Leaflet: information for the user

Droperidol Hikma 2.5 mg/ml injectable solution EFG

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 pharmacist.
• This medicine has been prescribed for you only and should not be given to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects,consult your doctor or pharmacist,evenifthey are not listed in this leaflet. See section 4.

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

2. What you need to know before starting to use Droperidol Hikma

3. How to use Droperidol Hikma

4. Possible side effects

5.Storage ofDroperidol Hikma

6. Contents of the pack and additional information

Droperidol Hikma is an injectable solution of droperidol, which is used in adults, children (2 to 11 years of age) and adolescents (12 to 18 years of age) to prevent a feeling of nausea or vomiting when waking up after an operation or in adults to prevent a feeling of nausea or vomiting when receiving morphine-derived analgesics after an operation.

The active ingredient of Droperidol Hikma is droperidol. Droperidol belongs to a group of antipsychotics known as butyrophenone derivatives.

Do not useDroperidol Hikmaif:

• You are allergic to droperidol, or to any of the other components of this medication (listed in section 6).
• You are allergic to a group of medications used to treat psychiatric disorders, called butyrophenones (e.g. haloperidol, triperidol, benperidol, melperona, domperidona)
• You or someone in your family has abnormalities in the electrocardiogram (ECG).
• You have low levels of potassium or magnesium in your blood
• You have a heart rate of less than 55 beats per minute (your doctor or nurse will check this), or you are taking medications that may cause this situation
• You have a tumor in your adrenal gland (pheochromocytoma)
• You are in a coma
• You have Parkinson's disease
• You have severe depression

Warnings and precautions

Inform your doctor or pharmacist before starting to use droperidol, especially if:

• You have epilepsy, or a history of epilepsy
• You have heart problems or a history of heart disease
• You have a family history of sudden death
• You have kidney problems (especially if you are on long-term dialysis)
• You have any lung disease or breathing difficulties
• You have prolonged vomiting or diarrhea
• You are using insulin
• You are taking diuretics that cause potassium loss (e.g. furosemide or bendroflumethiazide)

• You are taking laxatives
• You are taking glucocorticoids (a type of steroid hormone)
• You or someone in your family has a history of blood clots, as this type of medication has been associated with blood clot formation

• You are or have been a heavy drinker (of alcohol)

Other medications and Droperidol Hikma

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Do not useDroperidol Hikma if you are taking any of the following medications:

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

Droperidol, the active ingredient in Droperidol Hikma, may increase the effects of sedatives such as barbiturates, benzodiazepines, and morphine derivatives. It may also increase the effects of medications used to lower blood pressure (anti-hypertensives) and other medications, such as certain antifungals, antivirals, and antibiotics. Some medications may also increase the effects of droperidol, such as cimetidine (for stomach ulcers), ticlopidine (to prevent blood clotting), and mibefradil (for angina). If you have any other questions, ask your doctor or nurse.

Use of Droperidol Hikma with food and alcohol

Avoid consuming alcoholic beverages during the 24 hours before and after using droperidol.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before taking this medication.

If you are breastfeeding and plan to take droperidol, a single administration of droperidol is recommended. You can resume breastfeeding after the operation.

Driving and operating machinery

Droperidol has a significant effect on your ability to drive and operate machinery.

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

Droperidol will be administered by a doctor via an intravenous injection.

The amount and manner in which droperidol is administered will depend on the situation. Your doctor will determine the amount of droperidol you need based on various criteria, including your weight, age, and medical condition.

The recommended dose in adults is between 0.625 and 1.25 mg, reduced to 0.625 mg for elderly individuals (over 65 years old) and for patients with hepatic or renal insufficiency. The recommended dose in children (2 to 11 years old) and adolescents (12 to 18 years old) is based on body weight (10 to 50 micrograms/kg) up to a maximum of 1.25 mg. Droperidol is not recommended for use in children under 2 years old.

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Contact your doctor immediatelyif you experience any increase in your body temperature, muscle stiffness, tremors, rapid swelling in the face or throat, or if you feel chest pain after taking this medicine.

The following side effects have been reported: If any of these side effects are severe, or if you notice any side effect not mentioned in this leaflet, please inform your doctor, nurse or pharmacist.

Reporting of side effects

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

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

Do not use this medication after the expiration date that appears on the packaging and vial after "Cad." The expiration date is the last day of the month indicated.

Store in the original packaging.

The solution must be used immediately, once opened.

Droperidol has been demonstrated to be compatible with morphine sulfate in a 0.9% sodium chloride solution (14 days at room temperature) in plastic syringes. From a microbiological standpoint, the diluted product must be used immediately. If not used immediately, the time and conditions under which it has been stored once opened, before being used, are the responsibility of the user and normally should not exceed 24 hours, stored at a temperature between 2 and 8 °C, unless the solution has been stored in validated and controlled aseptic conditions.

Do not use Droperidol Hikma if you observe visible signs of deterioration. The product must be visually inspected prior to use and only solutions that are transparent and free of particles should be used.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

Composition of Droperidol Hikma

• The active ingredient is droperidol, each milliliter of solution contains 2.5 mg of droperidol.
• The other components are lactic acid and water for injectable preparations.

Appearance of the product and contents of the package

Droperidol Hikma is a transparent and colorless injectable solution contained in amber glass vials of 2 ml. Each vial contains 1 milliliter of solution and is packaged in boxes containing 10 or 25 vials.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Hikma Farmacêutica (Portugal), S.A.

Estrada do Rio da Mó, 8 - Terrugem

2705-906 Sintra

Portugal

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

Hikma España, S.L.U.

Calle Anabel Segura nº11, Edificio A, planta 1ª, oficina 2

28108 - Alcobendas, Madrid

Spain

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Portugal: Droperidol Hikma

Spain: Droperidol Hikma 2.5 mg injectable solution EFG

France: Dropéridol Hikma 2.5 mg/ 1 ml, solution injectable

Germany: Droperidol Hikma 2.5 mg/ml Injektionslösung

Italy: Droperidolo Hikma

United Kingdom: Droperidol 2.5 mg/ml Solution for injection

Last review date of this leaflet:December 2017

Further information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.

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The following information is intended only for healthcare professionals:

In addition to the information included in section 3, the following practical information is provided for the preparation/handling of the medicinal product:

Incompatibilities:

Incompatible with barbiturates.

Instructions for use, handling and disposal

For single use only. Unused solution must be discarded.

The solution must be visually inspected before use. Only transparent and colorless solutions, free of visible particles, should be used.

To use in PCA: Extract droperidol and morphine with a syringe and reach the desired volume with 0.9% sodium chloride for injection.

Disposal of unused medicinal product and all materials that have been in contact with it, will be carried out in accordance with local regulations.