LEVOSIMENDAN WAYMADE 2.5 mg/ml CONCENTRATE FOR INFUSION SOLUTION

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

Do not use Levosimendan Waymade

• If you are allergic to levosimendan or any of the other ingredients of this medicine (listed in section 6).
• If you have low blood pressure or tachycardia (abnormally high heart rate).
• If you have severe kidney or liver damage.
• If you have any heart disease that makes it difficult for the heart to fill and empty.
• If your doctor has told you that you have had an arrhythmia called Torsades de Pointes.

Warnings and Precautions

Consult your doctor or nurse before starting to use this medicine

• If you have liver or kidney disease.
• If you have anemia and chest pain at the same time.
• If you have tachycardia, an abnormal heart rate, your doctor has told you that you have atrial fibrillation or you have abnormally low potassium levels in your blood, your doctor should use this medicine with caution.

Children and Adolescents

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

Other Medicines and Levosimendan Waymade

Tell your doctor if you are using, have recently used, or might use any other medicines.

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

Tell your doctor or nurse if you are taking isosorbide mononitrate, because the use of this medicine 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 plan to become pregnant, consult your doctor before using this medicine. It is not known if this medicine affects your baby. Your doctor will decide if the benefit outweighs any possible risk to the child.

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

Levosimendan Waymade contains Alcohol

This medicine contains 3925 mg of alcohol (ethanol) in each 5 ml vial. The amount in each 5 ml vial of this medicine is equivalent to less than 99.2 ml of beer or 41.3 ml of wine.

The amount of alcohol contained in this medicine may affect your ability to drive and use machines because it can alter 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 contained 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 have an alcohol addiction, consult your doctor or pharmacist before taking this medicine.

Since this medicine is usually administered slowly over 24 hours, the effects of alcohol may be reduced.

3. How to use Levosimendan Waymade

This medicine must be administered by intravenous infusion (drip). For this reason, it should only be administered in a hospital where your doctor can monitor you. Your doctor will decide the dose of levosimendan to administer. Your doctor will follow your response to treatment (for example, measuring your heart rate, blood pressure, electrocardiogram, and your subjective feelings), and modify the dose if necessary. Your doctor may want to monitor you for 4 or 5 days after the end of the administration of this medicine.

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 this medicine at different times. This way, they may decrease the infusion 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 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 and you are not experiencing side effects, they may increase the infusion.

Your doctor will continue the infusion of this medicine for as long as they consider necessary to help your heart. It is usually recommended to infuse this medicine for 24 hours.

The effect on your heart function will continue for 24 hours after the infusion of the product has ended. The effect may continue for 7 or 10 days after the end of the infusion.

If you use more Levosimendan Waymade than you should

An overdose of this medicine 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.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicology Information Service Tel. 91 562 04 20, indicating the medicine and the amount ingested.

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.
• Low blood pressure.

Common (may affect up to 1 in 10 people):

• Low potassium levels in the blood
• Insomnia
• Dizziness
• An abnormal heart rhythm called atrial fibrillation (heart palpitations instead of a proper heartbeat)
• Extra heartbeats
• Heart failure
• Reduced oxygen supply to the heart
• Nausea
• Constipation
• Diarrhea
• Vomiting
• Low blood count

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

Tell your doctor immediately if you experience any side effects. Your doctor may reduce or stop the infusion of this medicine.

If any of the side effects get worse or if you experience any side effect not listed in this leaflet, tell your doctor.

Reporting of Side Effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: http://www.aemps.gob.es/. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Levosimendan Waymade

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 carton after “EXP”. The expiry date refers to the last day of the month shown.

After dilution

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

From a microbiological point of view, the medicine should be used immediately. If not used immediately, the in-use storage time and conditions are the responsibility of the user and normally should not exceed 24 hours at a temperature between 2°C and 8°C, unless the dilution has been made in controlled and validated aseptic conditions. The storage and in-use time 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 protect the environment.

6. Contents of the Pack and Other Information

Composition of Levosimendan Waymade

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

Appearance of the Product and Contents of the Pack

The concentrate is a clear yellow or orange solution to be diluted before use.

Package Sizes:

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

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Waymade B.V.

Herikerbergweg 88,

1101CM Amsterdam,

Netherlands

Manufacturer

Drehm Pharma GmbH

Grünbergstraße 15/3/3,

1120 Wien

Austria

Waymade B.V.

Herikerbergweg 88,

1101CM Amsterdam,

Netherlands

You can obtain more information about this medicine by contacting the local representative of the Marketing Authorisation Holder.

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

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

Date of Last Revision of this LeafletSeptember 2024

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

------------------------------------------------------------------------------------------------------------

This information is intended only for healthcare professionals:

Levosimendan Waymade 2.5 mg/ml Concentrate for Solution for Infusion EFG.

Instructions for Use and Handling

For single use.

Levosimendan Waymade 2.5 mg/ml Concentrate for Solution for Infusion EFG 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 0.025 mg/ml infusion, mix 5 ml of this medicine with 500 ml of 5% glucose solution.
• To prepare the 0.05 mg/ml infusion, mix 10 ml of this medicine with 500 ml of 5% glucose solution.

Posology and Method of Administration

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

Levosimendan Waymade should be diluted before administration.

Infusion should be performed exclusively by intravenous route, both by peripheral and central route.

Consult the summary of product characteristics for information on posology.