Aloxi 500 micrograms soft capsules

Do not take Aloxi

• If you are allergic to the active substance or any of the other ingredients of Aloxi (for a full list of the ingredients, see section 6 ?Further information?).

Take special care with Aloxi

• If you have acute bowel obstruction or a history of repeated constipation.
• If you are taking 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).

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

Using other medicines

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Taking 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.

Important information about some of the ingredients of Aloxi

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).

A doctor or nurse will normally give you Aloxi capsules about 60 minutes before the start of chemotherapy.

The usual 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, as your dose will be given to you by a doctor or nurse. 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.

Like all medicines, Aloxi 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 (affects more than 1 user in 10); common (affects 1 to 10 users in 100); uncommon (affects 1 to 10 users in 1,000); rare (affects 1 to 10 users in 10,000); very rare (affects less than 1 user in 10,000); not known (frequency cannot be estimated from the available data).

Common side effect:
headache

Uncommon side effects:
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 side effect:
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.

If any of the side effects gets serious or if you notice any side effects not listed in this leaflet, please tell your doctor.

Keep out of the reach and sight of children.
Do not use Aloxi 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.

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 approved in