Summary of Product Characteristics: Information for the User

Levosimendan Zentiva2.5 mg/ml Concentrate for Solution for Infusion EFG

Read this entire summary carefully before you start using this medicine, because it contains important information for you.

• Keep this summary, 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 summary. See section 4.

1. What Levosimendan Zentiva is and what it is used for

2. What you need to know before you start using Levosimendan Zentiva

3. How to use Levosimendan Zentiva

4. Possible side effects

5. Storage of Levosimendan Zentiva

6. Contents of the pack and additional information

Levosimendan Zentiva is presented in the form of a concentrate that must be diluted before its administration through intravenous infusion.

Levosimendan acts by increasing the heart's pumping force and allowing the relaxation of blood vessels. Levosimendan will reduce pulmonary congestion and facilitate the circulation of blood and oxygen through your body. Levosimendan helps to alleviate respiratory difficulty in severe heart failure.

Levosimendan is indicated for the additional short-term treatment of heart failure in adults who continue to have difficulty breathing despite taking other medications to remove fluids from the body.

Do not use Levosimendán Zentiva

• 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 had 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 levosimendan with great caution.

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

Children and adolescents

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

Other medications and Levosimendán Zentiva

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription.

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medication.

The effects of levosimendan on the baby are unknown.Your doctor will decide if the benefits obtained are greater than any possible risk to the child.

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

Levosimendán Zentiva contains alcohol

This medication contains 98% alcohol by volume.This is equivalent to 3,848 mg in each 5 ml vial, which is the same as 98 ml of beer or 41 ml of wine.

The amount of alcohol in this medication may affect your ability to drive and use machines because it may impair 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 in this medication may interact with other medications. Consult your doctor or pharmacist if you are taking other medications.

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.

Levosimendan 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 levosimendan 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 completion of levosimendan administration.

You may receive a rapid infusion for 10 minutes, followed by a slower infusion for a maximum of 24 hours.

Your doctor will evaluate your response to levosimendan at different times. In this way, they can decrease the infusion if your blood pressure falls 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 think 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 as long as they deem necessary to help your heart. It is generally recommended to infuse levosimendan 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 Levosimendan Zentiva Than You Should

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

If you have any other questions about the use of this medication, ask your doctor.

Like all medications, this medication may produce adverse effects, although not all people 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)

• Decrease in potassium levels in the blood.
• Insomnia.
• Dizziness.
• A type of irregular heartbeat called atrial fibrillation (a consequence of heart palpitations instead of a normal heartbeat).
• Extra heartbeats.
• Heart failure.
• Decreased oxygen supply to the heart through the blood.
• Nausea.
• Constipation.
• Diarrhea.
• Vomiting.
• Decrease in hemoglobin levels.

Cases of a type of irregular heartbeat called ventricular fibrillation (a consequence of heart palpitations instead of a normal heartbeat) have been reported in patients who received levosimendan.

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

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

Reporting 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 prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines 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.

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

Storage Conditions

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

The product is a transparent solution, yellow or orange in color, without visible particles.

Storage Conditions after Dilution:

Chemical and physical stability has been demonstrated for 48 hours at 25°C.

From a microbiological standpoint, unless the opening / reconstitution / dilution method prevents the risk of microbial contamination, the product should be used immediately.

If not used immediately, storage times during use and conditions before use are the responsibility of the user.

Composition of Levosimendan Zentiva

• The active ingredient is levosimendan
• One vial of 5ml of concentrate for solution for infusion contains 12.5mg of levosimendan.

• The other components are:povidone, citric acid, anhydrous ethanol.

Appearance of the product and contents of the pack

Size of the pack: 1vial colourless (type I glass) of 5ml.

Levosimendan Zentiva 2.5mg/ml of concentrate for solution for infusion is a transparent, yellow or orange-coloured solution free of visible particles, packed in a transparent type I glass vial of 6ml, closed with a 20mm rubber stopper and sealed with a flip-off MT 20mm label.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Zentiva, k.s.,

U kabelovny 130,

Prague 10 – Dolní Mecholupy,

102 37 Czech Republic

Responsible for manufacturing[1]

MIAS Pharma Limited

Suite 2, Stafford House,

Strand Road,

Portmarnock,

Co. Dublin,

Ireland

or

Tillomed Malta Limited,

Malta Life Sciences Park,

LS2.01.06 Industrial Estate,

San Gwann, SGN 3000, Malta

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Zentiva Spain S.L.U.,

Avenida de Europa, 19, Edificio 3, Planta 1.

28224 Pozuelo de Alarcón, Madrid

Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

Austria:Levosimendan Tillomed 2.5 mg / ml Concentrate for the preparation ofan infusion solution

Czech Republic:Levosimendan Zentiva

Denmark:Levosimendan Tillomed

Finland:Levosimendan Tillomed2.5 mg/ml infusion concentrate,for dilution

France:LÉVOSIMENDAN TILLOMED 2.5 mg/ml, solution to be dilutedfor infusion

Germany:Levosimendan Tillomed 2.5 mg / ml Concentrate for the preparation ofan infusion solution

Italy:Levosimendan Tillomed

Norway:Levosimendan Tillomed

Poland:Levosimendan Zentiva

Portugal:Levossimendan Tillomed 2.5 mg/ml concentrate for solutionfor infusion

Slovakia:Levosimendan Zentiva 2.5 mg/ml concentrate for infusion solution

Slovenia:Levosimendan Tillomed 2.5 mg/ml concentrate for infusion solution

Spain:Levosimendan Zentiva 2.5 mg/ml concentrate for solutionfor infusion EFG

Sweden:Levosimendan Tillomed

Last review date of this leaflet:November 2021

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

This information is intended solely for medical professionals or healthcare professionals:

Instructions for use and handling

Levosimendan Zentiva 2.5mg/ml concentrate for solution for infusion is designed exclusively for single use.

Levosimendan Zentiva 2.5mg/ml concentrate for solution for infusion should not be diluted to concentrations above 0.05mg/ml as indicated below, otherwise opalescence and precipitation may occur.

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

• To prepare the infusion of 0.025mg/ml, mix 5ml of levosimendan concentrate with 500ml of 5 % glucose solution.
• To prepare the infusion of 0.05mg/ml, mix 10ml of levosimendan concentrate with 500ml of 5% glucose solution.

Dosage and administration

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

Levosimendan should be diluted before administration.

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

See the technical data sheet for information on dosage.