LEVOSIMENDAN ALTAN 2.5 mg/ml CONCENTRATE FOR INFUSION SOLUTION

Introduction

Package Leaflet: Information for the User

Levosimendan Altan 2.5 mg/ml Concentrate for Solution for InfusionEFG

Levosimendan

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.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

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

Levosimendan Altan is presented as a concentrate that must be diluted before administration by intravenous infusion.

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

Levosimendan is indicated for the treatment of heart failure in people who continue to have difficulty breathing despite taking other medications to eliminate fluid from the body.

2. What you need to know before you start using Levosimendan Altan

Do not use Levosimendan Altan

• If you are allergic (hypersensitive) to levosimendan or any of the other components of this medicine (see section 6)
• If you have very low blood pressure or an abnormally high heart rate (tachycardia).
• 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.

Be especially careful withLevosimendan Altan

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

Talk to your doctor before starting treatment with Levosimendan Altan if you have any of the diseases or symptoms mentioned above.

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

Other medicines and Levosimendan Altan

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

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine. The effects of Levosimendan Altan on the child are unknown.

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

Levosimendan Altan contains Ethanol

This medicine contains 98% by volume of ethanol (alcohol), i.e., up to 3925 mg per 5 ml vial, equivalent to 99.2 ml of beer, 41.3 ml of wine per 5 ml vial. 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 if you are taking other medicines. If you are pregnant or breastfeeding, consult your doctor or pharmacist before taking this medicine.

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 ability.

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 Altan

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

Levosimendan Altan should be administered by intravenous infusion.

The dose and duration of treatment will be individualized according to your clinical condition and response.

Normally, treatment can be started with a rapid infusion (loading dose of 6-12 micrograms/kg) for 10 minutes followed by a slow infusion (continuous infusion of 0.1 micrograms/kg/min) for 24 hours.

Your doctor will decide the dose of Levosimendan Altan to be administered and will continuously monitor your response to treatment (e.g., by measuring your heart rate, blood pressure, electrocardiogram, and subjective sensations) and modify the dose if necessary.

Tell your doctor or nurse if you feel that your heart is racing, if you feel dizzy, or if you feel that the effect of Levosimendan Altan is too strong or too weak. The doctor may reduce your infusion if your blood pressure drops or your heart starts beating too fast or if you are not feeling well.

If your doctor considers that you need a higher dose of Levosimendan Altan and you are not experiencing side effects, they may increase the infusion.

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

The effect on your heart function will last for at least 24 hours after the infusion of Levosimendan Altan is stopped. The effect may continue for 7-10 days after the infusion is finished. This is why you should only receive Levosimendan Altan in a hospital where your doctor can monitor you for up to 4-5 days after the infusion is finished.

Renal insufficiency

Levosimendan Altan should be used with caution in patients with mild to moderate renal insufficiency. Levosimendan Altan should not be used in patients with severe renal insufficiency (creatinine clearance <30 ml min) (see section 2. "what you need to know before using levosimendan altan").< p>

Hepatic insufficiency

Levosimendan Altan should be used with caution in patients with mild to moderate hepatic insufficiency, although it does not seem necessary to adjust the dose in these patients. Levosimendan Altan should not be administered to patients with severe hepatic insufficiency (see section 2. "What you need to know before using Levosimendan Altan").

If you use more Levosimendan Altan than you should

An overdose of Levosimendan Altan 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 (affect more than 1 in 10 people)

• Abnormally high heart rate.
• Headache.
• Low blood pressure.

Common (affect between 1 and 10 in 100 people)

• Potassium decrease in blood
• Insomnia
• Dizziness
• Abnormal heartbeat called atrial fibrillation (as a consequence of heart palpitations instead of proper heartbeat).
• Additional heartbeats
• Heart failure
• Decreased oxygen supply to the heart through the blood
• Nausea
• Constipation
• Diarrhea
• Vomiting.
• Decrease in hemoglobin

There have been reports of a heart rhythm disorder called ventricular fibrillation (as a consequence of heart palpitations instead of 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 Altan.

If you consider that any of the side effects you are suffering from is serious or if you notice any side effect not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you experience any side effects, talk to your doctor, even if it is possible side effects 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 Altan

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

Do not use Levosimendan Altan after the expiry date stated on the carton after "EXP". The expiry date is the last day of the month stated.

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

Do not freeze

After dilution

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

From a microbiological point of view, unless the method of opening/reconstitution/dilution precludes the risk of microbiological contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.

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

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 further information

Composition of Levosimendan Altan

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

Appearance of the product and pack contents

The concentrate is a clear yellow or orange solution for dilution before use, packaged in type I colorless glass vials with a chlorobutyl rubber stopper with a fluoropolymer coating and an aluminum flip-off cap.

Pack sizes:

1 vial of 5 ml

Marketing authorization holder and manufacturer

Altan Pharma Limited

The Lennox Building

50 South Richmond Street

Dublin 2

D02 FK02, Ireland

Local representative:

Altan Pharmaceuticals, S.A.

C/ Cólquide, Nº 6, Portal 2, 1ª Planta, Oficina F.

Edificio Prisma, Las Rozas, 28230 Madrid

Spain

Manufacturer

Altan Pharmaceuticals S.A.

Polígono Industrial de Bernedo,

s/n, Bernedo, 01118 Álava (Spain)

Altan Pharmaceuticals S.A.

Avda. de la Constitución, 198-199, Polígono Industrial Monte Boyal,

Casarrubios del Monte, 45950 Toledo (Spain)

Date of last revision of this leaflet:April 2025.

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:

Levosimendan Altan 2.5 mg/ml Concentrate for Solution for Infusion

Instructions for use and handling

Levosimendan Altan 2.5 mg/ml concentrate for solution for infusion is designed exclusively for single use. As with other parenteral products, the diluted solution should be inspected visually for particles and discoloration before administration.

Levosimendan Altan 2.5 mg/ml concentrate for solution for infusion should not be diluted to a concentration higher than 0.05 mg/ml as indicated below, otherwise opalescence and precipitation may occur.

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

Posology and method of administration

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

Levosimendan Altan should be diluted before administration.

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

Consult the summary of product characteristics for information on posology.