Label: information for the user

Levosimendan Accord 2.5 mg/ml concentrate for solution for infusionEFG

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

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

This medication is presented in a concentrated form that must be diluted before administration via intravenous infusion.

Levosimendan acts by increasing the heart's pumping force and allowing the relaxation of blood vessels. Levosimendan will reduce pulmonary congestion and facilitate the circulation of blood and oxygen throughout the body. Levosimendan helps to alleviate respiratory difficulty in severe heart failure.

Levosimendan is indicated for the treatment of heart failure in individuals who continue to experience difficulty breathing despite taking other medications to remove fluids from the body.

Levosimendan is indicated for use in adults

No use Levosimendán Accord

• If you are allergic (hypersensitive) to levosimendan or to any of the other components of this medication (listed in section 6)
• If you have very low blood pressure or an abnormally high heart rate (tachycardia)
• If you have a severe kidney or liver problem
• If you have a heart condition that makes it difficult for the heart to fill and empty
• If your doctor has told you that you have had a type of irregular heartbeat called Torsades de Pointes

Warnings and precautions

Consult your doctor or nurse before using Levosimendán Accord

• If you have a liver or kidney disease
• If you have anemia and chest pain at the same time
• If you have an abnormally high heart rate (tachycardia), abnormal heart rhythm, your doctor has told you that you have atrial fibrillation, or if you have abnormally low potassium levels in your blood, your doctor should use this medication with caution

Children and adolescents

Levosimendan should not be administered to children and adolescents under 18 years old.

Other medications and Levosimendán Accord

Inform your doctor or pharmacist if you are using or have recently used other medications, including those obtained without a prescription.

If you have been given other intravenous cardiac medications, the administration of levosimendan may cause a drop in blood pressure.

Inform your doctor if you are taking isosorbide mononitrate, as the use of levosimendan may increase the drop in blood pressure when standing up.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medication. The effects of levosimendan on the child are unknown.

There is evidence that levosimendan passes into breast milk. Do not breastfeed while being treated with levosimendan to avoid possible cardiovascular adverse effects in the child.

Levosimendán Accord contains Ethanol

This medication contains 98% by volume of ethanol (alcohol), that is, up to 3.925 mg per 5 ml vial, equivalent to 99.2 ml of beer, 41.3 ml of wine per 5 ml vial.

The amount of alcohol contained in this medication may affect your ability to drive and use machines due to its potential to alter your judgment and reaction time.

If you have epilepsy or liver problems, consult your doctor or pharmacist before taking this medication.

The amount of alcohol contained in this medication may alter the effect of other medications. Consult your doctor or pharmacist if you are taking other medications.

If you are pregnant or breastfeeding, consult your doctor or pharmacist before taking this medication.

If you have a history of alcohol addiction, consult your doctor or pharmacist before taking this medication.

Since this medication is generally administered slowly over 24 hours, the effects of alcohol may be reduced.

This medication must be administered through intravenous infusion (drip). Therefore, it should only be administered in a hospital where your doctor can monitor you. Your doctor will decide the dose of levosimendan to administer. Your doctor will follow your response to treatment (for example, by measuring your heart rate, blood pressure, electrocardiogram, and subjective sensations), and adjust the dose if necessary. Your doctor may want to monitor you for 4-5 days after the completion of levosimendan administration.

Treatment can be initiated with a rapid infusion for 10 minutes followed by a slow infusion for 24 hours.

Your doctor will evaluate your response to levosimendan at different time periods. This way, they can decrease the infusion if your blood pressure drops or your heart rate becomes too fast or you do not feel well. If you feel that your heart is racing, you feel dizzy, or you have the impression that the effect of levosimendan is too strong or weak, you should inform your doctor or nurse.

If your doctor considers that you need a higher dose of levosimendan and you are not experiencing side effects, they may increase the infusion.

Your doctor will continue the infusion of levosimendan as long as they deem necessary to help your heart. Generally, it is recommended to infuse levosimendan for 24 hours.

The effect on your cardiac function will continue for 24 hours after the infusion of the product has ended. The effect may last up to 9 days after stopping the infusion.

Renal Insufficiency

Levosimendan should be used with caution in patients with mild to moderate renal insufficiency. Levosimendan should not be used in patients with severe renal insufficiency (see section 2).

