LEVOSIMENDAN EQL PHARMA 2.5 mg/ml CONCENTRATE FOR INFUSION SOLUTION

2. What you need to know before using Levosimendan EQL Pharma

Do not use Levosimendan EQL Pharma

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

Warnings and precautions

Consult your doctor or nurse before starting to use Levosimendan EQL Pharma:

• If you have liver or kidney disease.
• If you have anemia and chest pain at the same time.
• If you have tachycardia, an abnormal heart rate, your doctor has told you that you have atrial fibrillation or you have abnormally low potassium levels in your blood, your doctor should use levosimendan with caution.

Children and adolescents

This medicinal product should not be administered to children and adolescents under 18 years of age.

Other medicines and Levosimendan EQL Pharma

Tell your doctor if you are using or have recently used or may need to use any other medicinal product.

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or plan to become pregnant, consult your doctor before using this medicinal product.

Pregnancy

There are no data available on the effects of levosimendan on the child. Your doctor will decide if the benefit outweighs any possible risk to the child.

Breastfeeding

There are indications that levosimendan passes into breast milk. You should not breastfeed while being treated with levosimendan to avoid possible side effects on the child's cardiovascular system.

Levosimendan EQL Pharma contains ethanol

This medicinal product contains 3883 mg of alcohol (ethanol) in each 5 ml vial.

The amount in a vial of this medicinal product is equivalent to 98.2 ml of beer or 39.3 ml of wine.

It is likely that the amount of alcohol present in this preparation will affect children. Among its effects are drowsiness and changes in behavior. It may also affect their ability to concentrate and participate in physical activities.

The amount of alcohol contained in this medicinal product may affect your ability to drive and use machines because it can alter your judgment and reaction time.

If you suffer from epilepsy or liver problems, consult your doctor or pharmacist before using this medicinal product.

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

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medicinal product.

If you have an alcohol addiction, consult your doctor or pharmacist before using this medicinal product.

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

3. How to use Levosimendan EQL Pharma

Levosimendan must be administered by intravenous infusion (drip).

For this reason, levosimendan should only be administered in a hospital where your doctor can monitor you.

Your doctor will adjust the individual dose to be administered. Your doctor will follow your response to levosimendan treatment (for example, measuring your heart rate, blood pressure, electrocardiogram, and your subjective feelings), and modify the dose if necessary. Your doctor may want to monitor you in the 4-5 days following the end of levosimendan treatment.

Usually, you will be given a rapid infusion for 10 minutes followed by a slow infusion for 24 hours.

Your doctor will constantly evaluate your response to levosimendan. In this way, they can reduce 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 too 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 levosimendan infusion for as long as they consider necessary to help your heart. Usually, infusion for 24 hours is recommended.

The effect on your heart will continue for 24 hours after the end of the levosimendan infusion. The effect may continue for 7-10 days after the end of the infusion.

Renal impairment

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

Hepatic impairment

Levosimendan should be administered with caution in patients with mild to moderate hepatic impairment. Levosimendan should not be administered in patients with severe hepatic impairment (see section 2).

If you use more Levosimendan EQL Pharma 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 treat you according to your medical history.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or go to the nearest hospital, or call the Toxicology Information Service. Phone 91 562 04 20 (indicating the medicinal product and the amount ingested). It is recommended to take the package and package leaflet of the medicinal product to the healthcare professional.

4. Possible side effects

Like all medicinal products, this medicinal product can cause side effects, although not everybody gets 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)

Low potassium levels in the blood

Insomnia

Dizziness

Abnormal heart rhythm called atrial fibrillation (as a consequence of heart palpitations instead of a proper heartbeat)

Extra heartbeats

Heart failure

Decreased oxygen supply to the heart through the blood

Nausea

Constipation

Diarrhea

Vomiting

Low blood cell count

There have been reports of a heart rhythm disorder called ventricular fibrillation (as a consequence of heart palpitations instead of a proper heartbeat) in patients who received levosimendan.

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

Reporting of side effects

If you experience side effects, consult your doctor or nurse, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines Surveillance System for Human Use: www.notificaRAM.es By reporting side effects, you can help provide more information on the safety of this medicinal product.

5. Storage of Levosimendan EQL Pharma

Keep this medicinal product out of the sight and reach of children.

Do not use this medicinal product after the expiry date which is stated on the vial or on the outer packaging after EXP. The expiry date is the last day of the month stated.

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

The color of the concentrate may change to orange during storage. However, this does not mean that it loses its potency, so the medicinal product can still be used until the expiry date stated, provided that the storage instructions have been followed.

After dilution

Physical and chemical stability has been demonstrated for 24 hours at 25 °C and for 24 hours at a temperature between 2 and 8 °C. From a microbiological point of view, the medicinal product should be used immediately. If not, both the in-use storage conditions and the in-use storage time are the responsibility of the user.

Regarding all parenteral medicinal products, visually inspect the diluted solution for particulate matter and discoloration before administration.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and further information

Composition of Levosimendan EQL Pharma

• The active substance is levosimendan.
• The other ingredients are povidone, citric acid, and anhydrous ethanol.

Appearance and package contents

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

Package sizes:

1 vial of 5 ml.

Marketing authorisation holder and manufacturer:

EQL Pharma AB

Stortorget 1

222 23 Lund

Sweden

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

Austria: Levosimendan EQL Pharma 2.5 mg/ml solution for infusion

Denmark: Levosimendan EQL Pharma 2.5 mg/ml koncentrat til infusionsvæske, opløsning

Finland: Levosimendan EQL Pharma 2.5 mg/ml infuusiokonsentraatti, liuosta varten

Germany: Levosimendan EQL Pharma 2.5 mg/ml konzentrat zur Herstellung einer infusionslösung

Norway: Levosimendan EQL Pharma 2.5 mg/ml konsentrat til infusjonsvæske, oppløsning

Spain: Levosimendán EQL Pharma 2.5 mg/ml concentrado para solución para perfusión

Sweden: Levosimendan EQL Pharma 2.5 mg/ml koncentrat till infusionsvätska, lösning

Date of last revision of this package leaflet:November 2022

Other sources of information

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

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This information is intended only for healthcare professionals:

Levosimendan EQL Pharma 2.5mg/ml concentrate for solution for infusion EFG

Instructions for use and handling

For single use.

This medicinal product must be visually inspected before use. Only clear solutions without particles should be used.

Once opened, the medicinal product must be used immediately. Any remaining content must be discarded.

Levosimendan EQL Pharma 2.5 mg/ml concentrate for solution for infusion should not be diluted to concentrations higher than 0.05 mg/ml as indicated below, as this may cause opalescence and precipitation.

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

Regarding all parenteral medicinal products, visually inspect the diluted solution for particulate matter and discoloration before administration.

Compatibility of Levosimendan EQL Pharma has been demonstrated with the following concentrations of medicinal products in concomitant administrations in intravenous lines:

• Furosemide 1 mg/ml and 10 mg/ml
• Digoxin 0.25 mg/ml
• Glyceryl trinitrate 0.1 mg/ml
• Dopamine 2 mg/ml
• Dobutamine 5 mg/ml
• Milrinone 0.4 mg/ml

Posology and method of administration

Levosimendan EQL Pharma is for hospital use only. It should be administered in a hospital unit where there are adequate monitoring facilities and experience with the use of inotropic agents.

Levosimendan EQL Pharma should be diluted before administration.

The infusion should be performed exclusively by the intravenous route, both by peripheral and central routes.

Consult the summary of product characteristics for information on posology.