Patient Information Leaflet

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

Keep this leaflet so that you can read it again if necessary.
If you have any further questions, please consult your doctor or nurse.
If the patient experiences any side effects, including any not listed in this leaflet, please inform your doctor or nurse. See section 4.

Table of contents

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

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

Levosimendan Mercapharm is a medicine in the form of a concentrate that must be diluted before
being administered to the patient as an intravenous infusion.
Levosimendan Mercapharm increases the force with which the heart pumps blood and causes the
blood vessels to relax. As a result, Levosimendan Mercapharm reduces pulmonary congestion
and facilitates blood and oxygen flow throughout the body. Levosimendan Mercapharm helps
alleviate breathlessness caused by severe heart failure.
Levosimendan Mercapharm is used as an additional, short-term treatment for acute decompensated episodes of severe chronic heart failure in adult patients who continue to experience breathing difficulties despite receiving other medications that remove excess fluid from the body.
Levosimendan Mercapharm is intended for use in adults.

2. Important information before using Levosimendan Mercapharm

When not to use Levosimendan Mercapharm:

if the patient is allergic to levosimendan or to 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 a heart disease that impairs filling or emptying of the heart;
if the patient has severe kidney disease;
if the patient has severe liver disease;
if the patient has ever been informed by a doctor of having an abnormal heart rhythm called torsades de pointes.

Warnings and precautions
Please discuss this with your doctor or nurse before starting treatment with this medicine:

if the patient has low blood pressure;
if the patient has reduced blood volume (hypovolemia);
if the patient has any kidney or liver disease;
if the patient has ever been told by a doctor of having abnormally low potassium levels in the blood;
if the patient has a low number of red blood cells (anemia) and chest pain;
if the patient has a rapid heartbeat, an irregular heart rhythm, or if the patient has ever been told by a doctor of having atrial fibrillation.

If the patient has any of the above conditions or symptoms, please discuss this with a doctor or nurse.
Children and adolescents
The safety and efficacy of Levosimendan Mercapharm in children and adolescents under 18 years of age have not been established.
Levosimendan Mercapharm and other medicines
Tell your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including over-the-counter medicines.
If the patient is receiving other intravenous heart medications, the use of Levosimendan Mercapharm may cause a drop in blood pressure.
Tell your doctor or nurse if the patient is taking isosorbide mononitrate (used to treat angina pectoris (chest pain)), as levosimendan may worsen 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 baby, she should consult her doctor before using this medicine. It is not known whether Levosimendan Mercapharm affects the unborn child. In animal studies, a harmful effect on fertility has been observed; therefore, levosimendan is not recommended during pregnancy and in women who may become pregnant and who are not using contraception.
Levosimendan Mercapharm has been shown to pass into human breast milk. Breastfeeding should be avoided during treatment with Levosimendan Mercapharm to prevent possible adverse effects on the cardiovascular system of the infant.
Levosimendan Mercapharm 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. It may be harmful for individuals with alcohol-related disorders.
The alcohol content should be taken into account in pregnant or breastfeeding women, children, and patients in high-risk groups, such as patients with liver disease or epilepsy. The alcohol contained in this medicine may alter the effects of other medicines.

3. How to use Levosimendan Mercapharm

Levosimendan Mercapharm is intended for hospital use only. The medicine must be administered in a hospital setting where appropriate monitoring equipment and medical personnel with specialist knowledge in the use of inotropic drugs are available.
Levosimendan Mercapharm will be given as an intravenous infusion (via an IV drip).
The dose and duration of treatment will be adjusted according to the individual patient's clinical condition and response to treatment.
Typically, the medicine is administered as a rapid infusion (loading dose of 6 to 12 micrograms/kg body weight) over 10 minutes. This is followed by a slower intravenous infusion (continuous infusion of 0.1 microgram/kg body weight/min) lasting up to 24 hours.
The physician will determine the appropriate dose of Levosimendan Mercapharm based on the patient's body weight and renal and hepatic function.
Periodically, the physician will assess the patient's response to Levosimendan Mercapharm (e.g. by measuring pulse or blood pressure, performing ECG examinations and/or asking about well-being) and adjust the dose if necessary.
Inform the physician or nurse if palpitations, dizziness or any feeling that the effect of Levosimendan Mercapharm is too strong or too weak occur. If the patient experiences a drop in blood pressure, increased heart rate or general deterioration in well-being, the physician may reduce the infusion rate.
The physician may increase the infusion rate if a higher dose of Levosimendan Mercapharm is deemed necessary and no adverse reactions are present.
The physician will continue the Levosimendan Mercapharm infusion for as long as cardiac support is required. This usually lasts 24 hours.
The effect of Levosimendan Mercapharm on the heart persists for at least 24 hours after the end of the infusion. The medicine may remain active for up to 9 days after the infusion ends. Therefore, Levosimendan Mercapharm must be used exclusively in a hospital setting where the physician can monitor the patient's condition for 4–5 days after the infusion ends.