Liver Insufficiency

Levosimendan should be used with caution in patients with mild to moderate liver insufficiency, although it may not be necessary to adjust the dose in these patients. Levosimendan should not be administered to patients with severe liver insufficiency (see section 2).

If You Use More Levosimendan Accord Than You Should

A levosimendan overdose will cause a drop in blood pressure and an increase in heart rate. Your doctor will know how to treat it based on your medical history.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, call or the Toxicological Information Service Tel. 91 562 04 20, indicating the medication and the amount ingested.

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

Very Common(affect more than 1 in 10 people)

• Abnormally high heart rate.
• Headache.
• Hypotension.

Common(affect between 1 and 10 in 100 people)

• Decrease in potassium levels in the blood.
• Insomnia.
• Dizziness.
• Abnormal heart rhythm called atrial fibrillation (a consequence of heart palpitations instead of a normal heartbeat).
• Additional heartbeats.
• Heart failure.
• Decreased oxygen supply to the heart through the blood.
• Nausea.
• Constipation.
• Dysentery.
• Vomiting.
• Decrease in hemoglobin.

Cases of a heart rhythm alteration called ventricular fibrillation (a consequence of heart palpitations instead of a normal heartbeat) have been reported in patients who received levosimendan

Please inform your doctor immediately if you experience any side effects. Your doctor may reduce or stop the infusion of this medication.

Reporting Adverse Effects

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

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

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

Store in refrigerator (between2°Cand8°C).

Do not freeze

Do not use this medication after the expiration date that appears on the box.

The expiration date refers to the last day of that month.

The storage and use time after dilution should never exceed 24 hours.

Medicines should not be disposed of through drains. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. In this way, you will help protect the environment.

Composition of Levosimendan Accord

• The active ingredient is levosimendan 2.5 mg/ml. Each ml of concentrate contains 2.5 mg of levosimendan.
• The other components are povidone, anhydrous citric acid, and anhydrous ethanol.

Appearance of the product and contents of the pack

The concentrate is a clear yellow or orange solution to be diluted before use.

Package sizes:

• 1, 4, 10 vial (glass type I) of 5 ml

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

Accord Healthcare, S.L.U

World Trade center

Moll de Barcelona, s/n

Edifici Est 6th floor

08039 Barcelona

Spain

Manufacturer responsible

BAG Health Care GmbH

Amtsgerichtsstrasse 1-5

D-35423 Lich

Germany

O

Wessling GmbH

Johann-Krane-Weg 42

48149 Münster

Germany

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Member statesMedicinal product names

AustriaLevosimendan Accord 2.5 mg/ml Concentrate for the preparation of an infusion solution

Infusionslösung

GermanyLevosimendan Accord 2.5 mg/ml Concentrate for the preparation of an infusion solution

Infusionslösung

SpainLevosimendan Accord 2.5 mg/ml concentrate for solution for infusion EFG

EFG

FranceLevosimendan Accord 2.5 mg/mL solution to be diluted for perfusion

ItalyLevosimendan Accord

PortugalLevossimendano Accord

PolandLevosimendan Accord

Last review date of this leaflet:December/2021.

More detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es

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This information is intended solely for healthcare professionals:

Instructions for use and handling

For single use only.

Levosimendan Accord 2.5 mg/ml concentrate for solution for infusion EFG must not be diluted to a concentration higher than 0.05 mg/ml as indicated below, otherwise opalescence and precipitation may occur.

Like all parenteral medicines, visually inspect the diluted solution for particles and discoloration before administration.

• To prepare the infusion of 0.025 mg/ml, mix 5 ml of Levosimendan Accord 2.5 mg/ml concentrate for solution for infusion EFG with 500 ml of 5% glucose solution.
• To prepare the infusion of 0.05 mg/ml, mix 10 ml of Levosimendan Accord 2.5 mg/ml concentrate for solution for infusion EFG with 500 ml of 5% glucose solution.

Dosage and administration

Levosimendan Accord is only for hospital use. It should be administered in a hospital unit with monitoring facilities and experience with the use of inotropic agents.

Levosimendan Accord must be diluted before administration.

The infusion must be administered exclusively by intravenous route, both peripheral and central.

See the technical data sheet for information on dosage.