Levosimendan Accord

Package Leaflet: Information for the User

Levosimendan Accord, 2.5 mg/mL, Concentrate for Solution for Infusion

Levosimendan

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or nurse. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Levosimendan Accord and what is it used for
• 2. Important information before using Levosimendan Accord
• 3. How to use Levosimendan Accord
• 4. Possible side effects
• 5. How to store Levosimendan Accord
• 6. Contents of the pack and other information

1. What is Levosimendan Accord and what is it used for

Levosimendan Accord is a medicine in the form of a concentrate that must be diluted before intravenous infusion.
Levosimendan Accord increases the strength with which the heart pumps blood and allows blood vessels to relax.
This reduces congestion in the lungs and facilitates blood and oxygen flow in the body.
It helps to alleviate shortness of breath caused by severe heart failure.
Levosimendan Accord is used to treat heart failure in patients who still have breathing difficulties despite taking other medicines that remove excess water from the body.
Levosimendan Accord is intended for use in adults.

2. Important information before using Levosimendan Accord

When not to use Levosimendan Accord:

• if the patient is allergic to levosimendan or any of the other ingredients of this medicine (listed in section 6);
• if the patient has very low blood pressure and a rapid heart rate;
• if the patient has severe kidney or liver disease;
• if the patient has heart disease that makes it difficult for the heart to fill or empty;
• if the patient has ever been told by a doctor that they have an abnormal heart rhythm called Torsades de Pointes.

Warnings and precautions

Before starting treatment with Levosimendan Accord, the patient should discuss it with their doctor or nurse:

• if the patient has any kidney or liver disease;
• if the patient has a low number of blood cells and chest pain;
• if the patient has an abnormally fast heart rate, abnormal heart rhythm, or if the doctor has ever told the patient that they have atrial fibrillation or low potassium levels in the blood, Levosimendan Accord should be used with caution.

Children and adolescents

Levosimendan Accord should not be given to children and adolescents under 18 years of age.

Levosimendan Accord and other medicines

The patient should tell their doctor about all medicines they are taking or have recently taken, as well as any medicines they plan to take.
If the patient is taking other intravenous heart medicines, the use of Levosimendan Accord may cause a drop in blood pressure.
The patient should tell their doctor or nurse if they are taking isosorbide mononitrate, as the use of Levosimendan Accord may increase the drop in blood pressure when standing up.

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 using this medicine.
It is not known whether the use of Levosimendan Accord affects the unborn child.
The doctor will decide whether the benefit to the patient outweighs the potential risk to the child.
It has been shown that Levosimendan Accord passes into human milk.
Therefore, breastfeeding should be avoided during treatment with Levosimendan Accord to prevent any potential adverse effect on the baby's cardiovascular system.

Levosimendan Accord contains alcohol

This medicine contains 3925 mg of alcohol (anhydrous ethanol) in each 5 mL vial, which is equivalent to 98% v/v ethanol.
The amount in one 5 mL vial of this medicinal product is equivalent to 99.2 mL of beer or 41.3 mL of wine.
The alcohol content in this medicine may affect the ability to drive and use machines, as it may affect the assessment of the situation and reaction time.
If the patient has epilepsy or liver problems, they should talk to their doctor or pharmacist before using this medicine.
The alcohol content in this medicine may affect the effect of other medicines.
If the patient is taking other medicines, they should talk to their doctor or pharmacist.
If the patient is pregnant or breastfeeding, they should talk to their doctor or pharmacist before using this medicine.
If the patient is addicted to alcohol, they should talk to their doctor or pharmacist before using this medicine.
Since this medicine is usually administered slowly over 24 hours, the effect of the alcohol may be reduced.

3. How to use Levosimendan Accord

Levosimendan Accord will be administered as an intravenous infusion (drip).
For this reason, Levosimendan Accord should only be administered in a hospital where the doctor can monitor the patient's condition.
The doctor will decide what dose of Levosimendan Accord to administer.
The doctor will assess the patient's response to Levosimendan Accord (e.g., by measuring pulse or blood pressure, performing an ECG, and/or asking about their well-being) and adjust the dose if necessary.
The doctor may decide to monitor the patient's condition for 4-5 days after stopping treatment with Levosimendan Accord.
The patient may receive the medicine as a rapid infusion over 10 minutes followed by a slower infusion over a period of up to 24 hours.
The doctor should check the patient's response to Levosimendan Accord from time to time.
If the patient experiences a drop in blood pressure, rapid heart rate, or feels unwell, the doctor may reduce the infusion rate.
The patient should tell their doctor or nurse if they experience palpitations, dizziness, or if the effect of Levosimendan Accord seems too strong or too weak.
The doctor may increase the infusion rate if they think a higher dose of Levosimendan Accord is needed and the patient is not experiencing side effects.
The doctor will continue the infusion of Levosimendan Accord for as long as it is necessary to support the heart.
Usually, this is for 24 hours.
The effect on the heart lasts for at least 24 hours after the end of the infusion of Levosimendan Accord.
The medicine may work for up to 9 days after the end of the infusion.
Renal impairment
Caution should be exercised when using Levosimendan Accord in patients with mild or moderate renal impairment.
Levosimendan Accord should not be used in patients with severe renal impairment (see section 2).
Hepatic impairment
Caution should be exercised when using Levosimendan Accord in patients with mild or moderate hepatic impairment, although dose adjustment is not necessary in these patients.
Levosimendan Accord should not be used in patients with severe hepatic impairment (see section 2).

