PALONOSETRON SALA 250 micrograms Injectable Solution

Introduction

Package Leaflet: Information for the User

Palonosetron Sala 250 micrograms solution for injection EFG

Read all of this leaflet carefully before you are given 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, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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. Storage of Palonosetron Sala
6. Contents of the pack and further 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 called 'serotonin (5HT3) antagonists'.

Palonosetron Sala is used in adults, adolescents, and children over 1 month of age to prevent nausea and vomiting when they receive cancer treatment (chemotherapy).

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

2. What you need to know before you are given Palonosetron Sala

Do not take Palonosetron Sala:

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

You will not be given Palonosetron Sala if any of the above applies to you. If you are unsure, consult your doctor, pharmacist, or nurse before you are given this medicine.

Warnings and precautions

Tell your doctor, pharmacist, or nurse before you are given Palonosetron Sala if:

• you have a blockage in your 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 your heartbeat ('prolonged QT interval');
• you have an imbalance of certain minerals in your blood that has not been treated, such as potassium and magnesium.

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

Other medicines and Palonosetron Sala

Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines. In particular, tell them if you are taking any of 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 (may cause serotonin syndrome and should be used with caution).

Medicines that may affect your heartbeat

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

• medicines for heart problems, such as amiodarone, nicardipine, and quinidine;
• medicines for infections, such as moxifloxacin and erythromycin;
• medicines for severe mental health problems, such as haloperidol, chlorpromazine, quetiapine, and thioridazine;
• a medicine for nausea and vomiting called domperidone.

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

Pregnancy

If you are pregnant or think you may be pregnant, your doctor will not give you Palonosetron Sala unless it is clearly necessary. This is because we do not know if Palonosetron Sala can harm the baby.

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

Breast-feeding

It is not known if Palonosetron Sala passes into breast milk.

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

Driving and using machines

You may feel dizzy or tired after you are given this medicine. If this happens, do not drive or use tools or machines.

Palonosetron Sala contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per vial; this is essentially 'sodium-free'.

3. How you will be given Palonosetron Sala

A doctor or nurse will usually give you Palonosetron Sala.

• You will be given the medicine about 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)

• Your doctor will calculate the dose based on your weight.
• The maximum dose is 1500 micrograms.
• Palonosetron Sala will be given as a drip (a slow infusion into a vein).

It is not recommended that you are given Palonosetron Sala 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 side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects may happen with this medicine:

Serious side effects

Tell your doctor immediately if you notice any of the following serious side effects:

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

Tell your doctor immediately if you notice any of the serious side effects mentioned above.

Other side effects

Tell your doctor if you notice any of the following side effects:

Adults

Common:may affect up to 1 in 10 people

• headache, dizziness;
• constipation, diarrhea.

Uncommon:may affect up to 1 in 100 people

• change in the color of the vein and enlarged veins;
• feeling unusually happy or feeling anxious;
• drowsiness or sleep problems;
• decreased or lost appetite;
• weakness, tiredness, fever, or flu-like symptoms;
• numbness, burning, itching, or tingling of the skin;
• skin rash with itching;
• vision changes or eye irritation;
• movement disorders;
• ringing in the ears;
• hiccups, gas (flatulence), dry mouth, or indigestion;
• abdominal pain (stomach pain);
• difficulty urinating;
• joint pain.

Tell your doctor if you notice any of the side effects mentioned above.

Uncommon side effects seen in clinical trials:may affect up to 1 in 100 people

• high or low blood pressure;
• abnormal heartbeat or lack of blood flow to the heart;
• 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 bilirubin in the blood;
• high levels of certain liver enzymes;
• abnormalities in the electrocardiogram ('prolonged QT interval).

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;
• spasms;
• abnormal heartbeat;
• cough or shortness of breath;
• nosebleeds;
• skin rash with itching or hives;
• fever;
• pain at the infusion site.

Tell your doctor if you notice any of the side effects mentioned above.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

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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 which is stated on the vial and carton after EXP. The expiry date is the last day of the month stated.

• No special storage conditions are required.
• For single use, any unused solution should be discarded.

6. Contents of the pack and further information / Further 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 ingredients are mannitol, disodium edetate (dihydrate), sodium citrate (dihydrate), citric acid monohydrate, and water for injections.

Appearance and packaging

Palonosetron Sala solution for injection is a clear and colorless solution and is presented in a type I glass vial with a siliconized chlorobutyl rubber stopper and an aluminum cap, which contains 5 ml of the solution. Each vial contains a single dose.

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

Marketing authorization holder and manufacturer:

Laboratorio Reig Jofre, S.A.

Gran Capitán, 10

08970 Sant Joan Despí (Barcelona)

Spain

Date of last revision of this leaflet: February 2022

Detailed information on this medicine is available on the Spanish Medicines Agency's website: http://www.aemps.gob.es/