Levosimendan Kalceks

Patient Information Leaflet: Information for the User

Levosimendan Kalceks 2.5 mg/ml concentrate for solution for infusion

levosimendan
Generic medicine
Read this leaflet carefully before you are given 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, inform your doctor or nurse. See section 4.

Contents of this leaflet:

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

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

Levosimendan Kalceks is a concentrate medicine that must be diluted before being administered as an intravenous infusion.
Levosimendan works by increasing the heart's pumping force and promoting relaxation of the blood vessels. Levosimendan Kalceks will reduce congestion in the lungs and improve circulation of blood and oxygen throughout the body. This medicine will help relieve shortness of breath caused by severe heart failure.
Levosimendan Kalceks is used to treat heart failure in adults who continue to experience breathing difficulties despite taking other medications to remove excess fluid from the body.
Levosimendan Kalceks is intended for use in adults.

2. What you need to know before receiving Levosimendan Kalceks

Do not use Levosimendan Kalceks

• 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 excessively rapid heart rate;
• if you have severe kidney or liver disease;
• if you have a heart condition that makes it more difficult for the heart to fill or empty;
• if your doctor has told you that you have or have had a heart rhythm disorder called torsade de pointes.

Warnings and precautions
Talk to your doctor or nurse before receiving this medicine:

• if you have kidney or liver disease;
• if you have a low number of blood cells (anaemia) and chest pain;
• if you have an excessively rapid heartbeat, an abnormal heart rhythm, or if your doctor has told you that you suffer from a heart condition called “atrial fibrillation” or that you have abnormally low levels of potassium in your blood;
• if you have low blood pressure;
• if you have a severe reduction in blood volume in the body (hypovolemia). Your doctor must use this medicine with great caution. If you are unsure whether any of the above apply to you, consult your doctor or nurse.

Children and adolescents
This medicine must not be given to children and adolescents under 18 years of age.
Other medicines and Levosimendan Kalceks
Tell your doctor or nurse if you are taking, have recently taken, or might take any other medicines.
If you have received other heart medications administered intravenously, your blood pressure may drop further if you are given levosimendan.
Tell your doctor or nurse if you are taking isosorbide mononitrate (used to treat angina (chest pain)), because levosimendan may increase the drop in blood pressure when you stand up.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor for advice before receiving this medicine.
It is not known whether this medicine has effects on the unborn child. Your doctor will need to decide whether the benefit to the mother outweighs the potential risk to the child.
There is information available about levosimendan passing into breast milk. You must not breastfeed during treatment with this medicine to avoid potential cardiovascular adverse events in the newborn.

Levosimendan Kalceks contains alcohol
This medicine contains 3925 mg of alcohol (anhydrous ethanol) in each 5 ml vial, equivalent to 785 mg/ml (approximately 98% w/v). The amount of alcohol in one 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 use machinery. This is because alcohol may impair your judgment and your reaction speed.
If you are pregnant, have epilepsy, or have liver problems, speak with your doctor or nurse before receiving this medicine.
The alcohol in this medicine may alter the effects of other medicines. Speak with your doctor or nurse if you are taking other medicines.
If you are alcohol-dependent, speak with your doctor or nurse before receiving this medicine.
Since this medicine is usually administered slowly over 24 hours, the effects of the alcohol may be reduced.

3. How Levosimendan Kalceks is administered

This medicine will be given to you as an intravenous infusion (drip into a vein). This is why
this medicine must only be administered in a hospital setting, where your doctor can monitor you.
Your doctor will decide the dose of medicine you should receive. Your doctor will measure your response to
treatment (for example, by measuring your heart rate and blood pressure, performing an
electrocardiogram (ECG) and/or asking how you feel). If necessary, your doctor may then adjust the dose.
Your doctor may wish to monitor you for up to 4–5 days after stopping this medicine.
You may receive a rapid infusion over 10 minutes, followed by a slower infusion for up to 24 hours.
Your doctor will periodically check your response to levosimendan. The infusion may be reduced
if your blood pressure drops, if your heart starts beating too fast, or if you feel unwell. Inform your doctor or nurse
if you feel your heart beating too fast, if you feel dizzy, or if you think the effect of this medicine is too strong or
too weak.
If your doctor considers that you need a higher dose of levosimendan and you are not experiencing
any adverse effects, the infusion rate may be increased.
Your doctor will continue the levosimendan infusion for as long as needed to support your heart;
this is usually for 24 hours.
The effect on the heart will last for at least 24 hours after the end of the levosimendan infusion.
The effect may continue for 7–10 days after the end of the infusion.

Renal impairment
This medicine must be used with caution in patients with mild to moderate renal impairment. Levosimendan must not be used in patients with severe renal impairment (see section 2, Do not use Levosimendan Kalceks).

