Palonosetron Accord

Package leaflet: Information for the patient

Palonosetron Accord 250 microgrammes injectable solution

palonosetron
Read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet. See section 4.

Contents of this leaflet:

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

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

Palonosetron Accord belongs to a class of medicines known as serotonin antagonists (5HT ).
These medicines are able to block the action of serotonin, a chemical substance that can cause nausea and vomiting.
Palonosetron Accord is used to prevent nausea and vomiting associated with cytotoxic chemotherapy in adults, adolescents, and children over one month of age.

2. What you need to know before taking Palonosetron Accord

Do not use Palonosetron Accord

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

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Palonosetron Accord

• if you have acute intestinal obstruction or a history of repeated constipation.
• if you are using Palonosetron Accord in combination with other medicines that may cause heart rhythm abnormalities, such as amiodarone, nicardipine, quinidine, moxifloxacin, erythromycin, haloperidol, chlorpromazine, quetiapine, thioridazine, domperidone.
• if you or a family member has a history of heart rhythm disorders (QT prolongation).
• if you have other heart problems.
• if you have an untreated imbalance of certain minerals in the blood, such as potassium or magnesium.

The use of Palonosetron Accord is not recommended in the days following chemotherapy unless you are undergoing another cycle of chemotherapy.
Other medicines and Palonosetron Accord
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including:
Selective serotonin reuptake inhibitors (SSRIs) used to treat depression and/or anxiety, including fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram.
Serotonin-norepinephrine reuptake inhibitors (SNRIs) used to treat depression and/or anxiety, including venlafaxine, duloxetine.
Pregnancy and breastfeeding
Pregnancy
If you are or think you might be pregnant, your doctor will not administer Palonosetron Accord unless absolutely necessary.
It is not known whether Palonosetron Accord may cause harm when used during pregnancy.
Ask your doctor or pharmacist for advice before taking any medicine if you are or think you might be pregnant.
Breast-feeding
It is not known whether Palonosetron Accord passes into breast milk.
Ask your doctor or pharmacist for advice before using Palonosetron Accord while breast-feeding.
Driving and using machines
Palonosetron Accord may cause dizziness or fatigue. If these symptoms occur, do not drive or operate tools or machinery.
Palonosetron Accord contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per vial, i.e., essentially “sodium-free”.

3. How to take Palonosetron Accord

Your doctor or nurse will normally inject Palonosetron Accord approximately 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 1,500 micrograms.
Palonosetron Accord is administered as a slow infusion into a vein.
If you have any questions about the use of this medicine, consult your doctor, pharmacist or nurse.

4. Possible side effects

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

Adults
Common:
may affect up to 1 in 10 people

• headache
• dizziness
• constipation and diarrhoea

Uncommon:
may affect up to 1 in 100 people

• low or high blood pressure
• abnormal heart rate or lack of blood flow to the heart
• change in vein colour and/or swelling of veins
• abnormally high or low potassium levels in the blood
• high blood sugar levels or presence of sugar in urine
• low calcium levels in the blood
• high levels of the pigment bilirubin in the blood
• high levels of certain liver enzymes
• euphoric mood or feelings of anxiety
• drowsiness or difficulty sleeping
• decreased or loss of appetite
• weakness, fatigue, fever or flu-like symptoms
• sensations of numbness, burning, itching or tingling of the skin
• itchy rash
• changes in vision or eye irritation
• motion sickness
• ringing in the ears
• hiccups, flatulence (intestinal gas), dry mouth or indigestion
• abdominal (stomach) pain
• difficulty urinating
• joint pain
• abnormalities in the electrocardiogram (ECG) (QT prolongation)

Very rare:
may affect up to 1 in 10,000 people

• allergic reactions to Palonosetron Accord. Signs may include swelling of the lips, face, tongue or throat, difficulty breathing or collapse. You may also notice a rash with raised lumps and itching (urticaria), or 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
• jerky body movements
• irregular heart rate
• cough or shortness of breath
• nosebleed
• itchy rash or urticaria
• fever
• pain at the infusion site

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system listed in Annex V.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Palonosetron Accord

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and vial after "Exp.". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
For single use only; dispose of any unused solution.

6. Package contents and other information

What Palonosetron Accord contains

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

Description of the appearance of Palonosetron Accord and package contents
Palonosetron Accord injectable solution is a clear, colourless solution supplied in a 6 ml glass vial with a closure consisting of a chlorobutyl rubber stopper and an aluminium flip-off seal. Each vial contains one dose.
Pack: 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,
The Netherlands
Accord Healthcare Polska Sp.z o.o.,
ul. Lutomierska 50, 95-200 Pabianice,
Poland

Other sources of information
More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.