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Aloxi (palonosetron hydrochloride) – Package leaflet - A04AA05

Updated on site: 05-Oct-2017

Medication nameAloxi
ATC CodeA04AA05
Substancepalonosetron hydrochloride
ManufacturerHelsinn Birex Pharmaceuticals Ltd.

Package leaflet: Information for the user

Aloxi 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.

-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 Aloxi is and what it is used for

2.What you need to know before you use Aloxi

3.How to use Aloxi

4.Possible side effects

5.How to store Aloxi

6.Contents of the pack and other information

1.What Aloxi is and what it is used for

Aloxi 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.

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

2. What you need to know before you use Aloxi

Do not use Aloxi:

-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 Aloxi

-If you have acute bowel obstruction or a history of repeated constipation.

-If you are using Aloxi 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 Aloxi in the days following chemotherapy unless you are receiving another chemotherapy cycle.

Other medicines and Aloxi

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 Aloxi to you unless it is clearly necessary.

It is not known whether Aloxi 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 Aloxi is found in breast milk.

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

Driving and using machines

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

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

3.How to use Aloxi

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

Adults

The recommended dose of Aloxi 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 dose is 1500 micrograms.

Aloxi 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:

Adults

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 Aloxi.

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 (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. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5.How to store Aloxi

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 medicine does not require any special storage conditions. Single use only, any unused solution should be disposed of.

6. Contents of the pack and other information

What Aloxi 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, disodium edetate, sodium citrate, citric acid monohydrate, and water for injections, sodium hydroxide and hydrochloric acid.

What Aloxi looks like and contents of the pack

Aloxi solution for injection is a clear, colourless solution and is supplied in a pack of one Type I glass vial with chlorobutyl siliconised rubber stopper and aluminium 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

Helsinn Birex Pharmaceuticals Ltd.,

Damastown,

Mulhuddart,

Dublin 15,

Ireland.

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu

Package leaflet: Information for the user

Aloxi 500 micrograms soft capsules

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 Aloxi is and what it is used for

2.What you need to know before you use Aloxi

3.How to use Aloxi

4.Possible side effects

5.How to store Aloxi

6.Contents of the pack and other information

1. What Aloxi is and what it is used for

Aloxi 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.

Aloxi 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 Aloxi

Do not use Aloxi:

-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 taking Aloxi

-If you have acute bowel obstruction or a history of repeated constipation.

-If you are using Aloxi 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 Aloxi in the days following chemotherapy unless you are receiving another chemotherapy cycle.

Children

This medicinal product is not recommended for use in children.

Other medicines and Aloxi

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.

Aloxi with food and drink

Aloxi can be taken with or without food.

Pregnancy

If you are pregnant or think you might be, your doctor will not use Aloxi unless it is clearly necessary. It is not known whether Aloxi 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 Aloxi is found in breast milk.

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

Driving and using machines

Aloxi may cause dizziness or tiredness. If affected, do not drive or operate machines.

Aloxi contains sorbitol (E420).

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

This medicine may contain a trace of lecithin which is derived from soya. If you are allergic to peanut or soya, see your doctor straight away if you notice any signs of an allergic reaction. 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).

3. How to use Aloxi

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

You will normally take Aloxi capsules about 60 minutes before the start of chemotherapy.

The recommended dose is one capsule (500 micrograms) of Aloxi, taken with or without food.

If you take more Aloxi than you should

The usual dose is one Aloxi capsule. If you think you may have taken more Aloxi than you should, inform your doctor immediately.

If you forget to take Aloxi

It is unlikely that you will forget to take Aloxi, however, if you think you have forgotten to take your dose, tell your doctor immediately.

If you stop taking Aloxi

Aloxi is taken to prevent nausea and vomiting caused by chemotherapy. If you do not wish to receive Aloxi, you should discuss this fully with your doctor. If you decide not to take Aloxi (or other similar medicine), you can expect your chemotherapy to cause you to feel nauseous and/or vomit.

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.

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

Uncommon (may affect up to 1 in 100 people):

trouble sleeping shortness of breath eye swelling

abnormal electrical impulses in the heart constipation

nausea

high levels of the pigment bilirubin (a marker of liver problems) in the blood muscle pain

Very rare (may affect up to 1 in 10,000 people): allergic reaction

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). See your doctor straight away if you notice any of these signs of allergic reaction.

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 national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Aloxi

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 blister and carton after “EXP”. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

6. Contents of the pack and other information

What Aloxi contains

-The active substance is palonosetron.

Each capsule contains 500 micrograms palonosetron (as hydrochloride).

-The other ingredients are mono/diglycerides of caprylic/capric acid, polyglycerol oleate, glycerol, purified water, butylhydroxyanisole (BHA), gelatin, sorbitol (E420), titanium dioxide (E171), iron oxide black (E172), polyvinyl acetate phthalate and macrogol 400.

What Aloxi looks like and contents of the pack

Aloxi 500 micrograms soft capsules are light beige, opaque, oval, imprinted with black logo “AlO” and filled with a clear yellowish solution. They are supplied in polyamide/aluminium/PVC blisters containing one or five capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Helsinn Birex Pharmaceuticals Ltd.,

Damastown,

Mulhuddart,

Dublin 15,

Ireland.

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu

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