Levosimendan Farmak

Package Leaflet: Information for the User

Levosimendan Farmak, 2.5 mg/mL, concentrate for solution for infusion
Levosimendanum

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

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

Table of Contents of the Leaflet

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

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

Levosimendan Farmak is a concentrate that must be diluted before intravenous infusion.
Levosimendan Farmak increases the strength of the heart's pumping and allows blood vessels to relax.
This reduces congestion in the lungs and facilitates blood and oxygen flow in the body.
It helps alleviate shortness of breath caused by severe heart failure.
Levosimendan Farmak is used to treat heart failure in patients who still have difficulty breathing despite taking other medications to remove excess fluid from the body.

2. Important information before using Levosimendan Farmak

When not to use Levosimendan Farmak

torsades de pointes.

Warnings and precautions

If you have any of the following conditions or symptoms, you should discuss them with your doctor before starting treatment with Levosimendan Farmak:

Your doctor should use Levosimendan Farmak with caution. If you are unsure whether any of the above conditions or symptoms apply to you, you should discuss them with your doctor.

Children and adolescents

Levosimendan Farmak should not be used in children and adolescents under 18 years of age.

Levosimendan Farmak and other medicines

Tell your doctor about all the medicines you are taking or have recently taken, including those obtained without a prescription.
If you are taking other intravenous heart medications, using Levosimendan Farmak may cause a drop in blood pressure.

Pregnancy, breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor for advice before taking this medicine.
It is not known whether the use of Levosimendan Farmak affects the unborn child. Your doctor will decide whether the benefit to you outweighs the potential risk to the baby.
It has been shown that Levosimendan Farmak passes into human milk. You should not breastfeed while taking Levosimendan Farmak to avoid any potential adverse effect on the baby's cardiovascular system.

Levosimendan Farmak contains alcohol

This medicine contains 3925 mg of alcohol (anhydrous ethanol) in each 5 mL vial, which is approximately 98% v/v alcohol.
The amount of alcohol in one vial of the medicinal product with a capacity of 5 mL is equivalent to 100 mL of beer or 42 mL of wine.
The amount of alcohol in this medicine may affect your ability to drive or operate machinery, as alcohol may affect your assessment of the situation and reaction time.
If you have epilepsy or liver problems, you should consult your doctor or pharmacist before taking this medicine.
The amount of alcohol in this medicine may alter the effects of other medicines. If you are taking other medicines, you should consult your doctor or pharmacist.
If you are pregnant or breastfeeding, you should consult your doctor or pharmacist before taking this medicine.
If you are addicted to alcohol, you should consult your doctor or pharmacist before taking this medicine.

3. How to use Levosimendan Farmak

Levosimendan Farmak will be administered as an intravenous infusion (drip). Therefore, the medicine should be administered in a hospital setting where the patient's condition can be monitored by a doctor.
Your doctor will determine the correct dose of Levosimendan Farmak. The doctor will assess the patient's response to Levosimendan Farmak (e.g., by measuring pulse or blood pressure, performing an ECG, and asking about well-being) and adjust the dose if necessary. The doctor may monitor the patient's condition for 4-5 days after the infusion is completed.
The patient may receive the medicine as a rapid infusion over 10 minutes, followed by a slower intravenous infusion for up to 24 hours.
The doctor should check the patient's response to Levosimendan Farmak from time to time. If the patient experiences a drop in blood pressure, rapid heart rate, or poor well-being, the doctor may reduce the infusion rate. You should tell your doctor or nurse if you experience palpitations, dizziness, or if the effect of Levosimendan Farmak seems too strong or too weak.
The doctor may increase the infusion rate if a higher dose of Levosimendan Farmak is needed and the patient does not experience any side effects.
The doctor will continue the infusion of Levosimendan Farmak for as long as heart support is necessary. This usually lasts 24 hours.
The effect of Levosimendan Farmak on the heart lasts for at least 24 hours after the infusion is completed. The medicine may work for 7 to 10 days after the infusion is completed.

Overdose of Levosimendan Farmak

If too much Levosimendan Farmak is administered, it may cause a decrease in blood pressure and rapid heart rate. The doctor will provide appropriate treatment based on the patient's condition.

4. Possible side effects

Like all medicines, Levosimendan Farmak can cause side effects, although not everybody gets them.
Very common (may affect more than 1 in 10 people):

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

Common (may affect 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 red blood cell count (seen in blood tests).

In patients receiving Levosimendan Farmak, 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 immediately.
Your doctor may reduce the infusion rate or stop the infusion of Levosimendan Farmak.
If any side effects worsen or if you experience any side effects not listed in this leaflet, you should tell your doctor.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or nurse.
Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, phone: 22 49-21-301, fax: 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 Farmak

Keep the medicine out of the sight and reach of children.
Store in a refrigerator (2°C – 8°C).
Do not use this medicine after the expiry date stated on the vial and carton after: “EXP”.
The expiry date refers to the last day of the month.
The prepared solution can be stored for 24 hours at 25°C.

6. Contents of the pack and other information

What Levosimendan Farmak contains

• The active substance is levosimendan. Each mL of concentrate contains 2.5 mg of levosimendan.
• The other ingredients are: povidone K23, citric acid, and anhydrous ethanol.

What Levosimendan Farmak looks like and contents of the pack

Levosimendan Farmak is a clear, yellow, orange-yellow to orange solution.
Pack sizes:
6 mL glass vials type I (with a fill volume of 5 mL) with a grey rubber stopper and an aluminum seal with a plastic cap. One vial in a cardboard box.

Marketing authorization holder

Farmak International Sp. z o.o.
ul. Koszykowa 65
00-667 Warsaw
phone: +48 22 822 93 06

Importer

Farmak International Sp. z o.o.
ul. Chełmżyńska 249
04-458 Warsaw

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

Czech Republic:
Levosimendan FMK
Denmark:
Levosimendan Farmak
Poland:
Levosimendan Farmak
Slovakia:
Levosimendan FMK
Date of last revision of the leaflet:May 2025