FERANT 250 micrograms injectable solution

Introduction

Package Leaflet: Information for the User

Ferant 250 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 pharmacist.

• 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 experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Ferant and what is it used for
2. What you need to know before you use Ferant
3. How to use Ferant
4. Possible side effects

5 Storage of Ferant

1. Contents of the pack and further information

1. What is Ferant and what is it used for

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

Ferant is used in adults, adolescents, and children over 1 month of age to prevent nausea and vomiting associated with cancer 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 use Ferant

Do not use Ferant:

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

Ferant will not be administered to you if any of the above applies to you. If in doubt, consult your doctor or nurse before they administer this medicine to you.

Warnings and precautions

Tell your doctor or nurse before you start using Ferant:

• If you have a blockage in your 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 («prolonged QT interval»).
• If you have an imbalance of certain minerals in the blood that has not been treated - such as potassium and magnesium.

If any of the above applies to you (or if you are in doubt), consult your doctor or nurse before they administer this medicine to you.

Using Ferant with other medicines

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 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 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 Ferant. 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 treating nausea and vomiting called domperidone.

If any of the above applies to you (or if you are in doubt), consult your doctor or nurse before they administer Ferant to you - this is because these medicines may 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 administer Ferant to you unless it is clearly necessary. This is because we do not know if Ferant is harmful to the baby.

Consult your doctor or nurse before they administer this medicine to you if you are pregnant or think you may be pregnant.

Breastfeeding

It is not known if Ferant passes into breast milk.

Consult your doctor or nurse before they administer this medicine to you if you are breastfeeding.

Driving and using machines

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

Ferant contains sodium

This medicine 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 on a low-sodium diet.

3. How to use Ferant

Ferant will usually be administered to you by a doctor or nurse.

• They will administer the medicine 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)

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

Ferant should not be administered to you on the days following chemotherapy unless you are going to receive another cycle of chemotherapy.

If you have any further questions on 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 occur 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 fainting, 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 and 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 loss of appetite;
• weakness, tiredness, fever, or flu-like symptoms;
• numbness, burning, itching, or tingling sensation in the skin;
• skin rash with itching;
• vision changes or eye irritation;
• movement disorders;
• ringing in the ears;
• hiccups, gas (flatulence), dry mouth, or dyspepsia;
• abdominal pain (stomach pain);
• difficulty urinating;
• joint pain.

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

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 («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;
• spasmodic movements;
• abnormal heart rhythm;
• cough or shortness of breath;
• nosebleeds;
• skin rash with itching or hives;
• exanthema 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 experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ferant

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 label on the carton after EXP. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions. Keep the ampoule in the outer packaging to protect it from light.

For single use only, any unused solution should be discarded.

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 further information

Composition of Ferant

• The active substance is palonosetron (as hydrochloride).

Each ml of solution contains 50 micrograms of palonosetron. Each 5 ml ampoule contains 250 micrograms of palonosetron.

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

Appearance and packaging

Ferant solution for injection is a clear and colorless solution and is presented in transparent glass ampoules, which contain 5 ml of the solution.

Packs containing 1, 5, or 10 ampoules.

Not all pack sizes may be marketed.

Marketing authorisation holder

Medochemie Ltd

1-10 Constantinoupoleos street

3011 Limassol

Cyprus

Manufacturer

Medochemie Ltd

48 Iapetou Street,

Agios Athanassios Industrial Area,

Agios Athanassios, 4101 Limassol

Cyprus

You can obtain further information on this medicine from the representative of the marketing authorisation holder:

Saniproject, S.L.

C/ Retamas 11 – Urb. Puentelasierra

28210 Valdemorillo, Madrid

SPAIN

Date of last revision of this leaflet: November 2021