PACKAGE LEAFLET: INFORMATION FOR THE USER Q ProStfakatl

Xomolix® 2.5 mg/ml solution for injection (Droperidol)

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 nurse.

•    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    If you get any side effects, talk to your doctor, nurse or pharmacist.

This includes side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.    What Xomolix is and what it is used for

2.    What you need to know before you are given Xomolix

3.    How you will be given Xomolix

4.    Possible side effects

5.    How to store Xomolix

6.    Contents of the pack and other information

1.    What Xomolix is and what it is used for

Xomolix is a solution of droperidol for injection, which is used to prevent you feeling sick (nausea) or vomiting when you wake up after an operation or when you receive morphine based painkillers after an operation.

The active substance in Xomolix is droperidol. Droperidol belongs to a group of antipsychotics called butyrophenone derivatives.

2.    What you need to know before you are given Xomolix You should not be given Xomolix if you:

•    are allergic (hypersensitive) to the active ingredient droperidol, or any of the other ingredients in Xomolix. (A list of these can be found in Section 6 of this leaflet.)

•    are allergic to a group of medicines used to treat psychiatric disorders, called butyrophenones (e.g. haloperidol, triperidol, benperidol, melperone, domperidone)

•    or anyone in your family have an abnormal electrocardiogram (ECG) heart tracing

•    have low levels of potassium or magnesium in your blood

•    have a pulse rate of less than 55 beats per minute (the doctor or nurse will check this), or are taking any medicines that could cause this to happen

•    have a tumour in your adrenal gland (phaeochromocytoma)

•    are in a coma

•    have Parkinson’s disease

•    have severe depression

Take special care with Xomolix

Before you are given Xomolix injection, you should tell your doctor or nurse if you:

•    have epilepsy, or a history of epilepsy

•    have any heart problems or if you have any history of heart problems

•    have a family history of sudden death

•    have kidney problems (especially if you are on long-term dialysis)

•    have lung disease and any breathing difficulties

•    have prolonged sickness or diarrhoea

•    are taking insulin

•    are taking potassium-wasting diuretics i.e. water tablets (e.g. furosemide or bendroflumethiazide)

•    are taking laxatives

•    are taking glucocorticoids (a type of steroid hormone)

•    If you or someone else in your family has a history of blood clots, as medicines like these have been associated with formation of blood clots

•    are or have been a heavy drinker (of alcohol).

Other medicines and Xomolix

Always tell your doctor or nurse if you are taking or have recently taken any other medicines including those you have obtained without a prescription, as a number of medicines cannot be mixed with droperidol.

Do not take Xomolix if you are taking any of the following medicines:

What the medicine is used for	Medicine (s)
Heart Conditions	Quinidine, disopyramide, procainamide, amiodarone or sotalol
Antibiotics	Erythromycin, clarithromycin, sparfloxacin
Allergies	Astemizole, terfenadine
Mental illnesses e.g. schizophrenia etc.	Chlorpromazine, haloperidol, pimozide, thioridazine
Malaria	Chloroquine, halofantrine
Heartburn	Cisapride
Infection	Pentamidine
Nausea (feeling sick) or vomiting	Domperidone
Opiod dependence; pain	Methadone

Metoclopramide and other neuroleptics should be avoided when taking Xomolix since the risk of movement disorders induced by these medicines is increased.

Droperidol, the active ingredient in Xomolix, can increase the effects of sedatives such as barbiturates, benzodiazepines and morphine based products. It can also increase the effects of medication used to lower high blood pressure (antihypertensives) and a number of other medicines e.g. certain antifungals, antivirals, and antibiotics. Some medicines may also increase the effects of droperidol e.g. cimetidine (for gastric ulcers), ticlopidine (to prevent blood-clotting) and mibefradil (for angina). If you are in any doubt please talk to your doctor or nurse.

Xomolix with food and alcohol

Avoid drinking any alcohol for 24 hours before and after being given Xomolix.

Pregnancy, breast-feeding and fertility

If you are pregnant, inform your doctor who will decide if you should receive Xomolix.

If you are breast-feeding and are going to take Xomolix then it is recommended that you receive only one administration of Xomolix. Breast-feeding can be resumed on waking after your operation.

Ask your doctor for advice before taking any medicine.

Driving and using machines

Droperidol has a major effect on the ability to drive and use machines.

Do not drive or use machinery for at least 24 hours after taking Xomolix.

Xomolix contains sodium

This medicinal product contains less than 1 mmol sodium (23 mg) per 1ml, i.e. essentially ‘sodium-free’.

3. How you will be given Xomolix

Xomolix will be given to you by your doctor by an injection into a vein.

The amount of Xomolix and the way in which it is given will depend on the situation. Your doctor will determine how much Xomolix you need based on a number of things including your weight, age and medical condition.

The usual adult dosage is 0.625 to 1.25 mg, reduced to 0.625 mg for the elderly (over 65 years) and those with renal and hepatic impairment. The dosage in children (2 to 11 years) and adolescents (12 to 18 years) is based on their body weight (10 to 50 microgram/kg) but up to a maximum of 1.25 mg. Xomolix is not recommended in children below 2 years.

If you have any further questions on the use of this product, please ask your doctor or nurse.