Leaflet: information for the user

Droperidol Kalceks 2.5 mg/ml injectable solution EFG

droperidol

Read this 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 side effects, consult your doctor or nurse, even if they are not listed in this leaflet. See section 4.

1. What is Droperidol Kalceks and how is it used

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

3. How you will be given Droperidol Kalceks

4. Possible side effects

5. Storage of Droperidol Kalceks

6. Contents of the package and additional information

Droperidol Kalceks is an injectable solution that contains droperidol, an active ingredient that belongs to the group of medications called butyrophenone derivatives. Droperidol is used to prevent the feeling of nausea or vomiting when waking up after an operation or when receiving morphine-derived analgesics after an operation.

You should not be given Droperidol Kalceks

• if you are allergic to droperidol or any of the other components of this medication (listed in section6);
• if you are allergic to a group of medications used to treat psychiatric disorders, called butyrophenones (for example: haloperidol, triperidol, benperidol, melperona, domperidone);
• if you or someone in your family has abnormalities in the electrocardiogram (ECG);
• if you have low levels of potassium or magnesium in your blood;
• if your heart rate is less than 55beats per minute (your doctor or nurse will check this), or if you are taking medications that may cause this situation;
• if you have a tumor of the adrenal glands (pheochromocytoma);
• if you are in a coma;
• if you have Parkinson's disease;
• If you have severe depression.

Warnings and precautions

Consult your doctor or nurse before you are given this medication, as special precautions are required:

• 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 problems (especially if you are on 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 remove potassium (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 medication has been associated with the formation of blood clots;
• if you are or have been a heavy drinker (of alcohol).

Other medications and Droperidol Kalceks

Inform your doctor or nurse if you are taking, have taken recently, or may need to take any other medication, as some medications cannot be taken with droperidol.

You should not be giventhis medication if you are taking any of the following medications, as the combination increases the risk of irregular heartbeats that may lead to a heart attack (myocardial infarction):

Metoclopramide and other neuroleptics should be avoided while using droperidol, as the risk of movement disorders induced by these medications is increased.

Other medications that may affect or be affected when used simultaneously with droperidol.

The active ingredient of this medication, droperidol:

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

If you are taking any of these medications, inform your doctor or nurse.

Droperidol Kalceks with alcohol

Avoid drinking alcohol for 24hours before and after using droperidol.

Pregnancy, breastfeeding, and fertility

If you are pregnant, consult your doctor to decide whether you should receive this medication.

In newborns of mothers who received droperidol in the last trimester (last three months of pregnancy) may appear the following symptoms: tremors, stiffness, and/or muscle weakness, drowsiness, agitation, respiratory problems, and difficulty feeding. If your child shows any of these symptoms, you may need to consult your doctor.

If you are breastfeeding and are to receive droperidol, the treatment will be reduced to a single administration. You can resume breastfeeding after waking up from the operation.

Ask your doctor for advice before taking any medication.

Driving and operating machinery

The effect of droperidol on your ability to drive and operate machinery is important.

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

Droperidol Kalceks contains sodium

This medication contains less than 1mmol of sodium (23mg) per ml, which is essentially "sodium-free".

This medication will be administered to you by a doctor or nurse as an injection into a vein.

The dose of droperidol and how it is administered will depend on the situation. Your doctor will determine the amount of medication you need based on various criteria, such as your weight, age, and medical condition.

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

Like all medications, this medication may cause side effects, although not everyone will experience them.

Inform your doctor or nurse immediatelyif you experience any of the following serious side effects:

• Increased body temperature, sweating, salivation, muscle stiffness, or tremors. These may be symptoms of a condition known as malignant neuroleptic syndrome (rare side effect).
• Severe allergic reaction or rapid swelling in the face or throat; difficulty swallowing; hives, and difficulty breathing (rare side effect).

