Esmocard 100 mg/10 ml

Leaflet attached to the packaging: patient information

ESMOCARD 100 mg/10 ml, solution for injection
Esmolol hydrochloride

You should read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult your doctor or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor. See section 4.

Table of contents of the leaflet.

• 1. What is ESMOCARD 100 mg/10 ml and what is it used for?
• 2. Important information before taking ESMOCARD 100 mg/10 ml
• 3. How to take ESMOCARD 100 mg/10 ml
• 4. Possible side effects
• 5. How to store ESMOCARD 100 mg/10 ml
• 6. Contents of the packaging and other information

1. What is ESMOCARD 100 mg/10 ml solution for injection and what is it used for

ESMOCARD 100 mg/10 ml belongs to a group of beta-adrenergic blockers. These medicines slow down the heart rate and lower blood pressure.
ESMOCARD 100 mg/10 ml is used for the short-term treatment of rapid heart rate.
ESMOCARD 100 mg/10 ml is also used during or immediately after surgery, if the patient has high blood pressure and/or rapid heart rate.

2. Important information before taking ESMOCARD 100 mg/10 ml

The doctor will not give the patient ESMOCARD 100 mg/10 ml if:

• the patient is allergic to esmolol hydrochloride - symptoms of an allergic reaction are shortness of breath, wheezing, rash, itching, or swelling of the face and lips,
• the patient has a very slow heart rate (less than 50 beats per minute),
• the patient has a fast or alternating fast and slow heart rhythm,
• the patient has a condition called atrioventricular block - a heart conduction disorder that controls the heart rate,
• the patient has low blood pressure,
• the patient has disorders related to blood flow to the heart,
• the patient has severe symptoms of heart failure,
• the patient is taking or has recently taken verapamil - ESMOCARD 100 mg/10 ml should not be administered within 48 hours of stopping verapamil,
• the patient has untreated adrenal gland disease, called pheochromocytoma (a tumor that can cause sudden high blood pressure, severe headache, excessive sweating, and rapid heart rate),
• the patient has high blood pressure in the lungs (pulmonary hypertension),
• the patient has suddenly worsened asthma symptoms,
• the patient has increased acid levels in the blood (a condition called metabolic acidosis).

If any of the above conditions apply to the patient, the doctor will not give ESMOCARD 100 mg/10 ml. In case of doubts, before receiving ESMOCARD 100 mg/10 ml, the patient should discuss this with their doctor or nurse. The doctor may examine the patient in detail and change the treatment.

Warnings and precautions

Before starting to take ESMOCARD 100 mg/10 ml, the patient should discuss this with their doctor or nurse.
The doctor will exercise particular caution when using this medicine:

• If the patient is being treated for certain heart rhythm disorders, called supraventricular arrhythmias, and:
• has other heart disorders,
• is taking other heart medicines. Using ESMOCARD 100 mg/10 ml in these cases may lead to severe reactions, including death. These include:
• loss of consciousness,
• shock (a condition in which the heart does not pump enough blood),
• heart attack (heart failure).
• If hypotension (excessive lowering of blood pressure) occurs, the symptoms of which may include dizziness or fainting, especially when standing up. These symptoms will quickly disappear after reducing the dose or discontinuing the medicine. Usually, during treatment with ESMOCARD 100 mg/10 ml, blood pressure and ECG are monitored. Low blood pressure usually normalizes within 30 minutes after stopping ESMOCARD 100 mg/10 ml administration.
• If the patient has a slow heart rate before administration.
• If the heart rate decreases below 50-55 beats per minute - in this case, the doctor may recommend a lower dose or discontinuation of ESMOCARD 100 mg/10 ml.
• If the patient has heart failure.
• If the patient has conduction disorders that control the heart rate (atrioventricular block).
• If the patient has adrenal gland disease, called pheochromocytoma, which is treated with medicines called alpha-adrenergic blockers.
• If the patient is being treated for high blood pressure caused by low body temperature (hypothermia).
• If the patient has bronchial constriction or wheezing, as in the case of asthma.
• If the patient has diabetes or low blood sugar (hypoglycemia) - the patient requires special supervision, as esmolol may mask the symptoms of low blood sugar and enhance the effect of antidiabetic medicines.
• If skin changes occur at the injection site. They may be caused by the solution leaking around the injection site. In this case, the doctor will administer the injection in a different vein.
• If the patient has a particular type of angina pectoris (chest pain), called Prinzmetal's angina.
• If the patient has low blood volume (with low blood pressure), as this may lead to circulatory collapse.
• If the patient has circulation disorders, such as Raynaud's disease or pain, fatigue, and sometimes burning pain in the legs.
• If the patient has kidney function disorders. In the case of kidney disease or the need for dialysis, high potassium levels in the blood (hyperkalemia) may occur. This can cause severe heart disorders.
• If the patient has an allergy or is at risk of anaphylactic reaction (severe allergic reaction), as ESMOCARD 100 mg/10 ml may exacerbate the allergy and make it difficult to treat.
• If the patient or a relative has a history of psoriasis (a disease in which scaly patches appear on the skin).
• If the patient has hyperthyroidism.

