PATIENT INFORMATION LEAFLET

HYPNOMIDATE 2 mg/ml injectable solution

Etomidate

Read this leaflet carefully before you start using the medicine, as 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.

- If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

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

3.How to administer HYPNOMIDATE 2 mg/ml injectable solution

4.Possible side effects

5. Storage of HYPNOMIDATE 2 mg/ml injectable solution

6.Contents of the pack and additional information

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

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

Do not use HYPNOMIDATE 2 mg/mlinjection

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

Warnings and precautions

Consult your doctor or nurse before they administer HYPNOMIDATE 2 mg/ml injection

• Single doses of etomidate induction may cause transient adrenal insufficiency and decreased cortisol serum levels.
• If you have any alterations in the function of a gland called the adrenal gland (located above the kidneys) as 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 levels of substances called cortisol and aldosterone.
• Etomidate should be used with caution in critically ill patients, including patients with sepsis, as it has been associated with a higher risk of mortality in these patient groups.
• If you have a hereditary disease (alteration in hemoglobin production), the use of HYPNOMIDATE should be avoided unless there is no better anesthetic.
• 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 there has been a risk of decreased cardiac performance with doses greater than recommended.

Adrenal or hepatic dysfunction

Always inform your doctor if you have liver or kidney diseases.

Other medications and HYPNOMIDATE 2 mg/mlinjection

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

Some medications taken concurrently with HYPNOMIDATE may alter its effect. This is especially important when taking medications to calm (such as neuroleptics), pain medications (such as opioids), and sedative medications, as they may increase the hypnotic effect (drowsiness) of HYPNOMIDATE.

The induction with etomidate may potentiate the effects of blood pressure-lowering medications.

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

Your doctor will assess whether it is necessary to administer HYPNOMIDATE with an analgesic to relieve pain.

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

Use of HYPNOMIDATE 2 mg/mlinjection with food and beverages

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

Pregnancy and lactation

Consult your doctor or pharmacist before using any medication.

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

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

Driving and operating machinery

Do not drive or operate tools or machinery during the first 24 hours after receiving HYPNOMIDATE, as this medication may affect your reaction time or ability to drive. Your doctor will indicate how long you should wait before driving or operating machinery.

Important information about some of the components of HYPNOMIDATE.

This medication contains propylene glycol. It may produce symptoms similar to those of alcohol, which may decrease your 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 other medications containing propylene glycol or alcohol have been administered.

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

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

HYPNOMIDATE is a hospital-use medication, which will be administered intravenously in a hospital by the corresponding healthcare personnel.

HYPNOMIDATE must be administered exclusively by experienced doctors, and the necessary equipment for artificial respiration must be available at all times.

It must be injected slowly, usually over a period of 30 seconds. It must 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 anesthetic dose (producing sleep) effective for a duration of sleep of 4-5 minutes is 0.3 milligrams/kilogram of body weight. This dose can be adapted to body weight.

Hypnosis (sleep) can be prolonged by additional injections of HYPNOMIDATE without

exceeding the total amount of 3 ampoules (30 milliliters).

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

Use in children

In children under 15 years, if a sufficient depth of sleep is not achieved with the usual adult dose, this 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 between0.15 to0.2 milligrams/kilogram of body weight, and then adjust as needed based on effects.

The dose of HYPNOMIDATE should be adjusted:

• if you have a severe liver disease (cirrhosis)
• if you have previously received treatment with tranquilizers (neuroleptics), pain relievers (opioids), or sedatives.

If you have been administered more HYPNOMIDATE 2 mg/mlinjectable solutionthan you should:

In case of overdose, the most common symptoms are: low blood pressure, interruption of breathing (apnea) for short periods of time, prolongation of 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 Toxicological Information Service.

Telephone (91) 562 04 20

Information for the doctor in case of overdose

In addition to supportive measures (e.g. assisted respiration), administration of 50-100 mg of hydrocortisone (not Adrenocorticotropic Hormone [ACTH]) may be necessary.

