Package leaflet: Information for the user

Levosimendan Farmak, 2.5 mg/mL, concentrate for solution for infusion
Levosimendanum
Read all of this leaflet carefully before this medicine is administered because it contains
important information for you.

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

Contents of the leaflet

What Levosimendan Farmak is and what it is used for
Before you use Levosimendan Farmak
How to use Levosimendan Farmak
Possible side effects
How to store Levosimendan Farmak
Contents of the pack and other information

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

Levosimendan Farmak is a medicine in the form of a concentrate that must be diluted before
intravenous infusion.
Levosimendan Farmak increases the force with which the heart pumps blood and allows blood vessels
to relax. As a result, it reduces pulmonary congestion and improves blood and oxygen flow
throughout the body. It helps relieve breathlessness caused by severe heart failure.
Levosimendan Farmak is used in the treatment of heart failure in patients who still experience
breathing difficulties despite treatment with other medicines that remove excess fluid from the body.

2. Important information before using Levosimendan Farmak

When not to use Levosimendan Farmak

if the patient is allergic to levosimendan or any of the other ingredients of this medicine (listed in section 6);
if the patient has very low blood pressure or a rapid heartbeat;
if the patient has severe kidney or liver disease;
if the patient has a heart condition that impairs filling or emptying of the heart;
if the patient has ever been informed by a doctor of having an abnormal heart rhythm called torsades de pointes.

Warnings and precautions
If the patient has any of the following conditions or symptoms, discuss them with a doctor before
starting treatment with Levosimendan Farmak:

if the patient has any kidney or liver disease;
if the patient has a low number of red blood cells (anaemia) and chest pain;
if the patient has a rapid heartbeat, irregular heart rhythm, or if a doctor has ever informed the patient of having atrial fibrillation or low potassium levels in the blood.

The doctor should use Levosimendan Farmak very carefully. If the patient is unsure whether any of the
above conditions or symptoms apply, they should discuss this with their doctor.
Children and adolescents
Levosimendan Farmak must not be used in children and adolescents under 18 years of age.
Levosimendan Farmak and other medicines
Tell the doctor about all medicines the patient is currently taking or has recently taken, as well as any
medicines the patient plans to take. This includes medicines obtained without a prescription.
If the patient is receiving other intravenous medicines for the heart, administration of Levosimendan
Farmak may cause a drop in blood pressure.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a
child, she should consult a doctor before using this medicine.
It is not known whether use of Levosimendan Farmak affects the unborn child. The doctor will decide
whether the benefit to the patient outweighs the potential risk to the unborn child.
It has been shown that Levosimendan Farmak passes into human milk. Breastfeeding must not be
undertaken during treatment with Levosimendan Farmak, to avoid possible adverse effects on the
cardiovascular system of the infant.
Levosimendan Farmak contains alcohol
This medicine contains 3925 mg of alcohol (anhydrous ethanol) in each 5 mL vial, which corresponds to
approximately 98% by volume of alcohol. The amount of alcohol in one 5 mL vial is equivalent to
100 mL of beer or 42 mL of wine.
The amount of alcohol in this medicine may affect the ability to drive or operate machinery, as alcohol
can impair judgment and reaction speed.
If the patient has epilepsy or liver problems, he or she should consult a doctor or pharmacist before
using this medicine.
The amount of alcohol in this medicine may alter the effects of other medicines. If the patient is taking
other medicines, he or she should consult a doctor or pharmacist.
If the patient is pregnant or breastfeeding, she should consult a doctor or pharmacist before using
this medicine.
If the patient is alcohol-dependent, he or she should consult a doctor or pharmacist before using
this medicine.

