ESMOCARD 2500 mg Proszek Do Sporządzania Roztworu Do Infuzji

Treść ulotki

1. What is ESMOCARD 100 mg/10 ml injectable solution and what is it used for
2. What you need to know before you use ESMOCARD 100 mg/10 ml injectable solution
3. How to use ESMOCARD 100 mg/10 ml injectable solution
4. Possible side effects
5. How to store ESMOCARD 100 mg/10 ml injectable solution
6. Package Contents and Other Information
7. Esmocard 100 mg/10 ml injectable solution in a 10 ml vial is a pure solution
   1. What is ESMOCARD and what is it used for
   2. What you need to know before you use ESMOCARD
   3. How to use ESMOCARD
   4. Possible side effects
   5. How to store ESMOCARD
   6. Package contents and other information
8. ESMOCARD 2500 mg powder for concentrate for solution for infusion MUST NOT

ESMOCARD 100 mg/10 ml injectable solution
Esmolol hydrochloride

Generic medicine
contains important information for you

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor. See section 4.

Contents of this leaflet:

• 1. What ESMOCARD 100 mg/10 ml injectable solution is and what it is used for
• 2. What you need to know before you use ESMOCARD 100 mg/10 ml injectable solution
• 3. How to use ESMOCARD 100 mg/10 ml injectable solution
• 4. Possible side effects
• 5. How to store ESMOCARD 100 mg/10 ml injectable solution
• 6. Contents of the pack and other information

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

ESMOCARD 100 mg/10 ml belongs to the group of beta-blockers. These medicines
slow down the heartbeat and reduce blood pressure.
ESMOCARD 100 mg/10 ml is used for short-term treatment if your heart is beating
too quickly.
ESMOCARD 100 mg/10 ml is also used during or immediately after surgery if
your blood pressure becomes too high and/or your heart is beating too quickly.

2. What you need to know before you use ESMOCARD 100 mg/10 ml injectable solution

Your doctor will not administer ESMOCARD 100 mg/10 ml if

• you are allergic to esmolol hydrochloride. The signs of an allergic reaction include difficulty breathing, wheezing, skin rash, itching or swelling of the face and lips
• you have a very slow heart rate (less than 50 beats per minute)
• you have a fast or alternating fast-slow heart rate
• you suffer from a condition called “severe heart block”. Heart block is a problem with the electrical signals that control the heartbeat
• you have low blood pressure
• you have a problem regarding blood flow to the heart
• you have symptoms of severe heart failure
• you are taking or have recently taken verapamil. You should not take ESMOCARD 100 mg/10 ml within 48 hours of stopping verapamil
• you have a disease of the adrenal gland called pheochromocytoma that has not been treated. Pheochromocytoma originates in the adrenal gland and may be accompanied by a sudden increase in blood pressure, severe headache, sweating and increased heart rate
• you have increased blood pressure in the lungs (pulmonary hypertension)
• you have rapidly worsening asthma symptoms
• you have an increase in the level of acids in your body (a problem called metabolic acidosis) If any of the above applies to you, ESMOCARD 100 mg/10 ml will not be administered to you. If you are unsure if any of these cases apply to you, ask your doctor or nurse before receiving ESMOCARD 100 mg/10 ml.

Warnings and precautions
Before you are administered ESMOCARD 100 mg/10 ml, speak to your doctor or
nurse. The doctor will pay particular attention with this medicine if:

• you have been treated for some heart rhythm disorders called supraventricular arrhythmias and:
• You have other heart problems or
• You are taking other medicines for the heart The use of ESMOCARD 100 mg/10 ml in these cases may lead to serious, potentially fatal reactions, including:
• Loss of consciousness
• Shock (when the heart does not pump enough blood)
• Heart attack (cardiac arrest)
• develops low blood pressure (hypotension). The signs of this disorder may be feeling dizzy or lightheaded, especially when standing up. This condition is rapidly reversible by reducing the dose or stopping the medicine. Normally, during treatment with ESMOCARD 100 mg/10 ml your blood pressure and electrocardiogram (ECG) will be kept under constant monitoring. Usually low blood pressure improves within 30 minutes of the end of treatment with ESMOCARD 100 mg/10 ml
• you have a low heart rate before treatment
• the heart rate drops below 50-55 beats per minute. In this case the doctor may decrease the dose or stop treatment with ESMOCARD 100 mg/10 ml
• you suffer from heart failure
• you have problems with the electrical signals that control your heartbeat (heart block)
• you have a disease of the adrenal gland called pheochromocytoma that has been treated with medicines called alpha-receptor blockers
• you are taking medicines to treat high blood pressure (hypertension) caused by low body temperature (hypothermia)
• you have a lung disease that causes narrowing of the airways or wheezing, such as asthma
• you have diabetes (high blood sugar levels) or low blood sugar levels (hypoglycemia). In this case you will need to be monitored particularly closely as esmolol may mask the symptoms of low blood sugar. ESMOCARD 100 mg/10 ml may increase the effects of your diabetes medicines
• you experience skin problems. These may be caused by leakage of the solution around the injection site. If this happens, the doctor will use a different vein for the injection
• you have a particular type of angina (chest pain) called “Prinzmetal’s angina”
• you have a reduced blood volume (with low blood pressure). You may be more likely to experience circulatory collapse
• you have circulatory problems, such as pale skin on the fingers (Raynaud’s disease) or pain, fatigue and sometimes burning in the legs
• you have kidney problems. If you have kidney disease or need dialysis, you may have high potassium levels in your blood (hyperkalemia). This can cause serious heart problems
• you suffer from any allergies or are at risk of anaphylactic reactions (severe allergic reactions). ESMOCARD 100 mg/10 ml may worsen allergies and make them difficult to treat
• You, or a family member, have a history of psoriasis (when the skin produces scaly patches)
• you have a disease called hyperthyroidism (an overactive thyroid gland). Usually it is not necessary to change the dosage if you have liver problems. If any of the above applies to you (or if you are unsure), speak to your doctor or nurse before you are administered this medicine. Checks may need to be made and your treatment may need to be adjusted. For athletes: the use of the drug without a therapeutic need constitutes doping and may still result in a positive doping test. Other medicines and ESMOCARD 100 mg/10 ml injectable solutionTell your doctor or nurse if you are taking, have recently taken or might take any other medicines, including those available without a prescription, herbal medicines or natural products. Your doctor will check that the medicines you are taking do not change the way ESMOCARD 100 mg/10 ml works. In particular, tell your doctor or nurse if you are taking any of the following medicines:
• Medicines that can lower blood pressure or slow the heart rate
• Medicines used to treat heart rhythm problems or chest pain (angina), such as verapamil and diltiazem. You will not be administered 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 heart rhythm problems (such as quinidine, disopyramide, amiodarone) and heart failure (such as digoxin, digitoxin, digitalis)
• Medicines used to treat diabetes, including insulin and oral medicines
• Medicines known as ganglionic blockers (e.g. trimethaphan)
• Medicines used as painkillers, such as non-steroidal anti-inflammatory drugs (NSAIDs)
• Floctafenine, a painkiller
• Amisulpride, a medicine used to treat mental problems
• “Tricyclic” antidepressants (such as imipramine and amitriptyline) or any other drug for the treatment of mental health problems
• Barbiturates (such as phenobarbital, used to treat epilepsy) or phenothiazines (such as chlorpromazine, used to treat mental disorders)
• Clozapine, used to treat mental disorders
• Epinephrine, used to treat allergic reactions
• Medicines used to treat asthma
• Medicines used to treat colds or nasal congestion, also called “nasal decongestants”
• Reserpine, used to treat high blood pressure
• Clonidine, used to treat high blood pressure and headache
• Moxonidine, used to treat high blood pressure
• Derivatives of ergot, medicines used mainly to treat Parkinson’s disease
• Warfarin, used to thin the blood
• Morphine, a strong painkiller
• Succinylcholine chloride (also known as succinylcholine or scolline) or mivacurium, used to relax muscles, usually during surgery. Your doctor will also pay particular attention to the use of ESMOCARD 100 mg/10 ml during surgery, in case of administration of anesthetics and other treatments. If you have any doubts about whether any of these limitations may apply to your case, speak to your doctor or nurse before receiving ESMOCARD 100 mg/10 ml.