Hepatic impairment
This medicine must be used with caution in patients with mild to moderate hepatic impairment, although dose adjustment does not appear to be necessary in these patients.
Levosimendan must not be used in patients with severe hepatic impairment (see section 2, Do not use Levosimendan Kalceks).

If you are given more Levosimendan Kalceks than you should
If you have been given too much of this medicine, your blood pressure may drop and your heart rate may increase.
Your doctor will know what treatment to provide based on your 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)

• Headache
• Excessively rapid heartbeat
• Lowering of blood pressure

Common (may affect up to 1 in 10 people)

• Low blood potassium levels
• Insomnia
• Dizziness
• Irregular heartbeat called "atrial fibrillation" (a part of the heart beats rapidly and irregularly instead of beating properly)
• Increased heart rate
• Extra heartbeats
• Heart failure
• The heart does not receive enough oxygen
• Nausea
• Constipation
• Diarrhoea
• Vomiting
• Low number of blood cells

Not known (frequency cannot be estimated from the available data)

• Hypersensitivity (symptoms may include skin rash and itching)

An irregular heartbeat called "ventricular fibrillation" (a part of the heart beats rapidly and irregularly instead of beating properly) has been reported in patients treated with levosimendan.
Inform your doctor immediately if any side effects occur. Your doctor may reduce the infusion rate or stop the levosimendan infusion.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, tell your doctor or nurse. You can also report side effects directly via the national reporting system at: 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 Kalceks

Keep this medicine out of the sight and reach of children.
Store in a refrigerator (2 °C – 8 °C).
The colour of the concentrate may turn orange during storage, but this does not imply a loss of potency and the medicine can be used up to the expiry date stated on the label and packaging after “EXP” or “Scad.”. The expiry date refers to the last day of that month, provided storage instructions have been followed.
Period of validity after dilution
Chemical and physical in-use stability has been demonstrated for 24 hours at a temperature of 2 °C – 8 °C and at 25 °C.
From a microbiological standpoint, the medicine should be used immediately. If not used immediately, the in-use storage times and conditions prior to use are the responsibility of the user and should normally not exceed 24 hours at a temperature of 2 °C – 8 °C.
Do not use this medicine after the expiry date which is stated on the label and the carton after “EXP” or “Scad.”. The expiry date refers to the last day of that month.
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 Kalceks contains

• The active substance is levosimendan. Each ml of concentrate contains 2.5 mg of levosimendan. Each 5 ml vial of solution contains 12.5 mg of levosimendan.
• The other components are povidone K 12, citric acid and anhydrous ethanol.

Description of the appearance of Levosimendan Kalceks and package contents
Clear yellow or orange solution.
5 ml solution in a colourless glass vial closed with a rubber stopper, sealed with a plastic snap-off cap and aluminium seal. The vials are packed in a cardboard box.
Pack sizes: 1 or 4 vials
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
AS KALCEKS
Krustpils iela 71E, Rīga, LV-1057, Latvia
Tel.: +371 67083320
E-mail: [email protected]

The following information is intended exclusively for doctors and healthcare professionals:

Instructions for use and handling
For single use only.
Once opened, the medicinal product must be used immediately. Any residual contents must be
discarded.
Levosimendan Kalceks 2.5 mg/ml concentrate for solution for infusion must not be diluted to a
concentration higher than 0.05 mg/ml, as indicated below, otherwise opalescence and precipitation
may occur.

• To prepare the 0.025 mg/ml infusion, mix 5 ml of Levosimendan Kalceks 2.5 mg/ml concentrate for solution for infusion with 500 ml of 5% glucose solution for infusion or 0.9% sodium chloride solution for infusion.
• To prepare the 0.05 mg/ml infusion, mix 10 ml of Levosimendan Kalceks 2.5 mg/ml concentrate for solution for infusion with 500 ml of 5% glucose solution for infusion or 0.9% sodium chloride solution for infusion.

As with all parenteral medicinal products, visually inspect the diluted solution for presence of particles or discoloration prior to administration.
The following medicinal products may be administered simultaneously with levosimendan via connected infusion lines:

• Furosemide 10 mg/ml
• Digoxin 0.25 mg/ml
• Glycerol trinitrate 0.1 mg/ml

Any unused medicinal product and waste material derived from this medicinal product must be disposed of in accordance with local regulations.
Dosage and method of administration
Levosimendan Kalceks is restricted to hospital use. It must be administered in a hospital setting where adequate monitoring facilities and experience in the use of inotropic agents are available.
Levosimendan Kalceks must be diluted before administration.
The infusion is for intravenous use only and may be administered via peripheral or central route.
For dosage information, refer to the summary of product characteristics.