Palonosetron Macure

Document: Palonosetron Macure solution for injection ENG PL change

Package leaflet: Information for the user

Palonosetron Macure 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, pharmacist or nurse.

- 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 or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

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

2. What you need to know before you use Palonosetron Macure

3. How to use Palonosetron Macure

4. Possible side effects

5. How to store Palonosetron Macure

6. Contents of the pack and other information

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

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

2. What you need to know before you use Palonosetron Macure

Do not use Palonosetron Macure:

- 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 Macure:

If you have acute bowel obstruction or a history of repeated constipation.
If you are using Palonosetron Macure 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.

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

Other medicines and Palonosetron Macure

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 and breast-feeding

Pregnancy

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

It is not known whether Palonosetron Macure 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 Macure is found in breast milk.

Ask your doctor or pharmacist for advice before using Palonosetron Macure if you are breast-feeding.

Driving and using machines

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

This medicinal product contains 0.20mmol (or 4.65mg) sodium per dose (up to 1.2mmol or 27.9mg for the highest dose). To be taken into consideration by patients on a controlled sodium diet.

3. How to use Palonosetron Macure

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

Adults

The recommended dose of Palonosetron Macure is 250 micrograms given as a rapid injection into a vein.

Use in children and Adolescents (aged 1 month to 17 years)

The doctor will decide the dose, depending on bodyweight, however the maximum dose is 1500 micrograms.

Palonosetron Macure 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.

The following side effects were reported in adults:

Common side effects (may affect up to 1 in 10 people):

headache, dizziness, constipation and diarrhoea.

Uncommon side effects (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 color 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 side effects (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 an itchy, lumpy rash (hives)),
Burning or pain at the site of injection.

The following side effects were reported in children:

Common side effects (may affect up to 1 in 10 people):

headache

Uncommon side effects (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 possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system to:

[To be completed nationally]

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Palonosetron Macure

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 ampoule and carton after ‘EXP’. The expiry date refers to the last day of that month.

This medicinal product does not require any special temperature storage conditions. Store in the original package, in order to protect from light.

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 Macure contains

- The active substance is palonosetron (as hydrochloride). Each ml of solution contains 50 micrograms palonosetron. Each ampoule of 5 ml 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), water for injections.

What Palonosetron Macure looks like and contents of the pack

Palonosetron Macure solution for injection is a clear, colourless solution and is supplied in clear glass ampoules of 5 ml filling capacity.

Carton box of 1, 5, 10 ampoules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

[To be completed nationally]

This leaflet was last revised in 20 April 2016