Levosimendan Accord 2.5 mg/ml concentrate for infusion solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

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

Leaflet contents

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

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

This medicine is presented as a concentrate that must be diluted before administration by intravenous infusion.

Levosimendan works by increasing the heart's pumping force and allowing relaxation of the blood vessels. Levosimendan reduces pulmonary congestion and improves blood and oxygen circulation throughout the body. Levosimendan helps alleviate breathing difficulties in severe heart failure.

Levosimendan is indicated for the treatment of heart failure in patients who continue to experience breathing difficulties despite taking other medications to remove fluid from the body.

Levosimendan is indicated in adults.

2. What you need to know before using Levosimendán Accord

Do not use Levosimendán Accord

• If you are allergic (hypersensitive) to levosimendan or to any of the other ingredients of this medicine (listed in section 6)
• If you have very low blood pressure or abnormally fast heart rate (tachycardia)
• If you have severe kidney or liver problems
• If you have a heart condition that impairs the heart's ability to fill and empty properly
• If your doctor has told you that you have had an arrhythmia called Torsades de Pointes

Warnings and precautions

Talk to your doctor or nurse before using Levosimendán Accord

• If you have liver or kidney disease
• If you have anemia and chest pain at the same time
• If you have abnormally fast heart rate (tachycardia), other abnormal heart rhythms, if your doctor has diagnosed you with atrial fibrillation, or if you have abnormally low levels of potassium in your blood, your doctor should use this medicine with great caution

Children and adolescents

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

Other medicines and Levosimendán Accord

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription.

If you are receiving other intravenous heart medications, administration of levosimendan may cause a drop in blood pressure.

Tell your doctor if you are taking isosorbide mononitrate, as using 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 are planning to become pregnant, consult your doctor before using this medicine. The effects of levosimendan on the child are unknown.

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

Levosimendán Accord contains ethanol

This medicine contains 98% by volume of ethanol (alcohol), i.e. up to 3.925 mg per 5 ml vial, equivalent to 99.2 ml of beer or 41.3 ml of wine per 5 ml vial.

The amount of alcohol contained in this medicine may affect your ability to drive or operate machinery, as it may impair your judgment and reaction time.

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

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

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

If you are alcohol-dependent, consult your doctor or pharmacist before taking this medicine.

Because this medicine is usually administered slowly over 24 hours, the effects of the alcohol may be reduced.

3. How to use Levosimendán Accord

This medicine must be administered by intravenous infusion (drip). For this reason, it should only be given in a hospital setting where your doctor can monitor you. Your doctor will decide the dose of levosimendán to administer. Your doctor will monitor your response to treatment (for example, by measuring your heart rate, blood pressure, electrocardiogram, and your subjective sensations) and will adjust the dose if necessary. Your doctor may wish to monitor you for 4–5 days after levosimendán administration has ended.

Treatment may be initiated with a rapid infusion over 10 minutes followed by a slow infusion over 24 hours.

Your doctor will assess your response to levosimendán at different time intervals. In this way, the infusion may be reduced if your blood pressure drops or if your heart rate becomes too fast or you feel unwell. If you feel your heart racing, feel dizzy, or perceive that the effect of levosimendán is too strong or too weak, you must inform your doctor or nurse.

If your doctor considers that you require a higher dose of levosimendán and you are not experiencing side effects, the infusion rate may be increased.

Your doctor will continue the levosimendán infusion for as long as considered necessary to support your heart function. Generally, a 24-hour infusion of levosimendán is recommended.

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

Renal impairment

Levosimendán should be used with caution in patients with mild to moderate renal impairment. Levosimendán must not be used in patients with severe renal impairment (see section 2).

Hepatic impairment

Levosimendán should be used with caution in patients with mild to moderate hepatic impairment, although dose adjustment does not appear to be necessary in these patients. Levosimendán must not be administered to patients with severe hepatic impairment (see section 2).

If you use more Levosimendán Accord than you should

An overdose of levosimendán will cause a drop in blood pressure and an increased heart rate. Your doctor will know how to treat this based on your medical history.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, call, or contact the Toxicology Information Service at Tel. 91 562 04 20, indicating the medicine and the amount ingested.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Very common (affects more than 1 in 10 people)

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

Common (affects between 1 and 10 in every 100 people)

• Decreased potassium levels in blood
• Insomnia
• Dizziness
• Abnormal heart rhythm called atrial fibrillation (resulting from irregular heart palpitations instead of regular beats)
• Extra heartbeats
• Heart failure
• Reduced oxygen supply to the heart through the blood
• Nausea
• Constipation
• Diarrhea
• Vomiting
• Decreased hemoglobin levels

Frequency not known (cannot be estimated from available data):

• Hypersensitivity (symptoms may include rash and itching).

Cases of a disturbance in heart rhythm called ventricular fibrillation (resulting from irregular heart palpitations instead of regular beats) have been reported in patients receiving levosimendan.

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Levosimendan Accord

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

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.

Store in a refrigerator (between 2°C and 8°C).

Do not freeze.

Do not use this medicine after the expiry date shown on the carton.

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

The storage and usage time after dilution must never exceed 24 hours.

Medicines should not be disposed of via wastewater. Ask your pharmacist how to properly dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Levosimendán Accord

• The active substance 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 for dilution before use.

Pack sizes:

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

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Accord Healthcare, S.L.U
World Trade Center
Moll de Barcelona, s/n
Edifici Est, 6th floor
08039 Barcelona
Spain

Manufacturer

BAG Health Care GmbH
Amtsgerichtsstrasse 1-5
D-35423 Lich
Germany

Or

ALS Germany GmbH
Johann-Krane-Weg 42
48149 Münster
Germany

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

Member States – Names of the medicinal products

Austria: Levosimendan Accord 2.5 mg/ml Konzentrat zur Herstellung einer Infusionslösung
Germany: Levosimendan Accord 2.5 mg/ml Konzentrat zur Herstellung einer Infusionslösung
Spain: Levosimendan Accord 2.5 mg/ml concentrate for solution for infusion EFG
France: Levosimendan Accord 2.5 mg/mL solution à diluer pour perfusion
Italy: Levosimendan Accord
Portugal: Levossimendano Accord
Poland: Levosimendan Accord

Date of the most recent review of this leaflet: October 2025.

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es

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This information is intended for healthcare professionals only:

Instructions for use and handling

For single use only.

Levosimendán 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.

As with all parenteral medications, visually inspect the diluted solution for particles and discoloration prior to administration.

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

Dosage and method of administration

Levosimendán Accord is for hospital use only. It must be administered in a hospital unit equipped with monitoring facilities and experienced in the use of inotropic agents.

Levosimendán Accord must be diluted before administration.

The infusion must be administered intravenously, either via peripheral or central route.

Refer to the Summary of Product Characteristics for information on dosage.