Droperidol Aguettant 2.5 mg/ml solution for injection EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Droperidol Aguettant 2.5 mg/ml injection solution EFG

droperidol

Read all of this leaflet carefully before you are given this medicine, because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist 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 leaflet

1. What Droperidol Aguettant is and what it is used for
2. What you need to know before you are given Droperidol Aguettant
3. How Droperidol Aguettant is administered
4. Possible side effects
5. How to store Droperidol Aguettant
6. Contents of the pack and other information

1. What Droperidol Aguettant is and what it is used for

Droperidol Aguettant contains the active substance droperidol, which belongs to a group of antipsychotics known as butyrophenone derivatives. It is used to prevent nausea or vomiting when waking up after surgery or when receiving morphine-derived analgesics following an operation.

2. What you need to know before Droperidol Aguettant is administered to you

Do not take Droperidol Aguettant:

• if you are allergic to droperidol or to any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to a group of medicines used to treat psychiatric disorders called butyrophenones (such as haloperidol, triperidol, benperidol, melperone, domperidone);
• if you or someone in your family has an abnormal electrocardiogram (ECG);
• if you have low levels of potassium or magnesium in your blood;
• if your heart rate is less than 55 beats per minute (your doctor or nurse will check this), or if you are taking any medicine that may cause this;
• if you have a tumor in your adrenal gland (pheochromocytoma);
• if you are in a coma;
• if you have Parkinson's disease;
• if you have severe depression.

Warnings and precautions

Talk to your doctor or nurse before Droperidol is administered to you:

• if you have epilepsy or a history of epilepsy;
• if you have heart problems or a history of heart problems;
• 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 lung disease and breathing difficulties;
• if you have prolonged nausea or diarrhea;
• if you are using insulin;
• if you are taking potassium-losing diuretics (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 medicines like this have been associated with blood clot formation;
• if you are or have been a heavy drinker (of alcohol).

Other medicines and Droperidol Aguettant

Tell your doctor if you are taking, have recently taken, or might need to take any other medicines.

Droperidol Aguettant must not be administered to you if you are taking any of the following medicines:

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

Other medicines that may affect or be affected when used concomitantly with Droperidol Aguettant:

• may increase the effects of sedatives such as barbiturates, benzodiazepines, and morphine-derived medications;
• may increase the effects of medications used to lower high blood pressure;
• may increase the effects of other medications such as certain antifungals, antivirals, and antibiotics.

Talk to your doctor or nurse if you are taking any of these medicines.

Droperidol and alcohol

Consumption of alcoholic beverages and medications should be avoided.

Pregnancy and breastfeeding

If you are pregnant, consult your doctor, who will decide whether you should receive Droperidol Aguettant.

The following symptoms may occur in newborns whose mothers have used this medication during the third trimester (last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your baby develops any of these symptoms, inform your doctor immediately.

If you are breastfeeding and are to be given Droperidol Aguettant, treatment will be limited to a single dose. Breastfeeding may be resumed upon waking after the procedure.

Driving and use of machines

Droperidol has a major effect on the ability to drive and use machines.

Do not drive or operate machinery for at least 24 hours after receiving this medication.

Droperidol Aguettant contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per ampoule; essentially, it is “sodium-free”.

3. How Droperidol Aguettant is administered

Droperidol Aguettant will be administered to you by your doctor.

The amount of Droperidol Aguettant and the way it will be administered will depend on your condition. Your doctor will determine the required dose of Droperidol Aguettant based on several factors, including your weight, age, and medical condition.

Droperidol Aguettant will be given by intravenous injection (into a vein).

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

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 stiffness, tremor. These may be symptoms of a condition called neuroleptic malignant syndrome (a rare adverse effect).
• severe allergic reaction or rapid swelling of the face or throat; difficulty swallowing; hives and difficulty breathing (a rare adverse effect).

The following adverse effects have also been reported:

Frequent: may affect up to 1 in 10 people

• drowsiness.
• low blood pressure.

Uncommon: may affect up to 1 in 100 people

• anxiety.
• rolling of the eyes.
• fast pulse, for example more than 100 beats per minute.
• dizziness.

Rare: may affect up to 1 in 1,000 people

• confusion.
• agitation.
• irregular heartbeat.
• skin rash.

Very rare: may affect up to 1 in 10,000 people

• blood disorders (usually affecting red blood cells or platelets). Your doctor may advise you.
• change in mood to sadness, anxiety, depression, and irritability.
• involuntary muscle movements.
• seizures or tremors.
• heart attack (cardiac arrest).
• sudden death.
• torsade de pointes (an irregular heart rhythm that may be life-threatening).
• prolonged QT interval on ECG (a heart condition affecting heartbeats).

Frequency not known (cannot be estimated from available data)

• inappropriate antidiuretic hormone secretion (excessive hormone release leading to excess water and low sodium levels in the body).
• hallucinations.
• epileptic seizures.
• Parkinson's disease.
• fainting.
• breathing difficulties.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Droperidol Aguettant

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 on the ampoule after EXP. The expiry date refers to the last day of the month indicated.

Store in the original packaging to protect from light.

After dilution

Chemical and physical stability of droperidol during use has been demonstrated:

• with glucose 50 mg/ml (5%) solution in PVC infusion bags and non-PVC infusion bags and polypropylene syringes for 48 hours at 25°C.
• with sodium chloride 9 mg/ml (0.9%) injectable solution in PVC infusion bags and non-PVC infusion bags and polypropylene syringes for 48 hours at 25°C.
• with morphine in sodium chloride 9 mg/ml (0.9%) injectable solution in polypropylene syringes for 14 days at 25°C and from 2 to 8°C.

From a microbiological standpoint, the diluted medicine should be used immediately. If not used immediately, the storage duration and conditions prior to use are the responsibility of the user and normally should not exceed 24 hours at 2–8°C, unless the dilution was carried out under controlled and validated aseptic conditions.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Droperidol Aguettant

• The active substance is droperidol.

Droperidol Aguettant 2.5 mg/ml solution for injection

Each 1 ml ampoule contains 2.5 mg of droperidol.

• The other components are mannitol (E 421), tartaric acid, sodium hydroxide (to adjust pH), water for injections.

Appearance of the medicine and contents of the pack

This medicine is a clear, colourless injectable solution (injection).

The solution is contained in amber glass ampoules.

Pack of 10 ampoules.

Marketing Authorisation Holder and Manufacturer

Laboratoire Aguettant
1 rue Alexander Fleming
69007 Lyon
France

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Aguettant Ibérica
Baldiri Reixac, 4-8, Torre I, 4º
08028 Barcelona
Spain

This medicine is authorised in the Member States of the European Economic Area under the following names:

AT, BE, DE, DK, FI, IS, LU, NL, NO, PT, RO, SE: Droperidol Aguettant
IE: Droperidol
IT: Droperidolo Aguettant

Date of the most recent review of this leaflet: 10/2024