LEVOSIMENDAN SALA 2.5 mg/mL concentrate for infusion solution

2. What you need to know before you use Levosimendan Sala

Do not use Levosimendan Sala

• if you are allergic to levosimendan or any of the other ingredients of this medicine (listed in section 6).
• if you have very low blood pressure or abnormally fast heartbeats;
• if you have severe kidney or liver disease;
• if you have any heart disease that makes it difficult for the heart to fill or empty;
• if your doctor has told you that you have ever had an abnormal heartbeat called Torsades de Pointes.

Warnings and precautions

Consult your doctor or nurse before you are given Levosimendan Sala

• if you have low blood pressure,
• if you are in a state of decreased blood volume (hypovolemia),
• if you have liver or kidney disease,
• if you have a low blood cell count (anemia) and chest pain;
• if you have an abnormally high heart rate, abnormal heart rhythm or your doctor has told you that you have atrial fibrillation or if you have abnormally low potassium levels in your blood, your doctor should use Levosimendan Sala with caution.

Children and adolescents

Levosimendan Sala should not be given to children and adolescents under 18 years of age.

Other medicines and Levosimendan Sala

Tell your doctor if you are using, have recently used or might use any other medicines, including those obtained without a prescription.

If you have been given other intravenous heart medicines, the administration of Levosimendan Sala may cause a drop in blood pressure.

Tell your doctor or nurse if you are taking isosorbide mononitrate, because the use of Levosimendan Sala may increase the drop in blood pressure when standing up.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. It is not known if Levosimendan Sala can affect your baby. Your doctor will have to decide if the benefits for the mother outweigh the possible risk for the baby.

There are indications that Levosimendan Sala passes into breast milk. You should not breastfeed while being treated with Levosimendan Sala to avoid possible cardiovascular side effects in the child.

Levosimendan Sala contains alcohol

This medicine contains 3.925 mg of alcohol (anhydrous ethanol) in each 5 ml vial, which is equivalent to 98% v. The amount 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 and use machines. This is because it can affect your judgment and reaction time.

If you suffer from epilepsy or liver problems, consult your doctor or pharmacist before taking this medicine.

The amount of alcohol in this medicine may alter the effect of other medicines. Consult your doctor or pharmacist before taking this medicine.

If you are pregnant or breastfeeding, consult your doctor or pharmacist before taking this medicine.

If you are addicted to alcohol, consult 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 Sala

Levosimendan Sala must be administered by infusion (drip) intravenously. For this reason, it should only be administered in a hospital where your doctor can monitor you. Your doctor will decide the amount of levosimendan to be administered to you. Your doctor will assess how you respond to treatment with levosimendan (for example, by measuring your heart rate, blood pressure, by electrocardiogram (ECG) and/or by asking you how you feel). Your doctor may adjust the dose if necessary. It is possible that the doctor may want to monitor you for up to 45 days after administration of levosimendan.

Treatment can be started with a rapid infusion for 10 minutes, followed by a slow infusion for 24 hours.

Your doctor will assess your response to Levosimendan Sala at different times. In this way, the infusion can be reduced if your blood pressure drops or your heart rate becomes too fast or you do not feel well. If you feel that your heart is racing, you feel dizzy or you have the impression that the effect of levosimendan is too strong or too weak, you should inform your doctor or nurse.

If your doctor considers that you need a higher dose of Levosimendan Sala and you are not experiencing side effects, the infusion can be increased.

Your doctor will continue the infusion of Levosimendan Sala for as long as necessary to help your heart. It is usually recommended to infuse Levosimendan Sala for 24 hours.

The effect on your heart function will continue for 24 hours after the infusion of the medicine is stopped. The effect may continue for 7-10 days after the infusion is stopped.

Kidney failure

Levosimendan Sala should be used with caution in patients with mild to moderate kidney failure. This medicine should not be used in patients with severe kidney failure (see section 2).

Liver failure

Levosimendan Sala should be used with caution in patients with mild to moderate liver failure, although it does not seem necessary to adjust the dose in these patients. Levosimendan should not be administered to patients with severe liver failure (see section 2).