Renal impairment
Caution should be exercised when administering Levosimendan Mercapharm to patients with mild or moderate renal impairment. The medicine should not be used in patients with severe renal impairment (creatinine clearance < 30 mL/min) (see section 2. Important information before using Levosimendan Mercapharm).

Hepatic impairment
Caution should be exercised when administering Levosimendan Mercapharm to patients with mild or moderate hepatic impairment, although dose adjustment is not usually necessary in these patients. Levosimendan Mercapharm should not be used in patients with severe hepatic impairment (see section 2. Important information before using Levosimendan Mercapharm).

Overdose of Levosimendan Mercapharm
If an excessive dose of Levosimendan Mercapharm is administered, a decrease in blood pressure and increased heart rate may occur. The physician will initiate appropriate treatment based on the patient's condition.

4. Possible side effects

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

abnormally rapid heartbeat
headache
reduced blood pressure.

Common (may affect less than 1 in 10 people):

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 Mercapharm, heart rhythm disorders called ventricular fibrillation (a part of the heart flutters instead of beating properly) have been observed.
If side effects occur, inform your doctor or nurse immediately. The doctor may reduce the infusion rate or discontinue the infusion of Levosimendan Mercapharm.
Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, tell your doctor or nurse. Side effects 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, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorisation holder.
Reporting of side effects helps to provide more information on the safety of the medicine.

5. How to store Levosimendan Mercapharm

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the vial or carton. The expiry date refers to the last day of the stated month.
Store at 2°C – 8°C (in a refrigerator). Do not freeze.
During storage, the concentrate may change color to orange, but this does not affect its potency, and the medicine may still be used up to the indicated expiry date, provided that storage instructions have been followed.

After dilution
Chemical and physical stability has been demonstrated for the prepared solution for 24 hours at 25°C and at temperatures between 2°C and 8°C.
From a microbiological standpoint, the product should be used immediately. If the product is not used immediately, the user is responsible for the storage duration and conditions prior to use. Generally, storage should not exceed 24 hours at 2–8°C, unless dilution has been carried out under controlled and validated aseptic conditions.
As with all parenteral products, the prepared solution should be visually inspected for particulate matter and discoloration before administration.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Levosimendan Mercapharm contains

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

What Levosimendan Mercapharm looks like and contents of the pack
The concentrate is a clear, yellow or orange solution which must be diluted before administration.
Type and contents of the container
An 8 mL vial made of colourless type I glass, closed with a chlorobutyl or bromobutyl rubber stopper coated with fluoropolymer, and sealed with an aluminium cap with a white polypropylene flip-off disc, containing 5 mL of solution.
Pack sizes

1 vial (type I glass) with a volume of 5 mL, in a cardboard carton.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Mercapharm Sp. z o.o.
Świętopełka 39
81-524 Gdynia
e-mail: [email protected]
Telephone: +48509368531
Manufacturer
Pharmidea SIA, Rupnicu Iela 4, Olaine, Olaines Novads, 2114, Latvia
This medicinal product is authorised in the European Economic Area countries under the following names:
Estonia Levosimendan Auxilia
France Levosimendan Pharmidea 2.5 mg/ml, solution à diluer pour perfusion
Spain Levosimendan ever pharma 2.5 mg/ml concentrado para solucion para perfusion efg
Poland Levosimendan Mercapharm
Portugal Levosimendano ever pharma 2.5 MG/ML Concentrado para solução para perfusão

Information intended exclusively for healthcare professionals:

Levosimendan Mercapharm, 2.5 mg/mL, concentrate for solution for infusion
Instructions for use and handling
Levosimendan Mercapharm 2.5 mg/mL, concentrate for solution for infusion, is intended for single use only.
As with all parenteral products, the prepared solution should be inspected visually for particulate matter and discoloration prior to administration.

Compatibility has been demonstrated for Levosimendan Mercapharm with 5% glucose solution in various types of containers made of PVC, PE, PP, and PE/PP copolymers, over a 24-hour period when stored both refrigerated and at room temperature. Compatibility has also been demonstrated with infusion bags and administration sets made of both PVC and non-PVC materials.
The diluted product does not require protection from light.
Levosimendan Mercapharm must not be diluted to a concentration higher than 0.05 mg/mL, as described in the instructions below; otherwise, opalescence and precipitation may occur.

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

The medicinal product Levosimendan Mercapharm may be administered simultaneously with the following medicinal products at specified concentrations through the same intravenous access:

Furosemide 10 mg/mL
Digoxin 0.25 mg/mL
Glyceryl trinitrate 0.1 mg/mL

Dosage and administration
Levosimendan Mercapharm is intended for hospital use only. The drug must be administered in a hospital setting where appropriate monitoring equipment and experienced personnel in the administration of inotropic agents are available.
Levosimendan Mercapharm must be diluted before administration.
The solution is intended for intravenous infusion only and may be administered via peripheral or central veins.
For information regarding dosage, refer to the Summary of Product Characteristics.