Levosimendan Accord

Patient Information Leaflet: Information for the User

Levosimendan Accord 2.5 mg/ml concentrate for solution for infusion

Generic medicine
Please read this leaflet carefully before using this medicine because it contains important information for you.

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

Contents of this leaflet:

1. What Levosimendan Accord is and what it is used for
2. What you need to know before using Levosimendan Accord
3. How to use Levosimendan Accord
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 concentrate medicine that must be diluted before being administered as an intravenous infusion.
Levosimendan Accord works by increasing the force of the heart's contractions and by promoting relaxation of the blood vessel walls. Levosimendan Accord will reduce congestion in your lungs and improve blood and oxygen delivery to your organs. It will help relieve shortness of breath caused by severe heart failure.
Levosimendan Accord is indicated for the treatment of heart failure in adults who continue to experience breathing difficulties despite taking medications that remove excess fluid from the body.
Levosimendan Accord is indicated in adults.

2. What you need to know before using Levosimendan Accord

Do not use Levosimendan Accord

• if you are allergic to levosimendan or to any of the other ingredients of this medicine (listed in section 6).
• if you have very low blood pressure or an abnormally fast heart rate.
• if you have severe liver or kidney disease.
• if you have a heart condition that impairs the heart's ability to fill and empty properly.
• if your doctor has told you that you have had an abnormal heart rhythm called Torsade de Pointes.

Warnings and precautions
Talk to your doctor or nurse before using Levosimendan Accord

• if you have liver or kidney disease.
• if you also have a low red blood cell count and chest pain.
• if you have an abnormally fast heart rate, an abnormal heart rhythm, or if your doctor has diagnosed you with atrial fibrillation or abnormally low levels of potassium in your blood, your doctor must administer Levosimendan Accord with great caution.

Children and adolescents
Levosimendan Accord must not be given to children and adolescents under 18 years of age.
Other medicines and Levosimendan Accord
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
If you have been given other intravenous heart medications, your blood pressure may drop further if you are given Levosimendan Accord.
Tell your doctor or nurse if you are taking isosorbide mononitrate, as using Levosimendan Accord may increase the drop in blood pressure when you stand up.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before using this medicine. It is not known whether Levosimendan Accord could affect your baby. Your doctor will assess whether the benefit to you outweighs the potential risks to your baby.
There is limited information available on whether Levosimendan Accord passes into breast milk. You must not breastfeed during treatment with Levosimendan Accord to avoid potential cardiovascular adverse events in the newborn.
Levosimendan Accord contains alcohol
This medicine contains 3925 mg of alcohol (anhydrous ethanol) in each 5 ml vial, equivalent to approximately 98 vol%. The amount of alcohol in a 5 ml vial of this medicine is equivalent to 99.2 ml of beer or 41.3 ml of wine.
The amount of alcohol in this medicine may affect your ability to drive or operate machinery, as it may impair your judgment and reaction speed.
If you have epilepsy or liver problems, talk to your doctor or pharmacist before taking this medicine.
The amount of alcohol in this medicine may alter the effects of other medicines. Consult your doctor or pharmacist if you are taking other medicines.
If you are pregnant or breastfeeding, consult your doctor or pharmacist before taking this medicine.
If you have alcohol dependence, talk to your doctor or pharmacist before taking this medicine.
Since this medicine is usually administered slowly over 24 hours, the effects of the alcohol may be reduced.

