Droperidol Aguettant

Package leaflet: Information for the patient

Droperidolo Aguettant 2.5 mg/mL injection solution

droperidol
Generic medicine
Please read 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 experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

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

Droperidolo 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 during the post-operative recovery period or when morphine-based painkillers are administered after a surgical procedure.

2. What you need to know before you are given Droperidol Aguettant

Droperidol Aguettant must not be administered to you:

• 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 in the treatment of psychiatric disorders called butyrophenones (e.g. haloperidol, triperidol, benperidol, melperone, domperidone);
• if you or a member of your family has an abnormal electrocardiogram (ECG) trace;
• if you have low levels of potassium or magnesium in your blood;
• if your heart rate is below 55 beats per minute (your doctor or nurse will check this), or if you are taking other medicines that may cause this effect;
• if you have a tumour of the adrenal gland (pheochromocytoma);
• if you are in a coma;
• if you have Parkinson's disease;
• if you suffer from severe depression.

Warnings and precautions
Talk to your doctor or nurse before you are given Droperidol Aguettant:

• if you have epilepsy or a history of epilepsy;
• if you have any heart problems or a history of heart problems;
• if there is a family history of sudden death;
• if you have kidney problems (especially if you are on long-term dialysis);
• if you have a lung disease or any breathing difficulties;
• if you have prolonged vomiting or diarrhoea;
• if you are taking insulin;
• if you are taking potassium-losing diuretics (e.g. 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 previously had 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
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
Droperidol Aguettant must not be administered to you if you are taking any of the following medicines:

Condition treated | Medicines --- | --- Cardiac arrhythmia, irregular heartbeat | Class IA and III antiarrhythmics Bacterial infection | Macrolide and fluoroquinolone antibiotics Malaria | Antimalarial medicines Allergies | Antihistamines Mental illnesses, e.g. schizophrenia | Antipsychotics Heartburn | Cisapride Parasitic infestation or fungal infection | Pentamidine Nausea or vomiting | Domperidone Opioid dependence; pain | Methadone

During treatment with Droperidol Aguettant, metoclopramide and other neuroleptics should be avoided, as this increases the risk of movement disorders induced by these medicines.
Other medicines that may interact with or be affected by concomitant use of Droperidol Aguettant:
Droperidol:

• may enhance the effects of sedatives such as barbiturates, benzodiazepines, and morphine-containing products;
• may enhance the effects of medicines used to lower blood pressure;
• may enhance the effects of certain other medicines such as some antifungals, antivirals, and antibiotics.

You must inform your doctor or nurse if you are taking any of these medicines.

Droperidol Aguettant and alcohol
Alcohol and alcohol-containing medicines should be avoided.

Pregnancy and breastfeeding
If you are pregnant, inform your doctor, who will decide whether Droperidol Aguettant should be administered to you.
The following symptoms may occur in newborns whose mothers used this medicine during the third trimester (the last three months of pregnancy): tremors, muscle rigidity and/or weakness, drowsiness, agitation, breathing difficulties, and feeding difficulties. If your baby develops any of these symptoms, contact your doctor.
If you are breastfeeding and are given Droperidol Aguettant, treatment will be limited to a single dose. Breastfeeding may be resumed upon waking after the surgical procedure.

Driving and using machines
Droperidol impairs the ability to drive and use machinery.
Do not drive or operate machinery for at least 24 hours after administration of this medicine.

Droperidol Aguettant contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e. essentially 'sodium-free'.

3. How to use Droperidolo Aguettant

Droperidolo Aguettant will be administered to you by your doctor.
The amount of Droperidolo Aguettant and the way it is given depend on your condition.
Your doctor will determine the dose of Droperidolo Aguettant you need based on several factors,
including body weight, age, and medical condition.
Droperidolo Aguettant will be given by injection into a vein (intravenous use).
If you have any questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Contact your doctor or nurse immediately if you experience any of the following serious side effects:

• increased body temperature, sweating, salivation, muscle stiffness, tremor. These may be signs of the so-called "neuroleptic malignant syndrome" (rare side effect)
• severe allergic reaction or rapid swelling of the face or throat; difficulty swallowing, hives, and breathing difficulties (rare side effect)

The following side effects have also been reported:
Common: 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
• increased heart rate (e.g. 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 diseases affecting red blood cells or platelets). Your doctor may advise you.
• mood changes tending towards sadness, anxiety, depression, and irritability
• involuntary muscle movements
• seizures or tremors
• heart attack (cardiac arrest)
• sudden death
• torsade de pointes (a life-threatening irregular heartbeat)
• prolonged QT interval on ECG (a condition affecting heart rhythm)

Frequency not known (frequency cannot be estimated from the available data):

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 carton and on the vial after
Exp. The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light. After dilution
The chemical and physical in-use stability of droperidol has been demonstrated:

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

From a microbiological point of view, the diluted medicine should be used immediately. If not used immediately, the time and conditions of in-use storage 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.

Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Droperidolo Aguettant contains

• The active substance is droperidol.

Droperidolo Aguettant 2.5 mg/mL injectable solution
Each 1 mL vial contains 2.5 mg of droperidol.

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

Description of the appearance of Droperidolo Aguettant and contents of the pack
This medicinal product is a clear, colourless injectable solution (injection).
The solution is contained in amber glass vials.
Pack size: 10 vials.
Marketing Authorisation Holder and Manufacturer
LABORATOIRE AGUETTANT
1, rue Alexander Fleming
69007 LYON
FRANCE
This medicinal product is authorised in the European Economic Area countries under the
following names:
AT, BE, DE, DK, ES, FI, IS, LU, NL, NO, PT, RO, SE: Droperidol Aguettant
IE: Droperidol
IT: Droperidolo Aguettant