General supportive measures and close observation are recommended.

Like all medicines,HYPNOMIDATE 2 mg/mlinjectable solutionmay cause side effects, although not everyone will experience them.

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

• Muscle spasms
• Decreased cortisol levels

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

• Muscle spasms, muscle contractions, or slow, stiff, or spasmodic movements
• Pain around the injection site
• Low blood pressure
• Temporary cessation of breathing
• Increased respiratory rate
• Twitching during breathing
• Vomiting
• Nausea
• Rash

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

• Muscle tension and/or stiffness
• Involuntary muscle contractions
• Muscle spasms of the eye muscles
• You may feel changes in your heart rate or rhythm (such as slow heart rate, irregular heartbeat, or palpitations)
• Phlebitis

• High blood pressure

• Abnormally slow and/or weak breathing
• Hiccup
• Coughing fit
• Excessive salivation
• 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 available clinical trial data)

• Allergic reaction (including anaphylactic shock, anaphylactic reaction, and anaphylactoid reaction) recognized by rash or redness of the skin, urticaria, or itching, difficulty breathing, or facial swelling
• Inadequate production of cortisol (hormone produced by the adrenal glands)
• Seizures
• Cardiac arrest
• Arrhythmias such as complete atrioventricular block
• Inadequate blood flow to body tissues (shock)
• Phlebitis associated with the formation of a blood clot (including superficial thrombophlebitis and deep vein thrombosis)
• Slow and inadequate breathing (respiratory depression)
• Spasms of the respiratory tract (including fatal outcome)
• A severe form of rash calledSterling-Johnson syndrome
• Urticaria or itching
• Muscle contractions around the jaw responsible for mastication

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. In those moments, 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, hiccup, coughing fit, muscle tension, or excessive salivation.

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

Store between 15 and 25°C.

Do not use HYPNOMIDATE 2 mg/ml injectable solution after the expiration date appearing on the packaging. The expiration date is the last day of the month indicated.

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

Composition of HYPNOMIDATE 2 mg/mlINJECTABLE SOLUTION

-The active ingredient is etomidate.

-The other components are: propylene glycol and water for injection.

Appearance of the product and contents of the package

HYPNOMIDATE is a transparent, colorless, and particle-free injectable solution.

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

Each ampoule (10 milliliters) contains 20 milligrams of etomidate in a ready-to-administer injectable solution, that is, 2 milligrams of etomidate per milliliter of solution.

Holder of the marketing authorization and responsible for manufacturing

-Holder

Piramal Critical Care B.V.

Rouboslaan 32, 2252 TR

Voorschoten

Netherlands

-Responsible for manufacturing

Piramal Critical Care B.V.

Rouboslaan 32, 2252 TR

Voorschoten

Holland

You can request more information about this medication 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 the last review of the leaflet:November 2021

The detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.

Information for the person administering Hypnomidate

Dosage

Hypnomidate 2 mg/ml injectable solution ampoules contain 10 ml of a ready-to-administer solution of 20 mg of etomidate, that is, 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 duration of sleep of 4-5 minutes. This dose can be adjusted according to body weight.

HYPNOMIDATE must be injected slowly intravenously.

Hypnosis can be prolonged by additional injections of HYPNOMIDATE.

The total amount of 3 ampoules (30 ml) should not be exceeded.

Since HYPNOMIDATE has no analgesic effect, it is recommended to administer intravenously an appropriate opioid, for example 1-2 ml 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 adjusted according to the effects

In children under 15 years, if the usual adult dose does not achieve sufficient depth of sleep, it may be necessary to increase the dose by a maximum of 30%, that is, up to 0.4 mg/kg of body weight, carefully evaluating the potential risk against the expected benefit.

Instructions for use

The injectable solution should not be mixed with other products.

Use gloves when opening or handling the ampoule.

In case of accidental exposure of the skin 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 on the skin.