LEVOSIMENDAN CARINOPHARM 12.5 mg POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the User

Levosimendan Carinopharm 12.5 mg powder for concentrate for solution for infusion

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• If you experience side effects, ask your doctor or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the pack

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

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

Levosimendan Carinopharm is a powder that must be reconstituted and diluted before administration by infusion.

This medicine works by increasing the heart's pumping force and allowing blood vessels to relax. Levosimendan will reduce pulmonary congestion and facilitate blood and oxygen circulation in your body. This medicine will help alleviate the breathing difficulties of severe heart failure.

This medicine is used to treat heart failure in adult patients who continue to have difficulty breathing despite taking other medicines to remove fluid from the body.

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

Do not use Levosimendan Carinopharm

• 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 an abnormally high heart rate (tachycardia),
• 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 had an arrhythmia called Torsades de Pointes.

Warnings and precautions

Consult your doctor or nurse before starting to use this medicine:

• if you have any kidney or liver disease,
• if your doctor has told you that your potassium level in the blood is low,
• if you have anemia and chest pain,
• if you have tachycardia, an abnormal heart rate, or your doctor has told you that you have atrial fibrillation.

Your doctor should use this medicine with great caution.

Consult your doctor or nurse before starting to use this medicine if you have any of the diseases or symptoms mentioned above.

Children and adolescents

This medicine must not be given to children and adolescents under 18 years.

Other medicines and Levosimendan Carinopharm

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

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

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 whether this medicine affects the baby.

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

Levosimendan Carinopharm contains sodium

This medicine contains 60.5 mg of sodium (main component of cooking/table salt) per vial. This is equivalent to 3% of the maximum recommended daily intake of sodium for an adult.

3. How to use Levosimendan Carinopharm

This medicine will be administered to you 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 dose that will be administered to you, check your response to this medicine (e.g., by measuring your heart rate or blood pressure, performing an electrocardiogram, or asking about your subjective feelings), and adjust the dose if necessary. Your doctor may want to monitor you for 4-5 days after the end of treatment with this medicine.

You may receive 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 and may reduce or stop the infusion of this medicine if your blood pressure drops, if your heart rate becomes too fast, or if you do not feel well. Tell your doctor or nurse 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.

If your doctor considers that you need a higher dose of this medicine 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. This usually lasts for 24 hours.

The effect on your heart function will continue for at least 24 hours after the end of the infusion of this medicine. The effect may continue for 7 to 10 days after the end of the infusion.

If you take more Levosimendan Carinopharm than you should

An overdose of this medicine may 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 1-10 in 100 people)

• Decrease in potassium levels in the blood
• Insomnia
• Dizziness
• Abnormal heartbeat, called atrial fibrillation (a part of the heart flutters instead of beating properly)
• Extra heartbeats
• Heart failure
• Decreased oxygen supply to the heart
• Nausea
• Constipation
• Diarrhea
• Vomiting
• Anemia

There have been reports of abnormal heartbeats, called atrial fibrillation (a part of the heart flutters instead of beating properly), in patients who received levosimendan.

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

Reporting of side effects

If you experience side effects, ask your doctor or nurse. Even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Levosimendan Carinopharm

Keep out of sight and reach of children.

Do not store above 25°C.

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

Do not use this medicine if you notice particles or discoloration in the reconstituted solution.

Storage and use after dilution and reconstitution must 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 Carinopharm

• The active substance is levosimendan.
• The other excipients are sulfobutylether beta-cyclodextrin sodium and sodium hydroxide for pH adjustment.

Appearance and pack contents

The vials are made of colorless glass (type I, Ph. Eur.) and are closed with a bromobutyl rubber stopper.

This medicine is packaged in cartons containing 1 vial each.

Marketing authorization holder and manufacturer

Marketing authorization holder

Carinopharm GmbH

Unter den Tannen 6

31036 Eime, Lower Saxony

Germany

Manufacturer

CbA Chemische Produkte-Beratung und Analyse GmbH

Konrad-Zuse-Sr. 10

66459 Kirkel-Limbach

Germany

This medicine has been authorized in the EEA member states with the following names:

Date of last revision of this leaflet: July 2022

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/

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This information is intended only for healthcare professionals:

Instructions for use and handling

This medicine is for single use only.

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

• To prepare the infusion of 0.025 mg/ml, reconstitute the contents of one vialwith 5 ml of water for injections and transfer the resulting concentrate to 500 ml of a 0.9% sodium chloride solution or Ringer's solution.
• To prepare the infusion of 0.05 mg/ml, reconstitute the contents of two vialswith 5 ml of water for injections each and transfer the resulting concentrate to 500 ml of a 0.9% sodium chloride solution or Ringer's solution.

Dosage and administration

This medicine is for hospital use only. It should be administered in a hospitalization unit with monitoring facilities and experience with the use of inotropic agents.

This medicine must be reconstituted and diluted before administration. The infusion should be administered exclusively by the intravenous route, either peripherally or centrally.

Consult the summary of product characteristics for information on posology.