PALONOSETRON KALCEKS 250 micrograms Injectable Solution

Introduction

Package Leaflet: Information for the User

Palonosetron Kalceks250 micrograms solution for injection EFG

palonosetron

Read all of this leaflet carefully before you start using 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 nurse.
• 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 get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

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

Palonosetron Kalceks is used in adults, adolescents, and children over 1 month of age to prevent nausea and vomiting when receiving cancer treatments called 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 Kalceks

You should not be given Palonosetron Kalceks if:

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

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

Warnings and precautions

Tell your doctor or nurse before you are given this medicine 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 heart rhythm (QT interval prolongation);
• you have an imbalance of certain minerals in your blood, such as potassium and magnesium, that has not been treated.

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 Kalceks

Tell your doctor or nurse if you are taking, have recently taken, or might take any other medicines. In particular, tell them if you are taking:

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 heart rhythm

Tell your doctor 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. 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 this medicine. This is because these medicines may cause heart rhythm problems when taken with Palonosetron Kalceks.

Pregnancy

If you are pregnant or think you may be pregnant, your doctor will only give you this medicine if it is clearly necessary. This is because it is not known if palonosetron is harmful to the baby.

Consult your doctor 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 is present in breast milk.

Consult your doctor or nurse before you are given this medicine if you are breast-feeding.

Driving and using machines

This medicine may cause dizziness or tiredness. If it affects you, do not drive or use tools or machines.

Palonosetron Kalceks contains sodium

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

3. How Palonosetron Kalceks is given

Palonosetron Kalceks will usually be given to you by a doctor or nurse.

• You will be given the medicine about 30 minutes before the start of chemotherapy.

Adults

• The recommended dose of this medicine 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 correct dose based on your body weight.
• The maximum dose is 1500 micrograms.
• Palonosetron Kalceks will be given as a drip (a slow infusion into a vein).

This medicine should not be given to you on the days following chemotherapy, unless you are going to receive another cycle of chemotherapy.

If you have any other questions about the use of this medicine, ask your doctor 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:

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

• allergic reaction: signs may include swelling of the lips, face, tongue, or throat, difficulty breathing or fainting, itchy rash with blisters (urticaria)

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 vein color 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 sensation on the skin
• itchy rash
• 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

Uncommon side effects observed in trials(may affect up to 1 in 100 people)

• high or low blood pressure
• abnormal heart rhythm or lack of blood flow to the heart
• abnormally high or low potassium levels in the blood
• high blood sugar or sugar in the urine
• low calcium levels in the blood
• high bilirubin levels in the blood
• high 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 young people

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

• headache

Uncommon: (may affect up to 1 in 100 people)

• dizziness
• spasms
• abnormal heart rhythm
• cough or shortness of breath
• nasal bleeding
• itchy rash or urticaria
• fever
• pain at the infusion site

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

Reporting of side effects

If you experience any side effects, talk to your doctor, even if they are not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Agency (AEMPS) at www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Palonosetron Kalceks

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

This medicine does not require any special storage conditions.

Shelf life after opening the vial

Use immediately after opening the vial.

Shelf life after dilution

Chemical and physical stability has been demonstrated for 48 hours at 25°C and at temperatures between 2 and 8°C.

From a microbiological point of view, the diluted solution should be used immediately. If not used immediately, the in-use storage times and conditions are the responsibility of the user and normally should not be longer than 24 hours at a temperature between 2 and 8°C, unless the dilution has been made in controlled and validated aseptic conditions.

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 shown.

For single use only. Any unused solution should be discarded.

The solution should be inspected visually before use. Only clear and colorless solutions without visible particles should be used.

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 other information

Composition of Palonosetron Kalceks

The active substance is palonosetron (as hydrochloride).

Each ml of solution contains 50 micrograms of palonosetron (as hydrochloride).

Each 5 ml vial of solution contains 250 micrograms of palonosetron (as hydrochloride).

The other ingredients are mannitol, disodium edetate, sodium citrate, citric acid monohydrate, hydrochloric acid, sodium hydroxide, water for injections.

Appearance and packaging

Clear and colorless solution, without visible particles.

5 ml glass vials, type I, with a constricted neck.

The vials are closed with bromobutyl rubber stoppers and sealed with flip-off aluminum caps.

The vials are packaged in cartons.

Pack size: 1 vial of 5 ml

Marketing Authorisation Holder and Manufacturer

AS KALCEKS

Krustpils iela 71E, Riga, LV-1057, Latvia

Tel.: +371 67083320

E-mail: kalceks@kalceks.lv

You can obtain further information about this medicine from the local representative of the Marketing Authorisation Holder:

Grindeks Kalceks España, S.L.

c/ José Abascal, 58 2º dcha

28003 Madrid

Spain

Date of last revision of this leaflet: April 2022.

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/).