Ferant 250 micrograms solution for injection EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ferant 250 micrograms injection solution EFG

palonosetron

Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.

• If you have any questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only, and you should not give it to other people even if they have the same symptoms as you, because it may harm them.

  • If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of this leaflet

1. What Ferant is and what it is used for
2. What you need to know before using Ferant
3. How to use Ferant
4. Possible side effects
5. How to store Ferant
6. Contents of the pack and other information

1. What Ferant is and what it is used for

Ferant contains the active substance palonosetron. It belongs to a group of medicines known as serotonin (5HT3) antagonists.

Ferant is used in adults, adolescents, and children older than 1 month to prevent general discomfort (nausea and vomiting) associated with cancer treatments known as chemotherapy.

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

2. What you need to know before using Ferant

Do not use Ferant:

• 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 Ferant if any of the above applies to you. If in doubt, consult your doctor or nurse before receiving this medicine.

Warnings and precautions

Talk to your doctor or nurse before receiving Ferant:

• If you have a bowel blockage or have had repeated constipation in the past.
• If you have heart problems or a family history of heart problems, such as changes in heart rhythm («prolonged QT interval»).
• If you have an untreated imbalance of certain blood minerals, such as potassium or magnesium.

If any of the above apply to you (or if you are unsure), consult your doctor or nurse before receiving this medicine.

Using Ferant with other medicines

Tell your doctor or nurse if you are taking, have recently taken, or might need to take any other medicines. In particular, inform them if you are taking any of the following:

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 (these may lead to the development of 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 conditions, such as amiodarone, nicardipine, and quinidine;
• Medicines for infections, such as moxifloxacin and erythromycin;
• Medicines for serious mental health conditions, such as haloperidol, chlorpromazine, quetiapine, and thioridazine;
• A medicine used to treat general malaise (nausea and vomiting) called domperidone.

If any of the above apply to you (or if you have any doubts), consult your doctor or nurse before receiving Ferant, as these medicines may cause heart rhythm problems when used together with Ferant.

Pregnancy and breastfeeding

Pregnancy

If you are pregnant or think you might be pregnant, your doctor will not give you Ferant unless clearly necessary. This is because it is unknown whether Ferant could harm your unborn baby.

Consult your doctor or nurse before receiving this medicine if you are pregnant or think you might be pregnant.

Breastfeeding

It is unknown whether Ferant passes into breast milk.

Consult your doctor or nurse before receiving this medicine if you are breastfeeding.

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.

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 consideration when treating patients on a low-sodium diet.

3. How to use Ferant

A doctor or nurse will normally administer Ferant to you.

• The medicine will be given approximately 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 intravenous drip).

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

If you have any further 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 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:

• Allergic reaction – 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 listed 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 diarrhoea.

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

• change in vein colour and enlarged veins;
• feeling happier than normal or sensation of anxiety;
• drowsiness or trouble sleeping;
• decreased or loss of appetite;
• weakness, tiredness, fever or flu-like symptoms;
• numbness, burning, itching or tingling sensation on the skin;
• itchy skin rash;
• vision disturbance or eye irritation;
• motion sickness;
• 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 listed above.

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

• high or low blood pressure;
• abnormal heartbeat or reduced blood flow to the heart;
• abnormally high or low levels of potassium in the blood;
• high blood sugar levels or sugar in urine;
• low calcium levels in blood;
• high bilirubin levels in blood;
• elevated 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 adolescents

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

• headache

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

• dizziness;
• spasmodic movements;
• abnormal heartbeat;
• cough or shortness of breath;
• nosebleed;
• itchy skin rash or hives;
• 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, talk to your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: 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 box, following EXP. The expiry date is the last day of the month indicated.

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

For single use only; any unused portion of the solution must be discarded.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Ferant

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

Appearance of the product and contents of the container

Ferant injectable solution is a clear, colourless solution supplied in clear glass vials containing 5 ml of solution.

Pack sizes containing 1, 5 or 10 vials.

Only certain pack sizes may be marketed.

Marketing Authorization 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

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Saniproject, S.L.

C/ Retamas 11 – Urb. Puentelasierra

28210 Valdemorillo, Madrid

SPAIN

Date of the most recent review of this product information: November 2021