Palonosetron Kalceks

Package leaflet: Information for the user

Palonosetron Kalceks 250 micrograms injection solution

palonosetron
Generic medicine
Please read 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 questions, ask your doctor or nurse.
• This medicine has been prescribed for you only. Do not give it to other people.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet:

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 administered
4. Possible side effects
5. How to store 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 (5HT ) receptor antagonists”.
Palonosetron Kalceks is used in adults, adolescents, and children over one month of age to help prevent the feeling or state of discomfort (nausea and vomiting) associated with anticancer treatments known as chemotherapy.
It works by blocking the action of a chemical substance called serotonin, which can cause feelings of nausea or vomiting.

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

Do not receive Palonosetron Kalceks if:

• you are allergic to palonosetron or to any of the other ingredients of this medicine (listed in section 6). You will not receive this medicine if any of the above apply. If you have any doubts, consult your doctor or nurse before receiving this medicine.

Warnings and precautions
Talk to your doctor or nurse before receiving this medicine if:

• you have intestinal blockage or have had repeated constipation in the past;
• you have had heart problems or your family members have had heart problems, such as irregular heartbeats ("QT prolongation");
• you have an untreated imbalance of certain minerals in the blood, such as potassium and magnesium.

If any of the above apply to you (or if you have any doubts), speak with your doctor or nurse before receiving 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, inform them if you are taking the following medicines:

Medicines for depression or anxiety
Tell your doctor or nurse if you are taking medicines for depression or anxiety, such as:

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

Medicines that may affect heart rhythm
Tell your doctor or nurse if you are taking medicines that affect heart rhythm; because they could cause heart rhythm problems when taken with palonosetron. These include:

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

If any of the above apply to you (or if you have any doubts), talk to your doctor or nurse before taking this medicine, as these medicines could cause heart rhythm problems when taken together with Palonosetron Kalceks.

Pregnancy
If you are pregnant or think you might be pregnant, your doctor will not administer this medicine unless clearly necessary. This is because it is not known whether palonosetron could harm the unborn baby.
Ask your doctor or nurse for advice before receiving this medicine if you are pregnant or think you might be pregnant.

Breast-feeding
It is not known whether palonosetron passes into breast milk.
Ask your doctor or nurse for advice 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 Kalceks contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e. essentially "sodium-free".

3. How Palonosetron Kalceks is administered

Palonosetron Kalceks is normally administered by a doctor or nurse.

• You will receive the medicine approximately 30 minutes before the start of chemotherapy.

Adults

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

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

• The doctor will calculate the correct dose based on body weight.
• The maximum dose is 1,500 micrograms.
• Palonosetron Kalceks is administered as an infusion (slow infusion into a vein).

Administration of this medicine is not recommended on the days following chemotherapy, unless you are due to undergo another cycle of chemotherapy.
If you have any doubts about the use of this medicine, consult your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. The following side effects may occur 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 collapse, skin rash with swelling and itching (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, diarrhoea

Uncommon (may affect up to 1 in 100 people)

• change in vein colour and swelling of veins
• feeling happier than usual or anxious
• feeling sleepy or difficulty sleeping
• decreased or loss of appetite
• weakness, feeling tired, fever or flu-like symptoms
• sensations of numbness, burning, itching or tingling of the skin
• itchy rash
• changes in vision or eye irritation
• motion sickness
• ringing in the ears
• hiccups, intestinal gas (flatulence), dry mouth or indigestion
• abdominal pain (stomach)
• difficulty urinating
• joint pain

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

• low or high blood pressure
• abnormal heart rate or reduced blood flow to the heart
• abnormally high or low levels of potassium in the blood
• high blood sugar levels or presence of 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
• abnormalities in the ECG (electrocardiogram) (“QT 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
• jerky body movements
• irregular heartbeat
• cough or shortness of breath
• nosebleeds
• itchy rash or hives
• fever
• pain at the infusion site

Tell your doctor if you notice any of the side effects listed above.
Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . Reporting side effects can help provide more information on the safety of this medicine.

5. How to store 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 in-use stability has been demonstrated for 48 hours at 25 °C and at 2-8 °C.
From a microbiological standpoint, the product should be used immediately. If not used immediately,
the times and conditions of in-use storage prior to use are the responsibility of the user and should
normally not exceed 24 hours at 2-8 °C, unless the dilution was carried out under controlled and
validated aseptic conditions.
Do not use this medicine after the expiry date stated on the vial label after “EXP” and on the carton
after “Scad.”. The expiry date refers to the last day of that month.
For single use only. Any unused solution must be discarded.
The solution should be inspected visually before use. Only clear, colourless solutions free from
visible particles should be used.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Palonosetron Kalceks contains

• 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 components are mannitol, sodium edetate, sodium citrate, citric acid monohydrate, concentrated hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment), water for injections.

Description of the appearance of Palonosetron Kalceks and contents of the pack
Clear, colourless solution free from visible particles.
5 ml of solution are filled into clear type I borosilicate glass vials with a crimp neck.
The vials are closed with bromobutyl rubber stoppers and sealed with aluminium flip-off caps.
The vials are packed in outer cartons.
Pack: 1 vial of 5 ml.

Marketing Authorisation Holder
AS KALCEKS
Krustpils iela 71E, Rīga, LV-1057, Latvia
Tel.: +371 67083320
E-mail: [email protected]

Manufacturer
AS KALCEKS
Krustpils iela 71E, Rīga, LV-1057, Latvia