Droperidol Kalceks

Package leaflet: Information for the user

Droperidolo Kalceks 1.25 mg/ml injection solution, 2.5 mg/ml injection solution

droperidol
equivalent medicine
Please read all of this leaflet carefully before you use 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 or nurse.
• If you get any side effects, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet:

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

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

Droperidolo Kalceks is an injectable solution containing the active substance droperidol, which
belongs to a group of medicines called butyrophenone derivatives. Droperidolo Kalceks is used
to prevent nausea or vomiting upon awakening from surgery or when morphine-based painkillers are
administered after a surgical procedure.

2. What you need to know before taking Droperidolo Kalceks

Do not take Droperidolo Kalceks

• 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 (e.g. haloperidol, trifluoperazine, benperidone, melperone, domperidone);
• if you or a family member has an abnormal electrocardiogram (ECG) trace;
• if you have low levels of potassium or magnesium in the blood;
• if your heart rate is below 55 beats per minute (your doctor or nurse will monitor this) or if you are taking medicines that could 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 receiving this medicine, as special precautions are necessary:

• if you suffer from epilepsy or have a history of epilepsy;
• if you have heart problems or a history of heart problems;
• if there is a family history of sudden death;
• if you have kidney problems (particularly if you are on long-term dialysis);
• if you have a lung disease and breathing difficulties;
• if you have prolonged vomiting or diarrhoea;
• if you are using insulin;
• if you are taking diuretics, i.e. tablets that increase urine production, potassium-wasting diuretics (e.g. furosemide or bendroflumethiazide);
• if you are taking laxatives;
• if you are taking glucocorticoids (a type of steroid hormone);
• if you or a family member 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 Droperidolo Kalceks
Inform your doctor or nurse if you are taking, have recently taken or might take any other medicine, because various medicines cannot be mixed with droperidol.
You must not receive this medicine if you are taking any of the following medicines, because their combination increases the risk of irregular heartbeat, which can lead to a heart attack:

| Purpose of medicine | Medicine(s) | |------------------------|-----------------| | Heart arrhythmia, irregular heartbeat | Class IA and III antiarrhythmics | | Infection (bacterial) | Macrolide or 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 |

Metoclopramide and other neuroleptics should be avoided during treatment with this medicine, as the risk of movement disorders induced by these medicines is increased.
Other medicines that may affect this medicine or be affected by this medicine when used concomitantly.
Droperidol, the active substance in this medicine:

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

Consult your doctor or nurse if you are taking any of these medicines.
Droperidolo Kalceks and alcohol
Avoid drinking alcohol for 24 hours before and after administration of this medicine.
Pregnancy, breastfeeding and fertility
If you are pregnant, inform your doctor, who will decide whether you should receive this medicine.
Newborns of mothers who have received droperidol during the last trimester of pregnancy may experience the following symptoms: tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing problems, and feeding difficulties. If your baby develops any of these symptoms, you may need to contact your doctor.
If you are breastfeeding and receive this medicine, treatment will be limited to a single dose. Breastfeeding can be resumed upon waking from the surgical procedure.
Ask your doctor for advice before taking any medicine.
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 receiving this medicine.
Droperidolo Kalceks contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per ml, i.e. essentially 'sodium-free'.

3. How to take Droperidolo Kalceks

This medicine will be administered to you by a doctor or nurse as an injection into a vein.
The dose of Droperidolo Kalceks and the method of administration will depend on your condition.
Your doctor will determine the amount of medicine you need based on several factors, including body weight, age, and medical condition.
If you have any doubts about how to use this medicine, consult your doctor or nurse.

4. Possible side effects

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

• Increased body temperature, sweating, salivation, muscle stiffness, tremor. These may be signs of a condition 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
• Eye rolling
• Fast heartbeat, e.g. more than 100 beats per minute
• Dizziness

Rare (may affect up to 1 in 1,000 people)

• Confusion
• Agitation
• Irregular heartbeat
• Rash

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

• Blood disorders (usually diseases affecting red blood cells or platelets). Your doctor can give you advice.
• Mood changes with tendency towards sadness, anxiety, depression and irritability
• Involuntary muscle movements
• Seizures or tremors
• Heart attack (cardiac arrest)
• Torsade de pointes (potentially fatal irregular heartbeat)
• Prolonged QT interval on electrocardiogram (ECG) (a condition affecting heart rhythm)
• Sudden death

Not known (frequency cannot be estimated from available data)

• Inappropriate antidiuretic hormone secretion (excessive release of the hormone, 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 or pharmacist.
You can also report side effects directly via 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 Kalceks

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage temperature.
Keep the vials in the outer packaging to protect the medicine from light.

Shelf-life after opening the vial
The solution must be used immediately after first opening.

Shelf-life after dilution
Compatibility and stability during use of Droperidol Kalceks 1.25 mg/ml solution for injection and
Droperidol Kalceks 2.5 mg/ml solution for injection with morphine in sodium chloride 9 mg/ml (0.9%)
injection solution have been demonstrated in polypropylene (PP) and polycarbonate (PC) syringes
for 14 days at a temperature of 25 °C (protected from light) and at a temperature of 2–8 °C.

From a microbiological standpoint, the diluted medicinal product should be used immediately.
If not used immediately, the in-use storage times and conditions prior to use are the responsibility
of the user and normally should not exceed 24 hours at 2–8 °C, unless dilution has been carried out
under strictly controlled and validated aseptic conditions.

Do not use this medicine after the expiry date stated on the carton and on the label of the vial after “Exp” or “EXP”.
The expiry date refers to the last day of that month.

For single use only. Any unused solution must be discarded.

The solution should be inspected visually before use. Do not use this medicine if visible signs of deterioration are observed.
Only clear, colourless solutions free from visible particles should be used.

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

6. Package contents and other information

What Droperidolo Kalceks contains

• The active substance is droperidol.

Droperidolo Kalceks 1.25 mg/ml injectable solution
Each 1 ml vial of injectable solution contains 1.25 mg of droperidol.
Droperidolo Kalceks 2.5 mg/ml injectable solution
Each 1 ml vial of injectable solution contains 2.5 mg of droperidol.

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

Description of the appearance of Droperidolo Kalceks and contents of the pack
Clear, colourless solution, free from visible particles.
1 ml of solution in type I amber glass vials with OPC snap-off system. The vials are placed in a pouch and packaged in an outer carton.
Pack sizes: 5 or 10 vials
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
AS KALCEKS
Krustpils iela 71E, Rīga, LV-1057, Latvia
Tel.: +371 67083320
E-mail: [email protected]

The following information is intended for healthcare professionals only:
Incompatibilities
Incompatible with barbiturates. This medicinal product must not be mixed with other medicinal products except those mentioned in the section “Instructions for use” below.
Instructions for use
For single use only. Any unused solution must be discarded.
The solution must be inspected visually before use. Do not use this medicinal product if signs of deterioration are observed. Only clear, colourless solutions free from visible particles should be used.
For use in PCA: aspirate droperidol and morphine into a syringe and dilute to volume with 9 mg/ml (0.9%) sodium chloride injectable solution.
Instructions for opening the vial

1. Turn the vial with the coloured tip upwards. If any solution is present in the upper part of the vial, gently tap with the finger to bring all the solution down into the lower part of the vial.
2. Use both hands to open; holding the lower part of the vial in one hand, break off the top part of the vial in the direction opposite to the coloured mark (see figures below).

Any unused medicine and waste material arising from this medicine must be disposed of in accordance with local applicable regulations.