Simdax 2.5 mg/ml concentrate for solution for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Simdax 2.5 mg/ml concentrate for solution for infusion .

Levosimendan

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

1. What SIMDAX is and what it is used for

Simdax is available as a concentrate that must be diluted before administration by intravenous infusion.

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

Simdax 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.

2. What you need to know before starting to use SIMDAX

Do not use SIMDAX

• 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 high 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 simultaneously have 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 Simdax with great caution.

Consult your doctor before starting to use Simdax if you have any of the conditions or symptoms mentioned above.

Children and adolescents

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

Other medicines and Simdax

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 received other intravenous cardiac medications, administration of Simdax 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 medicine. Your doctor will decide whether the benefit outweighs any possible risk to the unborn child.

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

Simdax contains alcohol

This medicine contains 3925 mg of alcohol (anhydrous ethanol) in each 5 ml vial, equivalent to 98% v/v. The amount of alcohol in one 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 capacity.

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

The amount of alcohol contained 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 SIMDAX

Simdax 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 decide the dose of Simdax to administer. 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 during the 4–5 days following the end of Simdax administration.

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

Your doctor will assess your response to Simdax at different time intervals. This allows adjustment of the infusion rate if your blood pressure drops, your heart rate becomes too fast, or you feel unwell. If you feel your heart racing, feel dizzy, or perceive that the effect of Simdax is too strong or too weak, you must inform your doctor or nurse.

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

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

If you use more SIMDAX than you should

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

4. Possible adverse effects

Like all medicines, this medicine may 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 regular heartbeat).

Extra heartbeats.

Heart failure.

Reduced oxygen supply to the heart through the blood.

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 (as a result of irregular heart palpitations instead of regular heartbeat) have been reported in patients receiving Simdax.

Please inform your doctor immediately if you experience any side effects. Your doctor may reduce or stop the Simdax infusion.

If you consider any of the side 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 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 SIMDAX

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 SIMDAX after the expiry date stated on the container after “EXP”. The expiry date refers to the last day of the month indicated.

Simdax must be used within 24 hours after reconstitution.

6. Contents of the pack and other information

Composition of SIMDAX

• The active substance is levosimendan 2.5 mg/ml.
• The other components are povidone, citric acid, and ethanol.

Appearance of the product and contents of the container

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

Pack sizes:

• 1, 4, 10 vials (type I glass) of 5 ml

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder:

Orion Corporation,

Orionintie 1

FI-02200 Espoo

Finland

Manufacturer:

Orion Corporation

Orion Pharma

Orionintie 1

FI-02200 Espoo

Finland

Additional information

Further information on this medicinal product is available upon request by contacting the local representative of the Marketing Authorization Holder:

Local Representative:

Orion Pharma SL

Telephone: +349 159 9 86 01

Date of the most recent review of this leaflet: September 2025.

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This information is intended for healthcare professionals only:

Simdax 2.5 mg/ml concentrate for solution for infusion

Instructions for Use and Handling

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

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

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

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

Dosage and Method of Administration

Simdax 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.

Simdax must be diluted before administration.

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

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

"Detailed and up-to-date 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/"