Levosimendan Altan

Package Leaflet: Information for the User

Levosimendan Altan 2.5 mg/ml, Concentrate for Solution for Infusion

Levosimendan

Read the Package Leaflet Carefully Before Using the Medicinal Product, as it Contains Important Information for the Patient.

• Keep this Package Leaflet, You May Need to Read it Again.
• If You Have any Further Questions, Ask Your Doctor or Nurse.
• If You Experience any Side Effects, Tell Your Doctor or Nurse. See Section 4.

Table of Contents of the Package Leaflet

• 1. What is Levosimendan Altan and What is it Used for
• 2. Important Information Before Using Levosimendan Altan
• 3. How to Use Levosimendan Altan
• 4. Possible Side Effects
• 5. How to Store Levosimendan Altan
• 6. Contents of the Pack and Other Information

1. What is Levosimendan Altan and What is it Used for

Levosimendan Altan is a Concentrate that Must be Diluted Before Intravenous Infusion.
Levosimendan Altan Increases the Force with Which the Heart Pumps Blood and Allows the Blood Vessels to Relax. This Leads to a Reduction in Congestion in the Lungs and Facilitates Blood and Oxygen Flow in the Body. Levosimendan Altan Helps to Relieve Shortness of Breath Caused by Severe Heart Failure.
Levosimendan Altan is Used for the Short-Term Treatment of Acute Episodes of Decompensated Severe Chronic Heart Failure in Adult Patients Who Continue to Experience Breathing Difficulties Despite Receiving Other Medicines that Remove Excess Fluid from the Body.

2. Important Information Before Using Levosimendan Altan

When Not to Use Levosimendan Altan:

• If the Patient is Hypersensitive (Allergic) to Levosimendan or Any of the Other Ingredients of this Medicinal Product (Listed in Section 6);
• If the Patient has Very Low Blood Pressure and a Rapid Heart Rate (Tachycardia);
• If the Patient has Severe Kidney or Liver Disease;
• If the Patient has Heart Disease that Makes it Difficult for the Heart to Fill or Empty;
• If the Patient has Been Informed by a Doctor that They Have an Abnormal Heart Rhythm Called Torsades de Pointes.

Warnings and Precautions

• If the Patient has Any Kidney or Liver Disease;
• If the Patient has a Low Number of Red Blood Cells (Anemia) and Chest Pain;
• If the Patient has a Rapid Heart Rate (Tachycardia), Abnormal Heart Rhythm, or Has Been Informed by a Doctor that They Have Atrial Fibrillation; Page 1 6
• If the Patient has Low Blood Pressure;
• If the Patient has Been Informed by a Doctor that They Have Low Potassium Levels in the Blood; Levosimendan Altan Should be Used with Caution.

If the Patient has Any of the Above Conditions or Symptoms, They Should Discuss this with Their Doctor Before Starting Treatment with Levosimendan Altan.

Children and Adolescents

Levosimendan Altan Should Not be Given to Children and Adolescents Under 18 Years of Age.

Levosimendan Altan and Other Medicinal Products

The Patient Should Tell Their Doctor About All Medicines They are Currently Taking or Have Recently Taken, as Well as Any Medicines They Plan to Take.
If the Patient is Taking Other Intravenous Heart Medicines, the Use of Levosimendan Altan May Cause a Drop in Blood Pressure.

Pregnancy and Breast-Feeding

If the Patient is Pregnant or Breast-Feeding, Thinks They May be Pregnant or is Planning to Have a Baby, They Should Consult Their Doctor Before Using this Medicinal Product. It is Not Known if the Use of Levosimendan Altan Affects the Unborn Baby.
There is Evidence that Levosimendan Altan Passes into Human Milk, Therefore, Breast-Feeding Should be Avoided During Treatment with Levosimendan Altan to Prevent Potential Side Effects on the Cardiovascular System in Infants.