In the case of liver function disorders, a dose change is not usually necessary.
If the patient has kidney function disorders, the doctor will exercise particular caution.

ESMOCARD 100 mg/10 ml and other medicines

The patient should tell their doctor or nurse about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including those that are available without a prescription, herbal medicines, or natural products.
The doctor will assess whether the medicines being taken will affect the action of ESMOCARD 100 mg/10 ml.
In particular, the patient should inform their doctor or nurse if they are taking any of the following medicines:

• medicines that lower blood pressure or slow down the heart rate,
• medicines used to treat heart rhythm disorders or chest pain (angina), such as verapamil and diltiazem - the patient will not receive ESMOCARD 100 mg/10 ml within 48 hours of stopping verapamil,
• nifedipine used to treat chest pain (angina), high blood pressure, and Raynaud's disease,
• medicines used to treat both heart rhythm disorders (such as quinidine, disopyramide, amiodarone) and heart failure (such as digoxin, digitoxin, digitalis glycosides),
• medicines used to treat diabetes, including insulin and oral antidiabetic medicines,
• so-called ganglionic blockers (e.g., trimethaphan),
• painkillers, such as non-steroidal anti-inflammatory drugs (NSAIDs),
• flecainide (a painkiller),
• amisulpride, a medicine used for mental disorders,
• tricyclic antidepressants (such as imipramine and amitriptyline) or other medicines used for mental disorders,
• barbiturates (such as phenobarbital, used to treat epilepsy) or phenothiazines (such as chlorpromazine, used to treat mental disorders),
• clozapine, which is used to treat mental disorders,
• epinephrine, which is used to treat allergic reactions,
• medicines used to treat asthma,
• medicines used to treat colds or nasal congestion, which constrict the nasal mucosa,
• reserpine, which is used to treat high blood pressure,
• clonidine, which is used to treat high blood pressure and migraine,
• moxonidine, which is used to treat high blood pressure,
• ergot derivatives, used mainly to treat Parkinson's disease,
• warfarin, which is used as an anticoagulant,
• morphine, which is a strong painkiller,
• suxamethonium chloride (also known as succinylcholine or scoline) or mivacurium, used to relax muscles, usually during surgery - the doctor will exercise particular caution when administering ESMOCARD 100 ml/10 g during surgery, along with anesthetics and other medicines.

In case of doubts about whether any of the above points apply to the patient, they should consult their doctor or nurse before receiving ESMOCARD 100 mg/10 ml.
Tests that may be performed during treatment with ESMOCARD 100 mg/10 ml
Treatment with medicines like ESMOCARD 100 mg/10 ml for a long period may cause a decrease in the strength of heart contractions. Since ESMOCARD 100 mg/10 ml is used for a limited time, the occurrence of such an effect is unlikely.
During administration, the doctor will monitor the patient's condition and reduce the dose or discontinue ESMOCARD 100 mg/10 ml if a decrease in the strength of heart contractions occurs.
During administration of ESMOCARD 100 mg/10 ml, the doctor will also recommend blood pressure measurements.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine.
There is insufficient data on the safety of esmolol in pregnant women. However, there is no evidence of increased risk of congenital defects in humans.
ESMOCARD 100 mg/10 ml should not be used during pregnancy, as there is no experience in this area.
The patient should inform their doctor about breastfeeding. ESMOCARD 100 mg/10 ml may pass into breast milk, so the product should not be administered to breastfeeding patients.
Before taking any medicine, the patient should consult their doctor.

ESMOCARD 100 mg/10 ml contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per vial, which means the medicine is considered "sodium-free".

3. How to take ESMOCARD 100 mg/10 ml

The doctor will adjust the dose individually for each patient - they will administer an initial dose, followed by a maintenance dose. They will determine the dosing schedule and modify the dose if side effects occur.
ESMOCARD 100 mg/10 ml will be administered by intravenous injection by a doctor or nurse.
The duration of treatment depends on the effect and potential side effects. The doctor will determine the duration of treatment.
A change in the dose of ESMOCARD 100 mg/10 ml is not usually necessary if the patient has liver function disorders.
If the patient has kidney function disorders, the doctor will exercise particular caution.