Tests that may be carried out during use of ESMOCARD 100 mg/10 ml
The use of medicines such as ESMOCARD 100 mg/10 ml for a long period of time can
cause a reduction in the strength of the heartbeat.
Since ESMOCARD 100 mg/10 ml is used only for a limited time, this is unlikely to
happen to you. During treatment you will be closely monitored and, if the strength of your
heartbeat decreases, treatment with ESMOCARD 100 mg/10 ml will be reduced or
stopped.
During treatment with ESMOCARD 100 mg/10 ml your doctor will also check your
blood pressure.

Pregnancy and breastfeeding
Ask your doctor for advice before using this medicine if you are pregnant,
suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding.
The available data on the use of esmolol in humans are insufficient to demonstrate its
safety during pregnancy. However, in humans there are no indicators of an increased
risk of birth defects.
Due to the lack of experience with the use of ESMOCARD 100 mg/10 ml, this is not
recommended during pregnancy.
Tell your doctor if you are breastfeeding. ESMOCARD 100 mg/10 ml may pass into
breast milk, therefore you should not be administered ESMOCARD 100 mg/10 ml if you are
breastfeeding.
Ask your doctor for advice before taking any medicine.

ESMOCARD 100 mg/10 ml injectable solution contains sodium
ESMOCARD 100 mg/10 ml contains approximately 7.88 mg of sodium per vial. This information
may be important if you are following a low-sodium diet.

3. How to use ESMOCARD 100 mg/10 ml injectable solution

The dosage must be adjusted on a case-by-case basis. It is recommended to administer an initial dose, followed by a maintenance dose. Your doctor will define the dosage regimen and adjust the dosage, if necessary, based on possible undesirable effects.
ESMOCARD 100 mg/10 ml is administered by infusion. It is administered intravenously by a doctor or a nurse.
The duration of use depends on the effect and the possible occurrence of undesirable effects. Your doctor will define the duration of treatment.

• Usually, it is not necessary to modify the dose of ESMOCARD 100mg/10 ml if you have liver problems. If you suffer from kidney problems, the doctor will take appropriate precautions.

Elderly patients
Your doctor will start treatment with a lower dose.

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

If you are given more ESMOCARD 100 mg/10 ml injectable solution than you should
Since ESMOCARD 100 mg/10 ml is administered by a trained and qualified person, it is unlikely that you will receive too much. However, if this happens, the doctor will stop ESMOCARD 100 mg/10 ml and, if necessary, administer additional treatment.

If you think that a dose of ESMOCARD 100 mg/10 ml has not been administered to you
Since ESMOCARD 100 mg/10 ml is administered by a trained and qualified person, it is unlikely that a dose will not be administered to you. However, if you believe that a dose has not been administered, inform the doctor or nurse as soon as possible.

When the administration of ESMOCARD 100 mg/10 ml injectable solution is stopped
The sudden discontinuation of ESMOCARD 100 mg/10 ml may cause the recurrence of symptoms of fast heartbeat (tachycardia) and high blood pressure (hypertension). To avoid this, the doctor must discontinue treatment gradually. If you suffer from coronary heart disease (which may be associated with a history of angina or heart attack), the doctor will pay particular attention when stopping treatment with ESMOCARD 100 mg/10 ml.
If you have any doubts about the use of ESMOCARD 100 mg/10 ml, ask your doctor or nurse .

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Most side effects disappear within 30 minutes of stopping
treatment with ESMOCARD 100 mg/10 ml. The following side effects have been
observed with ESMOCARD 100 mg/10 ml:

Seek immediate medical attention or contact your nurse if you notice the onset of any
of the following side effects, which may be serious. It may also be
necessary to stop the infusion.

