HYPNOMIDATE 2 mg/ml INJECTABLE SOLUTION

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

HYPNOMIDATE 2 mg/ml solution for injection

Etomidate

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.
• 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 HYPNOMIDATE 2 mg/ml solution for injection is and what it is used for
2. What you need to know before you are given HYPNOMIDATE 2 mg/ml solution for injection
3. How HYPNOMIDATE 2 mg/ml solution for injection is given
4. Possible side effects
5. Storage of HYPNOMIDATE 2 mg/ml solution for injection
6. Contents of the pack and other information

1. What HYPNOMIDATE 2 mg/ml solution for injection is and what it is used for

HYPNOMIDATE 2 mg/ml solution for injection is a sterile solution for injection that contains a substance called etomidate, which belongs to the group of general anesthetics.

HYPNOMIDATE 2 mg/ml solution for injection is used to induce general anesthesia (induces sleep during a surgical procedure).

2. What you need to know before you are given HYPNOMIDATE 2 mg/ml solution for injection

Do not use HYPNOMIDATE 2 mg/ml solution for injection

If you are allergic (hypersensitive) to etomidate or any of the other ingredients of HYPNOMIDATE 2 mg/ml solution for injection.

Warnings and precautions

Tell your doctor or nurse before you are given HYPNOMIDATE 2 mg/ml solution for injection

• Single induction doses of etomidate may cause transient adrenal insufficiency and decreased serum cortisol levels.
• If you have adrenal dysfunction (a condition affecting the gland above the kidneys), you may need a supplement of a substance called cortisol.
• HYPNOMIDATE should not be used for the maintenance of anesthesia, as it may cause a decrease in blood cortisol and aldosterone levels.
• Etomidate should be used with caution in critically ill patients, including those with sepsis, as it has been associated with an increased risk of mortality in these patient groups.
• If you have a hereditary disease (a disorder affecting the production of the heme group), the use of HYPNOMIDATE should be avoided unless there is no better anesthetic available.
• If you have hypotension, as the use of HYPNOMIDATE may be accompanied by a slight and transient decrease in blood pressure.
• In elderly patients, as higher doses than recommended have been associated with a risk of decreased cardiac performance.

Adrenal or hepatic impairment

Always tell your doctor if you have liver or kidney disease.

Other medicines and HYPNOMIDATE 2 mg/ml solution for injection

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.

Some medicines, if taken with HYPNOMIDATE, may cause an alteration in their effect. This is especially important in the case of taking medicines to calm (such as neuroleptics), pain relievers (such as opioids), or sedatives, as they may increase the hypnotic effect (drowsiness) of HYPNOMIDATE.

Induction with etomidate may potentiate the blood pressure-lowering effects of other drugs.

The combined use of HYPNOMIDATE with alfentanil (an opioid anesthetic) decreases etomidate concentrations below the hypnotic threshold (the value from which sleep is induced).

Your doctor will assess whether it is necessary to administer HYPNOMIDATE with a pain reliever to alleviate pain.

Your doctor may administer other medicines (narcotic analgesics or diazepam) before using HYPNOMIDATE to reduce spontaneous uncontrolled muscle movements that may occur in some patients.

Using HYPNOMIDATE 2 mg/ml solution for injection with food and drinks

Alcohol may increase the hypnotic effect (drowsiness, sleep) of HYPNOMIDATE.

Pregnancy and breastfeeding

Ask your doctor or pharmacist for advice before taking any medicine.

Etomidate has been identified in breast milk. The effect of etomidate on neonates is unknown. Breastfeeding should be interrupted during treatment and for a period of approximately 24 hours after treatment with HYPNOMIDATE.

If you think you are pregnant, inform the nurse or doctor.

Driving and using machines

Do not drive or operate tools or machines during the first 24 hours after receiving HYPNOMIDATE, as this medicine may affect your reaction ability or your ability to drive. Your doctor will tell you how long you should wait before driving or using machines.

