Prospect: Information for the User

Levosimendan Solution for Infusion, Concentrate, 2.5 mg/ml

Read this prospect carefully before starting to use the medicine, because it contains important information for you.

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

Levosimendan Sandoz is presented in the form of a concentrate, which must be diluted before administration via intravenous infusion.

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

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

Levosimendan is used in adults.

Do not use Levosimendan Sala

• if you are allergic to levosimendan or any of the other components of this medication (listed in section 6).
• if you have very low blood pressure or abnormally fast heartbeats;
• if you have a severe kidney or liver disease;
• if you have a heart disease that makes it difficult for the heart to fill or empty;
• if your doctor has told you that you have ever had an abnormal heart rhythm called Torsades de Pointes.

Warnings and precautions

Consult with your doctor or nurse before Levosimendan Sala is administered to you

• if you have low blood pressure,
• if you are in a state of decreased blood volume (hypovolemia),
• if you have liver or kidney disease,
• if you have anemia and chest pain;
• ifyou have an abnormally high heart rate, abnormal heart rhythm or 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 Levosimendan Sala with great caution.

Children and adolescents

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

Other medications and Levosimendan Sala

Inform your doctor if you are using, have used recently or may have to use any other medication, including those purchased without a prescription.

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

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant or intend to become pregnant, consult your doctor before using this medication. It is unknown ifLevosimendan Salamay affect your baby. Your doctor will decide if the benefits for the mother outweigh the possible risk to the baby.

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

Levosimendan Sala contains alcohol

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

The amount of alcohol contained in this medication may affect your ability to drive and use machines. This is because it may affect your judgment and the speed with which you react.

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 before taking this medication.

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 usually administered slowly over 24 hours, the effects of alcohol may be reduced.

Levosimendan Infusion 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 amount of levosimendan that you should receive. Your doctor will assess your response to treatment with levosimendan (for example, by measuring your heart rate, blood pressure, through an electrocardiogram (ECG), and/or asking how you feel). Your doctor may adjust the dose if necessary. It is possible that your doctor will want to monitor you for up to 4 ‑ 5 days after the administration of levosimendan.

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 Infusion 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 Infusion and you are not experiencing side effects, they may increase the infusion.

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

The effect on your cardiac function will continue for 24 hours after the infusion of the medication is completed. The effect may continue for 7–10 days after the infusion is finished.

Renal Insufficiency

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

Liver Insufficiency

Levosimendan Infusion 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 Infusion than you should

A Levosimendan Infusion 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.

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

Very Frequent:may affect more than 1 in 10 patients

Abnormally high heart rate.

Headache.

Drop in blood pressure

Frequent:may affect up to 1 in 10 patients

Decrease in potassium in the blood

Insomnia

Dizziness

Abnormal heart rhythm called atrial fibrillation (consequence of heart palpitations instead of the normal heartbeat)

Additional heartbeats

Heart failure

Decrease in oxygen supply to the heart through the blood

Nausea

Constipation

Diarrhea

Vomiting

Decrease in hemoglobin

Cases of a heart rhythm alteration called ventricular fibrillation (as a consequence of heart palpitations instead of the 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 levosimendan.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or nurse, 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 on the safety of this medication.

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

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

Do not freeze

Do not use this medication after the expiration date that appears on the label and on the box after CAD. The expiration date is 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 can be used until the indicated expiration date if storage instructions have been followed.

Period of validity after dilution

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

From a microbiological standpoint, the medication should be used immediately. If not used immediately, storage times in use and pre-use conditions are the responsibility of the user and should normally not exceed 24 hours at a temperature of 2 to 8 °C, unless the dilution has taken place in controlled and validated aseptic conditions. The storage time and use after dilution should never exceed 24 hours.

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

Composition of Levosimendan Solution

• The active principle is levosimendan.

Each ml of concentrate contains 2.5 mg of levosimendan.

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

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

Appearance of the product and contents of the package

The concentrate is a clear yellowish to orange-colored solution to be diluted before use.

Package sizes:

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

Only some package sizes may be commercially available.

Marketing authorization holder and manufacturer:

Marketing authorization holder:

Reig Jofre, S.A.

Gran Capitán, 10

08970 Sant Joan Despí (Barcelona)

Spain

Manufacturer:

Reig Jofre, S.A.

Gran Capitán, 10

08970 Sant Joan Despí (Barcelona)

Spain

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

Sweden: Levosimendan Bioglan

Denmark: Levosimendan Bioglan

Finland: Levosimendan Bioglan 2.5 mg/ml infusion concentrate, for solution for infusion

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 to be diluted for infusion

Poland: Levosimendan Reig Jofre

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

Last review date of this leaflet: April 2023.

Further 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/)

This information is intended solely for medical professionals or healthcare professionals:

Levosimendan Solution 2.5 mg/ml concentrate for solution for infusion

Instructions for use and handling

Levosimendan Solution 2.5 mg/ml concentrate for solution for infusion is designed exclusively for single use.

Levosimendan Solution 2.5 mg/ml concentrate for solution for infusion should not be diluted to concentrations above 0.05 mg/ml as indicated below, otherwise opalescence and precipitation may occur.

As with other parenteral products, 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 Solution 2.5 mg/ml concentrate for solution for infusion with 500 ml of 5% glucose solution.
• To prepare the infusion of 0.05 mg/ml, mix 10 ml of Levosimendan Solution 2.5 mg/ml concentrate for solution for infusion with 500 ml of 5% glucose solution.

Dosage and administration

Levosimendan Solution 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 Solution should be diluted before administration.

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

Consult the technical data sheet for information on dosage.