Very common(may affect more than 1 in 10 people) :

• Decrease in blood pressure. This can be corrected quickly by reducing the dose of ESMOCARD 100 mg/10 ml or stopping treatment. Blood pressure will be measured frequently during treatment
• Excessive sweating

Common (may affect up to 1 in 10 people) :

• Loss of appetite
• Feeling of anxiety or depression
• Dizziness
• Drowsiness
• Headache
• Tingling or stinging pains like “pins and needles”
• Difficulty concentrating
• Feeling of confusion or agitation
• Feeling unwell (nausea and vomiting)
• Feeling of weakness
• Feeling tired (fatigue)
• Irritation and hardening of the skin during the injection of ESMOCARD 100 mg/10 ml

Uncommon(may affect up to 1 in 100 people):

• Abnormal thoughts
• Sudden loss of consciousness
• Fainting or feeling faint
• Convulsions (epilepsy or seizures)
• Speech disorders
• Visual disturbances
• Slowing of the heartbeat
• Problems with the electrical signals that control the heartbeat
• Increased pressure in the arteries of the lungs
• Inability of the heart to pump enough blood (heart failure)
• A heart rhythm problem, sometimes known as “palpitations” (ventricular extrasystoles)
• Heart rhythm disorder (nodal rhythm)
• Chest discomfort caused by poor blood flow through the vessels of the heart muscle (angina pectoris)
• Poor circulation in the arms or legs
• Paleness or flushing
• Fluid in the lungs
• Shortness of breath or difficulty breathing due to tightness in the chest
• Wheezing
• Nasal congestion
• Abnormal crackles/crepitations during breathing
• Changes in the sense of taste
• Indigestion
• Constipation
• Dry mouth
• Pain in the stomach area
• Changes in skin color
• Skin redness
• Muscle or tendon pain, including the area around the shoulder blades and ribs
• Difficulty urinating (urinary retention)
• Chest pain
• Feeling cold or high temperature (fever)
• Pain and swelling (edema) of the vein during the injection of ESMOCARD 100 mg/10 ml Burning sensation at the injection site Very rare(may affect up to 1 in 10,000 people):
• Severe slowing of the heart rate (sinus arrest)
• Absence of electrical activity in the heart (asystole)
• Painful veins, with an area of skin that is warm and red (thrombophlebitis)
• Dead skin caused by leakage of solution around the injection site

Not known(the number of people affected is unknown)

• Increased levels of potassium in the blood (hyperkalemia)
• Increased levels of acids in the body (metabolic acidosis)
• Increased heart rate (accelerated idioventricular rhythm)
• Spasm of the heart arteries
• Interruption of normal blood circulation (cardiac arrest)
• Psoriasis (skin disease that produces scaly patches)
• Swelling of the skin of the face, limbs, tongue or throat (angioedema)
• Hives
• Inflammation of a vein or formation of blisters at the infusion site.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or nurse. You can also report side effects
directly through the national reporting system at
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects you can help provide more information on the
safety of this medicine.

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

Do not store at a temperature above 25°C. Keep the vial in the box to protect the medicine from light.
Keep this medicine out of sight and reach of children.
Do not use ESMOCARD 100 mg/10 ml after the expiry date which is stated on the box and
on the vial label after Exp. The expiry date refers to the last day of that month.
The opened product is stable for 24 hours at 2-8°C. However, it must be used
immediately after opening. If not used immediately, the duration and conditions of
storage are the responsibility of the user and should normally not exceed
24 hours at 2-8°C, unless the opening was carried out under controlled and validated aseptic
conditions.
Do not use ESMOCARD 100 mg/10 ml if you notice particles or changes in the color of the
solution.
Do not dispose of any medicine in wastewater or household waste. Ask your doctor
how to dispose of medicines you no longer use. This will help protect
the environment.

6. Package Contents and Other Information

What ESMOCARD 100 mg/10 ml injectable solution contains

• The active ingredient is esmolol hydrochloride.
• Each 10 ml vial of injectable solution contains 100 mg of esmolol hydrochloride. 1 ml of aqueous solution contains 10 mg of esmolol hydrochloride.
• The excipients are sodium acetate trihydrate, acetic acid 99%, hydrochloric acid 10% (for pH adjustment) and water for injections. Description of the appearance of ESMOCARD 100 mg/10 ml injectable solution and content of the packESMOCARD 100 mg/10 ml injectable solution is clear and colorless, available in vials containing 10 ml of solution each. The vial is made of transparent glass (type I) with a chlorobutyl rubber stopper.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Orpha-Devel Handels und Vertriebs GmbH
Wintergasse 85/1B
A-3002 Purkersdorf
Austria

Manufacturer
Amomed Pharma GmbH
Storchengasse 1
1150 Vienna
Austria
Hikma Italia S.P.A.,
Viale Certosa 10,
27100 Pavia,
Italy

This medicinal product is authorised in the Member States of the European Economic Area
with the following denominations:
Czech Republic: ESMOCARD 100mg/10ml injekční roztok
Denmark: ESMOCARD injektionsvæske, opløsning 10 mg/ml
Estonia: ESMOCARD 10 mg/ml süstelahus
Finland: ESMOCARD 10 mg/ml injektioneste, liuos
France: ESMOCARD 100 mg/10 ml, solution injectable
Germany: ESMOCARD 100 mg/10 ml Injektionslösung
Greece: ESMOCARD 100 mg/10 ml ενέσιμο διάλυμα
Hungary: ESMOCARD 10 mg/ml oldatos injekció
Ireland: ESMOCARD 100 mg/10 ml solution for injection
Italy: ESMOCARD 100 mg/ 10 ml soluzione iniettabile
Latvia: ESMOCARD 100 mg/10 ml šķīdums injekcijām
Lithuania: ESMOCARD 100 mg/10 ml injekcinis tirpalas
Netherlands: ESMOLOL HCl Orpha 100 mg/10 ml oplossing voor injective
Poland: ESMOCARD 100 mg/10 ml, roztwór do wstrzykiwań
Slovakia: ESMOCARD 100mg/10ml injekčný roztok
Slovenia: ESMOCARD 10 mg/ml raztopina za injiciranje
Sweden: ESMOCARD 10 mg/ml injektionsvätska, lösning
United Kingdom: Esmolol hydrochloride 10 mg/ml solution for injection

The following information is intended exclusively for physicians or healthcare
professionals:
This section contains practical information regarding administration. Read the
Summary of Product Characteristics for complete information on dosage, method of
administration, contraindications, warnings, etc.

