of other medicines, called corticosteroids. This may be 8-20 mg of dexamethasone, administered before the start of radiotherapy or chemotherapy treatment, or 250 mg of methylprednisolone administered 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

This medicine is administered by intravenous infusion as described above, with the dose adjusted according to the child's weight. The infusions are administered 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.

Special populations

Elderly patients:

Same dose as for adults

Patients with renal impairment:

Same dose as for adults

If you think 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 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 on the use of this product, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If you experience any of the following side effects, you should immediately consult your doctor:

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

Other side 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 sleeping (insomnia)

changes in liver function shown by blood tests

diarrhea

Uncommon: may affect up to 1 in 100 people

skin rash 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 heart rate, agitation, confusion, hallucinations, chills, muscle spasms, shaking, 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 side effects directly through the National Reporting System: https://www.notificaram.es. By reporting side 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 the sight and reach of children.

Do not use the infusion solution after the expiry date which is stated on the container after "EXP". The expiry date is the last day of the month shown.

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. Contents of the pack and further information

Composition of Granisetron Altan

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

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

Appearance of Granisetron Altan and contents of the pack

The medicine comes in bags with a metalized overbag. The bags contain a sterile, clear, and colorless solution for infusion.

They are supplied in packs of 1 or 5 bags.

Not all pack sizes may be marketed.

Marketing authorization holder

Altan Pharmaceuticals, S.A.

C/ Cólquide, 6 Portal 2, 1ª Planta, Oficina F, Edificio Prisma

28230 - Las Rozas (Madrid)

Manufacturer

Altan Pharmaceuticals, S.A.

Polígono Industrial de Bernedo s/n

01118 - Bernedo (Álava)

Date of last revision of this leaflet:January 2017

Other sources of information

"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/"

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This information is intended only for healthcare professionals:

The bags of Granisetron Altan are ready for immediate administration.

Compatibility with other medicines:

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

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

The mixtures will have a validity period of 24 hours.