The following side effects have been reported:

Frequent (may affect fewer than 1in 10people):

• Drowsiness
• Low blood pressure

Occasional (may affect fewer than 1in 100people):

• Anxiety
• Blank stare
• Fast heart rate, for example, more than 100beats per minute
• Dizziness

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

• Confusion
• Agitation
• Irregular heartbeats
• Skin rash

Very rare (may affect fewer than 1in 10,000people)

• Blood disorders (usually related to red blood cells or platelets). Your doctor will advise you
• Mood changes to sadness, anxiety, depression, and irritability
• Involuntary muscle movements
• Seizures or tremors
• Heart attack (cardiac arrest)
• Torsade de pointes(irregular heartbeat that can be fatal)
• Prolongation of the QT interval on the electrocardiogram (ECG) (a condition that affects heartbeats)
• Sudden death

Unknown frequency (cannot be estimated from available data)

• Inadequate secretion of the antidiuretic hormone (excessive release of the hormone, leading to excess water and decreased sodium levels in the body)
• Hallucinations
• Seizure crises
• Parkinson's disease
• Fainting
• Difficulty breathing

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.esBy reporting side effects, you can contribute to providing more information on the safety of this medication.

Maintain this medication out of the sight and reach of children.

This medication does not require any special temperature of conservation. of conservation .

Store the ampoules in the outer packaging to protect them from light.

Expiration period after opening the ampoule

Immediate use after the first opening.

Expiration period after dilution

Compatibility and stability have been demonstrated in the use of Droperidol Kalceks 2.5 mg/ml injectable solution EFG with morphine in a 0.9% sodium chloride injectable solution 9 mg/ml in polypropylene (PP) and polycarbonate (PC) syringes for 14 days at 25° C (protected from light) and at temperatures between 2° C and 8° C.

From a microbiological point of view, the diluted solution must be used immediately. If not used immediately, the storage times in use and the previous conditions are the responsibility of the user and are normally not greater than 24 hours at a temperature of 2° C to 8° C, unless the dilution was made in controlled and validated aseptic conditions.

Do not use this medication after the expiration date that appears on the box and on the ampoule after 'CAD/EXP'. The expiration date is the last day of the month indicated.

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

The solution must be visually inspected before use. Do not use this medication if visible signs of deterioration are observed. It should only be used if the solution is transparent, colorless, and free of visible particles.

Medications should not be thrown away through the drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that are no longer in use. This will help protect the environment.

Droperidol Kalceks Composition

• The active ingredient is droperidol.

Each ampoule of 1ml of injectable solution contains 2.5mg of droperidol.

?The other components are: tartaric acid, mannitol, sodium hydroxide (for pH adjustment), water forinjectable preparations.

Appearance of Droperidol Kalceks and packaging contents

Clear and colorless solution, without visible particles.

Amber type I glass ampoules containing 1ml of injectable solution with a cutting point. The ampoules are placed in a tray and packaged in a cardboard box.

Packaging sizes: 5or 10ampoules.

Only some packaging sizes may be commercially available.

Marketing authorization holder and responsible manufacturer:

AS KALCEKS

Krustpils iela 71E, Riga, LV‑1057, Latvia

Phone: +37167083320

Email: [email protected]

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Grindeks Kalceks España, S.L.

c/ José Abascal, 58 2º dcha

28003 Madrid

Spain

Last review date of this leaflet:March 2021

For detailed information about this medicinal product, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)(http://www.aemps.gob.es/)

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This information is intended solely for healthcare professionals:

Incompatibilities

Incompatible with barbiturates. This medicinal product should not be mixed with other products, except as mentioned in the "Instructions for use" section.

Instructions for use

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

The solution must be visually inspected before use. Do not use this medicinal product if you observe visible signs of deterioration. It should only be used if the solution is clear, colorless, and free of visible particles.

For use in PCA (patient-controlled analgesia): draw up the droperidol and morphine with a syringe and prepare the desired volume with a 9mg/ml sodium chloride injectable solution (0.9%).

Instructions for opening the ampoule:

1. Turn the ampoule with the color point upwards. If there is any solution left in the upper part of the ampoule, gently tap it with your finger to allow all the solution to flow to the lower part of the ampoule.
2. Use both hands to open it and while holding the lower part of the ampoule with one hand, use the other hand to break the upper part of the ampoule in the opposite direction to the color point (see the images below).

The disposal of unused medicinal product and all materials that have come into contact with it will be carried out in accordance with local regulations.