Esmocard 100 mg/10 ml injectable solution in a 10 ml vial is a pure solution

ready for use for intravenous administration. The concentration of this product is 10 mg/ml of
esmolol hydrochloride.

SUPRAVENTRICULAR TACHYARRHYTHMIA
The dosage of Esmocard 100 mg/10 ml must be titrated individually. It is necessary to
administer an initial dose, followed by a maintenance dose.
The effective dose of Esmocard 100 mg/10 ml is between 50 and 200 micrograms/kg/min,
although doses up to 300 micrograms/kg/min have been used. In some patients, an
average effective dose of 25 micrograms/kg/min has proven adequate.
Flow chart relating to the initial dosage and the maintenance dosage
Infusion of the loading dose of
500 micrograms/kg/min for 1 minute,
FOLLOWED BY 50 micrograms/kg/min for 4 minutes
Response
Maintain the infusion at
50 micrograms/kg/min
Inadequate response within 5 minutes
Repeat 500 micrograms/kg/min for 1 minute
Increase the maintenance infusion to 100 micrograms/kg/min for 4 minutes
Response
Maintain the infusion at
100 micrograms/kg/min
Inadequate response within 5 minutes
Repeat 500 micrograms/kg/min for 1 minute
Increase the maintenance infusion to 150 micrograms/kg/min for 4 minutes
Response
Maintain the infusion at
150 micrograms/kg/min
Inadequate response
Repeat 500 micrograms/kg/min for 1 minute
Increase the maintenance infusion to 200 micrograms/kg/min and maintain
As you approach the desired heart rate or the safety endpoint
(e.g. reduced blood pressure), DISCONTINUE the loading infusion and reduce the dose
incrementally in the maintenance infusion from 50 micrograms/kg/min to 25
micrograms/kg/min or less. If necessary, it is possible to increase the interval between titration steps from 5 to 10 minutes.
NB: Doses higher than 200 micrograms/kg/min have not been shown to
significantly increase benefits, furthermore the safety of doses higher than 300
micrograms/kg/min has not been studied.
In case of an adverse reaction, it is possible to reduce the dosage of Esmocard 100 mg/10 or
discontinue administration. Drug-related adverse reactions should
resolve within 30 minutes.
If a localized reaction at the infusion site occurs, an alternative infusion site must be
used and caution must be exercised to avoid any
extravasation.
The administration of Esmocard 100 mg/10 infusions for more than 24 hours has not
been thoroughly evaluated. It is recommended to use caution with infusions longer than
24 hours.

No cases have been reported in which the sudden discontinuation of Esmocard 100 mg/10 ml
has caused withdrawal effects that can occur in case of abrupt cessation of
chronic beta-blocker treatment in patients with coronary artery disease (CAD). However, particular caution is recommended in patients with coronary artery disease in case of
sudden interruption of Esmocard 100 mg/10 ml infusions.

PERIOPERATIVE TACHYCARDIA AND HYPERTENSION
For tachycardia and hypertension, the dosage regimen may vary as follows:
a) For intraoperative treatment – during anesthesia, when immediate control is needed, administer a bolus injection of 80 mg in 15-30 seconds,
followed by an infusion of 150 micrograms/kg/min. Titrate the infusion rate
as needed up to 300 micrograms/kg/min.
b) Upon awakening from anesthesia, administer an infusion of 500
micrograms/kg/min for 4 minutes followed by an infusion of 300
micrograms/kg/min.
c) In the postoperative period, if there is time for titration, administer the loading dose of 500 micrograms/kg/min over one minute
before each titration step, in order to produce a rapid onset of action.
Use titration steps of 50, 100, 150, 200, 250 and 300 micrograms/kg/min
administered every four minutes, stopping once the desired therapeutic effect is achieved.

Switching therapy from Esmocard 100 mg/10 ml to alternative drugs
After achieving adequate heart rate control and a stable clinical condition,
it is possible to switch to the administration of alternative drugs (such as antiarrhythmics or
calcium channel blockers).

Dosage reduction:
When Esmocard 100 mg/10 ml is replaced with alternative drugs, the physician must
carefully consider the instructions of the chosen alternative drug and reduce the dosage of
Esmocard 100 mg/10 ml as follows:

• 1) Within the first hour after administration of the first dose of the alternative drug, reduce the infusion rate of Esmocard 100 mg/10 ml by half (50%)
• 2) After administration of the second dose of the alternative drug, carefully monitor the patient's response and, if satisfactory control has been maintained in the first hour, discontinue the Esmocard 100 mg/10 ml infusion.

Further dosage information: As soon as the desired therapeutic effect is achieved or
the safety endpoint (e.g. reduced blood pressure) is reached, the loading dose is suspended and
the incremental infusion is reduced to 12.5-25 micrograms/kg/min. If desired, the interval between titration steps can also be increased from five to ten minutes.
When the heart rate, or blood pressure, approaches, rapidly or exceeds the
safety limit, the administration of Esmocard 100 mg/10 ml must be stopped;
then restart, without administering a loading infusion, at a lower dose after the heart rate, or blood pressure, has returned to an acceptable level.

Special populations
Elderly
Elderly patients should be treated with caution, starting with a lower dose. No
particular studies have been conducted in the elderly. However, an analysis of data relating to 252
patients over 65 years of age did not reveal any changes in pharmacodynamic effects compared to the results obtained in patients under 65 years of age.
Patients with renal insufficiency
Particular caution is necessary in patients with renal insufficiency when
administering Esmocard 100 mg/10 ml by infusion, as the acidic metabolite of Esmocard
100 mg/10 ml is eliminated through the kidneys. The elimination of the acidic metabolite is reduced
significantly in patients with renal disease, with an increase in the elimination half-life of approximately ten times normal levels, along with significantly elevated plasma levels.
Patients with hepatic insufficiency
In case of hepatic insufficiency, no particular precautions are necessary due to the predominant role played by plasma esterases in the metabolism of Esmocard 100 mg/10 ml.
Paediatric population (under 18 years of age):
The safety and efficacy of Esmocard 100 mg/10 ml in children under 18 years of age
have not yet been established. Therefore, the use of Esmocard 100 mg/10 ml is not indicated
in the paediatric population.

