Palonosetron Reig Jofre

Package leaflet: Information for the user

Palonosetron Reig Jofre 250 micrograms injection solution

palonosetron
equivalent medicine
Please read this leaflet carefully before receiving 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, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

1. What Palonosetron Reig Jofre is and what it is used for
2. What you need to know before receiving Palonosetron Reig Jofre
3. How Palonosetron Reig Jofre is administered
4. Possible side effects
5. How to store Palonosetron Reig Jofre
6. Contents of the pack and other information

1. What Palonosetron Reig Jofre is and what it is used for

Palonosetron contains the active substance palonosetron. This belongs to a class of medicines called “serotonin (5HT₃) antagonists”.
Palonosetron is used in adults, adolescents, and children over one month of age to help prevent the feeling or state of discomfort (nausea and vomiting) during anti-cancer treatments known as chemotherapy.
It works by blocking the action of a chemical called serotonin, which can cause nausea or vomiting.

2. What you need to know before receiving Palonosetron Reig Jofre

Do not take Palonosetron Reig Jofre

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

You will not be given Palonosetron Reig Jofre if any of the above apply to you. If you have any doubts, consult your doctor, pharmacist, or nurse before receiving this medicine.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before receiving Palonosetron Reig Jofre:

• if you have intestinal blockage or have previously had repeated constipation
• if you or your family members have had heart problems, such as irregular heartbeats (“QT prolongation”)
• if 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, pharmacist, or nurse before receiving Palonosetron Reig Jofre.
Other medicines and Palonosetron Reig Jofre
Tell your doctor, pharmacist, 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-noradrenaline 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, pharmacist, or nurse if you are taking medicines that affect heart rhythm; this is because they could cause heart rhythm problems when taken with Palonosetron Reig Jofre. 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 Palonosetron Reig Jofre, as these medicines could cause heart rhythm problems when taken together with Palonosetron Reig Jofre.
Pregnancy, breastfeeding, and fertility
Pregnancy
If you are or think you may be pregnant, your doctor will not administer Palonosetron Reig Jofre unless absolutely necessary. This is because it is unknown whether Palonosetron Reig Jofre could harm the unborn baby.
Ask your doctor, pharmacist, or nurse for advice before receiving this medicine if you are or think you may be pregnant.
Breastfeeding
It is not known whether Palonosetron Reig Jofre passes into breast milk.
Ask your doctor, pharmacist, or nurse for advice before receiving this medicine if you are breastfeeding.
Driving and using machines
You may feel dizzy or tired after receiving this medicine. If this occurs, do not drive or operate tools or machinery.
Palonosetron Reig Jofre contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per vial. However, if the maximum pediatric dose is administered (6 vials), the sodium content amounts to 1.2 mmol of sodium (27.90 mg).

3. How Palonosetron Reig Jofre is administered

Palonosetron Reig Jofre 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 Reig Jofre 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 1500 micrograms.
• Palonosetron Reig Jofre is administered as an intravenous infusion (slow infusion into a vein).

Administration of Palonosetron Reig Jofre 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, 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 occur with this medicine:
Serious side effects
Contact your doctor immediately if you notice any of the following serious side effects:

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

Contact your doctor immediately if you notice any of the serious side effects listed above.
Other side effects
Contact your doctor if you notice any of the following side effects:
Adults
Common: may affect up to 1 in 10 people

• headache, feeling dizzy,
• constipation, diarrhoea. Uncommon: may affect up to 1 in 100 people
• change in the appearance of veins and swelling of veins
• feeling happier than usual or feeling 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 on the skin
• skin rash with itching
• 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. Contact your doctor if you notice any of the side effects listed above.

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
• unusually high or low levels of potassium in the blood
• high blood sugar levels or presence of sugar in 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.

Additional side effects in 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 heart rate
• cough or shortness of breath
• nosebleeds
• skin rash with itching or hives
• fever
• pain at the infusion site.

Contact 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, pharmacist, or nurse.
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 Reig Jofre

• 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 the outer carton after "Exp.". The expiry date refers to the last day of that month.
• This medicine does not require any special storage conditions.
• For single use only; any unused solution must be discarded.

6. Package contents and other information

What Palonosetron Reig Jofre contains

• 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.

Description of the appearance of Palonosetron Reig Jofre and package contents
Palonosetron Reig Jofre injectable solution is a clear, colourless solution supplied in a
package containing one type I glass vial with a chlorobutyl rubber stopper siliconised with fluorotec and an aluminium cap, containing 5 ml of solution. Each vial contains one dose.
Available in packages containing 1 vial with 5 ml of solution.

Marketing Authorisation Holder and Manufacturer
Laboratorio Reig Jofre S.A.
Gran Capitán, 10
08970 Sant Joan Despí (Barcelona)
Spain

This medicinal product is authorised in the European Economic Area Member States under the following names:
Denmark: Palonosetron Reig Jofre
Finland: Palonosetron Reig Jofre 250 mikrogrammaa, injektioneste, liuos
France: Palonosetron Reig Jofre 250 microgrammes, solution injectable
Italy: Palonosetron Reig Jofre
Norway: Palonosetron Reig Jofre
Spain: Palonosetron Sala 250 microgramos solución para inyección EFG
Sweden: Palonosetron Reig Jofre 250 mikrogram injektionsvätska, lösning
United Kingdom: Palonosetron 250 micrograms solution for injection

Other sources of information
More detailed information on this medicinal product is available on the website of the Italian Medicines Agency (www.aifa.gov.it)