Elderly patients

The doctor will start treatment with a lower dose.

Use in children and adolescents

The safety and efficacy of ESMOCARD 100 mg/10 ml in children and adolescents have not been established. ESMOCARD 100 mg/10 ml should not be used in children and adolescents under 18 years of age.

Use of a higher than recommended dose of ESMOCARD 100 mg/10 ml

Since ESMOCARD 100 mg/10 ml is administered by a trained and qualified person, administration of too high a dose is unlikely. However, if this happens, the doctor will stop administering the product and, if necessary, provide additional treatment.

Missed dose of ESMOCARD 100 mg/10 ml

Since ESMOCARD 100 mg/10 ml is administered by a trained and qualified person, it is unlikely that a dose will be missed. However, if the patient has doubts about whether a dose has been missed, they should consult their doctor or nurse as soon as possible.

Discontinuation of ESMOCARD 100 mg/10 ml

Sudden discontinuation of ESMOCARD 100 mg/10 ml may cause a recurrence of symptoms, such as rapid heart rate (tachycardia) or high blood pressure (hypertension).
To avoid this, the doctor will gradually discontinue administration. In patients with coronary heart disease (e.g., angina pectoris or myocardial infarction in their medical history), the doctor will exercise particular caution when discontinuing ESMOCARD 100 mg/10 ml.
In case of any further doubts about the use of this medicine, the patient should consult their doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Most side effects disappear within 30 minutes of discontinuing ESMOCARD 100 mg/10 ml.
The following side effects have been reported during treatment with ESMOCARD 100 mg/10 ml:
If any of the following side effects occur (which may be severe), the patient should immediately inform their doctor or nurse. It may be necessary to discontinue the infusion.
Very common(may occur in at least 1 in 10 patients):

• lowering of blood pressure (can be quickly corrected by reducing the dose of ESMOCARD 100 mg/10 ml or discontinuing administration) - the doctor will recommend frequent blood pressure measurements during treatment
• excessive sweating

Common(may occur in less than 1 in 10 patients):

• loss of appetite
• feeling of anxiety or depression
• dizziness
• drowsiness
• headache
• tingling or numbness
• concentration disorders
• feeling of disorientation or agitation
• nausea or vomiting
• feeling of weakness
• feeling of fatigue (exhaustion)
• irritation and hardening of the skin at the injection site

Uncommon(may occur in less than 1 in 100 patients):

• unusual thoughts
• sudden loss of consciousness
• feeling of fainting or fainting
• seizures (convulsions)
• speech disorders
• vision disorders
• slow heart rate
• disorders of electrical impulses that control the heart rate
• increased pressure in the pulmonary arteries
• heart failure (a condition in which the heart does not pump enough blood)
• heart rhythm disorders, sometimes called palpitations (extra ventricular contractions)
• heart rhythm disorders (nodal rhythm)
• heart disorders caused by poor blood flow through the coronary arteries (angina pectoris)
• poor circulation in the upper or lower limbs
• pallor or sudden flushing (especially of the face and neck)
• fluid in the lungs
• shortness of breath or chest tightness that makes breathing difficult
• wheezing
• nasal congestion
• rhonchi or wheezing heard during medical examination
• taste disorders
• indigestion
• constipation
• dryness of the mucous membranes of the mouth
• abdominal pain
• skin discoloration
• redness of the skin
• muscle or tendon pain, including around the shoulders, scapulae, and ribs
• difficulty urinating (urinary retention)
• chest pain
• feeling of cold or high temperature (fever)
• pain and swelling (edema) of the vein at the injection site
• burning sensation at the injection site

Rare(may occur in less than 1 in 10,000 patients):

• significant decrease in heart rate (sinus arrest)
• absence of electrical activity of the heart (asystole)
• fragility of blood vessels with an area of hot red skin (thrombophlebitis)
• skin necrosis caused by the solution leaking around the injection site

Unknown(frequency cannot be estimated from the available data)

• increased potassium levels in the blood (hyperkalemia)
• increased acid levels in the body (metabolic acidosis)
• increased heart rate (accelerated ventricular rhythm)
• coronary artery spasm
• lack of blood circulation (cardiac arrest)
• psoriasis (scaly patches on the skin)
• swelling of the skin of the face, limbs, tongue, or throat (angioedema)
• hives
• inflammation of the vein or blisters at the infusion site