Important information about some of the ingredients of HYPNOMIDATE

This medicine contains propylene glycol. It may cause symptoms similar to those of alcohol, which may decrease the ability to drive or operate machinery.

HYPNOMIDATE contains propylene glycol

If the child is under 5 years of age, consult your doctor or pharmacist, especially if they have been given other medicines that contain propylene glycol or alcohol.

If you are pregnant or breastfeeding, do not take this medicine unless it is recommended by your doctor. Your doctor may perform additional checks while you are taking this medicine.

If you have liver or kidney failure, do not take this medicine unless it is recommended by your doctor. Your doctor may perform additional checks while you are taking this medicine.

3. How HYPNOMIDATE 2 mg/ml solution for injection is given

HYPNOMIDATE is a hospital-only medicine, so it will be administered intravenously in a hospital by the corresponding healthcare personnel.

HYPNOMIDATE should only be administered by expert doctors, and the necessary equipment for artificial respiration should be available at all times.

It should be injected slowly, usually over 30 seconds. It should not be mixed with any other product.

Your doctor will adjust the dose based on each patient's response and clinical effects.

The recommended dose is:

Use in adults

The effective anesthetic dose (which induces sleep) to obtain a sleep duration of 4-5 minutes is 0.3 milligrams/kilogram of body weight. This dose may be adapted to body weight.

Sedation can be prolonged by additional injections of HYPNOMIDATE, without exceeding a total of 3 ampoules (30 milliliters).

Since HYPNOMIDATE has no analgesic effect, it is recommended to administer an appropriate opioid intravenously, for example, 1-2 milliliters of fentanyl, 1-2 minutes before the injection of HYPNOMIDATE.

Use in children

In children under 15 years of age, if sufficient depth of sleep is not achieved with the usual adult dose, the dose may need to be increased by up to 0.4 milligrams/kilogram of body weight (a maximum of 30%), carefully weighing the potential risk against the expected benefit.

Use in elderly patients

The recommended dose is a single dose of 0.15-0.2 milligrams/kilogram of body weight, and then adjust according to the effects.

The dose of HYPNOMIDATE should be adjusted:

If you have been given too much HYPNOMIDATE 2 mg/ml solution for injection:

In case of overdose, the most frequent symptoms are: low blood pressure, interruption of breathing (apnea) for short periods, prolonged sleep time, increased depth of sleep, disorientation, and/or difficulty waking up. Respiratory depression may also occur, which can lead to respiratory arrest, in which case assisted ventilation should be performed.

In case of overdose or accidental ingestion, consult the Toxicology Information Service.

Phone (91) 562 04 20

Information for the doctor in case of overdose

In addition to supportive measures (such as assisted respiration), the administration of 50-100 milligrams of hydrocortisone (not Adrenocorticotropic Hormone [ACTH]) may be necessary.

General supportive measures and close monitoring are recommended.

4. Possible side effects

Like all medicines, HYPNOMIDATE 2 mg/ml solution for injection can cause side effects, although not everybody gets them.

Very common side effects (affect more than 1 in 10 patients)

• Involuntary muscle movements
• Decreased cortisol

Common side effects (affect less than 1 in 10 patients)

• Involuntary muscle movements with muscle spasms, muscle contractions, or slow, rigid, or spastic movements
• Pain around the injection site
• Low blood pressure
• Temporary cessation of breathing
• Increased respiratory rate
• Wheezing during breathing
• Vomiting
• Nausea
• Rash

Uncommon side effects (affect less than 1 in 100 patients)

• Muscle tension and/or rigidity
• Involuntary muscle contraction
• Involuntary eye movements
• You may feel changes in your heart rate or rhythm (such as slow heart rate, irregular heartbeats, or palpitations)
• Phlebitis

• High blood pressure

• Abnormally slow and/or weak breathing
• Hiccup
• Cough
• Excessive saliva
• Redness of the skin
• Pain at the injection site
• Effects related to anesthesia, including delayed recovery from anesthesia, inadequate pain relief, or other complications such as nausea

Side effects of unknown frequency(cannot be estimated from the available data from clinical trials)

