Active ingredient
- droperidol
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 16508/0036.
Xomolix 2.5 mg/ml solution for injection
Package leaflet: Information for the user
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.
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 for injection containing the active substance droperidol, which belongs to a group of antipsychotics called butyrophenone derivatives. Xomolix 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.
2. What you need to know before you are given Xomolix
You should not be given Xomolix if you:
Warnings and precautions
Talk to your doctor or nurse before using Xomolix:
Other medicines and Xomolix
Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines, as a number of medicines cannot be mixed with droperidol.
You should not be given Xomolix if you are taking any of the following medicines since the combination increases the risk of irregular heart beat which may lead to heart attack:
What the medicine is used for Medicine(s)
Class IA and III antiarrhythmics – these are medicines used for heart arrhythmia, irregular heart beats
Antibiotics of the macrolide and fluoroquinolone type – these are medicines used for infection (bacterial)
Anti-malaria medicines – these are medicines used for malaria
Antihistamines – these are medicines used for allergies
Antipsychotics – these are medicines used for mental illness, e.g. schizophrenia
Cisapride – this is a medicine used for heartburn
Pentamidine – this is a medicine used for parasite infestation or fungal infection
Domperidone – this is a medicine used for nausea (feeling sick) or vomiting
Methadone – this is a medication used for opioid dependence; pain
Metoclopramide and other neuroleptics should be avoided when taking Xomolix since the risk of movement disorders induced by these medicines is increased.
Other medicines that may affect or be affected when used concomitantly with Xomolix.
Droperidol, the active substance in Xomolix:
You should talk to your doctor or nurse if you are taking any of these medicines.
Xomolix with 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.
The following symptoms may occur in newborn babies, of mothers that have used Xomolix in the last trimester (last three months of their pregnancy): shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding. If your baby develops any of these symptoms you may need to contact your doctor.
If you are breast-feeding and will be given Xomolix, the treatment will be limited to only one administration. 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.
If you have any further questions on the use of this medicine, ask your doctor or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor or nurse immediately if you experience any of the following serious side effects:
The following side effects have also been reported:
Common side effects (may affect up to 1 in 10 people)
Uncommon side effects (may affect up to 1 in 100 people)
Rare side effects (may affect up to 1 in 1,000 people)
Very rare side effects (may affect up to 1 in 10,000 people)
Other side effects which may occur are:
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via:
United Kingdom
or search for MHRA Yellow Card in the Google Play or Apple App Store
Ireland
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Xomolix
6. Contents of the pack and other information
What Xomolix contains
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 10 ampoules
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder (UK)
Manufacturer
This medicinal product is authorised in the Member States of the EEA under the following names:
Xomolix
Austria, France, Germany, Greece, Spain, Hungary, Ireland, Italy, Portugal, Slovenia, Slovak Republic, UK.
Dehydrobenzperidol
Belgium, Denmark, Finland, Luxembourg, Netherlands
Dridol
Iceland, Norway, Sweden
This leaflet was last revised in October 2018.
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