Label: information for the user

Palonosetron Injection 250 micrograms EFG

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this label. See section 4.

Palonosetron Sala belongs to a group of medications known as serotonin (5HT3antagonists.

These medications have the ability to block the action of a chemical called serotonin, which can cause nausea and vomiting.

Palonosetron Sala is used in the prevention of nausea and vomiting associated with chemotherapy in adults, adolescents, and children over one month of age.

No use Palonosetron Sala:

If you are allergic to palonosetron or any of the other components of this medication (listed in section 6).

Warnings and Precautions

Consult your doctor or pharmacist before starting to use Palonosetron Sala

• If you have an acute intestinal obstruction or a history of repeated constipation.
• If you are using Palonosetron Sala with other medications that may cause abnormal heart rhythm, such as amiodarone, nicardipine, quinidine, moxifloxacin, erythromycin, haloperidol, chlorpromazine, quetiapine, thioridazine, domperidone.
• If you have a personal or family history of heart rhythm alterations (prolongation of the QT interval).
• If you have other heart problems.
• If you have an imbalance of certain minerals in the blood, such as potassium and magnesium, that has not been treated.

It is not recommended to use Palonosetron Sala in the days following chemotherapy, unless it is for another cycle of chemotherapy.

Use of Palonosetron Sala with other medications

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

SSRIs (selective serotonin reuptake inhibitors) used to treat depression and/or anxiety, such as fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, and escitalopram; SNRIs (inhibitors of serotonin and noradrenaline reuptake) used to treat depression and/or anxiety, such as venlafaxine and duloxetine.

Pregnancy

If you are pregnant or think you may be pregnant, your doctor will not administer Palonosetron Sala unless it is clearly necessary.

The effects of Palonosetron Sala on the fetus are unknown.

Consult your doctor or pharmacist before using any medication if you are pregnant or think you may be pregnant.

Breastfeeding

The presence of Palonosetron Sala in breast milk is unknown.

Consult your doctor or pharmacist before using Palonosetron Sala if you are breastfeeding.

Driving and operating machinery

Palonosetron Sala may cause dizziness or fatigue. If it affects you, do not drive or use tools or machinery.

Palonosetron Sala contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per vial, but if the maximum dose for children (6 vials) is administered, the sodium content corresponds to 1.2 mmol of sodium (27.90 mg).

A healthcare professional, such as a doctor or nurse, will typically inject Palonosetron Injection into a vein about 30 minutes before the start of chemotherapy.

Adults

The recommended dose of Palonosetron Injection is 250 micrograms administered as a rapid injection into a vein.

Children and Adolescents (1 month to 17 years of age)

The doctor will decide the dose based on the child's body weight; however, the maximum dose is 1500 micrograms.

Palonosetron Injection will be administered as a slow infusion into a vein.

If you have any other questions about the use of this medication, ask your doctor.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

The following are possible side effects and their frequencies:

Adults

Frequent (may affect up to 1 in 10 people):

• headache, dizziness, constipation, and diarrhea.

Less frequent (may affect up to 1 in 100 people):

• high or low blood pressure
• abnormal heart rhythm or reduced blood flow to the heart
• change in the color of the vein and/or enlarged veins
• abnormally high or low levels of potassium in the blood
• high levels of sugar in the blood or sugar in the urine
• low levels of calcium in the blood
• high levels of the pigment bilirubin in the blood
• high levels of certain liver enzymes
• euphoria or feeling of anxiety
• drowsiness or difficulty sleeping
• decreased or loss of appetite
• weakness, fatigue, fever, or flu-like symptoms
• numbness, burning, itching, or tingling sensation in the skin
• exanthema with itching
• vision changes or eye irritation
• movement disorder
• tinnitus
• hiccups, flatulence, dry mouth, or indigestion
• abdominal pain (stomach)
• difficulty urinating
• joint pain
• electrocardiogram anomalies (prolongation of the QT interval)

Very rare (may affect up to 1 in 10,000 people):

• Allergic reactions to Palonosetron Sal.

The symptoms may include swelling of the lips, face, tongue, or throat, with difficulty breathing or collapse; you may also notice itching, skin rash with hives (urticaria), burning, or pain at the injection site.

Children and adolescents:

Frequent (may affect up to 1 in 10 people):

• headache

Less frequent (may affect up to 1 in 100 people):

• dizziness
• spasmodic movements
• abnormal heart rhythm
• cough or shortness of breath
• nosebleed
• exanthema with itching or urticaria
• fever
• pain at the infusion site

Reporting of side effects

If you experience any type of side effect, consult your doctor, even if it is a possible side effect that does not appear in this prospectus.You can also report them directlythrough the Spanish System of Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the vial and the box after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

For single use, any remaining solution must be discarded without use.

Composition of Palonosetron Sala

• The active ingredient is palonosetron (as hydrochloride).

Each milliliter of solution contains 50 micrograms of palonosetron. Each vial of 5 milliliters of solution contains 250 micrograms of palonosetron.

• The other components are mannitol, disodium edetate (dihydrate), sodium citrate (dihydrate), citric acid monohydrate, and water for injections.

Appearance of the product and contents of the packaging

Palonosetron Sala injectable solution is a transparent and colorless solution and is presented in a type I glass vial with a chlorobutyl siliconized rubber stopper and an aluminum capsule, which contains 5 milliliters of the solution. Each vial contains a dose.

It is presented in packaging of 1 vial containing 5 milliliters of solution.

Holder of the marketing authorization andResponsible for manufacturing:

Reig Jofre, S.A. Laboratory

Gran Capitán, 10

08970 Sant Joan Despí (Barcelona)

Spain

Revision date of this leaflet: March 2021

The detailed information of this medicine is available on the website of the Spanish Agency of Medicines (AEMPS):http://www.aemps.gob.es/