If you use more Levosimendan Sala than you should

An overdose of Levosimendan Sala will cause a drop in blood pressure and an increase in heart rate. Your doctor will know how to treat you according to your history.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very common:may affect more than 1 in 10 people

Abnormally high heart rate.

Headache.

Drop in blood pressure

Common:may affect up to 1 in 10 people

Low potassium levels in the blood

Insomnia

Dizziness

Abnormal heartbeat called atrial fibrillation (as a consequence of heart palpitations instead of a proper heartbeat)

Extra heartbeats

Heart failure

Decreased oxygen supply to the heart through the blood

Nausea

Constipation

Diarrhea

Vomiting

Decreased hemoglobin

There have been reports of a heart rhythm disorder called ventricular fibrillation (as a consequence of heart palpitations instead of a proper heartbeat) in patients who received levosimendan.

Please inform your doctor immediately if you experience side effects. Your doctor may reduce or stop the infusion of levosimendan.

Reporting of side effects

If you experience any side effects, talk to your doctor or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Levosimendan Sala

Keep this medicine out of the sight and reach of children.

Store in a refrigerator (between 2 °C and 8 °C).

Do not freeze

Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiry date is the last day of the month stated.

The color of the concentrate may change to orange during storage, but there is no loss of potency and the product can be used until the expiry date stated if the storage instructions have been followed.

Shelf life after dilution

Chemical and physical stability in use has been demonstrated for 24 hours at 25 °C.

From a microbiological point of view, the medicine should be used immediately. If not used immediately, the storage times and conditions prior to use are the responsibility of the user and normally should not exceed 24 hours at a temperature of 2 to 8 °C, unless the dilution has taken place in controlled and validated aseptic conditions. The storage time and use after dilution should never exceed 24 hours.

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

6. Contents of the pack and other information

Composition of Levosimendan Sala

• 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 ingredients are: povidone, citric acid (for pH adjustment) and anhydrous ethanol.

Appearance and pack size

The concentrate is a clear yellow or orange solution for dilution before use.

PACK SIZES:

• 1, 4, 10 vials (glass vial closed with a chlorobutyl plug and aluminum cap and seal) of 5 ml

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Laboratorio Reig Jofre, S.A.

Gran Capitán, 10

08970 Sant Joan Despí (Barcelona)

Spain

Manufacturer:

Laboratorio Reig Jofre, S.A.

Gran Capitán, 10

08970 Sant Joan Despí (Barcelona)

Spain

This medicine is authorised in the Member States of the European Economic Area under the following names:

Sweden: Levosimendan Bioglan

Denmark: Levosimendan Bioglan

Finland: Levosimendan Bioglan 2.5 mg/ml infuusiokonsentraatti, liuosta varten

Norway: Levosimendan Bioglan

Spain: Levosimendan Sala 2,5 mg/ml concentrado para solución para perfusión EFG

France: LEVOSIMENDAN REIG JOFRE 2,5 mg/mL, solution à diluer pour perfusion

Poland: Levosimendan Reig Jofre

Portugal: Levossimendano Reig Jofre 2,5 mg/ml concentrado para solução para perfusão

Date of last revision of this leaflet: April 2023.

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)

This information is intended only for healthcare professionals:

Levosimendan Sala 2.5 mg/ml concentrate for solution for infusion

Instructions for use and handling

The Levosimendan Sala 2.5 mg/ml concentrate for solution for infusion is designed exclusively for single use.

Levosimendan Sala 2.5 mg/ml concentrate for solution for infusion should not be diluted to concentrations higher than 0.05 mg/ml as indicated below, as this may cause opalescence and precipitation.

As with other parenteral products, the diluted solution should be visually inspected for particles and discoloration before administration.

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

Posology and method of administration

Levosimendan Sala is for hospital use only. It should be administered in a hospital unit where there are monitoring facilities and experience with the use of inotropic agents.

Levosimendan Sala should be diluted before administration.

The infusion is for intravenous use only and can be administered by peripheral or central route.

Consult the summary of product characteristics for information on posology.