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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Levosimendán EVER Pharma 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.

Leaflet contents

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

1. What Levosimendán EVER Pharma is and what it is used for

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

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

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

Levosimendán is used in adults.

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

Do not use Levosimendan EVER Pharma

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

Warnings and precautions

Talk to your doctor or nurse before starting this medicine if:

• you have low blood pressure,
• you are in a state of reduced blood volume (hypovolemia),
• you have liver or kidney disease,
• your doctor has told you that you have abnormally low levels of potassium in your blood,
• you have both low blood count (anemia) and chest pain simultaneously,
• you have abnormally rapid heartbeat, an irregular heart rhythm, or your doctor has told you that you have atrial fibrillation.

Consult your doctor or nurse if you are unsure whether you have any of the conditions or symptoms mentioned above.

Children and adolescents

The safety and efficacy of levosimendan have not yet been established in children and adolescents under 18 years of age.

Other medicines and Levosimendan EVER Pharma

Tell 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 may cause a drop in blood pressure.

Inform your doctor or nurse if you are taking isosorbide mononitrate (used to treat angina), as levosimendan may increase the drop in your blood pressure upon standing.

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 medicine. It is unknown whether levosimendan affects your baby. Some negative reproductive effects have been observed in animals; therefore, the use of levosimendan is not recommended during pregnancy or in women who may become pregnant and who are not using contraception.

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

Levosimendan EVER Pharma contains alcohol (ethanol)

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

It is harmful for individuals suffering from alcoholism.

This should be taken into account in pregnant or breastfeeding women, children, and high-risk groups such as patients with liver disease or epilepsy. The amount of alcohol contained in this medicine may alter the effect of other medicines.

3. How to use Levosimendán EVER Pharma

Levosimendan is for hospital use only. It must be administered in a hospital setting equipped with adequate monitoring facilities and with practical experience in the use of inotropic agents.

Levosimendan must be given by intravenous infusion (drip).

The dose and duration of treatment will be individualized according to your clinical condition and response.

Typically, you will receive a rapid infusion (loading dose of 6–12 micrograms/kg) over ten minutes, followed by a slower infusion (continuous infusion of 0.1 micrograms/kg/min) for up to 24 hours.

Your doctor will determine the amount of levosimendan to be administered based on your body weight and renal and hepatic function.

Your doctor will monitor your response to levosimendan treatment (for example, by measuring your heart rate, blood pressure, electrocardiogram, and your subjective sensations) and will adjust the dose if necessary.

Inform your doctor or nurse if you feel your heart racing, feel dizzy, or sense that the effect of levosimendan is too strong or too weak. Your doctor may reduce the infusion rate if your blood pressure drops, your heart rate becomes too fast, or you feel unwell.

If your doctor considers that you need 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 considered necessary to support your heart function. Generally, a 24-hour infusion of levosimendan is recommended.

The effect on your cardiac function will continue for at least 24 hours after stopping the levosimendan infusion. The effect may persist for up to 9 days after the end of the infusion. For this reason, levosimendan should only be administered in a hospital where your doctor can monitor you for 4 to 5 days after the infusion has ended.

Renal impairment

Levosimendan should be used with caution in patients with mild or moderate renal impairment. Levosimendan must not be used in patients with severe renal impairment (creatinine clearance <30 ml/min) (see section 2, “What you need to know before starting to use Levosimendán EVER Pharma”).

Hepatic impairment

Levosimendan 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. Levosimendan must not be used in patients with severe hepatic impairment (see section 2, “What you need to know before starting to use Levosimendán EVER Pharma”).

If you use more Levosimendán EVER Pharma than you should

If an excessive amount of levosimendan is administered, your blood pressure may drop and your heart rate may increase. Your doctor will know how to treat you based on your condition.

4. Possible adverse effects

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

Very common (may affect more than 1 in 10 people):

Abnormally high heart rate,

Headache,

Drop in blood pressure.

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

Decrease in blood potassium,

Insomnia,

Dizziness,

Abnormal heart rhythm called atrial fibrillation (caused by heart palpitations instead of a proper heartbeat),

Extra heartbeats,

Heart failure,

Reduced oxygen supply to the heart,

Nausea,

Constipation,

Diarrhea,

Vomiting,

Decrease in hemoglobin.

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 heart palpitations instead of a proper heartbeat) have been reported in patients receiving levosimendan.

Inform your doctor or nurse immediately if you experience any side 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 EVER Pharma

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

Do not use Levosimendan EVER Pharma after the expiry date stated on the vial or packaging. 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.

The colour of the concentrate may change to orange during storage, but this does not indicate loss of potency, and provided storage instructions are followed, the product may be used up to the indicated expiry date.

After dilution

Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C and between 2°C and 8°C.

From a microbiological standpoint, the product should be used immediately. If not used immediately, the user is responsible for any storage times and conditions prior to use, which in general should not exceed 24 hours at 2–8°C, unless the dilution has been carried out under controlled and validated aseptic conditions.

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

Medicines must not be disposed of via wastewater or household waste. 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 EVERPharma

• The active substance is levosimendan 2.5 mg/ml. Each ml of concentrate contains 2.5 mg of levosimendan.
• The other components (excipients) are: povidone, citric acid, and anhydrous ethanol.

Appearance of the product and contents of the container

The concentrate is a clear yellow or orange solution, free from visible particles, to be diluted before administration.

Nature and contents of the container:

5 ml solution in an 8 ml colourless transparent type I glass vial, closed with a grey chlorobutyl or bromobutyl rubber stopper coated with fluoropolymer, aluminum cap, and white PP flip-off disk.

Pack sizes:

• 1, 4, 10 vials (type I glass) of 5 ml, packed in a folding cardboard box containing a leaflet.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

EVER Valinject GmbH
Oberburgau, 3
4866 Unterach am Attersee
Austria

Manufacturer:

PHARMIDEA SIA
Rupnicu Street 4
2114 Olaine
Latvia

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

EVER Pharma Therapeutics Spain, S.L.
C/Toledo 170
28005 Madrid
Spain

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

Estonia: Levosimendan Auxilia
France: Levosimendan Pharmidea 2.5 mg/ml, solution à diluer pour perfusion
Spain: Levosimendan EVER pharma 2.5 mg/ml concentrate for solution for infusion EFG
Poland: Levosimendan Mercapharm
Portugal: Levossimendano EVER Pharma 2.5 mg/ml concentrate for solution for infusion

Date of the most recent review of this leaflet: December 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 for healthcare professionals only:

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

Instructions for use and handling

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

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

Compatibility of levosimendan with 5% glucose solutions has been demonstrated in PVC, PE, PP, and PE/PP copolymer containers over a 24-hour period at room temperature or under refrigerated conditions. Compatibility has also been demonstrated with various types of PVC and non-PVC intravenous bags and tubing. The diluted product does not require protection from light.

Levosimendán EVER Pharma 2.5 mg/ml concentrate for solution for infusion must not be diluted to concentrations exceeding 0.05 mg/ml, as indicated below, to avoid opalescence and precipitation.

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

Levosimendán EVER Pharma has been shown to be compatible with the following medicinal products when administered simultaneously via connected intravenous lines:

• Furosemide 10 mg/ml
• Digoxin 0.25 mg/ml
• Glyceryl trinitrate 0.1 mg/ml

Dosage and method of administration

Levosimendán EVER Pharma is for hospital use only. It must be administered in a hospital setting equipped with adequate monitoring facilities and with practical experience in the use of inotropic agents.

Levosimendán EVER Pharma 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 dosage information.