Package leaflet: Information for the user

Levosimendan Waymade, 2.5 mg/ml, concentrate for solution for infusion
Levosimendanum
Please read all of this leaflet carefully before this medicine is used, because it contains
important information for the patient.

Keep this leaflet so that it can be read again if necessary.
If there are any doubts, please consult a doctor or nurse.
If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, they should inform a doctor or nurse. See section 4.

Contents of the leaflet

What Levosimendan Waymade is and what it is used for
Important information before using Levosimendan Waymade
How to use Levosimendan Waymade
Possible side effects
How to store Levosimendan Waymade
Contents of the pack and other information

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

Levosimendan Waymade is a medicine in the form of a concentrate which must be diluted before
intravenous infusion.
Levosimendan Waymade increases the force with which the heart pumps blood and allows blood vessels to relax. Levosimendan Waymade reduces pulmonary congestion and facilitates blood and oxygen flow throughout the body. Levosimendan Waymade helps relieve breathlessness caused by severe heart failure.
Levosimendan Waymade is used in the treatment of heart failure in patients who still have difficulty breathing despite receiving other medications to remove excess fluid from the body.
Levosimendan Waymade is indicated for use in adults.

2. Important information before using Levosimendan Waymade

When not to use Levosimendan Waymade:

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 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
Before starting treatment with Levosimendan Waymade, discuss with the doctor or
nurse:

if the patient has any kidney or liver disease;
if the patient has a low number of red blood cells and chest pain;
if the patient has a rapid heartbeat, an irregular heart rhythm, or if the doctor has ever informed the patient of having atrial fibrillation or low potassium levels in the blood, Levosimendan Waymade should be used with great caution.

Children and adolescents
Levosimendan Waymade must not be given to children and adolescents under 18 years of age.
Levosimendan Waymade and other medicines
Tell the doctor about all medicines the patient is currently taking, has recently taken, or plans to take.
If the patient is receiving other intravenous heart medications, the use of Levosimendan Waymade may cause a drop in blood pressure.
Inform the doctor if the patient is taking isosorbide mononitrate, as using Levosimendan Waymade may increase the drop in blood pressure upon standing.

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 Levosimendan Waymade affects the unborn child. The doctor will have to decide whether the benefits to the patient outweigh the possible risks to the child.
There is evidence suggesting that levosimendan passes into breast milk. The patient should not breastfeed during treatment with Levosimendan Waymade to avoid potential cardiovascular adverse effects in the infant.

Levosimendan Waymade contains alcohol
This medicine contains 3925 mg of alcohol (anhydrous ethanol) in each 5 ml vial, which corresponds to 98% v/v alcohol. This amount of alcohol is equivalent to 99.2 ml of beer or 41.3 ml of wine.
The amount of alcohol in this medicine may affect the ability to drive or operate machinery, as it may 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.
Since this medicine is usually administered slowly over more than 24 hours, the effects of alcohol may be reduced.

3. How to use Levosimendan Waymade

Levosimendan Waymade is administered as an intravenous infusion (in a drip). Levosimendan Waymade
is used only in a hospital setting, where a doctor can monitor the patient's condition. The doctor will decide the
appropriate dose of Levosimendan Waymade to administer. Periodically, the doctor will assess the patient's
response to Levosimendan Waymade (e.g., by measuring pulse or blood pressure, performing an ECG, and/or
asking about well-being). The doctor may adjust the dose if necessary.
The doctor may monitor the patient's condition for up to 4–5 days after completion of the Levosimendan Waymade
infusion.
Typically, the medicine is given as a rapid infusion over 10 minutes, followed by a slower intravenous infusion lasting
up to 24 hours.
The doctor should periodically check the patient's response to Levosimendan Waymade. The doctor may reduce the
infusion rate if the patient experiences low blood pressure, increased heart rate, or general discomfort. Inform the
doctor or nurse if you feel palpitations, dizziness, or if you think the effect of Levosimendan Waymade is too strong
or too weak.
If the doctor considers a higher dose of Levosimendan Waymade necessary and the patient does not experience
adverse effects, the infusion rate may be increased.
The doctor will continue the Levosimendan Waymade infusion for as long as cardiac support is required. This usually
lasts 24 hours.
The effect of Levosimendan Waymade on the heart persists for at least 24 hours after the end of the infusion. The
medicine may have effects for 7–10 days after the end of the infusion.
Overdose of Levosimendan Waymade
If an excessive dose of Levosimendan Waymade is administered, a decrease in blood pressure and increased
heart rate may occur. The doctor will provide appropriate treatment based on the patient's condition.

4. Possible adverse reactions

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

abnormally rapid heartbeat
headache
decreased blood pressure

Common (occur in up to 1 in 10 patients):

low blood potassium levels
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

In patients receiving Levosimendan, heart rhythm disorders called ventricular fibrillation (a part of the heart flutters instead of beating properly) have been observed.
If any adverse reactions occur, inform your doctor or nurse immediately. The doctor may reduce the infusion rate or discontinue the infusion of Levosimendan Waymade.
If any adverse reactions worsen or if any adverse reactions not listed in this leaflet occur, inform your doctor.

Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Levosimendan Waymade

Keep this medicine out of the sight and reach of children.
Store in a refrigerator (2°C – 8°C). Do not freeze.
Do not use this medicine after the expiry date stated on the outer carton after Exp. The expiry date refers to the last day of the stated month.
After dilution
Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C.
From a microbiological point of view, the product should be used immediately. If the product is not used immediately, the responsibility for storage conditions and duration prior to use lies with the user, and this period should usually not exceed 24 hours at a temperature of 2 to 8°C, unless the dilution was carried out under controlled and validated aseptic conditions. The total storage and in-use time after dilution must never exceed 24 hours.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Levosimendan Waymade contains

The active substance is levosimendan 2.5 mg/ml.
The other ingredients are: povidone K12, citric acid and anhydrous ethanol.

What Levosimendan Waymade looks like and contents of the pack
The concentrate is a clear, yellow to orange solution for dilution before administration.
Pack sizes

1, 4 or 10 vials (made of colourless type I glass) with a capacity of 5 ml. Outer packaging: cardboard box.

Not all pack sizes may be marketed.
Marketing Authorisation Holder
Waymade B.V.
Herikerbergweg 88
1101CM Amsterdam
The Netherlands
[email protected]
Importer:
Drehm Pharma GmbH
Grünbergstraße 15/3/3
1120 Vienna
Austria
Waymade B.V.
Herikerbergweg 88
1101CM Amsterdam
The Netherlands

Information intended exclusively for healthcare professionals:

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

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

Dosage and method of administration
Levosimendan Waymade is intended for hospital use only. The medicinal product must be administered in a hospital setting equipped with appropriate monitoring facilities and staff experienced in the administration of inotropic agents.
Levosimendan Waymade must be diluted prior to administration.
The solution is intended for intravenous infusion only and may be administered via peripheral or central venous access.
For dosage information, refer to the Summary of Product Characteristics.