XOMOLIX 2.5 mg/ml INJECTABLE SOLUTION
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How to use XOMOLIX 2.5 mg/ml INJECTABLE SOLUTION
Introduction
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.
- Keep this leaflet, you may need to read it again.
- If you have any further questions, ask your doctor or nurse.
- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
Contents of the pack:
- What is Xomolix and what is it used for
- What you need to know before you are given Xomolix
- How to use Xomolix
- Possible side effects
- Storage of Xomolix
- Contents of the pack and other information
1. What is Xomolix and what is it used for
Xomolix is a solution for injection that contains the active substance droperidol, which belongs to a group of antipsychotics called butyrophenone derivatives. Xomolix is used to prevent nausea or vomiting when waking up after an operation or when receiving morphine-derived analgesics after an operation.
2. What you need to know before you are given Xomolix
You should not be given Xomolix if:
- you are allergic to droperidol or any of the other ingredients of this medicine (listed in section 6).
- you are allergic to a group of medicines used to treat psychiatric disorders, called butyrophenones (e.g. haloperidol, triperidol, benperidol, melperone, domperidone)
- you or someone in your family has heart rhythm disorders (ECG).
- you have low levels of potassium or magnesium in your blood
- you have a heart rate of less than 55 beats per minute (your doctor or nurse will check this), or you are taking medicines that may cause this situation
- you have a tumor in your adrenal gland (pheochromocytoma)
- you are in a coma
- you have Parkinson's disease
- you have severe depression
Warnings and precautions
Talk to your doctor or nurse before starting to use Xomolix
Other medicines and Xomolix
Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines, as some medicines cannot be mixed with droperidol
Do not useXomolix if you are using any of the following medicines, as the combination increases the risk of irregular heartbeat, which can lead to a heart attack:
What the medicine is used for | Medicine(s) |
Heart rhythm disorders, irregular heartbeat | Class IA and III antiarrhythmics |
Bacterial infections | Macrolide and fluoroquinolone antibiotics |
Malaria | Anti-malarial medicines |
Allergies | Antihistamines |
Mental illnesses such as schizophrenia… | Antipsychotics |
Heartburn | Cisapride |
Parasite infestation or fungal infection | Pentamidine |
Nausea (feeling sick) or vomiting | Domperidone |
Opiate dependence; pain | Methadone |
Metoclopramide and other neuroleptics should be avoided during treatment with Xomolix, as the risk of movement disorders induced by these medicines is increased.
Other medicines may affect or be affected by concomitant use with Xomolix. Droperidol, the active substance of Xomolix:
- may increase the effects of sedatives such as barbiturates, benzodiazepines and morphine derivatives
- may increase the effects of medicines used to lower blood pressure (antihypertensives)
- may increase the effects of other medicines, such as certain antifungals, antivirals and antibiotics
You should talk to your doctor or nurse if you are taking any of these medicines.
Using Xomolix with alcohol
Avoid drinking alcoholic beverages during the 24 hours before and after using Xomolix.
Pregnancy, breastfeeding and fertility
If you are pregnant, consult your doctor, as they will decide whether you should use Xomolix.
The following symptoms may occur in newborns of mothers who have used Xomolix in the last trimester of pregnancy (the last three months of pregnancy): tremors, rigidity and/or muscle weakness, drowsiness, agitation, breathing problems and difficulty feeding. If your baby develops any of these symptoms, you may need to contact your doctor.
If you are breastfeeding and are given Xomolix, treatment will be limited to a single administration. You can breastfeed again when you wake up from the operation.
Consult your doctor before using any medicine.
Driving and using machines
Droperidol has a significant effect on the ability to drive and use machines.
Do not drive or use machines for at least 24 hours after taking Xomolix.
Xomolix contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per ml, i.e. it is essentially "sodium-free".
3. How Xomolix is administered
Xomolix will be administered to you by a doctor via an intravenous injection.
The amount and method of administration of Xomolix will depend on the situation. Your doctor will determine the amount of Xomolix you need based on different criteria, including your weight, age and medical situation.
If you have any further questions about the use of this medicine, ask your doctor or nurse.
In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor or nurse immediatelyif you experience any of the following serious side effects:
- increase in body temperature, sweating, salivation, muscle stiffness, tremors. These can be signs of a condition called malignant neuroleptic syndrome (rare side effect)
- severe allergic reaction or rapid swelling of the face or throat, difficulty swallowing; hives and difficulty breathing (rare side effect)
The following side effects have also been reported:
Common side effects (may affect up to 1 in 10 people) |
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Uncommon side effects (may affect up to 1 in 100 people) |
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Rare side effects (may affect up to 1 in 1,000 people) |
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Very rare side effects (may affect up to 1 in 10,000 people) |
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Other possible side effects of unknown frequency (frequency cannot be estimated from available data) are: |
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Reporting of side effects
If you experience any side effects, talk to your doctor, pharmacist or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines, website: www.notificaram.es.
By reporting side effects, you can help provide more information on the safety of this medicine.
5. Storage of Xomolix
- 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 carton and on the ampoule after EXP. The expiry date is the last day of the month stated.
- Store in the original package to protect from light.
- The solution should be used immediately after opening.
- Compatibility of droperidol with morphine sulfate in 0.9% sodium chloride (14 days at room temperature) in plastic syringes has been demonstrated. From a microbiological point of view, the diluted product should be used immediately. If not used immediately, the time and conditions of storage before use are the responsibility of the user and normally should not exceed 24 hours, stored at a temperature between 2 and 8°C, unless the solution has been stored under validated and controlled aseptic conditions.
- Do not use this medicine if you notice visible signs of deterioration. The product should be visually inspected prior to use and only clear solutions free of 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. This will help protect the environment.
6. Contents of the pack and other information
Composition of Xomolix
- The active substance is droperidol, each milliliter of solution contains 2.5 mg of droperidol.
- The other ingredients are mannitol, tartaric acid, sodium hydroxide, water for injections.
Appearance of the product and pack contents
Xomolix is a clear and colorless solution for injection.
The solution is contained in amber glass ampoules. Each ampoule contains 1 milliliter of solution and is packaged in boxes containing 10 ampoules.
Marketing authorization holder and manufacturer
Marketing authorization holder | Manufacturer |
SUBSTIPHARM 24 rue Erlanger 75016 Paris France | DELPHARM TOURS Rue Paul Langevin 37170 Chambray-les-Tours France |
This medicine is authorized in the Member States of the European Economic Area under the following names:
Xomolix
Greece, Spain, Italy, Portugal
Dehydrobenzperidol
Belgium, Denmark, Finland, Luxembourg, Netherlands
Dridol
Iceland, Norway, Sweden
Date of last revision of this leaflet: April 2023
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.
- Country of registration
- Active substance
- Prescription requiredYes
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
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