XOMOLIX 2.5 mg/ml INJECTABLE SOLUTION

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:

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:

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

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/.