3. How to use Levosimendan Farmak

Levosimendan Farmak will be administered as an intravenous infusion (via drip). Therefore, the medicine must be given in a hospital setting where the patient's condition can be monitored by a physician.
The doctor will determine the appropriate dose of Levosimendan Farmak. The doctor will assess the patient's response to Levosimendan Farmak (e.g. by measuring pulse or arterial blood pressure, performing an ECG, and asking about well-being) and, if necessary, adjust the dose accordingly. The doctor may monitor the patient’s condition for 4–5 days after the infusion has ended.
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 periodically check the patient's response to Levosimendan Farmak. If the patient experiences a drop in arterial blood pressure, increased heart rate, or feels unwell, the doctor may reduce the infusion rate. Inform the doctor or nurse if palpitations, dizziness, or any sensation that the effect of Levosimendan Farmak is too strong or too weak occurs.
The doctor may increase the infusion rate if a higher dose of Levosimendan Farmak is deemed necessary and no adverse effects are present.
The doctor will continue the Levosimendan Farmak infusion for as long as cardiac support is required. This usually lasts 24 hours.
The effect of Levosimendan Farmak on the heart persists for at least 24 hours after the infusion ends. The medicine may remain active for 7 to 10 days after the infusion ends.
If more Levosimendan Farmak than recommended has been administered
If an excessive dose of Levosimendan Farmak is given, a decrease in arterial blood pressure and increased heart rate may occur. The doctor will provide appropriate treatment based on the patient’s condition.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Very common (may occur in more than 1 in 10 people):

abnormally fast heartbeat;
headache;
decreased blood pressure.

Common (may occur in up to 1 in 10 people):

low potassium levels in the blood;
insomnia;
dizziness;
heart rhythm disorders called atrial fibrillation (a part of the heart flutters instead of beating properly);
extra heartbeats;
heart failure;
myocardial ischaemia;
nausea;
constipation;
diarrhoea;
vomiting;
low number of blood cells (visible in blood tests).

In patients receiving Levosimendan Farmak, heart rhythm disorders called ventricular fibrillation (a part of the heart flutters instead of beating properly) have been observed.
If any adverse effects occur, inform your doctor immediately.
The doctor may reduce the infusion rate or discontinue the infusion of Levosimendan Farmak.
If any adverse effects worsen or if any adverse effects not listed in this leaflet occur, inform your doctor.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or nurse.
Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49-21-301, fax: +48 22 49-21-309, website: https://smz.ezdrowie.gov.pl.
Adverse effects can also be reported to the marketing authorisation holder. Reporting adverse effects helps to provide more information on the safety of the 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 stated month.
The prepared solution can be stored for 24 hours at a temperature of 25°C.

6. Contents of the package 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 vials made of colourless type I glass (with a fill volume of 5 mL), fitted with a grey bromobutyl rubber stopper and an aluminium cap with a plastic flip-off cap. One vial in a cardboard box.
Marketing Authorisation Holder
Farmak International Sp. z o.o.
ul. Koszykowa 65
00-667 Warsaw
tel. +48 22 822 93 06
Importer
Farmak International Sp. z o.o.
ul. Chełmżyńska 249
04-458 Warsaw
This medicinal product is authorised in the following names in the European Economic Area countries:
Czech Republic: Levosimendan FMK
Denmark: Levosimendan Farmak
Poland: Levosimendan Farmak
Slovakia: Levosimendan FMK 2,5 mg/ml concentrate for infusion solution, con inf

Information intended exclusively for healthcare professionals:

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

To prepare an infusion solution at a concentration of 0.025 mg/mL, mix 5 mL of the concentrate for solution for infusion of Levosimendan Farmak, 2.5 mg/mL with 500 mL of 5% glucose solution.
To prepare an infusion solution at a concentration of 0.05 mg/mL, mix 10 mL of the concentrate for solution for infusion of Levosimendan Farmak, 2.5 mg/mL with 500 mL of 5% glucose solution.

Dosage and method of administration
Levosimendan Farmak is intended for hospital use only. The medicinal product must be administered in a hospital setting equipped with appropriate monitoring equipment and staff experienced in administering inotropic agents.
Levosimendan Farmak must be diluted prior to administration.
The solution is intended for intravenous infusion only and may be administered either peripherally or centrally.
For information regarding dosage, refer to the Product Characteristics.