Leaflet: information for the user

Simdax 2.5 mg/ml concentrate for solution for infusion.

Levosimendan

Read this leaflet carefully before you start using the 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.
• If you experience any side effects, consult your doctor or nurse, even if they are not listed in this leaflet. See section 4.

1. What isSIMDAXand what it is used for

2. What you need to know before starting to useSIMDAX

3. How to useSIMDAX

4. Possible side effects

5. Storage ofSIMDAX

6. Contents of the pack and additional information

SIMDAX is presented in a concentrated form that must be diluted before administration via intravenous infusion.

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

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

Do not use SIMDAX

• If you are allergic (hypersensitive) to levosimendan or to any of the other components of this medication (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 a type of irregular heartbeat called Torsades de Pointes.

Warnings and precautions

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

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

Children and adolescents

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

Other medications and Simdax

Inform your doctor or pharmacist if you are using or 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 Simdax may cause a drop in blood pressure.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or plan to become pregnant, consult your doctor before using this medication. Your doctor will decide if the benefits obtained are greater than any possible risk to the child.

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

Simdax contains alcohol

This medication contains 3925 mg of alcohol (anhydrous ethanol) 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 because it may alter your judgment and reaction time.

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..

Simdax must be administered through intravenous infusion (drip). For this reason, it should only be administered in a hospital where your doctor can monitor you. Your doctor will decide the dose of Simdax to administer. Your doctor will follow your response to treatment (for example, by measuring your heart rate, blood pressure, electrocardiogram, and subjective sensations), and adjust the dose if necessary. Your doctor may want to monitor you for 4-5 days after the end of Simdax administration.

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 Simdax at different times. In this way, they can decrease the infusion if your blood pressure falls or your heart rate begins to be too fast or you do not feel well. If you feel that your heart is racing, you feel dizzy or have the impression that the effect of Simdax is too strong or too light, 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, they may increase the infusion.

Your doctor will continue the infusion of Simdax as long as they deem necessary to help your heart. It is generally recommended to infuse Simdax for 24 hours.

The effect on your cardiac function will continue for 24 hours after the infusion of the product has ended. The effect may continue for 7-10 days after the infusion has ended.

If you use more Simdax than you should

A Simdax overdose will cause a drop in blood pressure and an increase in heart rate. Your doctor will know how to treat it according to your medical history.

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

Very Frequent(may affect1 in 10 patients or more)

Abnormally high heart rate.

Headache.

Hypotension.

Frequent(may affect up to1 in 10 patients)

Decrease in potassium levels 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 Simdax.

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

If you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting of Adverse Effects

If you experience any type of side effect, consult your doctor or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly through theSpanish System for Pharmacovigilance of Medicinal Products 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 (between2°Cand8°C).

Do not freeze

Do not use SIMDAX after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Simdax should be used within 24 hours following reconstitution.

Composition of SIMDAX

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

Aspect of the product and contents of the package

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

Package sizes:

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

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization:

Orion Corporation,

Orionintie 1

FI-02200 Espoo

Finland

Responsible for manufacturing:

Orion Corporation

Orion Pharma

Orionintie 1

FI-02200 Espoo

Finland

Additional information

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Local Representative:

Orion Pharma SL

Phone: +349 159 9 86 01

Date of the last review of this prospectus:April 2021.

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This information is intendedonly for medical professionals or healthcare professionals:

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 designed exclusively for single use.

Simdax 2.5 mg/ml concentrate for solution for infusion should not be diluted to concentrations above 0.05 mg/ml as indicated below, as 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 Simdax 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 Simdax 2.5 mg/ml concentrate for solution for infusion with 500 ml of 5% glucose solution.

Dosage and administration

Simdax is only for hospital use. It should be administered in a hospital unit with monitoring facilities and experience with the use of inotropic agents.

Simdax should be diluted before administration

The infusion should be administered exclusively by intravenous route, both peripherally and centrally.

Consult the technical data sheet for information on dosage.

“Detailed and updated information about this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/”