Palonosetron Sala 250 micrograms solution for injection EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Palonosetron Sala 250 micrograms solution for injection EFG

palonosetron

Read all of this leaflet carefully before you are given 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, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, even if they are side effects not listed in this leaflet. See section 4.

Contents of this leaflet

1. What Palonosetron Sala is and what it is used for
2. What you need to know before you are given Palonosetron Sala
3. How Palonosetron Sala will be given to you
4. Possible side effects
5. How to store Palonosetron Sala
6. Contents of the pack and other information

1. What Palonosetron Sala is and what it is used for

Palonosetron Sala contains the active substance palonosetron, which belongs to a group of medicines known as serotonin (5HT3) antagonists.

Palonosetron Sala is used in adults, adolescents, and children older than 1 month of age to prevent general discomfort (nausea and vomiting) associated with cancer treatments known as chemotherapy.

This medicine works by blocking the action of a chemical substance called serotonin, which can cause nausea or vomiting.

2. What you need to know before Palonosetron Sala is administered to you

Do not take Palonosetron Sala:

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

Palonosetron Sala will not be administered to you if the above applies. If in doubt, consult your doctor, pharmacist, or nurse before receiving this medicine.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before Palonosetron Sala is administered to you if:

• you have a blockage in the intestine or have had repeated constipation in the past;
• you have had heart problems or have a family history of heart problems, such as changes in heart rhythm («prolongation of the QT interval»);
• you have an untreated imbalance of certain minerals in your blood, such as potassium or magnesium.

If any of the above apply to you (or if you are unsure), consult your doctor or nurse before receiving this medicine.

Other medicines and Palonosetron Sala

Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might need to take any other medicines. In particular, inform them if you are taking the following medicines:

Medicines for depression or anxiety

Tell your doctor or nurse if you are taking any medicines for depression or anxiety, including:

• medicines called SSRIs (selective serotonin reuptake inhibitors), such as fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, and escitalopram;
• medicines called SNRIs (serotonin and noradrenaline reuptake inhibitors), such as venlafaxine and duloxetine (these may lead to the development of serotonin syndrome and should be used with caution).

Medicines that may affect your heart rhythm

Tell your doctor, pharmacist, or nurse if you are taking any medicines that affect your heart rhythm. This is because these medicines may cause heart rhythm problems when taken with Palonosetron Sala. These medicines include:

• medicines for heart conditions, such as amiodarone, nicardipine, and quinidine;
• medicines for infections, such as moxifloxacin and erythromycin;
• medicines for serious mental health conditions, such as haloperidol, chlorpromazine, quetiapine, and thioridazine;
• a medicine used to treat general malaise (nausea and vomiting) called domperidone.

If any of the above apply to you (or if you are unsure), consult your doctor or nurse before Palonosetron Sala is administered. This is because these medicines may cause heart rhythm problems when taken together with Palonosetron Sala.

Pregnancy

If you are pregnant or think you may be pregnant, your doctor will not administer Palonosetron Sala unless clearly necessary. This is because it is unknown whether Palonosetron Sala could harm the unborn baby.

Consult your doctor, pharmacist, or nurse before receiving this medicine if you are pregnant or think you may be pregnant.

Breast-feeding

It is unknown whether Palonosetron Sala passes into breast milk.

Consult your doctor, pharmacist, or nurse before receiving this medicine if you are breast-feeding.

Driving and using machines

You may feel dizzy or tired after receiving this medicine. If this happens, do not drive or operate tools or machinery.

Palonosetron Sala contains sodium

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

3. How Palonosetron Sala will be administered to you

A doctor or nurse will normally administer Palonosetron Sala to you.

• The medicine will be given to you approximately 30 minutes before the start of chemotherapy.

Adults

• The recommended dose of Palonosetron Sala is 250 micrograms.
• It is given as an injection into a vein.

Children and adolescents (from 1 month to 17 years of age)

• The doctor will calculate the dose based on body weight.
• The maximum dose is 1500 micrograms.
• Palonosetron Sala will be given as an infusion (a slow intravenous drip).

Palonosetron Sala is not recommended for administration on the days following chemotherapy unless you are going to receive another cycle of chemotherapy.

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The following adverse effects may occur with this medicine:

Serious adverse effects

Inform your doctor immediately if you notice any of the following serious adverse effects:

• allergic reaction: signs may include swelling of the lips, face, tongue or throat, difficulty breathing or fainting, skin rash with itching and hives (urticaria). This reaction is very rare: it may affect up to 1 in 10,000 people.

Inform your doctor immediately if you notice any of the serious adverse effects listed above.

Other adverse effects

Inform your doctor if you notice any of the following adverse effects:

Adults

Common: may affect up to 1 in 10 people

• headache, dizziness;
• constipation, diarrhoea.

Uncommon: may affect up to 1 in 100 people

• change in vein color and enlarged veins;
• feeling happier than normal or anxiety;
• drowsiness or trouble sleeping;
• decreased or loss of appetite;
• weakness, fatigue, fever or flu-like symptoms;
• numbness, burning, itching or tingling sensation in the skin;
• itchy skin rash;
• visual disturbances or eye irritation;
• motion sickness;
• ringing in the ears;
• hiccups, gas (flatulence), dry mouth or dyspepsia;
• abdominal pain (stomach pain);
• difficulty urinating;
• joint pain.

Inform your doctor if you notice any of the adverse effects listed above.

Uncommon adverse effects observed in clinical trials: may affect up to 1 in 100 people

• high or low blood pressure;
• abnormal heartbeat or reduced blood flow to the heart;
• abnormally high or low blood potassium levels;
• high blood sugar levels or sugar in urine;
• low blood calcium levels;
• high blood bilirubin levels;
• elevated levels of certain liver enzymes;
• abnormalities in the electrocardiogram («QT interval prolongation»).

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

• burning, pain or redness at the injection site.

Children and adolescents

Common: may affect up to 1 in 10 people

• headache

Uncommon: may affect up to 1 in 100 people

• dizziness;
• spasmodic movements;
• abnormal heartbeat;
• cough or shortness of breath;
• nosebleeds;
• itchy skin rash or hives;
• fever;
• pain at the infusion site.

Inform your doctor if you notice any of the adverse effects listed above.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, 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 Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Palonosetron Sala

• Keep this medicine out of the sight and reach of children.

• Do not use this medicine after the expiry date stated on the vial and carton following EXP. The expiry date refers to the last day of the month indicated.

• No special storage conditions are required.

• For single use only; any unused solution should be discarded.

6. Contents of the pack and other information

Composition of Palonosetron Sala

• The active substance is palonosetron (as hydrochloride). Each ml of solution contains 50 micrograms of palonosetron. Each 5 ml vial of solution contains 250 micrograms of palonosetron.
• The other components are mannitol, edetate disodium (dihydrate), sodium citrate (dihydrate), citric acid monohydrate and water for injections.

Appearance of the product and contents of the container

Palonosetron Sala solution for injection is a clear, colourless solution supplied in a Type I glass vial with a siliconized chlorobutyl rubber stopper and aluminium cap, containing 5 ml of solution. Each vial contains one dose.

It is available in packs of 1 vial containing 5 ml of solution.

Marketing Authorisation Holder and Manufacturer:

Laboratorio Reig Jofre, S.A.

Gran Capitán, 10

08970 Sant Joan Despí (Barcelona)

Spain

Date of the most recent revision of this leaflet: February 2022

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