Reporting side effects

If side effects occur, including any not listed in the leaflet, the patient should inform their doctor or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, ul. Jerozolimskie 181C, 02-222 Warsaw, tel. +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store ESMOCARD 100 mg/10 ml solution for injection

Store at a temperature below 25°C.
Store in the original outer packaging to protect from light.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the label after: EXP.
The expiry date refers to the last day of the specified month.
Once opened, the product is stable for 24 hours at a temperature between 2°C and 8°C. However, the product should be used immediately after opening. If it is not used immediately, the user is responsible for the storage time and conditions. This time should not exceed 24 hours at a temperature between 2°C and 8°C, unless the opening was done under controlled and validated aseptic conditions.
Do not use ESMOCARD 100 mg/10 ml if particles or discoloration of the solution are visible.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their doctor how to dispose of unused medicines. This will help protect the environment.

6. Contents of the packaging and other information

What ESMOCARD 100 mg/10 ml contains

• The active substance is esmolol hydrochloride.
• Each 10 ml vial of solution for infusion contains 100 mg of esmolol hydrochloride. 1 ml of aqueous solution contains 10 mg of esmolol hydrochloride.
• The medicine also contains: sodium acetate trihydrate, glacial acetic acid 99%, hydrochloric acid, water for injections.

What ESMOCARD 100 mg/10 ml looks like and what the pack contains

Each 10 ml vial of solution contains 100 mg of esmolol hydrochloride (10 mg/ml).
The vial made of colorless glass with a chlorobutyl rubber stopper contains 10 ml of solution for injection.
The vials are packed in cardboard boxes.

Marketing authorization holder and manufacturer

Marketing authorization holder

Orpha-Devel Handels und Vertriebs GmbH
Wintergasse 85/1B
A-3002 Purkersdorf
Austria

Manufacturer

AOP Orphan Pharmaceuticals GmbH
Leopold-Ungar-Platz 2
A-1190 Vienna
Austria

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Czech Republic:
ESMOCARD 10mg/ml injection solution
France:
ESMOCARD 100 mg/10 ml, solution injectable
Germany:
ESMOCARD 100 mg/10 ml Injektionslösung
Hungary:
ESMOCARD 10 mg/ml oldatos injekció
Ireland:
ESMOCARD 100 mg/10 ml solution for injection
Italy:
ESMOCARD 100 mg/ 10 ml soluzione iniettabile
Netherlands:
Esmolol HCl Orpha 100 mg/10 ml oplossing voor injective
Poland:
Esmocard 100 mg/10 ml, solution for injection
Slovakia:
Esmocard 100 mg/10 ml injekčný roztok
Slovenia:
Esmocard 10 mg/ml raztopina za injiciranje
United Kingdom:
Esmolol hydrochloride 10 mg/ml solution for injection

Date of approval of the updated leaflet: 09/2021

The following information is intended for healthcare professionals only:

This section contains practical information on administration. The patient should read the Summary of Product Characteristics to obtain full information on dosing and administration, contraindications, warnings, etc.
ESMOCARD 100 mg/10 ml, solution for injection in a 10 ml vial is a clear solution ready for intravenous administration. The concentration of this product is 10 mg/ml of esmolol hydrochloride.

Supraventricular tachycardia

The dose of ESMOCARD 100 mg/10 ml should be determined individually. An initial dose is required, followed by a maintenance dose.
The effective dose of ESMOCARD 100 mg/10 ml is between 50 and 200 micrograms/kg/min, although higher doses, such as 300 micrograms/kg/min, have also been used. In a few patients, the average effective dose was 25 micrograms/kg/min.
Administration schedule
Initial dose, infusion
500 micrograms/kg/min for 1 minute,
FOLLOWED BY 50 micrograms/kg/min for 4 minutes
Response
Maintain infusion at
50 micrograms/kg/min
Insufficient response within 5 minutes
Repeat 500 micrograms/kg/min for 1 minute
Increase maintenance infusion to 100 micrograms/kg/min for 4 minutes
Response
Maintain infusion at
100 micrograms/kg/min
Insufficient response within 5 minutes
Repeat 500 micrograms/kg/min for 1 minute
Increase maintenance infusion to 150 micrograms/kg/min for 4 minutes
Response
Maintain infusion at
150 micrograms/kg/min
Insufficient response
Repeat 500 micrograms/kg/min for 1 minute
Increase maintenance infusion to 200 micrograms/kg/min and maintain
If the desired heart rate or safety endpoint (e.g., lowered blood pressure) is achieved, the initial infusion should be omitted and the maintenance infusion dose increased by 25 micrograms/kg/min or less, rather than 50 micrograms/kg/min. If necessary, the interval between dose increases can be extended from 5 to 10 minutes.
Note: Maintenance doses greater than 200 micrograms/kg/min have not shown significant increased benefits, and the safety of doses greater than 300 micrograms/kg/min has not been studied.
In case of side effects, the dose of ESMOCARD 100 mg/10 ml can be reduced or the product discontinued. Pharmacological side effects should disappear within 30 minutes.
If a reaction occurs at the infusion site, a different infusion site should be used, and care should be taken to avoid extravasation.
No studies have been conducted on the administration of ESMOCARD 100 mg/10 ml infusions for more than 24 hours. Infusions longer than 24 hours should be used with caution.
After sudden discontinuation of ESMOCARD 100 mg/10 ml, no withdrawal symptoms have been reported in patients that may occur after sudden discontinuation of beta-blockers used long-term in patients with coronary heart disease.

