Leaflet: information for the user

Granisetrón Altan 3mg/50 ml solution for infusion

Read this leaflet carefully before you start taking this medicine, because 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 should not be given to others, even if they have the same symptoms, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4

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

2. What you need to know before using Granisetrón Altan

3. How to use Granisetrón Altan

4. Possible side effects

5. Storage of Granisetrón Altan

6. Contents of the pack and additional information

This medication contains the active substance called granisetrón. It belongs to a group of medications called 5-HT3 receptor antagonists, or antiemetics, which prevent or avoid nausea and vomiting.3,

Granisetrón Altan is used 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.

Do not use Granisetrón Altan

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

Warnings and precautions

Before using this medicationconsult your doctor, nurse or pharmacist if:

?you have intestinal obstruction causing constipation

?you have heart problems, are receiving cancer medications that may be harmful to your heart, and/or have any electrolyte imbalance such as potassium, sodium, or calcium.

?you are taking another medication from the group of “5-HT3 receptor antagonists”. This group includes dolasetron and ondansetron, which, like granisetron, are used to treat and prevent nausea and vomiting.

The serotonin syndrome is a rare but potentially fatal 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

medications (particularly fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram, venlafaxine, duloxetine).

Other medications and Granisetrón Altan

Inform your doctor, nurse or pharmacist if you are using or have recently used or may need to use any other medication.

Inform your doctor, nurse or pharmacist if you are taking any of the following medications:

?medications used to treat irregular heartbeats, other 5-HT3 receptor antagonists such as dolasetron or ondansetron (see “Be careful with Granisetrón Altan”).

?phenobarbital, a medication used to treat epilepsy

?ketoconazole, a medication 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

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

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

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The treatment will be administered intravenously.

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

Prevention of nausea or vomiting after radiation 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 radiation 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 must 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 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

This medication is administered by intravenous infusion as described above, with the dose adjusted according to the child's weight. Infusions are administered before radiation 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

Geriatric patients:

The same dose as in adults

Patients with renal insufficiency:

The same dose as in adults

If you estimate that the effect of this medication is too strong or too weak, inform your doctor or pharmacist.

If you use moreGranisetrón Altanthan you should

Since this infusion 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 mild headache (cephalalgia). 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, this medication may produce adverse effects, although not all people may 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, swelling of the face, lips, and mouth, and difficulty breathing or swallowing.

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

Very frequent: may affect more than one in 10 patients

?headache

?constipation. Your doctor will monitor your condition.

Frequent: may affect up to 1 in 10 patients

?difficulty falling asleep (insomnia)

?through blood tests, changes in liver function are shown

?diarrhea

Rare: may affect up to 1 in 100 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, twitching or stiffness, 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 National Notification System: 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 sight and reach of children.

Do not use the infusion 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 unused medicines. This will help protect the environment.

Composition of Granisetrón Altan

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

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

Appearance of Granisetrón Altan and content of the container

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

They are supplied in containers of 1 or 5 bags.

Only some sizes of containers may be commercially marketed.

Holder of the marketing authorization

Altan Pharmaceuticals, S.A.

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

28230 - Las Rozas (Madrid)

Responsible for manufacturing

Altan Pharmaceuticals, S.A.

Polígono Industrial de Bernedo s/n

01118 - Bernedo (Álava)

Last review date of this leaflet: January 2017

Other sources of information

"Detailed information about 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 medical professionals or healthcare professionals:

The Granisetrón 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 for sodium phosphate of dexamethasone.

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

The mixtures will have a validity period of 24 hours.