• Allergic reaction (including anaphylactic shock, anaphylactic reaction, and anaphylactoid reaction) recognized by rash or redness of the skin, urticaria or itching, difficulty breathing, or swelling of the face
• Insufficient production of cortisol (a hormone produced by the adrenal glands)
• Seizures
• Cardiac arrest
• Cardiac arrhythmias such as complete atrioventricular block
• Insufficient blood flow to the body's tissues (shock)
• Phlebitis associated with blood clot formation (including superficial thrombophlebitis and deep vein thrombosis)
• Slow and insufficient breathing (respiratory depression)
• Spasm of the airways (including fatal outcome)
• A severe form of rash called Stevens-Johnson syndrome may occur
• Urticaria or itching
• Contraction of the muscles around the jaw responsible for chewing

You may also experience problems recovering from anesthesia, such as delayed recovery or inadequate pain relief.

If other side effects occur, they usually appear while you are asleep. At these times, a doctor is always present to monitor you. Sometimes, you may feel some of these effects when you wake up, usually in the form of nausea and/or vomiting, hiccups, cough, muscle tension or rigidity, or excessive saliva.

5. Storage of HYPNOMIDATE 2 mg/ml solution for injection

Keep HYPNOMIDATE 2 mg/ml solution for injection out of the sight and reach of children.

Store between 15 and 25°C.

Do not use HYPNOMIDATE 2 mg/ml solution for injection after the expiry date stated on the packaging. The expiry date is the last day of the month indicated.

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 HYPNOMIDATE 2 mg/ml solution for injection

• The active substance is etomidate.
• The other ingredients are propylene glycol and water for injections.

Appearance of the product and packaging

HYPNOMIDATE is a clear, colorless, and particle-free solution for injection.

It is presented in 10-milliliter glass ampoules in packs of 5 units.

Each ampoule (10 milliliters) contains 20 milligrams of etomidate in solution for injection, ready for administration, i.e., 2 milligrams of etomidate per milliliter of solution.

Marketing authorization holder and manufacturer

• Marketing authorization holder

Piramal Critical Care B.V.

Rouboslaan 32, 2252 TR

Voorschoten

Netherlands

• Manufacturer

Piramal Critical Care B.V.

Rouboslaan 32, 2252 TR

Voorschoten

Netherlands

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Euromed Pharma Spain, S.L.

C/Eduard Maristany, 430-432

08918 Badalona

Barcelona - Spain

Date of last revision of the leaflet:November 2021

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

Information for the person administering Hypnomidate

Dosage

The ampoules of Hypnomidate 2 mg/ml solution for injection contain 10 ml of a ready-to-use solution of 20 mg of etomidate, i.e., 2 mg of etomidate per ml of solution. The effective hypnotic dose of HYPNOMIDATE is 0.3 mg/kg of body weight, sufficient to obtain a sleep duration of 4-5 minutes. This dose may be adapted to body weight.

HYPNOMIDATE should be injected slowly intravenously.

Sedation can be prolonged by additional injections of HYPNOMIDATE.

Do not exceed a total of 3 ampoules (30 milliliters).

Since HYPNOMIDATE has no analgesic effect, it is recommended to administer an appropriate opioid intravenously, for example, 1-2 milliliters of fentanyl, 1-2 minutes before the injection of HYPNOMIDATE.

The dose should be adjusted according to the individual response of each patient and the clinical effect.

In elderly patients, a single dose of 0.15-0.2 mg/kg of body weight should be administered, and then adjust according to the effects.

In children under 15 years of age, if sufficient depth of sleep is not achieved with the usual adult dose, the dose may need to be increased by up to 0.4 mg/kg of body weight (a maximum of 30%), carefully weighing the potential risk against the expected benefit.

Instructions for use

The solution for injection should not be mixed with other products.

Wear gloves when opening or handling the ampoule.

In case of accidental skin exposure to the product, the exposed area should be rinsed with plenty of water. Avoid using soap, alcohol, and other cleaning materials, as they may cause chemical or physical abrasions to the skin.