LEVOSIMENDAN ACCORD

Package leaflet: Information for the user

Levosimendan Accord, 2.5 mg/mL, concentrate for solution for infusion
Levosimendanum
Please read all of this leaflet carefully before this medicine is given to you, because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Levosimendan Accord is and what it is used for
2. What you need to know before you are given Levosimendan Accord
3. How Levosimendan Accord is given
4. Possible side effects
5. How to store Levosimendan Accord
6. Contents of the pack and other information

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

Levosimendan Accord is a medicine in the form of a concentrate that must be diluted before intravenous infusion.
Levosimendan Accord 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 to relieve breathlessness caused by severe heart failure.
Levosimendan Accord is used to treat heart failure in adults who continue to experience difficulty breathing despite treatment with other medicines that remove excess fluid from the body.
Levosimendan Accord is intended for use in adults.

2. Information before using Levosimendan Accord

When not to use Levosimendan Accord:

• 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 and 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 about having an abnormal heart rhythm called torsades de pointes.

Warnings and precautions
Before starting treatment with Levosimendan Accord, discuss this with the doctor or
nurse:

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

Children and adolescents
Levosimendan Accord must not be given to children and adolescents under 18 years of age.

Levosimendan Accord 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.
If the patient is receiving other intravenous heart medications, administration of Levosimendan Accord may
cause a drop in blood pressure.
Inform the doctor or nurse if the patient is taking isosorbide mononitrate, because using Levosimendan Accord 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 using
Levosimendan Accord 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 passes into human milk. Therefore, breastfeeding must be avoided during treatment with Levosimendan Accord to prevent possible adverse effects on the cardiovascular system of the infant.

Levosimendan Accord contains alcohol
This medicine contains 3925 mg of alcohol (anhydrous ethanol) in each 5 mL vial, equivalent to
98% v/v ethanol. The amount in one 5 mL vial of this medicinal product is equivalent to 99.2 mL of beer
or 41.3 mL of wine.
The alcohol content in this medicine may affect the ability to drive or operate machinery,
because it may impair judgment and reaction speed.
If the patient has epilepsy or liver problems, talk to a doctor or pharmacist before using this medicine.
The alcohol content in this medicine may affect the action of other medicines. If the patient is taking other
medicines, he or she should talk to a doctor or pharmacist.
If the patient is pregnant or breastfeeding, she should talk to a doctor or pharmacist before taking this medicine.
If the patient is alcohol-dependent, he or she should talk to a doctor or pharmacist before using this medicine.
Since this medicine is usually administered slowly over 24 hours, the effect of alcohol may be reduced.

3. How to use Levosimendan Accord

Levosimendan Accord will be administered as an intravenous infusion (via a drip).
For this reason, Levosimendan Accord must only be given in a hospital setting where a doctor can
monitor the patient's condition. The doctor will decide the dose of Levosimendan Accord to be administered.
The doctor will assess the patient's response to Levosimendan Accord (e.g. by measuring heart rate or
blood pressure, performing an ECG, and/or asking about symptoms) and, if necessary, adjust the dose accordingly.
The doctor may decide to monitor the patient's condition for 4–5 days after completion of Levosimendan Accord treatment.

The patient may receive the medicine 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 Accord. If the patient develops low blood pressure, increased heart rate, or feels unwell, the doctor may reduce the infusion rate.

Inform the doctor or nurse if you experience palpitations, dizziness, or if you feel that the effect of Levosimendan Accord is too strong or too weak.
The doctor may increase the infusion rate if a higher dose of Levosimendan Accord is considered necessary and no adverse effects are present.

The doctor will continue the Levosimendan Accord infusion for as long as cardiac support is required. This typically lasts 24 hours.

The effect on the heart persists for at least 24 hours after the end of the Levosimendan Accord infusion. The medicine may exert effects for up to 9 days after the infusion has ended.

Kidney function impairment
Caution is advised when administering Levosimendan Accord to patients with mild or moderate kidney impairment.
Levosimendan Accord should not be used in patients with severe kidney impairment (see section 2).

Liver function impairment
Caution is advised when administering Levosimendan Accord to patients with mild or moderate liver impairment, although dose adjustment is not usually required in these patients.
Levosimendan Accord should not be used in patients with severe liver impairment (see section 2).

Overdose of Levosimendan Accord
If too high a dose of Levosimendan Accord is administered, a drop 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 they do not occur in everyone.
Very common (occur in more than 1 in 10 patients):

• abnormally fast 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 hypoxia
• nausea
• constipation
• diarrhoea
• vomiting
• low number of blood cells

Frequency not known (cannot be estimated from the available data):

• hypersensitivity (symptoms may include rash and itching)

In patients receiving Levosimendan Accord, heart rhythm disorders called ventricular fibrillation (a part of the heart flutters instead of beating properly) have been observed.
If adverse reactions occur, inform your doctor or nurse immediately.
The doctor may reduce the infusion rate or discontinue the Levosimendan Accord infusion.
Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, tell your doctor or pharmacist. Adverse reactions 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
Reporting adverse reactions helps to provide more information on the safety of the medicine.
Adverse reactions can also be reported to the marketing authorization holder.

5. How to store Levosimendan Accord

Keep this medicine out of 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 vial or carton following EXP.
The expiry date refers to the last day of the stated month.
The storage and use time after dilution should not exceed 24 hours.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. These measures will help protect
the environment.

6. Contents of the pack and other information

What Levosimendan Accord contains

• The active substance is levosimendan 2.5 mg/mL.
• The other ingredients are: povidone, citric acid, and absolute ethanol.

What Levosimendan Accord 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 (colourless glass type I) with a volume of 5 mL.

Not all pack sizes may be marketed.
Marketing Authorisation Holder
Accord Healthcare Polska Sp. z o.o.
Taśmowa Street 7
02-677 Warsaw
Tel: +48 577 28 00
Manufacturer
BAG Health Care GmbH
Amtsgerichtsstrasse 1-5
35423 Lich
Germany
ALS Germany GmbH
Johann-Krane-Weg 42
48149 Muenster
Germany
This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Information intended exclusively for medical professionals:

Instructions for use and handling
For single use only.
The medicinal product Levosimendan Accord, 2.5 mg/mL, concentrate for solution for infusion, must not be diluted to a concentration greater than 0.05 mg/mL as described in the instructions below, otherwise opalescence and precipitation may occur.
As with all parenteral medicinal products, the prepared solution should be visually inspected before use for the presence of particulate matter and discoloration.

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

Dosage and method of administration
Levosimendan Accord is intended for hospital use only. The medicinal product must be administered in a hospital setting where appropriate monitoring equipment and personnel experienced in administering inotropic agents are available.
Levosimendan Accord must be diluted before administration.
The solution is intended for intravenous infusion only and may be administered either peripherally or centrally.
Dosage information is provided in the Summary of Product Characteristics.