Levosimendan Altan Contains Alcohol

This Medicinal Product Contains 98% v/v Ethanol (Alcohol), Which is Up to 3,925 mg per 5 ml in the Vial, Equivalent to 99.2 ml of Beer or 41.3 ml of Wine per 5 ml Vial.
Harmful for Individuals with Alcohol Dependence.
The Alcohol Content Should be Taken into Account in Pregnant or Breast-Feeding Women, Children, and Patients with High-Risk Groups, Such as Patients with Liver Disease or Epilepsy. The Alcohol in the Medicinal Product May Affect the Action of Other Medicines.

3. How to Use Levosimendan Altan

Levosimendan Altan is Intended for Use in a Hospital Setting Only. The Medicinal Product Should be Administered in a Hospital Setting Where Appropriate Monitoring Equipment and Specialist Knowledge in the Use of Inotropic Agents are Available.
Levosimendan Altan Will be Administered as an Intravenous Infusion.
The Dose and Duration of Treatment Will be Adjusted According to the Individual Patient's Clinical Condition and Response to Treatment.
Usually, the Medicinal Product is Administered to the Patient as a Rapid Infusion (Loading Dose 6 to 12 Micrograms/kg) Over 10 Minutes, Followed by a Slower Intravenous Infusion (Continuous Infusion 0.1 Micrograms/kg/min) for Up to 24 Hours.
At Regular Intervals, the Doctor Will Assess the Patient's Response to Levosimendan Altan (e.g., by Measuring Heart Rate or Blood Pressure, Performing an ECG, and/or Asking About the Patient's Well-Being) and Adjust the Dose if Necessary.
The Patient Should Tell Their Doctor or Nurse if They Experience a Feeling of a Racing Heart, Dizziness, or if the Action of Levosimendan Altan Seems Too Strong or Too Weak. The Doctor May Reduce the Infusion Rate if the Patient Experiences a Drop in Blood Pressure, Rapid Heart Rate, or Poor Well-Being.
If the Doctor Considers that a Higher Dose of Levosimendan Altan is Necessary and the Patient is Not Experiencing any Side Effects, the Doctor May Increase the Infusion Rate.
The Doctor Will Continue the Infusion of Levosimendan Altan for as Long as Support for the Heart is Necessary. This is Usually 24 Hours.
The Action of Levosimendan Altan on the Heart Lasts for at Least 24 Hours After the End of the Infusion. The Medicinal Product May Continue to Act for Up to 9 Days After the End of the Infusion. Therefore, Levosimendan Altan Should Only be Used in a Hospital Setting Where the Doctor Can Monitor the Patient's Condition for 4-5 Days After the End of the Infusion.
Kidney Function Disorders
Caution Should be Exercised When Using Levosimendan Altan in Patients with Mild or Moderate Kidney Function Disorders. The Medicinal Product Should Not be Used in Patients with Severe Kidney Function Disorders (Creatinine Clearance <30 ml min) (see section 2. important information before using levosimendan altan).
Liver Function Disorders
Caution Should be Exercised When Using Levosimendan Altan in Patients with Mild or Moderate Liver Function Disorders, Although No Dose Adjustment is Necessary for These Patients. The Medicinal Product Should Not be Used in Patients with Severe Liver Function Disorders (See Section 2. Important Information Before Using Levosimendan Altan).

Overdose of Levosimendan Altan

If the Patient Receives Too Much Levosimendan Altan, They May Experience a Drop in Blood Pressure and a Rapid Heart Rate. The Doctor Will Provide Appropriate Treatment Based on the Patient's Condition.

4. Possible Side Effects

Like All Medicines, Levosimendan Altan Can Cause Side Effects, Although Not Everybody Gets Them.
Very Common (Affects More Than 1 in 10 People):

• Abnormally Fast Heart Rate
• Headache
• Drop in Blood Pressure

Common (Affects Up to 1 in 10 People):

• Low Potassium Levels in the Blood
• Insomnia
• Dizziness
• Abnormal Heart Rhythm, Called Atrial Fibrillation (Part of the Heart Quivers Instead of Beating Properly)
• Extra Heartbeats
• Heart Failure
• Myocardial Ischemia
• Nausea
• Constipation
• Diarrhea
• Vomiting
• Low Number of Red Blood Cells

In Patients Receiving Levosimendan Altan, Abnormal Heart Rhythms, Called Ventricular Fibrillation (Part of the Heart Quivers Instead of Beating Properly), Have Been Reported.
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If Side Effects Occur, the Patient Should Inform Their Doctor or Nurse Immediately. The Doctor May Reduce the Infusion Rate or Stop the Infusion of Levosimendan Altan.