However, caution should be exercised when suddenly discontinuing the infusion of ESMOCARD 100 mg/10 ml in patients with coronary heart disease.

Perioperative tachycardia and hypertension

In the case of perioperative tachycardia and hypertension, the dosing schedule may change as follows:
a)
In the case of intraoperative treatment - during anesthesia, when immediate control is necessary, an injection of 80 mg in a bolus over 15 to 30 seconds, followed by an infusion of 150 micrograms/kg/min. The maintenance infusion rate should be adjusted up to 300 micrograms/kg/min.
b) After awakening from anesthesia, an infusion of 500 micrograms/kg/min should be administered for a maximum of 4 minutes, followed by a maintenance infusion of 300 micrograms/kg/min.
c)
In the postoperative period, when there is time to adjust the dose, an initial dose of 500 micrograms/kg/min should be administered for 1 minute before each dose increase to achieve a rapid onset of action. The dose should be increased as follows: 50, 100, 150, 200, 250, and 300 micrograms/kg/min over 4 minutes, using the dose that provides the desired therapeutic effect.

Switching from ESMOCARD 100 mg/10 ml to alternative medicines

After achieving adequate control of heart rate and stable clinical condition in the patient, the treatment can be changed to alternative medicines (such as antiarrhythmic and calcium channel blockers).

Dose reduction:

When switching from ESMOCARD 100 mg/10 ml to alternative medicines, the doctor should consult the Summary of Product Characteristics of the chosen alternative medicine and reduce the dose of ESMOCARD 100 mg/10 ml as follows:

• 1) Within the first hour of administering the first dose of the alternative medicine, the infusion rate of ESMOCARD 100 mg/10 ml should be reduced by half (50%).
• 2) After administering the second dose of the alternative medicine, the patient's response should be monitored, and if satisfactory control is maintained for the first hour, the infusion of ESMOCARD 100 mg/10 ml should be discontinued.

Additional information on dosing:

After achieving the desired therapeutic effect or safety endpoint (e.g., lowered blood pressure), the initial dose should be omitted, and the maintenance infusion dose increased by 12.5-25 micrograms/kg/min only. If necessary, the interval between dose increases can be extended from 5 to 10 minutes.
ESMOCARD 100 mg/10 ml should be discontinued if the heart rate and blood pressure quickly approach or exceed the safety range, and then, after restoring the heart rate and blood pressure to acceptable values, administration can be resumed at a lower dose without an initial infusion.
Special populations
Elderly patients
Caution should be exercised in elderly patients, and treatment should be started with a lower dose. No special studies have been conducted in elderly patients. However, an analysis of data from 252 patients over 65 years of age did not show any changes in pharmacodynamic effects compared to data from patients under 65 years of age.
Patients with renal impairment
Caution is required when administering ESMOCARD 100 mg/10 ml to patients with renal impairment, as the acidic metabolite of ESMOCARD 100 mg/10 ml is excreted by the kidneys. The excretion of the acidic metabolite is significantly lower in patients with impaired renal function, with approximately a tenfold longer half-life than under normal conditions, and significantly increased plasma concentrations.
Patients with hepatic impairment
In the case of hepatic impairment, no special precautions are necessary, as the esterases in red blood cells play a major role in the metabolism of ESMOCARD 100 mg/10 ml.
Children and adolescents (under 18 years of age)
The safety and efficacy of ESMOCARD 100 mg/10 ml have not been established in children under 18 years of age. Therefore, ESMOCARD 100 mg/10 ml should not be used in this age group (see section 4.1).