PALONOSETRON ACCORD 250 micrograms Injectable Solution

Introduction

Package Leaflet: Information for the Patient

Palonosetron Accord 250 micrograms solution for injection EFG

palonosetron

Read all of this leaflet carefully before this medicine is administered to you 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, pharmacist, or nurse.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the pack

1. What Palonosetron Accord is and what it is used for
2. What you need to know before Palonosetron Accord is administered to you
3. How Palonosetron Accord is administered
4. Possible side effects
5. Storage of Palonosetron Accord
6. Contents of the pack and further information

1. What Palonosetron Accord is and what it is used for

Palonosetron Accord belongs to a group of medicines called serotonin (5HT3) antagonists.

These medicines have the ability to block the action of a chemical substance called serotonin, which can cause nausea and vomiting.

Palonosetron Accord is used in the prevention of nausea and vomiting associated with anti-cancer chemotherapy in adults, adolescents, and children over one month of age.

2. What you need to know before Palonosetron Accord is administered to you

Do not use Palonosetron Accord:

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

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to use Palonosetron Accord

• if you have an acute obstruction in the intestine or a history of repeated constipation.
• if you are using Palonosetron Accord with other medicines that may cause an abnormal heart rhythm, such as amiodarone, nicardipine, quinidine, moxifloxacin, erythromycin, haloperidol, chlorpromazine, quetiapine, thioridazine, domperidone.
• if you have a personal or family history of heart rhythm disorders (prolongation of the QT interval).
• if you have other heart problems.
• if you have an imbalance of certain minerals in the blood, such as potassium and magnesium, that has not been treated.

It is not recommended to use Palonosetron Accord in the days following chemotherapy, unless it is for another cycle of chemotherapy.

Using Palonosetron Accord with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines, including:

selective serotonin reuptake inhibitors (SSRIs) used to treat depression and/or anxiety, such as fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, and escitalopram; serotonin and noradrenaline reuptake inhibitors (SNRIs) used to treat depression and/or anxiety, such as venlafaxine and duloxetine.

Pregnancy and breastfeeding

Pregnancy

If you are pregnant or think you may be pregnant, your doctor will not administer Palonosetron Accord to you unless it is clearly necessary.

It is not known if Palonosetron Accord causes harmful effects when used during pregnancy.

Talk to your doctor or pharmacist before using any medicine if you are pregnant or think you may be pregnant.

Breastfeeding

It is not known if Palonosetron Accord is found in breast milk.

Talk to your doctor or pharmacist before using Palonosetron Accord if you are breastfeeding.

Driving and using machines

Palonosetron Accord may cause dizziness or fatigue. If it affects you, do not drive or use tools or machines.

Palonosetron Accord contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per vial, so it is considered essentially "sodium-free".

3. How Palonosetron Accord is administered

Normally, a doctor or nurse will inject Palonosetron Accord into you about 30 minutes before the start of chemotherapy.

Adults

The recommended dose of Palonosetron Accord is 250 micrograms 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; however, the maximum dose is 1500 micrograms.

Palonosetron Accord will be administered as a slow infusion into a vein.

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Adults

Frequent

may affect up to 1 in 10 people

• headache
• dizziness
• constipation and diarrhea.

Uncommon

may affect up to 1 in 100 people

• high blood pressure or low blood pressure
• abnormal heart rhythm or lack of blood flow to the heart
• change in the color of the vein and/or enlarged veins
• abnormally high or low levels of potassium 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 the pigment bilirubin in the blood
• high levels of certain liver enzymes
• euphoria or feeling of anxiety
• drowsiness or sleep problems
• decreased or loss of appetite
• weakness, fatigue, fever, or flu-like symptoms
• numbness, burning, itching, or tingling sensation on the skin
• itchy rash
• vision changes or eye irritation
• movement disorders
• ringing in the ears
• hiccups, flatulence, dry mouth, or dyspepsia
• abdominal pain (stomach)
• difficulty urinating
• joint pain
• abnormalities in the electrocardiogram (prolongation of the QT interval)

Rare

may affect up to 1 in 10,000 people

• Allergic reactions to Palonosetron Accord.

The signs may include swelling of the lips, face, tongue, or throat, with difficulty breathing or collapse; you may also notice itching, hives, burning, or pain at the injection site.

Children and adolescents:

Frequent

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
• nasal bleeding
• itchy rash or hives
• fever
• pain at the infusion site

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report them directly through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Palonosetron Accord

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 carton and vial after EXP. The expiry date is the last day of the month shown.

No special storage conditions are required.

For single use, discard any remaining solution.

6. Contents of the pack and further information

Composition of Palonosetron Accord

• 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 ingredients are mannitol, disodium edetate, sodium citrate, citric acid monohydrate, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment), and water for injections. (See section 2 Palonosetron Accord contains sodium)

Appearance and packaging

Palonosetron Accord solution for injection is a clear and colorless solution and is presented in a 6 ml glass vial with a chlorobutyl rubber stopper and sealed with a peelable aluminum seal. Each vial contains one dose.

Pack size: one vial.

Marketing authorisation holder

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n,

Edifici Est 6ª planta,

08039 Barcelona,

Spain

Manufacturers

Accord Healthcare B.V.,

Winthontlaan 200,

3526 KV Utrecht,

Netherlands

Accord Healthcare Polska Sp.z o.o.,

ul. Lutomierska 50, 95-200 Pabianice, Poland

Date of last revision of this leaflet:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.