Label: information for the patient

Palonosetron Accord 250 micrograms injectable solution EFG

palonosetron

Read this label carefully before this medicine is administered to you, because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist or nurse.
• If you experience any adverse effects, consult your doctor or pharmacist or nurse, even if they are not listed in this label. See section 4

Palonosetron Accord belongs to a group of medicines known as serotonin (5HT3antagonists.

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

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

No use Palonosetron Accord:

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

Warnings and Precautions

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

• If you have an acute intestinal obstruction or a history of repeated constipation.
• If you are using Palonosetron Accord with other medications that may cause 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 alterations (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 the days following chemotherapy, unless it is for another cycle of chemotherapy.

Use of Palonosetron Accord with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, including:

The selective serotonin reuptake inhibitors (SSRIs) used to treat depression and/or anxiety, such as fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, and escitalopram; the SNRIs (serotonin and norepinephrine reuptake inhibitors) 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 unless it is clearly necessary.

The effects of Palonosetron Accord on pregnancy are unknown.

Consult your doctor or pharmacist before using any medication if you are pregnant or think you may be pregnant.

Breastfeeding

The presence of Palonosetron Accord in breast milk is unknown.

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

Driving and operating machinery

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

Palonosetron Accord contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per vial, making it essentially "sodium-free".

Normally, a doctor or nurse will inject Palonosetron Accord 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 (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 other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

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

Adults

Common

may affect up to 1 in 10 people

• headache
• dizziness
• constipation and diarrhea.

Uncommon

may affect up to 1 in 100 people

• high or low blood pressure
• abnormal heart rhythm or reduced 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 difficulty sleeping
• decreased or loss of appetite
• weakness, fatigue, fever, or flu-like symptoms
• numbness, burning, itching, or tingling sensation in the skin
• exanthema with itching
• vision changes or eye irritation
• movement disorder
• tinnitus
• hiccups, flatulence, dry mouth, or indigestion
• abdominal pain (stomach)
• difficulty urinating
• joint pain
• electrocardiogram anomalies (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, skin rash with hives (urticaria), burning, or pain 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
• muscle spasms
• abnormal heart rhythm
• cough or shortness of breath
• nosebleed
• exanthema with itching or urticaria
• fever
• pain at the infusion site

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the national notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and vial after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

For single use, discard any remaining solution.

Composition of Palonosetron Accord

• The active ingredient is palonosetron (as chlorhydrate).

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

• The other components are mannitol, disodium edetate, sodium citrate, citric acid monohydrate, sodium hydroxide (to adjust pH), concentrated hydrochloric acid (to adjust pH) and water for injection preparations. (See section 2 Palonosetron Accord contains sodium)

Appearance of the product and contents of the container

Palonosetron Accord injectable solution is a transparent and colorless solution and is presented in a container of a 6 ml glass vial with a chlorobutyl rubber stopper and sealed with a detachable aluminum seal. Each vial contains a dose.

Container size: one vial.

Marketing Authorization Holder

Accord Healthcare S.L.U.

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

Edifici Est 6th floor,

08039 Barcelona,

Spain

Manufacturers responsible

Accord Healthcare B.V.,

Winthontlaan 200,

3526 KV Utrecht,

Netherlands

Accord Healthcare Polska Sp.z o.o.,

ul. Lutomierska 50,95-200 Pabianice, Poland

Last review date of this leaflet:

Other sources of information

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