3. How to use Levosimendan Accord

Levosimendan Accord will be administered to you as an intravenous infusion (intravenous drip). For this reason,
Levosimendan Accord must be administered only in a hospital setting where your doctor can monitor you. Your
doctor will decide how much Levosimendan Accord you should receive. Your doctor will measure your response to
Levosimendan Accord (for example, by monitoring your heart rate, blood pressure, ECG, and by assessing how you feel).
If necessary, your doctor may then adjust the dosage. Your doctor may wish to monitor you for up to 4–5 days after
discontinuation of Levosimendan Accord.
You may receive it as a rapid infusion over ten minutes, followed by a slower infusion lasting up to 24 hours.
Your doctor must monitor your response to Levosimendan Accord on an ongoing basis. Your doctor may reduce
your infusion if your blood pressure drops suddenly, or if your heart starts beating too fast, or if you feel unwell. Inform
your doctor or nurse immediately if you feel your heart beating too fast, if you feel dizzy, or if you feel that the effect of
Levosimendan Accord is too strong or too weak.
If your doctor determines that you require a higher dose of Levosimendan Accord and you are not experiencing
side effects, the infusion rate may be increased.
Your doctor will continue the Levosimendan Accord infusion for as long as cardiac support is needed.
Typically, the infusion lasts 24 hours.
The effect on your heart function will continue for at least 24 hours after the Levosimendan Accord infusion has
ended. The effect may last up to 9 days after the infusion is completed.

Renal impairment
Levosimendan Accord should be used with caution in patients with mild to moderate renal impairment. Levosimendan
Accord must not be used in patients with severe renal impairment (see section 2).

Hepatic impairment
Levosimendan Accord should be used with caution in patients with mild to moderate hepatic impairment, although
dose adjustment does not appear to be necessary for these patients. Levosimendan Accord must not be used in
patients with severe hepatic impairment (see section 2).

If you have been given more Levosimendan Accord than you should have
If you have been given too much Levosimendan Accord, your blood pressure may decrease and your heart rate may
increase. Your doctor will know how to treat you based on your condition.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.

Very common (may affect more than 1 in 10 people):
Abnormally fast heartbeat
Headache
Lowering of blood pressure

Common (may affect up to 1 in 10 people):
Low blood potassium levels
Insomnia
Dizziness
An abnormal heart rhythm called atrial fibrillation (a part of the heart quivers rapidly and irregularly instead of beating properly)
Extrasystoles
Heart failure
Inadequate oxygen supply to the heart
Nausea
Constipation
Diarrhoea
Vomiting
Low blood count

Not known (frequency cannot be estimated from the available data):
Hypersensitivity (symptoms may include skin rash and itching).

Ventricular fibrillation (a part of the heart quivers rapidly and irregularly instead of beating properly), a heart rhythm disorder, has been reported in patients treated with Levosimendan Accord.

Please inform your doctor or nurse immediately if you experience any side effects. Your doctor may reduce the infusion rate or discontinue the Levosimendan Accord infusion completely.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor.
Website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Levosimendan Accord

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 carton.
The expiry date refers to the last day of that month.
The storage and usage time after dilution must never exceed 24 hours.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Levosimendan Accord contains

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

Description of the appearance of Levosimendan Accord and contents of the pack
The concentrate is a yellow or orange transparent solution to be diluted before administration.
Pack sizes:

• 1, 4, 10 vials (type I glass) of 5 ml

Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona, s/n,
Edifici Est 6ª planta,
08039 Barcelona,
Spain
Manufacturer
Bag Health Care GmbH,
Amtsgerichtsstrasse 1-5,
D-35423 Lich,
Germany
ALS Germany GmbH
Johann-Krane-Weg 42,
48149 Münster,
Germany

The following information is intended exclusively for healthcare professionals:
Instructions for use and handling
For single use only.
Levosimendan Accord 2.5 mg/ml concentrate for solution for infusion must not be diluted to a concentration higher than 0.05 mg/ml as specified below, otherwise opalescence and precipitation may occur.
As with all parenteral medicines, the diluted solution should be visually inspected before administration for the presence of particles and discoloration.

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

Dosage and method of administration
Levosimendan Accord is for hospital use only. It must be administered in a hospital setting where adequate monitoring equipment and experience in the use of inotropic agents are available.
Levosimendan Accord must be diluted before administration.
The infusion is for intravenous use only and may be administered via either peripheral or central route.
For dosage, refer to the Summary of Product Characteristics.