ESMOCARD 2500 mg powder for concentrate for solution for infusion
Esmolol hydrochloride

Equivalent Medicinal Product
Read this leaflet carefully before you start using this medicine as it contains
important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• This medicine has been prescribed for you. Do not pass it on to others, even if their symptoms are the same as yours, as it could be dangerous.
• If you get any side effects, talk to your doctor or nurse. See section 4.

Contents of this leaflet:

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

1. What is ESMOCARD and what is it used for

ESMOCARD belongs to the group of beta-blockers. These medicines slow down the
heartbeat and reduce blood pressure.
ESMOCARD is used for the short-term treatment if your heart is beating too
quickly.
ESMOCARD is also used during or immediately after surgery if your
blood pressure becomes too high and/or your heart is beating too quickly.

2. What you need to know before you use ESMOCARD

The doctor will not administer ESMOCARD if:

• you are allergic to esmolol hydrochloride. The signs of an allergic reaction include difficulty breathing, wheezing, skin rash, itching or swelling of the face and lips
• you have a very slow heartbeat (less than 50 beats per minute)
• you have a fast or irregular heartbeat (fast-slow)
• you suffer from a condition called “severe cardiac block”. Cardiac block is a problem with the electrical signals that control the heartbeat
• you have low blood pressure
• you have a problem regarding blood flow to the heart
• you are taking or have recently taken verapamil. You should not take ESMOCARD within 48 hours of stopping verapamil if you have symptoms of severe heart failure
• you have a disease of the adrenal gland called pheochromocytoma which has not yet been treated. Pheochromocytoma originates in the adrenal gland and may be accompanied by a sudden increase in blood pressure, severe headache, sweating and increased heartbeat
• you have increased blood pressure in the lungs (pulmonary hypertension)
• you have rapidly worsening asthma symptoms
• you have an increase in acid levels in your body (a problem called metabolic acidosis)

Warnings and precautions

• ESMOCARD MUST BE RECONSTITUTED/DILUTED BY THE DOCTOR OR NURSE Before you are given ESMOCARD, talk to your doctor or nurse. The doctor will pay particular attention with this medicine if:
• You have been treated for some heart rhythm disorders called supraventricular arrhythmias and:
• You have other heart problems or
• You are taking other medicines for the heart The use of ESMOCARD in these cases may lead to serious, potentially fatal reactions, including:
• Loss of consciousness
• Shock (when the heart does not pump enough blood)
• Heart attack (cardiac arrest)
• develops low blood pressure (hypotension). The signs of this disorder may be feeling dizzy or lightheaded, especially when standing up. This condition is rapidly reversible by reducing the dose or stopping the medicine. Normally, during treatment with ESMOCARD, your blood pressure and electrocardiogram (ECG) will be constantly monitored. Usually, low blood pressure improves within 30 minutes of the end of treatment with ESMOCARD
• you have a low heart rate before treatment
• the heart rate drops below 50-55 beats per minute. In this case, the doctor may decrease the dose or stop treatment with ESMOCARD
• you suffer from heart failure
• you have problems with the electrical signals that control your heartbeat (cardiac block)
• you have a disease of the adrenal gland called pheochromocytoma that has been treated with medicines called alpha-receptor blockers
• you are taking medicines to treat high blood pressure (hypertension) caused by low body temperature (hypothermia)
• you have a lung disease that causes narrowing of the airways or wheezing, such as asthma
• you have diabetes (high blood sugar levels) or low blood sugar levels (hypoglycemia). In this case, you will need to be monitored particularly closely as ESMOCARD may mask the symptoms of low blood sugar. ESMOCARD may increase the effects of your diabetes medicines
• you experience skin problems. These may be caused by leakage of the solution around the injection site. If this happens, the doctor will use a different vein for the injection
• you have a particular type of angina (chest pain) called “Prinzmetal's angina”
• you have a reduced blood volume (with low blood pressure). You may be more likely to experience circulatory collapse
• you have circulatory problems, such as pale skin on the fingers (Raynaud's disease) or pain, fatigue or burning in the legs
• you have kidney problems. If you have kidney disease or need dialysis, you may develop high potassium levels in your blood (hyperkalemia). This can cause serious heart problems
• you suffer from any allergies or are at risk of anaphylactic reactions (severe allergic reactions). ESMOCARD may worsen allergies and make them difficult to treat
• You, or a family member, have a history of psoriasis (when the skin produces scaly patches)
• you have a condition called hyperthyroidism (an overactive thyroid gland). Usually, it is not necessary to change the dosage if you have liver problems. If any of the above applies to you (or if you are not sure), talk to your doctor or nurse before you are given this medicine. Checks may need to be carried out and your treatment may need to be adjusted. For athletes: the use of the drug without a therapeutic need constitutes doping and can still result in a positive doping test.

Other medicines and ESMOCARD
Tell your doctor or nurse if you are taking, have recently taken or might
take any other medicines, including those available without a prescription, herbal
medicines or natural products. Your doctor will check that the medicines you are taking
do not change the way ESMOCARD works.
In particular, tell your doctor or nurse if you are taking any of the following medicines:

