ESMERON 10 mg/ml INJECTABLE SOLUTION AND PERFUSION SOLUTION

Introduction

Package Leaflet: Information for the User

Esmeron 10 mg/ml solution for injection and infusion

Rocuronium, bromide

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 experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the package leaflet

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

1. What is Esmeron and what is it used for

Esmeron belongs to a group of medicines called muscle relaxants. Muscle relaxants are used in general anesthesia for surgical operations to relax the muscles completely. This makes the operation easier for the surgeon. Normally, nerves send messages to the muscles through impulses. Esmeron works by blocking these impulses, causing the muscles to relax. Since the muscles needed 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 regularly monitored during the operation, and if necessary, more medication will be administered. The effects disappear at the end of the operation, and then you can start breathing on your own. Sometimes, another medication is given to speed up this process. Esmeron can also be used in the Intensive Care Unit to keep the muscles relaxed.

This medicine is for hospital use only.

2. What you need to know before you use Esmeron

Do not use Esmeron:

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

Warnings and precautions

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

Tell your anesthesiologist if you have had or currently have any of the following diseases:

• allergy to muscle relaxants
• kidney disease
• heart disease
• edema (fluid retention, for example, in the calves)
• liver or bile duct disease, or liver function disorders
• diseases that affect the nerves and muscles.

Also, inform your anesthesiologist if you have had:

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

Certain medical conditions may affect how Esmeron works. For example, if you have any of these conditions, your anesthesiologist will take them into account when deciding the correct dose of Esmeron:

• low potassium levels in the blood
• high magnesium levels in the blood
• low calcium levels in the blood
• low protein levels in the blood
• dehydration
• too much acid in the blood
• too much carbon dioxide in the blood
• poor overall health
• overweight
• burns.

Children/elderly patients

Esmeron can be used in children and adolescents (from birth to 17 years) and elderly patients, but your anesthesiologist will evaluate your medical history first.

Using Esmeron with other medicines

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

Other medicines may affect the effects of Esmeron or vice versa. If you take (or think you might take) any of the following medicines, you should inform your doctor.

The following medicines may increasethe effect of Esmeron:

• certain anesthetics
• prolonged use of corticosteroids with Esmeron for a long time in the Intensive Care Unit (anti-inflammatory medications)
• certain medications for bacterial infections (antibiotics)
• certain medications for bipolar disorder (such as lithium)
• certain medications for heart disease or high blood pressure (quinidine, calcium antagonists, beta-blockers)
• certain medications for malaria (quinine)
• medications that increase urine production, such as diuretics
• magnesium salts
• local anesthetics (lidocaine, bupivacaine)
• use of medications for epilepsy during an operation (phenytoin).

The following medicines may decreasethe effect of Esmeron:

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

The following medicines have a variable effecton Esmeron:

• other muscle relaxants.

Esmeron may affect the effects of the following medicines:

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor before Esmeron is administered to you.

Breastfeeding should be stopped 6 hours after the use of this medicine.

Driving and using machines

Your doctor will inform you when you can drive and use potentially hazardous machines safely after the administration of Esmeron.

Esmeron contains sodium

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

3. How to use Esmeron

Your doctor will adjust the dose to your needs. You will be given 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 monitored. If necessary, you will be given more doses, which will depend on various factors, such as possible interactions with other medicines, the expected duration of the operation, your age, or your state of health.

Your doctor will administer Esmeron to you, either by intravenous injection or by continuous infusion.

If you use more Esmeron than you should

The medical staff will be monitoring the operation, and it is unlikely that you will be given too much Esmeron. However, if this happens, artificial respiration will be maintained until you are able to breathe on your own.

Your doctor may speed up your recovery by giving you a medication that counteracts the effects of the muscle relaxant.

4. Possible side effects

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

Rare or uncommon (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 relaxant effect of Esmeron.

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

• allergic reactions such as changes in blood pressure and heart rate, and shock due to low blood circulation
• chest pressure due to muscle spasms in the airways (bronchospasm)
• skin disorders (such as edema, redness, rash, or hives)
• muscle weakness or paralysis
• chronic muscle disorder, usually observed after the 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 the available data)

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Esmeron

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

Esmeron is only available in hospitals.

Store in a refrigerator (between 2°C and 8°C). Keep in the original packaging to protect from light.

The product can be stored outside the refrigerator at a temperature of up to 30°C for a maximum of 3 months. The product can be put in and taken out of the refrigerator at any time during the 36-month validity period, but the total storage time outside the refrigerator must not exceed 3 months. The storage period must not exceed the expiry date stated on the packaging.

Do not use this medicine after the expiry date stated on the packaging. The expiry date is the last day of the month indicated.

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

6. Contents of the pack and further information

Composition of Esmeron

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

Appearance of the product and pack contents

Esmeron is a clear solution for injection and infusion that contains 10 mg/ml of rocuronium bromide. Esmeron is presented in 5 ml vials that contain 50 mg of rocuronium bromide, in packs of 10 vials.

Marketing authorization holder and manufacturer

Marketing authorization holder

Schering-Plough, S.A.; C/ Josefa Valcárcel, 42; 28027 Madrid; Spain

Manufacturer

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

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

Local representative:

Merck Sharp & Dohme of Spain, S.A.; C/ Josefa Valcárcel, 42; 28027 Madrid; Spain.

Tel.: 91 3210600

Date of last revision of this leaflet:12/2022.

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