Levosimendan Sala 2.5 mg/ml concentrate for solution for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Levosimendan Sala 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 or nurse.
• If you experience any adverse reactions, consult your doctor or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

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

Levosimendán Sala works by increasing the heart's pumping strength and promoting relaxation of the blood vessels. Levosimendán Sala reduces pulmonary congestion and improves blood and oxygen circulation throughout the body. Levosimendán Sala helps alleviate breathing difficulties associated with severe heart failure.

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

Levosimendán is used in adults.

2. What you need to know before using Levosimendan Sala

Do not use Levosimendan Sala

• if you are allergic to levosimendan or any of the other ingredients of this medicine (listed in section 6);
• if you have very low blood pressure or abnormally rapid heartbeats;
• if you have severe kidney or liver disease;
• if you have a heart condition that impairs the heart's filling or emptying;
• if your doctor has told you that you have ever had an abnormal heart rhythm called Torsades de Pointes.

Warnings and precautions

Consult your doctor or nurse before being administered Levosimendan Sala

• if you have low blood pressure;
• if you are in a state of reduced blood volume (hypovolemia);
• if you have liver or kidney disease;
• if you have low blood cell count (anemia) and chest pain;
• if you have abnormally high heart rate, abnormal heart rhythm, or if your doctor has told you that you have atrial fibrillation, or if you have abnormally low levels of potassium in your blood—your doctor must use Levosimendan Sala with great caution.

Children and adolescents

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

Other medicines and Levosimendan Sala

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

If you are receiving other intravenous cardiac medications, administration of Levosimendan Sala may cause a drop in blood pressure.

Inform your doctor if you are taking isosorbide mononitrate, as the use of Levosimendan Sala may increase the drop in blood pressure upon standing.

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 Sala may affect your baby. Your doctor will decide whether the benefits to the mother outweigh the potential risks to the baby.

There is evidence that Levosimendan Sala passes into human milk. You must not breastfeed while being treated with Levosimendan Sala to avoid potential cardiovascular adverse effects in the infant.

Levosimendan Sala contains alcohol

This medicine contains 3.925 mg of alcohol (anhydrous ethanol) in each 5 ml vial, equivalent to 98% v/v. The amount of alcohol in a 5 ml vial of this medicine is equivalent to 99.2 ml of beer or 41.3 ml of wine.

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 speed.

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 before taking this medicine.

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 Levosimendan Sala

Levosimendán Sala must be administered by intravenous infusion (drip). For this reason, it should only be given in a hospital where your doctor can monitor you. Your doctor will decide the amount of levosimendán you should receive. Your doctor will assess how you respond to treatment with levosimendán (for example, by measuring your heart rate, blood pressure, performing an electrocardiogram (ECG) and/or asking how you feel). Your doctor may adjust the dose if necessary. Your doctor may wish to monitor you for up to 4–5 days after administration of levosimendán.

Treatment may begin with a rapid infusion over 10 minutes, followed by a slow infusion over 24 hours.

Your doctor will evaluate your response to Levosimendán Sala at different time intervals. In this way, the infusion may be reduced if your blood pressure drops or your heart rate becomes too fast, or if you do not feel well. If you feel your heart racing, feel dizzy, or notice that the effect of levosimendán is too strong or too weak, you must inform your doctor or nurse.

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

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

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

Renal impairment

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

Hepatic impairment

Levosimendán Sala 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 Sala than you should

An overdose of Levosimendán Sala 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.

4. Possible adverse effects

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

Very common: may affect more than 1 in 10 patients

Abnormally high heart rate.

Headache.

Drop in blood pressure.

Common: may affect up to 1 in 10 patients

Decreased potassium levels in blood.

Insomnia.

Dizziness.

Abnormal heart rhythm called atrial fibrillation (caused by irregular heart palpitations instead of regular heartbeat).

Extra heartbeats.

Heart failure.

Reduced supply of oxygen 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 (caused by irregular heart palpitations instead of regular heartbeat) 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 levosimendan infusion.

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 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 Sala

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

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

Do not freeze.

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

The color of the concentrate may change to orange during storage, but there is no loss of potency and the product may be used up to the indicated expiry date provided storage instructions have been followed.

Period of validity after dilution

Chemical and physical in-use stability has been demonstrated for 24 hours at 25 °C.

From a microbiological standpoint, the medicine should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and normally should not exceed 24 hours at a temperature of 2 to 8 °C, unless the dilution was carried out under controlled and validated aseptic conditions. The total storage and use time after dilution must never exceed 24 hours.

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

6. Contents of the pack and other information

Composition of Levosimendán Sala

• The active substance is levosimendán.

Each ml of concentrate contains 2.5 mg of levosimendán.

Each 5 ml vial of solution contains 12.5 mg of levosimendán.

• The other components are: povidone, citric acid (for pH adjustment), and anhydrous ethanol.

Appearance of the product and contents of the pack

The concentrate is a clear yellow or orange-yellow solution for dilution before use.

Pack sizes:

• 1, 4, 10 vials (glass vials closed with a chlorobutyl stopper and aluminum seal) of 5 ml

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder:

Laboratorio Reig Jofre, S.A.

Gran Capitán, 10

08970 Sant Joan Despí (Barcelona)

Spain

Manufacturer:

Laboratorio Reig Jofre, S.A.

Gran Capitán, 10

08970 Sant Joan Despí (Barcelona)

Spain

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

Sweden: Levosimendan Bioglan

Denmark: Levosimendan Bioglan

Finland: Levosimendan Bioglan 2.5 mg/ml infuusiokonsentraatti, liuosta varten

Norway: Levosimendan Bioglan

Spain: Levosimendan Sala 2.5 mg/ml concentrate for solution for infusion EFG

France: LEVOSIMENDAN REIG JOFRE 2.5 mg/mL, solution à diluer pour perfusion

Poland: Levosimendan Reig Jofre

Portugal: Levossimendano Reig Jofre 2.5 mg/ml concentrate for solution for infusion

Date of the most recent review of this summary of product characteristics: 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/)

This information is intended exclusively for physicians or healthcare professionals:

Levosimendán Sala 2.5 mg/ml concentrate for solution for infusion

Instructions for use and handling

Levosimendán Sala 2.5 mg/ml concentrate for solution for infusion is intended for single use only.

Levosimendán Sala 2.5 mg/ml concentrate for solution for infusion must not be diluted to concentrations higher than 0.05 mg/ml, as indicated below, since opalescence and precipitation may otherwise occur.

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

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

Dosage and method of administration

Levosimendán Sala 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 Sala must be diluted before administration.

The infusion is for intravenous use only and may be administered via peripheral or central route.

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