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PALONOSETRON HYDROCHLORIDE 250 MICROGRAMS SOLUTION FOR INJECTION

Active substance(s): PALONOSETRON HYDROCHLORIDE

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Package leaflet: Information for the patient

Palonosetron hydrochloride 250 micrograms solution for injection
Palonosetron

Read all of this leaflet carefully before
you start using this medicine 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 or pharmacist.
• 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.
• If you get any side effects, talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this leaflet.
See section 4.
What is in this leaflet
1. What Palonosetron hydrochloride is and
what it is used for
2. What you need to know before you use
Palonosetron hydrochloride
3. How to use Palonosetron hydrochloride
4. Possible side effects
5. How to store Palonosetron hydrochloride
6. Contents of the pack and other information

1. What Palonosetron hydrochloride
is and what it is used for
Palonosetron belongs to a group of medicines
known as serotonin (5HT3) antagonists.

It is not recommended to take Palonosetron in
the days following chemotherapy unless you
are receiving another chemotherapy cycle.

Other medicines and Palonosetron
hydrochloride
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.

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

Driving and using machines
Palonosetron may cause dizziness or
tiredness. If affected, do not drive or use any
tools or machines.

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

Palonosetron hydrochloride contains less
than 1 mmol sodium (23 mg) per vial, i.e.
essentially ‘sodium-free’.

2. What you need to know before you
use Palonosetron

3. How to use Palonosetron
hydrochloride

Do not use Palonosetron:
−− If you are allergic to palonosetron or any
of the other ingredients of this medicine
(listed in section 6).

A doctor or nurse will normally inject
Palonosetron hydrochloride about 30 minutes
before the start of chemotherapy.

Warnings and precautions:
−− Talk to your doctor or pharmacist before
using Palonosetron
−− If you have acute bowel obstruction or a
history of repeated constipation.
−− 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.
−− If you have a personal or family history
of alterations in heart rhythm (QT
prolongation).
−− If you have other heart problems.
−− If you have an imbalance of certain
minerals in your blood such as potassium
and magnesium which has not been
treated.

Adults
The recommended dose of Palonosetron
hydrochloride is 250 micrograms given as a
rapid injection into a vein.
Children and Adolescents (aged 1 month
to 17 years)
The doctor will decide the dose, depending
on bodyweight; however the maximum does is
1500 micrograms.
Palonosetron will be given as a slow infusion
into a vein.
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.

Possible side effects and their frequencies are
listed below:

5. How to store Palonosetron
hydrochloride

Adults

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

Common (may affect up to 1 in 10 people)
• headache, dizziness, constipation and
diarrhoea.
Uncommon (may affect up to 1 in 100 people)
• high or low blood pressure
• abnormal heart rate or lack of blood flow to
the heart
• change in the colour of the vein and/or
veins becoming larger
• 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
• elevated moods or feelings of anxiousness
• sleepiness or trouble sleeping
• decrease or loss of appetite
• weakness, tiredness, fever or flu like
symptoms
• numbness, burning, prickling or tingling
sensations on the skin
• itchy skin rash
• impaired vision or eye irritation
• motion sickness
• ringing in the ear
• hiccups, flatulence, dry mouth or
indigestion
• abdominal (stomach) pain
• difficulty urinating
• joint pain
• electrocardiogram abnormalities (QT
prolongation)
Very rare (may affect up to 1 in 10,000 people)
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
itchy, lumpy rash (hives), burning or pain at
the site of injection.
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
• abnormal heart rate
• coughing or shortness of breath
• nosebleed
• itchy skin rash or hives
• fever
• pain at the site of infusion
Reporting of side effects
If you get any side effects, talk to your doctor
or nurse. This includes any side effects not
listed in this leaflet. You can also report side
effects directly via 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.

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.
Keep the vial in the outer carton in order to
protect from light.
Single use only, any unused solution should
be disposed of.

6. Contents of the pack and other
information
What Palonosetron hydrochloride contains
• The active substance is palonosetron (as
hydrochloride).
Each ml of solution contains 50
micrograms palonosetron. Each vial of 5 ml
of solution contains 250
micrograms of palonosetron.
• The other ingredients are mannitol, sodium
citrate, citric acid monohydrate and water
for injections.
What Palonosetron hydrochloride looks
like and contents of the pack
Palonosetron hydrochloride solution for
injection is a clear, colourless solution and is
supplied in a pack of one 6 ml Type I glass
vial with brominized butyl rubber stopper
and a 20 mm aluminium-plastic seal flip cap,
which contains 5 ml of the solution. Each vial
contains one dose.
Available in packs of 1 vial containing 5 ml of
solution.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
QILU PHARMA SPAIN S.L.U,
Paseo de la Castellana 40,
8, Madrid, 28046,
Spain
Manufacturer
Wave Pharma Limited
4th Floor, Cavendish House,
369 Burnt Oak Broadway,
Edgware, HA8 5AW,
United Kingdom
Kymos Pharma Services, S.L.
Ronda de Can Fatjó,
7B (Parque Tecnológico del Vallès),
Cerdanyola del Vallès, 08290
Barcelona, Spain
This leaflet was last revised in 05/2016.

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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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