Prospect: information for the user

Ferant 250 micrograms injectable solution EFG

palonosetrón

Read this prospect carefully before starting to use this medication,because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult yourdoctor pharmacist.

-This medication has been prescribedonlyto you, and you should not give it to other people even iftheyhave the same symptomsas you,as it may harm them.

• If you experience any adverse effects,consult your doctor or pharmacist, evenifthey are not listed in this prospect. See section 4.

1.What is Ferant and for what it is used

2.What you need to knowbeforestarting touse Ferant

3.How to use Ferant

4.Possible adverse effects

5Storage of Ferant

6.Contents of the package and additional information

Ferant contains the active ingredient palonosetrón. This belongs to a group of medicines called serotonin antagonists (5HT3).

Ferantis used in adults, adolescents, and children over 1 month of age to prevent general discomfort (nausea and vomiting) when receiving cancer treatments known as chemotherapy.

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

No use Ferant:

- If you are allergic to palonosetron or any of the other components of this medication (listed in section 6).

Do not be given Ferant if the above applies to you. In case of doubt, consult your doctor or nurse before being administered this medication.

Warnings and precautions

Consult your doctor or nurse before starting to use Ferant:

• If you have a blockage in the intestine or have had repeated constipation in the past.
• If you have had heart problems or have a family history of heart problems, such as changes in heart rhythm («prolongation of the QT interval»).
• If you have an imbalance of certain minerals in the blood that have not been treated - such as potassium and magnesium, which have not been treated.

If any of the above points apply to you (or if you have doubts), consult your doctor or nurse before being administered this medication.

Use of Ferantwithother medications

Inform your doctor or nurse if you are using, have used recentlyor may have to use any other medication.Specifically, inform them if you are taking the following medications:

Depression or anxiety medications

Inform your doctor or nurse if you are taking any medication for depression or anxiety, including:

• the medications called SSRIs («selective serotonin reuptake inhibitors»), such as fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, and escitalopram;
• the medications called SNRIs («serotonin and norepinephrine reuptake inhibitors»), such as venlafaxine and duloxetine (may cause the development of serotonin syndrome and should be used with caution).

Medications that can affect your heart rhythm

Inform your doctor or nurse if you are taking any medication that affects your heart rhythm. This is because these medications can cause heart rhythm problems when taken with Ferant. These medications are:

• heart medications, such as amiodarone, nicardipine, and quinidine;
• infection medications, such as moxifloxacin and erythromycin;
• serious mental health medications, such as haloperidol, chlorpromazine, quetiapine, and thioridazine;
• a medication to treat general discomfort (nausea and vomiting) called domperidone.

If any of the above points apply to you (or if you have doubts), consult your doctor or nurse before being administered Ferant - this is because these medications can cause heart rhythm problems when taken with Ferant.

Pregnancy and breastfeeding

Pregnancy

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

Consult your doctor or nurse beforebeing administered thismedication if you are pregnant or think you may be pregnant.

Breastfeeding

We do not know if Ferant is present in breast milk.

Consult your doctor or nurse before being administered this medication if you are breastfeeding.

Driving and operating machinery

You may feel dizzy or tired after being administered this medication. If this happens, do not drive or use tools or machinery.

Ferant contains sodium

This medication contains 0.20 mmol (or 4.65 mg) of sodium per dose (up to 1.2 mmol or 27.9 mg for the highest dose), which should be taken into account in the treatment of patients with low-sodium diets.

A doctor or nurse will normally administer Ferant to you.

• They will administer the medication about 30 minutes before the start of chemotherapy.

Adults

• The recommended dose of Ferant is 250 micrograms.
• It is administered as a rapid injection into a vein.

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

• The doctor will decide the dose based on body weight.
• The maximum dose is 1500 micrograms.
• Ferant will be administered as an infusion (a slow drip into a vein).

It is not recommended that you receive Ferant on the days following chemotherapy unless you are about to receive another cycle of chemotherapy.

If you have any other questions about the use of this medication, ask your doctor or nurse.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

The following side effects may occur with this medicine:

Severe side effects

Inform your doctor immediately if you observe any of the following severe side effects:

• allergic reaction-the signs may include swelling of the lips, face, tongue, or throat, difficulty breathing, dizziness, 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 observe any of the severe side effects mentioned above.

Other side effects

Inform your doctor if you observe any of the following side effects:

Adults

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

• headache, dizziness;
• constipation and diarrhea.

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

• change in the color of the vein and veins that become enlarged;
• feeling excessively happy or sensation of anxiety;
• drowsiness or difficulty sleeping;
• decreased or loss of appetite;
• weakness, fatigue, fever, or flu-like symptoms;
• numbness, burning, itching, or tingling sensation in the skin;
• skin rash with itching;
• alteration of vision or eye irritation;
• movement disorder;
• ringing in the ears;
• hiccups, gas (flatulence), dry mouth, or indigestion;
• abdominal pain (stomach);
• difficulty urinating;
• joint pain.

Inform your doctor if you observe any of the side effects mentioned above.

Side effects observed in tests (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 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;
• anomalies in the electrocardiogram («prolongation of the QT interval»).

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;
• muscle spasms;
• abnormal heart rhythm;
• cough or shortness of breath;
• nosebleed;
• skin rash with itching or hives;
• exanthema with itching or hives;
• fever;
• pain at the infusion site;

Inform your doctor if you observe any of the side effects mentioned above.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthe label on the box,after CAD. The expiration date is the last day of the month indicated.

This medication does not require any special storage temperature.Store the ampule in the outer packaging to protect it from light.

For single use, any remaining solution must be disposed of without use.

Medicines should not be thrown away through drains or in the trash. Ask your pharmacisthow to dispose ofthecontainers and themedicines that you no longerneed. This will help protect the environment.

Composition of Ferant

• The active principle is palonosetron (as hydrochloride).

Each milliliter of solution contains 50 micrograms of palonosetron. Each ampule of 5 milliliters of solution contains 250 micrograms of palonosetron.

• The other components are mannitol, disodium edetate, sodium citrate, citric acid monohydrate, sodium hydroxide (for pH adjustment), hydrochloric acid(for pH adjustment)and water for injection.

Appearance of the product and contents of the packaging

Ferant injectable solution is a transparent and colorless solution and is presented in transparent glass ampules, which contain 5 milliliters of the solution.

Packagings containing 1, 5 or 10 ampules.

Only some sizes of packaging may be marketed.

Holder of the marketing authorization

Medochemie Ltd

1-10 Constantinoupoleos street

3011 Limassol

Cyprus

Responsible for manufacturing

Medochemie Ltd

48 Iapetou Street,

Agios Athanassios Industrial Area,

Agios Athanassios, 4101 Limassol

Cyprus

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Saniproject, S.L.

C/ Retamas 11 – Urb.Puentelasierra

28210 Valdemorillo, Madrid

SPAIN

Date of the last review of thisleaflet: November 2021