Label: Information for the User

Esmeron 10 mg/ml Injectable Solution and for Infusion

Rocuronium, bromide

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

Esmeron belongs to the group of muscle relaxants. Muscle relaxants are used in general anesthesia for surgical operations, so that the muscles completely relax. This facilitates the operation for the surgeon. Normally, nerves send messages to muscles through impulses. Esmeron acts by blocking these impulses, so that the muscles relax. As the muscles necessary for breathing also relax, you will need help breathing (artificial respiration) during and after the operation until you can breathe on your own. The effect of the muscle relaxant is controlled regularly during the operation and if necessary, more medication would be administered. The effects disappear at the end of the operation and then you can start breathing on your own. Sometimes, another medication is administered to speed up this process. Esmeron can also be used in the Intensive Care Unit to keep the muscles relaxed.

This medication is solely for hospital use.

No use Esmeron:

- if you are allergic to rocuronium, bromide ions, or any of the other components of this medication (listed in section 6).

Warnings and precautions

Your medical history may influence how Esmeron is administered to you.

Inform your anesthesiologist if you have had or currently have any of the following conditions:

• allergy to muscle relaxants
• kidney diseases
• heart diseases
• edema (fluid retention, for example, in the ankles)
• liver or gallbladder disease, or liver function abnormalities
• neurological or muscular diseases.

Also inform your anesthesiologist if you have had:

• history ofmalignant hyperthermia (sudden fever with palpitations, rapid breathing, and stiffness, pain, and/or muscle weakness).

Some medical conditions may influence the action of Esmeron. For example, if you have any of these conditions, your anesthesiologist will take them into account when deciding on the correct dose of Esmeron:

• low levels of potassium in the blood
• high levels of magnesium in the blood
• low levels of calcium in the blood
• low levels of proteins in the blood
• dehydration
• excessive acidity in the blood
• excessive carbon dioxide in the blood
• fragile overall health
• obesity
• burns.

Children/elderly patients

Esmeron can be used in children and adolescents (from full-term newborns to 17-year-olds) and elderly patients, but your anesthesiologist will first evaluate your medical history.

Use of Esmeron with other medications

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

Other medications may influence the effects of Esmeron or vice versa. If you take (or think you will take) one of the following medications, you must inform your doctor.

The following medications mayincreasethe effect of Esmeron:

• some anesthetics
• concurrent and prolonged use of corticosteroids with Esmeron over a long period in the Intensive Care Unit (anti-inflammatory agents)
• some antibiotics for bacterial infections
• some medications for bipolar disorder (e.g., lithium)
• some medications for heart disease or hypertension (quinidine, calcium channel blockers, beta-blockers)
• some medications for malaria (quinine)
• diuretics that increase urine volume
• magnesium salts
• local anesthetics (lidocaine, bupivacaine)
• use of antiepileptic medications during surgery (phenytoin).

The following medications maydecreasethe effect of Esmeron:

• prolonged use of antiepileptic medications: phenytoin and carbamazepine
• medications for pancreatitis, blood clotting disorders, or acute blood loss (protease inhibitors: gabexate, ulinastatin).

The following medications have avariable effecton Esmeron:

• other muscle relaxants.

Esmeron may influence the effects of the following medications:

• may increase the effect of local anesthetics (such as lidocaine).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before Esmeron is administered.

Breastfeeding should be suspended 6hours after using this medication.

Driving and operating machinery

Your doctor will inform you when you can drive and use potentially hazardous machinery safelyafterthe administration of Esmeron.

Esmeron contains sodium

This medication contains less than 23mg of sodium (1mmol) per vial; it is essentially “sodium-free”.

Your doctor will adjust the dose according to your needs. They will administer Esmeron before or during the operation. The recommended dose is 0.6 mg per kilogram of body weight, and the effect lasts for 30 to 40 minutes. During the operation, the activity of Esmeron will be checked. If necessary, additional doses will be administered, depending on various factors, such as possible interactions with other medications, the expected duration of the operation, your age, or your health status.

Your doctor will be responsible for administering Esmeron to you, intravenously, through a simple injection or continuous infusion.

If you use more Esmeron than you should

The medical staff will be monitoring the operation and it is unlikely that they will administer an excessive amount of Esmeron to you. However, if this were to happen, artificial respiration will be maintained until you are able to breathe on your own.

Your doctor may accelerate your recovery by administering a medication that counteracts the effects of the muscle relaxant.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Rare or uncommon (in at least 1 in 10,000 patients)

• Increased heart rate (tachycardia)
• Decreased blood pressure (hypotension)
• Increased or decreased effect of Esmeron
• Pain at the injection site
• Prolonged muscle relaxation effect of Esmeron.

Very rare (less than 1 in 10,000 patients)

• Allergic reactions such as changes in blood pressure and heart rhythm and shock due to low blood circulation
• Chest pressure due to airway muscle spasms (bronchospasm)
• Skin changes (for example, edema, redness, rash, or hives)
• Muscle weakness or paralysis
• Chronic muscle alteration, typically observed after concomitant administration of Esmeron and corticosteroids (anti-inflammatory medications) in critically ill patients in the Intensive Care Unit (steroid myopathy).

Frequency not known (cannot be estimated from available data)

• Dilated pupils (mydriasis) or fixed pupils that do not change size with light or other stimuli
• Severe allergic spasm of coronary blood vessels (Kounis syndrome) causing chest pain (angina) or heart attack (myocardial infarction).

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medications for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Esmeron is only available in hospitals.

Store in refrigerator (between 2°C and 8°C). Store in the original packagingoriginalto protect it from light.

The product can be stored outside the refrigerator at a temperature of up to 30°C for a maximum of 3months. The product can be placed in and out of the refrigerator at any time during the 36month validity period, but the total storage time outside the refrigerator cannot exceed 3months. The storage period cannot exceed the expiration date indicated on the packaging.

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

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

Composition of Esmeron

• The active principle is bromide of rocuronium. Each ml of solution contains 10mg of bromide of rocuronium.
• The other components are sodium acetate, sodium chloride, acetic acid, and water for injectable preparations.1ml of Esmeron contains 1.64mg of sodium.

Appearance of the product and contents of the packaging

Esmeron is a transparent injectable and perfusion solution containing 10mg/ml of bromide of rocuronium. Esmeron is presented in 5ml vials containing 50mg of bromide of rocuronium, in packs of 10vials.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Schering‑Plough,S.A.; C/JosefaValcárcel,42;28027Madrid; Spain

Responsible for manufacturing

N.V. Organon; Kloosterstraat 6; 5349 BH Oss; Netherlandss

Merck Sharp & Dohme B.V.; Waarderweg 39; 2031 BN Haarlem; Netherlands

Local Representative:

MerckSharp&Dohme de España,S.A.; C/JosefaValcárcel,42; 28027Madrid; Spain.

Phone: 91 3210600

Date of the last review of this leaflet:12/2022.

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