PROSPECTO: INFORMATION FOR THE USER

Xomolix 2.5 mg/ml injectable solution

Droperidol

Read this prospectus carefully before starting to use this medication, as it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or nurse.
• If you experience adverse effects,consult your doctor, pharmacist, or nurse,eveniftheydo not appear in this prospectus. See section 4.

1. What is Xomolix and how it is used

2. What you need to know before Xomolix is administered

3. How to use Xomolix

4. Possible adverse effects

5.Storage ofXomolix

6. Contents of the package and additional information

Xomolix is an injection solution that contains the active ingredient droperidol, which belongs to a group of antipsychotics known as 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.

You should not be given Xomolix if:

• You are allergic to droperidol, or to any of the other components of this medication (listed in section 6).
• You are allergic to a group of medications used to treat psychiatric disorders, called butyrophenones (for example haloperidol, triperidol, benperidol, melperona, domperidona).
• If you or someone in your family has abnormalities in the electrocardiogram (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 medications 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

Consult your doctor or nurse before starting to use Xomolix.

• If you have epilepsy, or a history of epilepsy.
• If you have heart problems or a history of heart disease.
• If you have a family history of sudden death.
• If you have kidney problems (especially if you are on long-term dialysis).
• If you have any lung disease or breathing difficulties.
• If you have prolonged vomiting or diarrhea.
• If you are using insulin.
• If you are taking diuretics that cause potassium loss (for example furosemide or bendroflumethiazide).

• If you are taking laxatives.
• If you are taking glucocorticoids (a type of steroid hormone).
• If you or someone in your family has a history of blood clots, as this type of medication has been associated with the formation of blood clots.

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

Other medications and Xomolix

Inform your doctor or nurse if you are taking, have taken recently, or may need to take any other medication, as some medications cannot be taken with droperidol.

You should not use Xomolix if you are using any of the following medications, as the combination increases the risk of irregular heartbeat, which can lead to a heart attack:

Metoclopramide and other neuroleptics should be avoided during treatment with Xomolix, as the risk of movement disorders induced by these medications increases.

Other medications may affect or be affected when used concomitantly with Xomolix. Droperidol, the active ingredient in Xomolix:

• May increase the effects of sedatives such as barbiturates, benzodiazepines, and morphine derivatives.
• May increase the effects of medications used to lower blood pressure (anti-hypertensives).
• May increase the effects of other medications, such as certain antifungals, antivirals, and antibiotics.

You should talk to your doctor or nurse if you are taking any of these medications.

Use of Xomolix with alcohol

Avoid drinking alcoholic beverages for 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 used Xomolix in the last trimester of pregnancy (the last three months of pregnancy): tremors, stiffness, and/or muscle weakness, drowsiness, agitation, breathing difficulties, and feeding difficulties. If your baby develops any of these symptoms, you may need to contact your doctor.

If you are breastfeeding and are to be given Xomolix, treatment will be limited to a single administration. You can resume breastfeeding when you wake up from the operation.

Consult your doctor before using any medication.

Driving and operating machinery

Droperidol has a significant effect on your ability to drive and operate machinery.

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

Xomolix contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per ml, making it essentially "sodium-free".

Xomolix will be administered by a doctor via an intravenous injection.

The amount and manner in which Xomolix is administered will depend on the situation. Your doctor will determine the amount of Xomolix you need based on various criteria, including your weight, age, and medical condition.

If you have any other questions about the use of this medication, 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.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Contact your doctor or nurse immediatelyif you experience any of the following serious side effects:

• an increase in your body temperature, sweating, salivation, muscle stiffness, tremors. These may be signs of a condition known as malignant neuroleptic syndrome (rare side effect)
• severe allergic reaction or rapid swelling in the face or throat, difficulty swallowing; hives and difficulty breathing (rare side effect)

The following side effects have also been reported:

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use, website:www.notificaram.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Composition of Xomolix

• The active principle is droperidol, each milliliter of solution contains 2.5 mg of droperidol.
• The other components are mannitol, tartaric acid, sodium hydroxide, water for injectable preparations.

Appearance of the product and contents of the packaging

Xomolix is a transparent and colorless injectable solution.

The solution is contained in amber-colored glass ampoules. Each ampoule contains 1 milliliter of solution and is packaged in boxes containing 10 ampoules.

Holder of the marketing authorization and responsible for manufacturing

This medicine is authorized in the member states of the European Economic Area with the following names:

Xomolix

Greece, Spain, Italy, Portugal

Dehydrobenzperidol

Belgium, Denmark, Finland, Luxembourg, Netherlands

Dridol

Iceland, Norway, Sweden

Last review date of this leaflet: April 2023

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/ .