• Medicines that can lower blood pressure or slow down the heartbeat
• Medicines used to treat heart rhythm problems or chest pain (angina) such as verapamil and diltiazem. You will not be given ESMOCARD within 48 hours of stopping verapamil
• Nifedipine, used to treat chest pain (angina), high blood pressure and Raynaud's disease
• Medicines used to treat heart rhythm problems (such as quinidine, disopyramide, amiodarone) and heart failure (such as digoxin, digitoxin, digitalis) Medicines used to treat diabetes, including insulin and oral medications
• Medicines known as ganglionic blockers (e.g. trimethaphan)
• Medicines used as painkillers, such as non-steroidal anti-inflammatory drugs (NSAIDs)
• Floctafenine, a painkiller
• Amisulpride, a medicine used to treat mental problems.
• “Tricyclic” antidepressants (such as imipramine and amitriptyline) or any other medicine for mental health problems
• Barbiturates (such as phenobarbital, used to treat epilepsy) or phenothiazines (such as chlorpromazine, used to treat mental disorders)
• Clozapine, used to treat mental disorders
• Epinephrine, used to treat allergic reactions
• Medicines used to treat asthma
• Medicines used to treat colds or nasal congestion, also called “nasal decongestants”
• Reserpine, used to treat high blood pressure
• Clonidine, used to treat high blood pressure and headaches
• Moxonidine, used to treat high blood pressure
• Ergot derivatives, medicines used mainly to treat Parkinson's disease
• Warfarin, used to thin the blood
• Morphine, a strong painkiller
• Succinylcholine chloride (also known as succinylcholine or scolines) or mivacurium, used to relax muscles, usually during surgery. Your doctor will also pay particular attention to the use of ESMOCARD during surgery, in case of administration of anesthetics and other treatments. If you have any doubts as to whether any of these limitations may apply to your case, talk to your doctor or nurse before receiving ESMOCARD.

Tests that may be carried out during the use of ESMOCARD
The use of medicines like ESMOCARD for a long time can cause a reduction
in the strength of the heartbeat.
Since ESMOCARD is used only for a limited time, this is unlikely to
happen to you. You will be carefully monitored during treatment and, if the strength of your heartbeat decreases, treatment with ESMOCARD will be reduced or stopped.
During treatment with ESMOCARD, your doctor will also check your
blood pressure.

Pregnancy and breastfeeding
Ask your doctor for advice before using this medicine if you are pregnant,
suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding.
The available data on the use of ESMOCARD in humans are insufficient to demonstrate its
safety during pregnancy. However, in humans there are no indications of an increased
risk of birth defects.
Due to the lack of experience with the use of ESMOCARD, it is not recommended
during pregnancy.
Tell your doctor if you are breastfeeding. ESMOCARD may pass into breast milk, so you
should not be given ESMOCARD if you are breastfeeding.
Ask your doctor or nurse for advice before taking any medicine.

3. How to use ESMOCARD

ESMOCARD MUST BE RECONSTITUTED/DILUTED BEFORE USE
The dosage must be adapted case by case. It is recommended to administer an initial
dose, followed by a maintenance dose. Your doctor will define the dosage regimen
and adjust the dosage, if necessary, based on possible undesirable effects.
ESMOCARD is administered by infusion. It is administered intravenously by a doctor or a
nurse. The administration of the 50 mg/ml solution using an infusion pump must be strictly
done in a large vein or through a central venous catheter.
The duration of use depends on the effect and the possible occurrence of undesirable effects. Your
doctor will define the duration of treatment.
Usually, it is not necessary to modify the dose of ESMOCARD if you have liver problems
If you suffer from kidney problems, the doctor will take appropriate precautions.

Elderly
Your doctor will start treatment with a lower dose.

Use in children and adolescents
The safety and efficacy of ESMOCARD have not been demonstrated in children and
adolescents.
ESMOCARD should not be administered to children under 18 years of age.

If you are given more ESMOCARD than you should
Since ESMOCARD is administered by a trained and qualified person, it is
unlikely that you will receive too much. However, if this happens, the doctor will suspend
ESMOCARD and, if necessary, administer additional treatment.

If you think that a dose of ESMOCARD has not been given to you
Since ESMOCARD is administered by a trained and qualified person, it is
unlikely that a dose will not be given to you. However, if you believe that a dose has not
been given to you, inform your doctor or nurse as soon as possible.

When the administration of ESMOCARD is stopped
The sudden discontinuation of ESMOCARD may cause the reappearance of symptoms of rapid
heartbeat (tachycardia) and high blood pressure (hypertension). To prevent this from happening,
the doctor must discontinue treatment gradually. If you suffer from coronary artery disease
(which may be associated with a history of angina or heart attack), the
doctor will pay particular attention when stopping treatment with ESMOCARD.
If you have any doubts about the use of ESMOCARD, consult your doctor or nurse .

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Most side effects disappear within 30 minutes of stopping
treatment with ESMOCARD. The following side effects have been observed with
ESMOCARD:
Contact your doctor or nurse immediately if you notice any of the following side effects, which may be serious. It may also be
necessary to stop the infusion.

Very common(may affect more than 1 in 10 people) :

• Decrease in blood pressure. This can be corrected quickly by reducing the dose of ESMOCARD or stopping treatment. Blood pressure will be measured frequently during treatment
• Excessive sweating

Common(may affect up to 1 in 10 people):

• Loss of appetite
• Feeling of anxiety or depression
• Dizziness
• Drowsiness
• Headache
• Tingling or piercing pains like “pins and needles”
• Difficulty concentrating
• Feeling of confusion or agitation
• Feeling unwell (nausea and vomiting)
• Feeling of weakness
• Feeling tired (fatigue)
• Irritation and hardening of the skin during the injection of ESMOCARD

Uncommon(may affect up to 1 in 100 people):

• Abnormal thoughts
• Sudden loss of consciousness
• Fainting or feeling faint
• Convulsions (epilepsy or seizures)
• Speech disorders
• Visual disturbances
• Slowing of the heartbeat
• Problems with the electrical signals that control the heartbeat
• Increased pressure in the arteries of the lungs
• Inability of the heart to pump enough blood (heart failure)
• A heart rhythm problem, sometimes known as “palpitations” (ventricular extrasystoles)
• Heart rhythm disorder (nodal rhythm)
• Chest discomfort caused by poor blood flow through the blood vessels of the heart muscle (angina pectoris)
• Poor circulation in the arms or legs
• Pallor or flushing
• Fluid in the lungs
• Shortness of breath or difficulty breathing due to a feeling of tightness in the chest
• Wheezing
• Blocked nose
• Abnormal crackles/crepitations during breathing
• Changes in taste
• Indigestion
• Constipation
• Dry mouth
• Stomach pain
• Changes in skin color
• Skin redness
• Muscle or tendon pain, including the area around the shoulder blades and ribs
• Difficulty urinating (urinary retention)
• Chest pain
• Feeling cold or high temperature (fever)
• Pain and swelling (edema) of the vein during the injection of ESMOCARD Burning sensation at the injection site

