Levosimendan Zentiva 2.5 mg/ml concentrate for infusion solution EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

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

Read the entire leaflet carefully before you start using this medicine, as 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 or nurse, even if they are not listed in this leaflet. See section 4.

Leaflet Contents

1. What Levosimendán Zentiva is and what it is used for
2. What you need to know before using Levosimendán Zentiva
3. How to use Levosimendán Zentiva
4. Possible adverse effects
5. How to store Levosimendán Zentiva
6. Package contents and additional information

1. What Levosimendán Zentiva is and what it is used for

Levosimendán Zentiva is presented as a concentrate that must be diluted before administration by intravenous infusion.

Levosimendan works by increasing the heart's pumping force and promoting relaxation of blood vessels. Levosimendan will reduce pulmonary congestion and improve blood and oxygen circulation throughout your body. Levosimendan helps alleviate breathing difficulties associated with severe heart failure.

Levosimendan is indicated for short-term additional treatment of heart failure in adults who continue to experience breathing difficulties despite receiving other medications to remove fluid from the body.

2. What you need to know before starting Levosimendan Zentiva

Do not use Levosimendan Zentiva

• If you are allergic (hypersensitive) to levosimendan or to any of the other components of this medicine (listed in section 6).
• If you have low blood pressure or tachycardia (abnormally fast heart rate).
• If you have severe kidney or liver damage.
• 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 experienced an arrhythmia called Torsades de Pointes.

Warnings and precautions

• If you have liver or kidney disease.
• If you have both anemia and chest pain.
• If you have tachycardia, an abnormal heart rhythm, have been diagnosed with atrial fibrillation, or have abnormally low levels of potassium in your blood, your doctor must use levosimendan with great caution.

Consult your doctor before starting levosimendan if you have any of the conditions or symptoms listed above.

Children and adolescents

This medicine must not be administered to children and adolescents under 18 years of age.

Other medicines and Levosimendan Zentiva

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

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

It is unknown whether levosimendan affects your baby. Your doctor will decide whether the benefit outweighs any possible risk to the unborn child.

There is evidence that levosimendan passes into human milk. You must not breastfeed while receiving levosimendan treatment to avoid possible cardiovascular adverse effects in the infant.

Levosimendan Zentiva contains alcohol

This medicine contains 98% alcohol by volume. This corresponds to up to 3.848 mg per 5 ml vial, equivalent to 98 ml of beer or 41 ml of wine.

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

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

The amount of alcohol 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.

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

3. How to use Levosimendán Zentiva

Levosimendan 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 determine the dose of levosimendan to be administered. 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 the completion of levosimendan administration.

You may receive a rapid infusion over ten minutes, followed by a slower infusion for up to 24 hours.

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

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

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

The effect on your cardiac function will continue for 24 hours after the infusion has ended. The effect may persist for 7–10 days after completion of the infusion.

If you use more Levosimendán Zentiva than you should

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

If you have any further questions about the use of this medicine, ask your doctor.

4. Possible adverse effects

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

Very common (may affect 1 in 10 patients or more):

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

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

• Decreased potassium levels in blood.
• Insomnia.
• Dizziness.
• Abnormal heart rhythm called atrial fibrillation (resulting from irregular heart palpitations instead of a proper heartbeat).
• Extra heartbeats.
• Heart failure.
• Reduced oxygen supply to the heart via 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 a proper heartbeat) have been reported in patients receiving levosimendan.

Inform your doctor immediately if you experience any side effects. Your doctor may reduce or stop the levosimendan infusion.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects

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

5. Storage of Levosimendan Zentiva

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.

Storage conditions

Store in a refrigerator (between 2°C and 8°C). Do not freeze.

The product is a clear, yellow or orange solution, free from visible particles.

Storage conditions after dilution:

Chemical and physical stability has been demonstrated for 48 hours at 25°C.

From a microbiological standpoint, unless the method of opening / reconstitution / dilution prevents the risk of microbial contamination, the product should be used immediately.

If not used immediately, the storage times and conditions prior to use are the responsibility of the user.

6. Contents of the pack and other information

Composition of Levosimendan Zentiva

• The active substance is levosimendan.

One 5 ml vial of concentrate for solution for infusion contains 12.5 mg of levosimendan.

• The other components are: povidone, citric acid, anhydrous ethanol.

Appearance of the medicinal product and content of the container

Container size: 1 colourless vial (type I glass) of 5 ml.

Levosimendan Zentiva 2.5 mg/ml concentrate for solution for infusion is a clear yellow or orange solution free from visible particles, packed in a 6 ml transparent type I glass vial, closed with a 20 mm rubber stopper and sealed with a 20 mm flip-off cap.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Zentiva, k.s.,

U kabelovny 130,

Prague 10 – Dolní Mecholupy,

102 37 Czech Republic

Manufacturer [1]

Tillomed Malta Limited,

Malta Life Sciences Park,

LS2.01.06 Industrial Estate,

San Gwann, SGN 3000, Malta

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Zentiva Spain S.L.U.,

Avenida de Europa, 19, Edificio 3, Planta 1.

28224 Pozuelo de Alarcón, Madrid

Spain

This medicinal product is authorised in the European Economic Area member states under the following names:

Austria: Levosimendan Tillomed 2.5 mg / ml Konzentrat zur Herstellung einer Infusionslösung

Czech Republic: Levosimendan Zentiva

Denmark: Levosimendan Tillomed

Finland: Levosimendaani Tillomed 2.5 mg/ml infuusiokonsentraatti, liuosta varten

France: LÉVOSIMENDAN TILLOMED 2.5 mg/ml, solution à diluer pour perfusion

Germany: Levosimendan Tillomed 2.5 mg / ml Konzentrat zur Herstellung einer Infusionslösung

Italy: Levosimendan Tillomed

Norway: Levosimendan Tillomed

Poland: Levosimendan Zentiva

Portugal: Levossimendano Tillomed 2.5 mg/ml concentrado para solução para perfusão

Slovakia: Levosimendan Zentiva 2.5 mg/ml koncentrát na infúzny roztok

Slovenia: Levosimendan Tillomed 2.5 mg/ml koncentrat za raztopino za infundiranje

Spain: Levosimendán Zentiva 2.5 mg/ml concentrate for solution for infusion EFG

Sweden: Levosimendan Tillomed

Date of latest revision of this leaflet: October 2025

Detailed and up-to-date 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/

This information is intended for healthcare professionals only:

Instructions for use and handling

Levosimendan Zentiva 2.5 mg/ml concentrate for solution for infusion is intended for single use only.

Levosimendan Zentiva 2.5 mg/ml concentrate for solution for infusion must not be diluted to concentrations exceeding 0.05 mg/ml as described below, since opalescence and precipitation may otherwise occur.

As with other parenteral products, the diluted solution should be inspected visually for particles and discoloration prior to administration.

• To prepare an infusion of 0.025 mg/ml, mix 5 ml of levosimendan concentrate with 500 ml of 5% glucose solution.
• To prepare an infusion of 0.05 mg/ml, mix 10 ml of levosimendan concentrate with 500 ml of 5% glucose solution.

Dosage and method of administration

Levosimendan is for hospital use only. It should be administered in a hospital setting where monitoring facilities and experience with inotropic agents are available.

Levosimendan must be diluted before administration.

The infusion must be administered exclusively by intravenous route, either peripheral or central.

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

[1] Only the actual manufacturing site will appear in the printed leaflet