Xomolix (Droperidol)

Xomolix 2.5 mg/ml solution for injection (Droperidol)

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.

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.
• 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)

Taking other medicines

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	Azithromycin, erythromycin, clarithromycin, sparfloxacin
Allergies	Astemizole, terfenadine
Depression	Amitriptyline, maprotiline, fluoxetine, sertraline, fluvoxamine
Mental illness e.g. schizophrenia etc.	Amisulpride, chlorpromazine, haloperidol, melperone, phenothiazines, pimozide, sulpiride, sertindole, tiapride
Malaria	Quinine, chloroquine, halofantrine
Heartburn	Cisapride
Infection	Pentamidine
Control of the immune system	Tacrolimus
Breast cancer	Tamoxifen
Increases blood flow to the brain	Vincamine
Nausea (feeling sick) or vomiting	Metoclopramide

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.

Taking Xomolix with food and drink

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

Pregnancy and breast-feeding

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.

Important information about some of the ingredients of Xomolix

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

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.

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

Possible side effects

Like all medicines, Xomolix can cause side effects, although not everybody gets them.

Contact your doctor immediately if you experience any increase in your body temperature, muscle stiffness, tremor, rapid swelling of the face or throat, or if you get chest pains after having this medicine.

The following side effects have also been reported: If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist.

Common side effects

(likely to affect less than 1 in 10 people and more than 1 in)

• Drowsiness
• Low blood pressure

Uncommon side effects

(likely to affect less than 1 in 100 people and more than 1 in 1,000)

• Anxiety
• Rolling of the eyes
• Fast heartbeat e.g. more than 100 beats per minute
• Dizziness

Rare side effects

(likely to affect less than 1 in 1,000 people and more than 1 in 10,000)

• Serious allergic reaction known as anaphylaxis or anaphylactic shock
• Confusion
• Agitation
• Irregular heartbeat
• Rash
• Neuroleptic malignant syndrome, symptoms include fever, sweating, salivation, muscle stiffness and tremors

Very rare side effects

(likely to affect less than 1 in 10,000 people)

• Blood disorders (usually diseases affecting red blood cells or platelets).
• Your doctor can advise you.
• Change in mood towards sadness, anxiety, depression and irritability
• Involuntary muscle movements
• Convulsions or tremors
• Heart attack (cardiac arrest)
• Sudden death

Other side effects which may occur are

• Inappropriate anti-diuretic hormone secretion (too much of the hormone is released leading to excess water and low sodium levels in the body)
• Hallucinations
• Epileptic seizures
• Parkinson’s disease
• Psychomotor hyperactivity
• Coma
• Torsade de pointes (life-threatening irregular heartbeat)
• Prolonged QT interval in ECG (a heart condition affecting the heartbeat)
• Fainting
• Breathing difficulties.

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

How to store Xomolix

Keep out of the reach and sight of children.

Do not use Xomolix after the expiry date which is stated on the carton and ampoule after Exp. The expiry date refers to the last day of that month.

In order to protect from light, store in the original package.

The solution should be used immediately on first opening.

Compatibility of droperidol with morphine sulphate in 0.9% sodium chloride (14 days at room temperature) has been demonstrated in plastic syringes. From a microbiological point of view, the diluted product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.

Do not use Xomolix if you notice signs of deterioration. The product should be visually inspected prior to use and only clear solutions practically free from particles should be used.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further information

What Xomolix contains

The active substance is droperidol, each millilitre of solution contains 2.5mg droperidol.

The other ingredients are mannitol, tartaric acid, sodium hydroxide, water for injections.

What Xomolix looks like and contents of the pack

Xomolix is a clear, colourless solution for injection.

The solution is contained in amber coloured glass ampoules. Each ampoule contains 1 millilitre of solution and packaged in cartons containing either 5 or 10 ampoules. Not all pack sizes may be marketed.

This medicinal product is authorised in the Member States of the EEA under the following names: Xomolix

Austria, Belgium, Czech Republic, Denmark, Greece, Spain, Finland, Hungary, Ireland, Italy, Poland, Portugal, Slovenia, Slovak Republic, UK.