Levosimendan Altan 2.5 mg/ml concentrate for infusion solution EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Levosimendán Altan 2.5 mg/ml concentrate for solution for infusion EFG

Levosimendan

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

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor.
• This medicine has been prescribed for you only, and you should not give it to other people even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of this leaflet

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

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

Levosimendán Altan is available as a concentrate that must be diluted before administration as an intravenous infusion.

Levosimendán Altan works by increasing the heart's pumping strength and promoting relaxation of the blood vessels. Levosimendán reduces pulmonary congestion and improves blood and oxygen circulation throughout the body. Levosimendán Altan helps alleviate the breathing difficulties associated with severe heart failure.

Levosimendán is indicated for the treatment of heart failure in patients who continue to experience shortness of breath despite receiving other medications to remove fluid from the body.

2. What you need to know before using Levosimendán Altan

Do not use Levosimendán Altan

• If you are allergic (hypersensitive) to levosimendan or to any of the other components of this medicine (see section 6)
• If you have very low blood pressure or abnormally fast heart rate (tachycardia)
• If you have severe kidney or liver damage
• If you have any heart disease that impairs the filling and emptying of the heart
• If your doctor has told you that you have had an arrhythmia called Torsades de Pointes

Take special care with Levosimendán Altan

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

Consult your doctor before starting treatment with Levosimendán Altan if you have any of the above-mentioned conditions or symptoms.

Levosimendán Altan must not be administered to children and adolescents under 18 years of age.

Other medicines and Levosimendán Altan

Inform 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 cardiac medications, administration of Levosimendán 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 Levosimendán Altan on the child are unknown.

There is evidence that Levosimendán Altan passes into human milk. You must not breastfeed while being treated with Levosimendán Altan to avoid potential cardiovascular adverse effects in the child.

Levosimendán 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 or 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 operate machinery, as it may alter your judgment and reaction capacity.

If you are alcohol-dependent, 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 Levosimendán Altan

Levosimendán Altan is intended for hospital use only. It must be administered in a hospital setting where appropriate monitoring facilities and expertise in the use of inotropic agents are available.

Levosimendán Altan should be administered by intravenous infusion (drip).

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

Treatment is usually initiated with a rapid infusion (loading dose of 6–12 micrograms/kg) over 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 Levosimendán Altan to administer and will continuously monitor your response to treatment (for example, by measuring your heart rate, blood pressure, electrocardiogram, and your subjective sensations), adjusting the dose if necessary.

Inform your doctor or nurse if you feel your heart racing, feel dizzy, or if you think the effect of Levosimendán Altan is too strong or too weak. The doctor may reduce your infusion rate if your blood pressure drops, if your heart begins to beat too fast, or if you feel unwell.

If your doctor considers that you require a higher dose of Levosimendán Altan and you are not experiencing side effects, the infusion rate may be increased.

Your doctor will continue the Levosimendán Altan infusion for as long as deemed necessary to support your heart function. Typically, a 24-hour infusion of Levosimendán Altan is recommended.

The effect on your cardiac function will last for at least 24 hours after the Levosimendán Altan infusion is stopped. The effect may persist for 7–10 days after the end of the infusion. For this reason, you should only receive Levosimendán Altan in a hospital where your doctor can monitor you for a period of up to 4–5 days after the infusion ends.

Renal impairment

Levosimendán Altan should be used with caution in patients with mild to moderate renal impairment. Levosimendán Altan must not be used in patients with severe renal impairment (creatinine clearance <30 ml/min) (see section 2, “What you need to know before using Levosimendán Altan”).

Hepatic impairment

Levosimendán Altan should be used with caution in patients with mild to moderate hepatic impairment, although dose adjustment does not appear to be necessary in these patients. Levosimendán Altan must not be administered to patients with severe hepatic impairment (see section 2, “What you need to know before using Levosimendán Altan”).

If you use more Levosimendán Altan than you should

An overdose of Levosimendán Altan will cause a drop in blood pressure and an increased heart rate. Your doctor will know how to treat this based on your medical history.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Very common (affects more than 1 in 10 people)

• Abnormally high heart rate.
• Headache.
• Hypotension.

Common (affects between 1 and 10 in every 100 people)

• Decreased potassium levels in blood
• Insomnia
• Dizziness
• Abnormal heart rhythm called atrial fibrillation (caused by irregular heart palpitations instead of a regular heartbeat).
• Extra heartbeats
• Heart failure
• Reduced supply of oxygen to the heart via the blood
• Nausea
• Constipation
• Diarrhea
• Vomiting.
• Decreased hemoglobin

Frequency not known (cannot be estimated from the available data)

• Hypersensitivity (symptoms may include rash and itching).

Cases of a disturbance in heart rhythm called ventricular fibrillation (caused by irregular heart palpitations instead of a regular heartbeat) have been reported in patients who received levosimendan.

Please inform your doctor immediately if you experience any side effects. Your doctor may reduce or stop the Levosimendán Altan infusion.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse 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 which is stated on the packaging after "EXP". The expiry date refers to the last day of the indicated month.

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

Do not freeze.

After dilution

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

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

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

Medicines should not be disposed of via wastewater. Ask your pharmacist how to properly dispose of any unused medicines and their packaging. This will help protect the environment.

6. Contents of the container and additional information

Composition of Levosimendán Altan

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

Appearance of the medicinal product and contents of the container

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

Pack sizes:

1 vial of 5 ml

Marketing Authorization Holder and Manufacturer

Altan Pharmaceuticals, S.A.

C/ Cólquide, No. 6, Portal 2, 1st Floor, Office F.

Edificio Prisma, Las Rozas, 28230 Madrid

Spain

Manufacturer Responsible

Altan Pharmaceuticals S.A.

Industrial Estate of Bernedo,

s/n, Bernedo, 01118 Álava (Spain)

Altan Pharmaceuticals S.A.

Avenida de la Constitución, 198-199, Polígono Industrial Monte Boyal,

Casarrubios del Monte, 45950 Toledo (Spain)

Date of latest review of this leaflet: 09/2025.

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

<------------------------------------------------------------------------------------------------------------------------>

This information is intended for healthcare professionals only:

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 intended for single use only. As with other parenteral products, the diluted solution should be inspected visually for particles and discoloration prior to administration.

Levosimendan Altan 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 an 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 an 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.

Dosage and method of administration

Levosimendan Altan is for hospital use only. It must be administered in a hospital unit equipped with monitoring facilities and experienced in the use of inotropic agents.

Levosimendan Altan must be diluted prior to administration.

The infusion must be administered exclusively by intravenous route, either via peripheral or central venous access.

Refer to the Summary of Product Characteristics for dosage information.