Xomolix 2.5 mg/ml solution for injection

Patient Information Leaflet

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Xomolix 2.5 mg/ml injectable solution

Droperidol

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or nurse.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Xomolix is and what it is used for
2. What you need to know before you are given Xomolix
3. How to use 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 an injection solution containing the active substance droperidol, which belongs to a group of antipsychotics known as butyrophenone derivatives. Xomolix is used to prevent nausea or vomiting when waking up after surgery or when receiving morphine-derived analgesics following surgery.

2. What you need to know before Xomolix is administered to you

Do not administer Xomolix if:

• you are allergic to droperidol, or to any of the other components of this medicine (listed in section 6).
• you are allergic to a group of medicines used to treat psychiatric disorders called butyrophenones (for example haloperidol, triperidol, benperidol, melperone, domperidone).
• if you or someone in your family has abnormalities in the electrocardiogram (ECG).
• you have low levels of potassium or magnesium in the blood.
• you have a heart rate below 55 beats per minute (your doctor or nurse will check this), or you are taking medicines that may cause this condition.
• 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:

• 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 disorders (especially if undergoing 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 medicine has been associated with blood clot formation.
• if you are or have been a heavy drinker (of alcohol).

Other medicines and Xomolix

Tell your doctor or nurse if you are taking, have recently taken, or might need to take any other medicines, as some medicines should not be used together with droperidol.

Do not use Xomolix if you are taking any of the following medicines, as the combination increases the risk of irregular heartbeat, which may lead to a heart attack:

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

Other medicines may interact with or be affected by concomitant use with Xomolix. Droperidol, the active substance in Xomolix:

• may enhance the effects of sedatives such as barbiturates, benzodiazepines, and morphine-derived products
• may increase the effects of medications used to lower blood pressure (antihypertensives)
• may enhance the effects of other medications, such as certain antifungals, antivirals, and antibiotics

You should speak with your doctor or nurse if you are taking any of these medications.

Use of Xomolix with alcohol

Avoid consuming alcoholic beverages during the 24 hours before and after administration of Xomolix.

Pregnancy, breastfeeding, and fertility

If you are pregnant, consult your doctor, who will decide whether you should use Xomolix.

The following symptoms may occur in newborns whose mothers have used Xomolix during the third trimester of pregnancy (the last three months of pregnancy): tremors, muscle rigidity and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. 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 dose. You may resume breastfeeding once you have woken up from the procedure.

Consult your doctor before using any medicine.

Driving and use of machines

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

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

Xomolix contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per ml and is therefore considered essentially "sodium-free".

3. How Xomolix is administered

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

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

If you have any further questions about the use of this medicine, ask your doctor or nurse.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Contact your doctor or nurse immediately if you experience any of the following serious adverse effects:

• increase in body temperature, sweating, salivation, muscle rigidity, tremors. These may be signs of the so-called neuroleptic malignant syndrome (a rare adverse effect)
• severe allergic reaction or rapid swelling of the face or throat, difficulty swallowing; hives and breathing difficulties (a rare adverse effect)

The following adverse effects have also been reported:

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor, pharmacist, or nurse, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products, website: www.notificaram.es.

By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Xomolix Storage

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the packaging and ampoule after Exp. The expiry date refers to the last day of the month indicated.
• Store in the original packaging to protect from light.
• The solution must be used immediately after opening.
• Compatibility of droperidol with morphine sulfate in 0.9% sodium chloride has been demonstrated (14 days at room temperature) in plastic syringes. From a microbiological standpoint, the diluted product should be used immediately. If not used immediately, the time and conditions under which the diluted product is stored prior to use are the responsibility of the user and should normally 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 there are any visible signs of deterioration. The product should be visually inspected before use, and only clear solutions free from particles should be administered.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and their packaging safely once they are no longer needed. This helps protect the environment.

6. Contents of the pack and other information

Composition of Xomolix

• The active substance is droperidol; each millilitre of solution contains 2.5 mg of droperidol.
• The other components are mannitol, tartaric acid, sodium hydroxide, water for injections.

Appearance of the product and contents of the pack

Xomolix is a clear, colourless injectable solution.

The solution is contained in amber-coloured glass ampoules. Each ampoule contains 1 ml of solution and is packaged in cartons containing 10 ampoules.

Marketing Authorisation Holder and Manufacturer

This medicinal product is authorized in the European Economic Area member states under the following names:

Xomolix

Greece, Spain, Italy, Portugal

Dehydrobenzperidol

Belgium, Denmark, Finland, Luxembourg, Netherlands

Dridol

Iceland, Norway, Sweden

Date of latest review of this leaflet: April 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.