Levosimendan Zentiva

Package Leaflet: Information for the User

Levosimendan Zentiva, 2.5 mg/mL, Concentrate for Solution for Infusion

Solution for Infusion
Levosimendanum

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or nurse. If you experience any side effects, including those not listed in this package leaflet, tell your doctor or nurse. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Levosimendan Zentiva and what is it used for
• 2. Important information before using Levosimendan Zentiva
• 3. How to use Levosimendan Zentiva
• 4. Possible side effects
• 5. How to store Levosimendan Zentiva
• 6. Contents of the pack and other information

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

Levosimendan Zentiva is a concentrated solution that must be diluted before intravenous infusion.
Levosimendan increases the strength with which the heart pumps blood and allows blood vessels to relax.
Levosimendan reduces congestion in the lungs and facilitates blood and oxygen flow in the body.
Levosimendan helps alleviate shortness of breath caused by severe heart failure.
Levosimendan Zentiva is used as an additional, short-term treatment for acute episodes of decompensated severe chronic heart failure in adult patients who still experience breathing difficulties despite taking other medications that remove excess fluid from the body.

2. Important information before using Levosimendan Zentiva

Levosimendan Zentiva

When not to use Levosimendan Zentiva:

• if the patient is allergic (hypersensitive) to levosimendan or any of the other ingredients of this medicine (listed in section 6);
• if the patient has very low blood pressure and a rapid heart rate;
• if the patient has heart disease that makes it difficult for the heart to fill or empty;
• if the patient has severe kidney or liver disease;
• if the patient has been informed by a doctor that they have an abnormal heart rhythm called Torsades de Pointes.

Warnings and precautions

• if the patient has any kidney or liver disease;
• if the patient has a low number of blood cells and chest pain;
• if the patient has a rapid heart rate, abnormal heart rhythm, or the doctor has informed the patient that they have atrial fibrillation or abnormally low potassium levels in the blood,

levosimendan should be used with caution.
If the patient experiences any of the above diseases or symptoms, they should discuss this with their doctor before starting treatment with Levosimendan Zentiva.

Children and adolescents

This medicine should not be used in children and adolescents under 18 years of age.

Levosimendan Zentiva and other medicines

Tell your doctor about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
If you are taking other intravenous heart medicines, using levosimendan may cause a drop in blood pressure.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor for advice before using this medicine.
It is not known whether levosimendan affects the unborn child. The doctor must decide whether the benefits to the mother outweigh the risks to the unborn child.
There are indications that levosimendan passes into human milk. You should not breastfeed while using levosimendan to avoid potential cardiovascular side effects in infants.

Levosimendan Zentiva contains alcohol

This medicine contains 98% v/v alcohol. This is 3848 mg per 5 mL in the vial, which is equivalent to 98 mL of beer or 41 mL of wine.
The alcohol content may affect your ability to drive or use machines.
It may affect your judgment and reaction speed.
If you have epilepsy or liver problems, you should talk to your doctor or pharmacist before taking this medicine.
The alcohol content may interact with other medicines. If you are taking other medicines, you should talk to your doctor or pharmacist.
If you are pregnant or breastfeeding, you should talk to your doctor or pharmacist before taking this medicine.
If you are addicted to alcohol, you should talk to your doctor or pharmacist before taking this medicine.
Since this medicine is usually given slowly over 24 hours, the effect of the alcohol may be reduced.

3. How to use Levosimendan Zentiva

Levosimendan Zentiva is given as an intravenous infusion (drip). Therefore, Levosimendan Zentiva should be administered in a hospital setting where the doctor can monitor the patient.
The doctor will decide on the dose of Levosimendan Zentiva.
The doctor will assess the patient's response to levosimendan (e.g., by measuring pulse or blood pressure, performing an ECG, and asking about well-being).
The doctor may adjust the dose if necessary. The doctor may monitor the patient's condition for 4-5 days after the end of the levosimendan infusion.
The patient may receive a rapid infusion lasting ten minutes, followed by a slower infusion lasting up to 24 hours.
The doctor should check from time to time how the patient is responding to levosimendan. The doctor may reduce the infusion in case of a drop in blood pressure, too rapid a heart rate, or poor well-being. You should tell the doctor or nurse if you experience a rapid heart rate, dizziness, or if you think the effect of levosimendan is too strong or too weak.
If the doctor decides that the patient needs more levosimendan and no side effects occur, the doctor may increase the infusion rate.
The doctor will continue the levosimendan infusion for as long as necessary to support the heart. This usually lasts for 24 hours.
The effect on the heart lasts for at least 24 hours after the end of the levosimendan infusion. This effect may last for 7-10 days after the end of the infusion.

Overdose of Levosimendan Zentiva

In case of overdose of Levosimendan Zentiva, a decrease in blood pressure and an increase in heart rate may occur. The doctor will provide appropriate treatment based on the patient's condition.
If you have any further questions about the use of this medicine, ask your doctor.

