DROPERIDOL HIKMA 2.5 mg/mL Injectable Solution

Introduction

Package Leaflet: Information for the User

Droperidol Hikma 2.5 mg/ml Solution for Injection EFG

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What is Droperidol Hikma and what is it used for
2. What you need to know before you use Droperidol Hikma
3. How to use Droperidol Hikma
4. Possible side effects
5. Storage of Droperidol Hikma
6. Contents of the pack and other information

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

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

The active substance of Droperidol Hikma is droperidol. Droperidol belongs to a group of antipsychotics called butyrophenone derivatives.

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

Do not useDroperidol Hikmaif:

• you are allergic to droperidol or any of the other ingredients of this medicine (listed in section 6).
• you are allergic to a group of medicines used to treat psychiatric disorders, called butyrophenones (e.g. haloperidol, triperidol, benperidol, melperone, domperidone)
• you or someone in your family has heart rhythm disorders (ECG).
• you have low potassium or magnesium levels in your blood
• you have a heart rate below 55 beats per minute (your doctor or nurse will check this), or you are taking medicines that may cause this situation
• you have an adrenal gland tumor (pheochromocytoma)
• you are in a coma
• you have Parkinson's disease
• you have severe depression

Warnings and precautions

Tell 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)
• if you or someone in your family has a history of blood clots, as this type of medicine has been associated with the formation of blood clots

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

Other medicines and Droperidol Hikma

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

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

The use of metoclopramide and other neuroleptics during treatment with droperidol should be avoided, as the risk of movement disorders induced by these medicines is increased.

Droperidol, the active substance of Droperidol Hikma, may increase the effects of sedatives such as barbiturates, benzodiazepines, and morphine-derived products. It may also increase the effects of medications used to lower blood pressure (antihypertensives) 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 pectoris). If you have any other questions, ask your doctor or nurse.

Using Droperidol Hikma with food and alcohol

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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

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 taking droperidol.

3. How to use Droperidol Hikma

Droperidol will be administered to you by a doctor through an injection into a vein.

The amount and method of administration of droperidol will depend on the situation. Your doctor will determine the amount of droperidol you need based on different criteria, including your weight, age, and medical situation.

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

If you have any other questions about the use of this medicine, 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.

4. Possible side effects

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

Contact your doctor immediatelyif you experience any increase in body temperature, muscle stiffness, tremors, rapid swelling of 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 effects not mentioned in this leaflet, please tell your doctor, nurse, or pharmacist.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Droperidol Hikma

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 vial after EXP. The expiry date is the last day of the month shown.

Store in the original package.

The solution should be used immediately after opening.

Compatibility of droperidol with morphine sulfate in 0.9% sodium chloride (14 days at room temperature) in plastic syringes has been demonstrated. From a microbiological point of view, the diluted product should be used immediately. If not used immediately, the time and conditions under which the product is stored after opening, before use, 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 under validated and controlled aseptic conditions.

Do not use Droperidol Hikma if you notice visible signs of deterioration. The product should be visually inspected before use and only clear solutions free of visible 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. This will help protect the environment.

6. Contents of the pack and other information

Composition of Droperidol Hikma

• The active substance is droperidol, each milliliter of solution contains 2.5 mg of droperidol.
• The other ingredients are lactic acid and water for injections.

Appearance and packaging of the product

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

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Hikma Farmacêutica (Portugal), S.A.

Estrada do Rio da Mó, 8 - Terrugem

2705-906 Sintra

Portugal

You can request more information about this medicine from 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 medicine is authorized in the Member States of the European Economic Area under the following names:

Portugal: Droperidol Hikma

Spain: Droperidol Hikma 2.5 mg solution for injection 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

Date of last revision of this leaflet:December 2017

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.

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The following information is intended for healthcare professionals only:

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

Incompatibilities:

Incompatible with barbiturates.

Instructions for use, handling, and disposal

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

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

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

Disposal of unused medicine and all materials that have come into contact with it will be carried out in accordance with local regulations.