2.5 mg / ml injection solution 
droperidol

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

– Save this information, you may need to read it again.

– If you have any further questions, ask your doctor or nurse.

– If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Dridol is and what it is used for 
2. What you need to know before you use Bridal 
3. How to use Dridol 
4. Possible side effects 
5. How to store Dridol 
6. Contents of the packaging and other information 

1. What Dridol is and what it is used for

Dridol is a solution for injection that contains the active substance droperidol, which belongs to a group of antipsychotic medicines called butyrophenone derivatives. Dridol is used to prevent you from feeling nauseous or vomiting when you wake up after an operation or when you are given morphine-based painkillers after an operation.

Droperidol contained in Dridol may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

2. What you need to know before you use Dridol

Do not use Dridol

  • if you are allergic to droperidol or any of the other ingredients of this medicine (listed in section 6)
  • if you are allergic to a group of medicines used to treat mental illnesses called butyrophenones (eg haloperidol, triperidol, bone peridol, melperon, domperidone)
  • if you or someone in your family has an abnormal ECG (examination that measures the electrical activity of the heart)
  • if you have low levels of potassium or magnesium in your blood
  • if you have a heart rate of fewer than 55 beats per minute (your doctor or nurse will check this) or take medicines that may cause it
  • if you have a tumor in the adrenal gland ( pheochromocytoma )
  • if you are in a coma
  • if you have Parkinson’s disease
  • if you have severe depression.

Warnings and cautions

Talk to your doctor or nurse before giving Dridol:

  • if you have or have had epilepsy
  • if you have or have had heart problems
  • if there have been sudden deaths in the family
  • if you have kidney problems (especially if you are on long-term dialysis)
  • if you have a lung disease and difficulty breathing
  • if you have persistent vomiting or diarrhea
  • if you are taking insulin
  • if you are taking potassium-depleting diuretics, ie. diuretic tablets (eg furosemide or bendroflumethiazide)
  • if you are taking a laxative
  • if you are taking medicines called glucocorticoids (a type of steroid hormone)
  • if you or anyone else in your family has had blood clots, as medicines like these have been linked to the formation of blood clots
  • if you are or have been a person who drinks a lot (alcohol).

Other medicines and Dridol

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

You should not be given Dridol if you are taking any of the following medicines as the combination increases the risk of the irregular heartbeat which could lead to a heart attack:

What the medicine is used for Drug
Cardiac arrhythmia/irregular heartbeat Class IA and III antiarrhythmics
Infection (bacterial) Antibiotics of the macrolide – and fluoroquinolone
Malaria Anti-malaria medication
Allergy is Antihistamines are
Mental illnesses, such as schizophrenia Antipsychotics
Heartburn Cisapride
Parasite infestation or fungal infection Pentamidine
Nausea or vomiting Domperidone
Opioid dependence; pain Methadone

Metoclopramide and other neuroleptics should be avoided when taking Dridol as the risk of movement disorders caused by these drugs increases.

Other medicines can affect or be affected by when used at the same time as Dridol.

Droperidol, the active substance in Dridol:

  • may increase the effects of sedatives such as barbiturates, benzodiazepines, and morphine-based drugs
  • may increase the effect of medicines used to lower blood pressure
  • may increase the effect of several other drugs e.g. certain antifungal drugs, antiviral drugs, and antibiotics.

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

Dridol with food, drink, and alcohol

Avoid drinking alcohol 24 hours before and after receiving Dridol.

Pregnancy, breastfeeding, and fertility

If you are pregnant, tell your doctor who will decide if you should receive Dridol.

The following symptoms may occur in newborns, to mothers who have used Dridol during the last trimester (last three months of pregnancy): tremors, muscle stiffness and/or weakness, fatigue, anxiety, difficulty breathing, and difficulty eating. If your child develops any of these symptoms, you should contact your doctor.

If you are breast-feeding and are about to receive Dridol, you will only receive one dose of Dridol. Breastfeeding can be resumed after you wake up after the operation.

Consult a doctor before taking 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 receiving Dridol.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Dridol contains excipients

This medicine contains less than 1 mmol sodium (23 mg) per 1 ml, ie essentially ‘sodium-free’.

3. How to use Dridol

You will be given Dridol by your doctor as an injection into a vein.

The amount of Dridol and how it is given depends on the situation. Your doctor will decide how much Dridol you need based on several factors, including your weight, age, and condition.

If you use more Dridol than you should 

This medicine is given to you by a doctor and you are probably not taking too much of the medicine. If you suspect that you have been given too much Dridol, tell your doctor or nurse immediately.

If you have any further questions on the use of this product, ask your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Contact a doctor or nurse immediately if you experience any of the following serious side effects:

  • Increase in body temperature, sweating, salivation, muscle stiffness, tremors. This may be a sign of so-called neuroleptic malignant syndrome (a very rare side effect).
  • Severe allergic reaction or rapid swelling of the face or throat, difficulty swallowing, hives, or difficulty breathing (very rare side effect).

The following side effects have also been reported:

Common side effects (may affect up to 1 in 10 people):

  • Drowsiness
  • Low blood pressure

Mind re common side effect is (may affect up to 1 in 100):

  • Anxiety
  • Eye rolls
  • Fast heartbeats, e.g. more than 100 beats per minute
  • Dizziness

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

  • Confusion
  • Agitated ( agitation )
  • Irregular heartbeats
  • Rash

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

  • Blood diseases (usually diseases that affect red blood cells or platelets ). You can consult your doctor.
  • Mood swings towards sadness, anxiety, depression, and irritability
  • Involuntary muscle movements
  • Seizures or tremors
  • Heart attack (cardiac arrest)
  • Sudden death
  • Torsades de pointes (irregular heartbeat, life-threatening)
  • Prolonged QT interval, seen on ECG (a heart problem that affects the heartbeat)

Has been reported (occurs in an unknown number of users):

  • Disturbed secretion of antidiuretic hormone (too much hormone is released which leads to a too high a level of water and too loa w level of sodium in the body)
  • Hallucinations
  • Epileptic seizures
  • Parkinson’s disease
  • Fainting
  • Breathing difficulties

5. How to store Dridol

  • 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 ampoule after EXP. respectively Exp. The expiration date is the last day of the specified month.
  • Store in the original package. Sensitive to light.
  • The solution should be used immediately after the first opening.
  • Compatibility between droperidol and morphine sulfate in 0.9% sodium chloride (14 days at room temperature) has been demonstrated in plastic syringes. From a microbiological point of view, diluted medicine should be used immediately. If not used immediately, in-use storage times and conditions before use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8 ° C, unless dilution has been performed under controlled and validated aseptic conditions.
  • Do not use this medicine if you notice signs of deterioration. The product must be inspected visually before use and only clear solutions that are practically 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. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is droperidol, one milliliter solution contains 2.5 mg droperidol.
  • The other ingredients are mannitol, tartaric acid, sodium hydroxide, and water for injections.

What the medicine looks like and the contents of the pack

Dridol is a clear, colorless solution for injection.

The solution is available in amber glass ampoules. One ampoule contains 1 milliliter of the solution and is packed in cartons containing 10 ampoules.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Kyowa Kirin Holdings BV

Bloemlaan 2

2132NP Hoofddorp

Netherlands

Manufacturer

Delpharm Tours

rue Paul Langevin

37170 Chambray-les-Tours

France

Muhammad Nadeem

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