4. Possible side effects

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

Very common (affects more than 1 in 10 people):

• abnormally rapid heart rate
• headache
• decrease in blood pressure

Common (affects up to 1 in 10 people):

• low potassium levels in the blood
• insomnia
• dizziness
• abnormal heart rhythms, called atrial fibrillation (part of the heart flutters instead of beating properly)
• extra heartbeats
• heart failure
• myocardial ischemia
• nausea
• constipation
• diarrhea
• vomiting
• low number of blood cells

In patients receiving levosimendan, abnormal heart rhythms, called ventricular fibrillation (part of the heart flutters instead of beating properly), have been observed.
If you experience any side effects, tell your doctor or nurse immediately. The doctor may reduce the infusion rate or stop the levosimendan infusion.
If any side effect becomes serious or if you notice any side effects not listed in this package leaflet, tell your doctor.

Reporting of side effects

If you experience any side effects, including those not listed in this package leaflet, tell your doctor or nurse. Side effects can be reported directly to the Department of Medicinal Product Monitoring, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Levosimendan Zentiva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the vial or carton after "EXP". The expiry date refers to the last day of the month.
Storage conditions
Store in a refrigerator (2°C – 8°C). Do not freeze.
This product is a clear, yellow or orange solution free from visible particles.

Storage conditions after dilution:

Chemical and physical stability has been demonstrated for 48 hours at 25°C.
From a microbiological point of view, unless the method of opening, reconstitution, or dilution precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, the responsibility for the storage conditions and the storage time before use lies with the user.

6. Contents of the pack and other information

What Levosimendan Zentiva contains

The active substance is levosimendan.
Each 5 mL vial of concentrate for solution for infusion contains 12.5 mg of levosimendan.
The other ingredients are: Povidone K-12 (E1201), Citric acid (E330), Anhydrous ethanol (E1510).

What Levosimendan Zentiva looks like and contents of the pack

Pack sizes
1 vial (colourless glass type I) of 5 mL in a cardboard box.
4 vials (colourless glass type I) of 5 mL in a cardboard box.
Levosimendan Zentiva 2.5 mg/mL concentrate for solution for infusion is available as a clear, yellow or orange solution free from visible particles, in a 6 mL clear glass type I vial, closed with a 20 mm rubber stopper and sealed with a 20 mm MT flip-off cap.

Marketing authorization holder:

Zentiva, k.s.,
U kabelovny 130,
Dolní Mĕcholupy,
102 37 Prague 10,
Czech Republic

Manufacturer/Importer:

MIAS Pharma Limited
Suite 2, Stafford House,
Strand Road,
Portmarnock,
Co. Dublin,
Ireland
Tillomed Malta Limited,
Malta Life Sciences Park,
LS2.01.06 Industrial Estate,
San Gwann, SGN 3000, Malta

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

Austria:
Levosimendan Tillomed 2.5 mg / mL Konzentrat zur Herstellung einer Infusionslösung
Czech Republic:
Levosimendan Zentiva
Denmark:
Levosimendan Tillomed
Finland:
Levosimendani Tillomed 2.5 mg/ml infuusiokonsentraatti, liuosta varten
France:
LÉVOSIMENDAN TILLOMED 2.5 mg/ml, solution à diluer pour perfusion
Germany:
Levosimendan Tillomed 2.5 mg / mL Konzentrat zur Herstellung einer Infusionslösung
Italy:
Levosimendan Tillomed
Norway:
Levosimendan Tillomed
Poland:
Levosimendan Zentiva
Portugal:
Levossimendano Tillomed 2.5 mg/ml concentrado para solução para perfusão
Slovakia:
Levosimendan Zentiva 2.5 mg/ml koncentrát na infúzny roztok
Slovenia:
Levosimendan Tillomed 2.5 mg/ml koncentrat za raztopino za infundiranje
Spain:
Levosimendán Zentiva 2.5 mg/ml concentrado para solución para perfusión
Sweden:
Levosimendan Tillomed
Date of last revision of the package leaflet:November 2023
Information intended for healthcare professionals only:

Instructions for use and handling

Levosimendan Zentiva 2.5 mg/mL, concentrate for solution for infusion, is intended for single use only.
Levosimendan Zentiva 2.5 mg/mL, concentrate for solution for infusion, should not be diluted to a concentration higher than 0.05 mg/mL, as otherwise opalescence and precipitation may occur.
As with all products for parenteral use, the diluted solution should be inspected visually for particulate matter and discoloration prior to administration.

• To prepare an infusion solution with a concentration of 0.025 mg/mL, 5 mL of Levosimendan Zentiva 2.5 mg/mL concentrate for solution for infusion should be mixed with 500 mL of 5% glucose solution.
• To prepare an infusion solution with a concentration of 0.05 mg/mL, 10 mL of Levosimendan Zentiva 2.5 mg/mL concentrate for solution for infusion should be mixed with 500 mL of 5% glucose solution.

Dosage and administration

Levosimendan Zentiva is intended for hospital use only. The medicine should be administered in a hospital setting where appropriate monitoring equipment and personnel experienced in the use of inotropic agents are available.
Levosimendan Zentiva should be diluted before administration.
The solution is intended for intravenous infusion only and may be administered peripherally or centrally.
For information on dosing, see the Summary of Product Characteristics.