Very rare(may affect up to 1 in 10,000 people):

• Severe slowing of the heart rate (sinus arrest)
• Absence of electrical activity in the heart (asystole)
• Painful veins, with an area of skin that is warm and red (thrombophlebitis)
• Dead skin caused by leakage of solution around the injection site

Not known(the number of people affected is not known)

• Increased levels of potassium in the blood (hyperkalemia)
• Increased levels of acids in the body (metabolic acidosis)
• Increased heart rate (accelerated idioventricular rhythm)
• Spasm of the heart arteries
• Interruption of normal blood circulation (cardiac arrest)
• Psoriasis (skin disease that produces scaly patches)
• Swelling of the skin of the face, limbs, tongue or throat (angioedema)
• Hives
• Inflammation of a vein or formation of blisters at the infusion site.

Reporting of side effects
If you get any side effects, talk to your doctor or nurse. This includes any side effects not listed in this leaflet.
You can also report side effects directly through the national reporting system at
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa .
By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store ESMOCARD

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is reported on the label after Expiry.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
The storage conditions for use are at a temperature of 25°C.
The opened, reconstituted and diluted product is physically and chemically stable for 24 hours at
25°C. From a microbiological point of view, the product should be used immediately after opening and
dilution. Otherwise, the user is responsible for the use and administration
of the medicine. Normally, the period of use is not more than 24 hours at a temperature of
2-8°C, unless the opening and reconstitution/dilution have been carried out in
controlled and validated aseptic conditions. Do not dispose of any medicine in the wastewater
and household waste. The pharmacist or nurse will take care of eliminating the medicines
that are no longer used. This will help protect the environment.

6. Package contents and other information

What ESMOCARD contains
The active ingredient is esmolol hydrochloride.
A 50 ml vial contains 2500 mg of esmolol hydrochloride. The product does not contain
any other components.
Each ml of reconstituted concentrate for infusion solution contains 50 mg of esmolol
hydrochloride (50 mg/ml).
Each ml of diluted solution for infusion contains 10 mg of esmolol hydrochloride (10 mg/ml).

Description of the appearance of ESMOCARD and contents of the pack
A vial contains 2500 mg of white or off-white powder.
The vial is made of colorless glass (type I).
A pack of ESMOCARD 2500 mg powder for solution for infusion contains 1
vial.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Orpha-Devel Handels und Vertriebs GmbH
Wintergasse 85/1B
A-3002 Purkersdorf
Austria

Manufacturer
Amomed Pharma GmbH
Storchengasse 1
1150 Vienna
Austria
Hikma Italia S.P.A.,
Viale Certosa 10,
27100 Pavia,
Italy

This medicinal product is authorised in the Member States of the European Economic Area
with the following denominations:
Belgium: ESMOCARD 2500 mg Powder for solution for dilution for solution for
infusion
Czech Republic: ESMOCARD LYO 2500 mg powder for concentrate for infusion solution
Denmark: ESMOCARD LYO 2500 mg Powder to concentrate for infusion fluid,
solution
Estonia: ESMOCARD LYO 2500 mg infusioonilahuse kontsentraadi pulber
Finland: ESMOCARD 2500 mg Dry powder for intermediate concentrate for infusion fluid
solution
France: ESMOCARD 2500 mg Poudre pour solution à diluer pour solution pour
perfusion
Germany: ESMOCARD LYO 2500 mg Powder for the preparation of an
infusion solution
Greece: ESMOCARD LYO 2500 mg κόνις για πυκνό σκεύασμα για παρασκευή
διαλύματος προς έγχυση
Hungary: ESMOCARD LYO 2500 mg por oldatos infúzióhoz való
koncentrátumhoz
Ireland: ESMOCARD LYO 2500 mg powder for concentrate for solution for
infusion
Italy: ESMOCARD 2500 mg powder for concentrate for solution for
infusion
Latvia: ESMOCARD LYO 2500 mg pulveris infūziju šķīduma koncentrāta
pagatavošanai
Lithuania: ESMOCARD LYO 2500 mg milteliai infuzinio tirpalo koncentratui
Netherlands: Esmolol HCl LYO Orpha 2500 mg powder for concentrate for
solution for infusion
Norway: ESMOCARD LYO 2500 mg powder for infusion fluid, solution
Slovak Republic: ESMOCARD LYO 2500 mg prášok na infúzny koncentrát
Slovenia: ESMOCARD LYO 2500 mg prašek za koncentrat za raztopino za
infundiranje
Sweden: ESMOCARD 2500 mg Powder to concentrate to infusion fluid,
solution
United Kingdom: Esmolol hydrochloride 2500 mg powder for concentrate for solution
for infusion

The following information is intended exclusively for doctors or healthcare
professionals:
This section contains practical information regarding administration. Read the
Summary of Product Characteristics for complete information on dosage, method of
administration, contraindications, warnings, etc.

ESMOCARD 2500 mg powder for concentrate for solution for infusion MUST NOT

BE ADMINISTERED WITHOUT RECONSTITUTION/DILUTION.
The reconstituted/diluted infusion solution must be used immediately after
opening.
Administration of ESMOCARD not correctly reconstituted/diluted can cause
death.

Posology
SUPRAVENTRICULAR TACHYARRHYTHMIA
The dosage of ESMOCARD must be titrated individually. It is necessary to administer
an initial dose, followed by a maintenance dose.
The effective dose of ESMOCARD is between 50 and 200 micrograms/kg/min, although doses up to 300 micrograms/kg/min have been used. In some patients, the
average effective dosage of 25 micrograms/kg/min has proven adequate.

