LEVOSIMENDAN ACCORD 2.5 mg/ml CONCENTRATE FOR INFUSION SOLUTION

2. What you need to know before you use Levosimendan Accord

Do not use Levosimendan Accord

• If you are allergic (hypersensitive) to levosimendan or any of the other ingredients of this medicine (listed in section 6).
• If you have very low blood pressure or abnormally high heart rate (tachycardia).
• If you have severe kidney or liver problems.
• If you have any heart disease 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 using Levosimendan Accord.

• If you have liver or kidney disease.
• If you have anemia and chest pain at the same time.
• If you have an abnormally high heart rate (tachycardia), abnormal heart rhythm, 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 this medicine with caution.

Children and adolescents

Levosimendan should not be administered to children and adolescents under 18 years of age.

Other medicines and Levosimendan Accord

Tell your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription.

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

Tell your doctor or pharmacist if you are taking isosorbide mononitrate, because the use of levosimendan may increase the drop in blood pressure when standing up.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine. The effects of levosimendan on the child are unknown.

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

Levosimendan Accord contains Ethanol

This medicine contains 98% v/v ethanol (alcohol), i.e., up to 3.925 mg per 5 ml vial, equivalent to 99.2 ml of beer, 41.3 ml of wine per 5 ml vial.

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

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

The amount of alcohol in this medicine may alter the effect of other medicines. Consult your doctor or pharmacist if you are taking other medicines.

If you are pregnant or breastfeeding, consult your doctor or pharmacist before taking this medicine.

If you have an alcohol addiction, consult your doctor or pharmacist before taking this medicine.

Because this medicine is usually administered slowly over 24 hours, the effects of alcohol may be reduced.

3. How to use Levosimendan Accord

This medicine must be administered by 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 levosimendan to be administered. Your doctor will follow your response to treatment (e.g., measuring your heart rate, blood pressure, electrocardiogram, and your subjective feelings) and modify the dose if necessary. Your doctor may want to monitor you for 4-5 days after the end of levosimendan administration.

Treatment can be started with a rapid infusion for 10 minutes followed by a slow infusion for 24 hours.

Your doctor will assess your response to levosimendan at different times. In this way, they may 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 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. It is usually recommended to infuse levosimendan for 24 hours.

The effect on your heart function will continue for 24 hours after the infusion of the product has ended. The effect may last up to 9 days after stopping the infusion.

Renal insufficiency

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

Hepatic insufficiency

Levosimendan should be used with caution in patients with mild to moderate hepatic insufficiency, although it does not seem necessary to adjust the dose in these patients. Levosimendan should not be administered to patients with severe hepatic insufficiency (see section 2).

If you use more Levosimendan Accord 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 history.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicology Information Service Tel. 91 562 04 20, indicating the medicine and the amount ingested.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very common(affect more than 1 in 10 people)

• Abnormally high heart rate.
• Headache.
• Low blood pressure.

Common(affect between 1 and 10 in 100 people)

• Potassium decrease in blood
• Insomnia
• Dizziness
• Abnormal heartbeat called atrial fibrillation (as a consequence of heart palpitations instead of proper heartbeat).
• Additional heartbeats
• Heart failure
• Decreased oxygen supply to the heart through the blood
• Nausea
• Constipation
• Diarrhea
• Vomiting.
• Hemoglobin decrease

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

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

Reporting of side effects

If you experience any side effects, talk to your doctor, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Levosimendan Altan

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

Do not use this medicine after the expiry date which is stated on the carton after “EXP”. The expiry date refers to the last day of the month stated.

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

Do not freeze.

Do not use this medicine after the expiry date stated on the carton.

The expiry date refers to the last day of that month.

The storage and use time after dilution should never exceed 24 hours.

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. Contents of the pack and other information

Composition of Levosimendan Accord

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

Appearance and pack size

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

Pack sizes:

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

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Accord Healthcare, S.L.U.

World Trade Center

Moll de Barcelona, s/n

Edifici Est 6ª planta

08039 Barcelona

Spain

Manufacturer

BAG Health Care GmbH

Amtsgerichtsstrasse 1-5

D-35423 Lich

Germany

Or

Wessling GmbH

Johann-Krane-Weg 42

48149 Münster

Germany

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

Member StatesMedicine names

Austria Levosimendan Accord 2.5 mg/ml Konzentrat zur Herstellung einer Infusionslösung

Germany Levosimendan Accord 2.5 mg/ml Konzentrat zur Herstellung einer Infusionslösung

Spain Levosimendan Accord 2.5 mg/ml concentrate for solution for infusion EFG

France Levosimendan Accord 2.5 mg/mL solution à diluer pour perfusion

Italy Levosimendan Accord

Portugal Levossimendano Accord

Poland Levosimendan Accord

Date of last revision of this leaflet:December 2021.

Detailed information on this medicine 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:

Instructions for use and handling

For single use.

Levosimendan Accord 2.5 mg/ml concentrate for solution for infusion EFG should not be diluted to a concentration higher than 0.05 mg/ml as indicated below, otherwise opalescence and precipitation may occur.

As with all parenteral medicines, visually inspect the diluted solution for particles and discoloration before administration.

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

Posology and method of administration

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

Levosimendan Accord should be diluted before administration.

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

Consult the summary of product characteristics for information on posology.