Overdose of Levosimendan Accord

In case of overdose of Levosimendan Accord, a drop in blood pressure and rapid heart rate may occur.
The doctor will provide appropriate treatment based on the patient's condition.

4. Possible side effects

Like all medicines, Levosimendan Accord can cause side effects, although not everybody gets them.
Very common(occurring in more than 1 in 10 patients):

• abnormally fast heart rate
• headache
• drop in blood pressure

Common(occurring in up to 1 in 10 patients):

• low potassium levels in the blood
• insomnia
• dizziness
• abnormal heart rhythms, called atrial fibrillation (part of the heart flutters instead of beating properly)
• extra heartbeats
• heart failure
• myocardial ischemia
• nausea
• constipation
• diarrhea
• vomiting
• low number of blood cells

In patients receiving Levosimendan Accord, abnormal heart rhythms, called ventricular fibrillation (part of the heart flutters instead of beating properly), have been observed.
If side effects occur, the patient should immediately inform their doctor or nurse.
The doctor may reduce the infusion rate or stop the infusion of Levosimendan Accord.

Reporting side effects

If the patient experiences any side effects, including those not listed in this package leaflet, they should inform their doctor or pharmacist.
Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
tel.: +48 22 49 21 301
fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
By reporting side effects, more information can be gathered on the safety of this medicine.
Side effects can also be reported to the marketing authorization holder.

5. How to store Levosimendan Accord

The medicine should be stored out of sight and reach of children.
Store in a refrigerator (2°C – 8°C).
Do not freeze.
Do not use this medicine after the expiry date stated on the vial or carton after EXP.
The expiry date refers to the last day of the month stated.
The shelf-life after dilution should not exceed 24 hours.
Medicines should not be disposed of via wastewater or household waste.
The patient should ask their pharmacist how to dispose of medicines no longer required.
This will help protect the environment.

6. Contents of the pack and other information

What Levosimendan Accord contains

• The active substance is levosimendan 2.5 mg/mL.
• The other ingredients are povidone, citric acid, and anhydrous ethanol.

What Levosimendan Accord looks like and contents of the pack

The concentrate is a clear solution, yellow to orange, for dilution prior to administration.
Pack sizes:

• 1, 4, or 10 vials (colorless glass type I) of 5 mL.

Not all pack sizes may be marketed.

Marketing authorization holder

Accord Healthcare Polska Sp. z o.o.
ul. Taśmowa 7
02-677 Warsaw

Manufacturer

BAG Health Care GmbH
Amtsgerichtsstrasse 1-5
35423 Lich
Germany
Wessling GmbH
Johann-Krane-Weg 42
48149 Muenster
Germany

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

Date of last revision of the package leaflet: May 2023

Information intended for healthcare professionals only:

Instructions for use and handling

For single use only.
Levosimendan Accord 2.5 mg/mL concentrate for solution for infusion should not be diluted to a concentration greater than 0.05 mg/mL according to the instructions below, otherwise opalescence and precipitation may occur.
As with all parenteral products, the prepared solution should be inspected visually for the presence of particulate matter and discoloration prior to administration.

• To prepare an infusion solution with a concentration of 0.025 mg/mL, 5 mL of Levosimendan Accord 2.5 mg/mL concentrate for solution for infusion should be mixed with 500 mL of 5% glucose solution.
• To prepare an infusion solution with a concentration of 0.05 mg/mL, 10 mL of Levosimendan Accord 2.5 mg/mL concentrate for solution for infusion should be mixed with 500 mL of 5% glucose solution.

Dosage and administration

Levosimendan Accord is intended for hospital use only.
The medicine should be administered under hospital conditions where appropriate monitoring equipment and personnel experienced in the use of inotropic agents are available.
Levosimendan Accord should be diluted before administration.
The solution is intended for intravenous infusion only and may be administered peripherally or centrally.
Information on dosing can be found in the Summary of Product Characteristics.