Palonosetron Fresenius 250 microgram/5 ml Solution

Palonosetron belongs to a group of medicines known as serotonin (5-HT 3 ) antagonists. These have the ability to block the action of the chemical serotonin, which can cause nausea and vomiting.

PALONOSETRON FRESENIUS is used for the prevention of nausea and vomiting associated with cancer chemotherapy.

PALONOSETRON FRESENIUS should not be administered to you:

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

Warnings and precautions

Tell your doctor or healthcare provider before being given PALONOSETRON FRESENIUS:

Special care should be taken with PALONOSETRON FRESENIUS:

• If you have acute bowel obstruction or a history of repeated constipation.
• If you are using PALONOSETRON FRESENIUS in addition to other medicines that may induce an abnormal heart rhythm such as amiodarone (used to treat and prevent heart rhythm disorders), quinidine (used to treat heart rhythm disorders), haloperidol (used to treat mental disorders), chlorpromazine (used to treat schizophrenia (a serious mental disorder)), domperidone (used for nausea and vomiting).
• 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 low potassium and low magnesium which has not been treated.

It is not recommended to receive PALONOSETRON FRESENIUS in the days following chemotherapy unless you are receiving another chemotherapy cycle.

You may develop serotonin syndrome. This occurs when you take or receive medicines such as PALONOSETRON FRESENIUS that cause high levels of the chemical serotonin to accumulate in your body. Severe serotonin syndrome can cause death if not treated. The risk is higher if you also take other medicines that cause serotonin to be liberated (such as those often used to treat migraines and depression). See “Other medicines and PALONOSETRON FRESENIUS”).

You may have severe constipation and complications due to constipation such as inability to pass stools, tears in the skin around the anus and incomplete urination. Tell your doctor if you suffer from constipation or have abdominal pain and problems passing a stool.

Children and adolescents

PALONOSETRON FRESENIUS is currently not recommended in patients under 18 years of age, as there is not adequate information on its use in children and adolescents.

Other medicines and PALONOSETRON FRESENIUS

Always tell your healthcare provider if you are taking any other medicine. (This includes complementary or traditional medicines.)

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. These medicines strengthen the effect of palonosetron on serotonin levels and increase the risk of serotonin syndrome (see “Warnings and precautions”);
• SNRIs (serotonin noradrenaline reuptake inhibitors) used to treat depression and/or anxiety including venlafaxine, duloxetine. These medicines strengthen the effect of palonosetron on serotonin levels and increase the risk of serotonin syndrome (see “Warnings and precautions”);
• medicines for nausea/vomiting (such as ondansetron, metoclopramide). These medicines may strengthen the effect of PALONOSETRON FRESENIUS on serotonin levels and increase the risk of serotonin syndrome (see “Warnings and precautions”);
• medicines for migraine (such as sumatriptan). These medicines strengthen the effect of PALONOSETRON FRESENIUS on serotonin levels and increase the risk of serotonin syndrome (see “Warnings and precautions”);
• medicines to control you heart beat (anti-arrhythmics) such as amiodarone, quinidine;
• medicines for serious mental health problems such as haloperidol, chlorpromazine;
• anti-cancer medicines such as cisplatin, cyclophosphamide, cytarabine, doxorubicin and mitomycin C.

Pregnancy, breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, please consult your doctor, pharmacist or other healthcare provider for advice before PALONOSETRON FRESENIUS is administered to you.

It is not known whether PALONOSETRON FRESENIUS will cause any harmful effects when used during pregnancy. You should therefore not receive PALONOSETRON FRESENIUS if you are pregnant.

It is not known if PALONOSETRON FRESENIUS is found in breast milk. You should therefore not breastfeed your baby if you receive PALONOSETRON FRESENIUS.

Driving and using machines

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

PALONOSETRON FRESENIUS contains sodium

PALONOSETRON FRESENIUS contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodium-free’.

You will not be expected to give yourself PALONOSETRON FRESENIUS. It will be given to you by a person who is qualified to do so.

Adults

A doctor or nurse will normally inject PALONOSETRON FRESENIUS about 30 minutes before the start of chemotherapy. The recommended dose of PALONOSETRON FRESENIUS is a 250 micrograms (5 mL) single-dose, given as a rapid injection into a vein.

If you have any further questions on the use of this medicine, ask your doctor.

If you use more PALONOSETRON FRESENIUS than you should

Since a healthcare provider will administer PALONOSETRON FRESENIUS, he/she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage.

If you forget to use PALONOSETRON FRESENIUS

Since a healthcare provider will administer PALONOSETRON FRESENIUS, it is unlikely that the dose will be missed.

PALONOSETRON FRESENIUS can have side effects. Not all side effects reported for PALONOSETRON FRESENIUS are included in this leaflet. Should your general health worsen or if you experience any untoward effects while receiving PALONOSETRON FRESENIUS, please consult your healthcare provider for advice.

If any of the following happens, tell your doctor or nurse immediately:

• 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. These are all very serious side effects. If you have them, you may have had a serious reaction to PALONOSETRON FRESENIUS. You may need urgent medical attention or hospitalisation.

Tell your doctor if you notice any of the following:

Frequent side effects:

• headache,
• dizziness,
• constipation and diarrhoea.

Less frequent side effects:

• abnormal heart rate or lack of blood flow to the heart,
• electrocardiogram abnormalities (QT prolongation).
• high or low blood pressure,
• 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,
• decrease or loss of appetite,
• elevated moods or feelings of anxiousness,
• sleepiness or trouble sleeping,
• numbness, burning, prickling or tingling sensations on the skin,
• impaired vision or eye irritation,
• ringing in the ear,
• motion sickness,
• hiccups, flatulence, dry mouth or indigestion,
• abdominal (stomach) pain,
• itchy skin rash,
• joint pain,
• difficulty urinating,
• weakness, tiredness, fever or flu-like symptoms.

Side effects with unknown frequency:

Injection site reactions (burning, hardening, discomfort and pain).

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of PALONOSETRON FRESENIUS.

Store all medicines out of reach of children. Store at or below 30 °C. Keep the container in the outer carton to protect from light. Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that month. Do not use this medicine if the solution is not clear or has visible particles. This medicine does not require any special storage conditions. Single use only, any unused solution should be disposed of. Return all unused medicine to your pharmacist. Do not dispose of unused medicines in drains or sewerage systems (e.g. toilets). These measures will help protect the environment.