Flow chart relating to the initial dosage and maintenance dosage
Infusion of the loading dose of
500 micrograms/kg/min for 1 minute,
FOLLOWED BY 50 micrograms/kg/min for 4 minutes
Response
Maintain the infusion at
50 micrograms/kg/min
Inadequate response within 5 minutes
Repeat 500 micrograms/kg/min for 1 minute
Increase the maintenance infusion to 100 micrograms/kg/min for 4 minutes
Response
Maintain the infusion at
100 micrograms/kg/min
Inadequate response within 5 minutes
Repeat 500 micrograms/kg/min for 1 minute
Increase the maintenance infusion to 150 micrograms/kg/min for 4 minutes
Response
Maintain the infusion at
150 micrograms/kg/min
Inadequate response
Repeat 500 micrograms/kg/min for 1 minute
Increase the maintenance infusion to 200 micrograms/kg/min and maintain
As you approach the desired heart rate or safety endpoint
(e.g. reduced blood pressure), DISCONTINUE the loading infusion and reduce the dose
incrementally in the maintenance infusion from 50 micrograms/kg/min to 25
micrograms/kg/min or less. If necessary, it is possible to increase the interval between titration steps from 5 to 10 minutes.
NB: Doses of maintenance greater than 200 micrograms/kg/min have not been shown to
significantly increase benefits, moreover the safety of doses greater than 300
micrograms/kg/min has not been studied.
In case of adverse reaction, the dosage of ESMOCARD can be reduced or
administration can be interrupted. Pharmacological adverse reactions should
resolve within 30 minutes.
If a localized reaction at the infusion site occurs, an alternative infusion site must be
used and caution must be exercised to avoid extravasation.
The administration of ESMOCARD infusions for more than 24 hours has not been thoroughly
evaluated. It is recommended to use caution with infusions lasting longer than 24 hours.
There have been no reports of sudden discontinuation of ESMOCARD causing
withdrawal effects that can occur with abrupt cessation of chronic beta-blocker treatment in patients with coronary artery disease (CAD). However, particular caution is recommended
in patients with coronary artery disease in case of sudden interruption of ESMOCARD infusions.

PERIOPERATIVE TACHYCARDIA AND HYPERTENSION
For tachycardia and hypertension that occur in the perioperative phase, the dosage
scheme may vary as follows:
a) For intraoperative treatment - during anesthesia, when immediate control is needed, administer a bolus injection of 80 mg in 15-30 seconds,
followed by an infusion of 150 micrograms/kg/min. Titrate the infusion rate
as needed up to 300 micrograms/kg/min.
b) Upon awakening from anesthesia, administer an infusion of 500
micrograms/kg/min for up to 4 minutes followed by an infusion of 300
micrograms/kg/min.
c) In the postoperative period, if there is time for titration, administer the loading dose of 500 micrograms/kg/min over one minute
before each titration step, in order to produce a rapid onset of action.
Use titration steps of 50, 100, 150, 200, 250 and 300 micrograms/kg/min
administered every four minutes, stopping once the desired therapeutic effect is achieved.

Replacement of ESMOCARD therapy with alternative drugs
After achieving adequate heart rate control and a stable clinical condition, it is possible to switch to the administration of alternative drugs (such as antiarrhythmics or
calcium channel blockers).

Dosage reduction
When ESMOCARD is replaced with alternative drugs, the physician must carefully consider
the instructions of the chosen alternative drug and reduce the dosage of ESMOCARD
as follows:

• 3) Within the first hour following the administration of the first dose of the alternative drug, reduce the infusion rate of ESMOCARD by half (50%).
• 2) After administering the second dose of the alternative drug, carefully monitor the patient's response and, if satisfactory control has been maintained in the first hour, discontinue the ESMOCARD infusion.

Further information on dosage
As soon as the desired therapeutic effect or safety endpoint is reached (e.g.
reduced blood pressure), the loading dose is stopped and the incremental infusion is reduced
to 12.5-25 micrograms/kg/min. If desired, the interval between titration steps can also be increased from five to ten minutes.
When the heart rate, or blood pressure, rapidly approaches or exceeds the
safety limit, ESMOCARD administration must be stopped; then
restart, without administering a loading infusion, at a lower dose after
the heart rate, or blood pressure, has returned to an acceptable level.

Special populations
Elderly
Elderly patients should be treated with caution, starting with a lower dose. No
specific studies have been conducted in the elderly. However, an analysis of data relating to 252
patients over 65 years of age did not reveal any changes in pharmacodynamic effects compared to the results obtained in patients under 65 years of age.
Patients with renal insufficiency
Particular caution is required when administering ESMOCARD infusion to patients with renal insufficiency, as the acidic metabolite of ESMOCARD is
eliminated through the kidneys. Elimination of the acidic metabolite is significantly reduced in patients with kidney disease, with an increase in the elimination half-life of approximately ten times normal levels, along with significantly elevated plasma levels.
Patients with hepatic insufficiency
In case of hepatic insufficiency, no particular precautions are necessary due to the predominant role played by plasma esterases in the metabolism of ESMOCARD.
Paediatric population (under 18 years of age):
The safety and efficacy of ESMOCARD in children under 18 years of age have not been
established. Therefore, the use of ESMOCARD is not indicated in the paediatric population.

Method of administration
The powder must be reconstituted/diluted before use. The reconstituted/diluted powder can
be administered in two different concentrations in two different volumes:

• 1. The standard concentration is 10 mg/ml, with a final volume of 250 ml
• 2. In some cases where a lower volume is deemed necessary, it is possible to prepare a higher concentration (50 mg/ml) by diluting the powder in a final volume of 50 ml and then administering it with a MOTORIZED/PERFUSION PUMP. Clinical experience with the use of this higher concentration is limited. This higher concentration must be infused only through a large vein or central catheter using a perfusion pump.

INFUSION RATE CONVERSION TABLES(micrograms/kg/min 
ml/min) for an infusion solution diluted (10 mg/ml)administered via

STANDARD INFUSION:

INFUSION RATE CONVERSION TABLES(micrograms/kg/min 
ml/min) for a concentratedinfusion solution (50 mg/ml)administered with a

PERFUSION PUMP/MOTORIZED: