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PALONOSETRON INRESA 250 MICROGRAMS SOLUTION FOR INJECTION

Active substance(s): PALONOSETRON HYDROCHLORIDE

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Package leaflet: Information for the patient

Palonosetron 250 micrograms
solution for injection
Palonosetron (as hydrochloride)
 ead all of this leaflet carefully before you start taking this medicine because it contains
R
important information for you.
n Keep this leaflet. You may need to read it again.
n If you have any further questions, ask your doctor, pharmacist or nurse.
n This medicine has been prescribed for you only. Do not pass it on to others.
It may harm them, even if their signs of illness are the same as yours.
n If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Palonosetron is and what it is used for
2. What you need to know before you use Palonosetron
3. How to use Palonosetron
4. Possible side effects
5. How to store Palonosetron
6. Contents of the pack and other information

1 What Palonosetron is and what it is used for
Palonosetron belongs to a group of medicines known as serotonin (5HT3) antagonists.
These have the ability to block the action of the chemical, serotonin, which can cause nausea
and vomiting.
Palonosetron is used for the prevention of nausea and vomiting associated with cancer
chemotherapy in adult patients.

2 What you need to know before you use Palonosetron
Do not take Palonosetron
n 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 or pharmacist before using Palonosetron
n If you have acute bowel obstruction or a history of repeated constipation.
n If you are using Palonosetron in addition to other medicines that may induce an abnormal
heart rhythm such as amiodarone, nicardipine, quinidine, moxifloxacin, erythromycin,
haloperidol, chlorpromazine, quetiapine, thioridazine, domperidone.
n If you have a personal or family history of alterations in heart rhythm (QT prolongation).
n If you have other heart problems.
n If you have an imbalance of certain minerals in your blood such as potassium and magnesium
which has not been treated.
It is not recommended to take Palonosetron in the days following chemotherapy unless you are
receiving another chemotherapy cycle.
Other medicines and Palonosetron
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines, including:
SSRIs (selective serotonin reuptake inhibitors) used to treat depression and/or anxiety including
fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram;
SNRIs (serotonin noradrenaline reuptake inhibitors) used to treat depression and/or anxiety
including venlafaxine, duloxetine.
Pregnancy
If you are pregnant or think you might be, your doctor will not administer Palonosetron to you
unless it is clearly necessary.
It is not known whether Palonosetron will cause any harmful effects when used
during pregnancy.
Ask your doctor or pharmacist for advice before using any medicine if you are pregnant or
think you might be.
Breast-feeding
It is not known if Palonosetron is found in breast milk.
Ask your doctor or pharmacist for advice before using Palonosetron if you are breast-feeding.
Driving and using machines
Palonosetron may cause dizziness or tiredness. If affected, do not drive or use any
tools or machines.
Palonosetron contains less than 1 mmol sodium (23 mg) per vial.

3 How to use Palonosetron
A doctor or nurse will normally inject Palonosetron about 30 minutes before the start
of chemotherapy.
Adults
The recommended dose of Palonosetron is 250 micrograms given as a rapid injection
into a vein.
Children and Adolescents (ages 1 month to 17 years)
If you have any further questions on the use of this medicine, ask your doctor.

4 Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The frequency of possible side effects listed below is defined using the following convention:
very common (may affect more than 1 in 10 people); common (may affect up to 1 in 10 people );
uncommon (may affect up to 1 in 100 people ); rare (may affect up to 1 in 1,000 people);
very rare (may affect up to 1 in 10,000 people); not known (frequency cannot be estimated from
the available data).

Common side effects
n headache
n dizziness
n constipation
n diarrhoea
Uncommon side effects
n high or low blood pressure
n abnormal heart rate or lack of blood flow to the heart
n change in the colour of the vein and/or veins becoming larger
n abnormally high or low levels of potassium in the blood
n high levels of sugar in the blood or sugar in the urine
n low levels of calcium in the blood
n high levels of the pigment bilirubin in the blood
n high levels of certain liver enzymes
n elevated moods or feelings of anxiousness
n sleepiness or trouble sleeping
n decrease or loss of appetite
n weakness, tiredness, fever or flu like symptoms
n numbness, burning, prickling or tingling sensations on the skin
n itchy skin rash
n impaired vision or eye irritation
n motion sickness
n ringing in the ear
n hiccups, flatulence, dry mouth or indigestion
n abdominal (stomach) pain
n difficulty urinating
n joint pain
n electrocardiogram abnormalities (QT prolongation)
Very rare side effects
Allergic reactions to Palonosetron
The signs may include swelling of the lips, face, tongue or throat, having difficulty breathing or
collapsing, you could also notice an itchy, lumpy rash (hives) burning or pain at the site of injection
Children and Adolescents:
Common
n headache
Uncommon
n dizziness
n jerky body movements
n abnormal heart rate
n coughing or shortness of breath
n nosebleed
n itchy skin rash or hives
n fever
n pain at site of infusion
Reporting of side effects
If you get 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 United Kingdom
Yellow Card Scheme.
Website: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.

5 How to store Palonosetron
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 vial and carton after ‘EXP’.
The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Do not use Palonosetron if you notice discolouration, cloudiness or particles, it should be a clear,
colourless solution.
Single use only, any unused solution should be disposed of.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how
to throw away medicines you no longer use. These measures will help protect the environment.

6 Contents of the pack and other information
What Palonosetron contains
n The

active substance is Palonosetron (as hydrochloride).
Each ml of solution contains 50 micrograms Palonosetron. Each vial of 5ml of solution contains
250 micrograms of Palonosetron.
n The

other ingredients are mannitol (E421), disodium edetate, sodium citrate (E331), citric acid
monohydrate (E330), and water for injections, sodium hydroxide and hydrochloric acid (E507).

What Palonosetron looks like and contents of the pack
Palonosetron solution for injection is a clear, colourless solution, free from visible particles with a
pH of 4.5 – 5.5 and is supplied in a pack of one Type I glass vial with grey rubber stopper and
aluminium cap, which contains 5ml of the solution. Each vial contains one dose.
Available in packs of 1 vial containing 5ml of solution.
Marketing Authorisation Holder and Manufacturer
The marketing authorisation holder is
Inresa Arzneimittel GmbH
Obere Hardtstraße 18
79114 Freiburg
Germany
The manufacturer is
Haupt Pharma Wolfratshausen GmbH
Pfaffenrieder Straße 5
82515 Wolfratshausen
Germany
This leaflet was last revised in 01/2015.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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