Reporting Side Effects

If the Patient Experiences any Side Effects, Including Those Not Listed in this Package Leaflet, They Should Inform Their Doctor or Nurse. Side Effects Can be Reported Directly to the Department of Pharmacovigilance of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl.
Side Effects Can Also be Reported to the Marketing Authorization Holder.
By Reporting Side Effects, More Information Can be Gathered on the Safety of the Medicinal Product.

5. How to Store Levosimendan Altan

The Medicinal Product Should be Stored Out of Sight and Reach of Children.
Do Not Use this Medicinal Product After the Expiration Date Stated on the Vial or Carton.
The Expiration Date Refers to the Last Day of the Month Stated.
Store in a Refrigerator (2°C - 8°C). Do Not Freeze.
After Dilution
Chemical and Physical Stability of the Prepared Solution has Been Demonstrated for 24 Hours at 25°C.
From a Microbiological Point of View, Unless the Method of Opening, Reconstitution or Dilution Precludes the Risk of Microbial Contamination, the Product Should be Used Immediately. If the Product is Not Used Immediately, the Responsibility for the Storage Conditions and Duration Before Use Lies with the User.
As with All Parenteral Medicinal Products, the Prepared Solution Should be Inspected Visually for Particulate Matter and Discoloration Before Administration.
Medicines Should Not be Disposed of via Wastewater or Household Waste. The Patient Should Ask Their Pharmacist How to Dispose of Medicines No Longer Required. This Will Help Protect the Environment.

6. Contents of the Pack and Other Information

What Levosimendan Altan Contains

• The Active Substance is Levosimendan 2.5 mg/ml. Each ml of Concentrate Contains 2.5 mg of Levosimendan.
• The Other Ingredients are: Povidone, Citric Acid, and Ethanol

What Levosimendan Altan Looks Like and Contents of the Pack

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The Concentrate is a Clear, Yellow to Orange Solution, for Dilution Prior to Administration, Packaged in Colorless Glass Type I Vials with a Rubber Stopper and an Aluminum Cap.
Pack Sizes: 1 Vial (Glass Type I) of 5 ml, in a Cardboard Box.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Altan Pharma Ltd.
The Lennox Building
50 South Richmond Street
Dublin 2, D02 FK02
Ireland

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

This Medicinal Product is Authorized in the Member States of the European Economic Area Under the Following Names:

Austria:Levosimendan Altan 2.5 mg/ml Konzentrat zur Herstellung einer Infusionslösung
Belgium:Levosimendan Altan 2.5 mg/ml solution à diluer pour perfusion
Spain:Levosimendan Altan 2.5 mg/ml concentrado para solución para perfusión EFG
France:Levosimendan Altan 2.5 mg/ml solution à diluer pour perfusion
Germany:Levosimendan Altan 2.5 mg/ml Konzentrat zur Herstellung einer Infusionslösung
Poland:Levosimendan Altan 2.5 mg/ml koncentrat do sporządzania roztworu do infuzji
Portugal:Levosimendan Altan 2.5 mg/ml concentrado para solução para infusão
Italy:Levosimendan Altan
Finland:Levosimendan Altan 2.5 mg/ml infuusiokonsentraatti, liuosta varten
Norway:Levosimendan Altan 2.5 mg/ml konsentrat for infusjonsvæske, oppløsning
Sweden:Levosimendan Altan 2.5 mg/ml koncentrat till infusionsvätska, lösning

Date of Last Revision of the Package Leaflet: 10/2022

Information 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 All Parenteral Medicinal Products, the Diluted Solution Should be Inspected Visually for Particulate Matter 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, According to the Instructions Below, Otherwise Opalescence and Precipitation May Occur.
To Prepare an Infusion Solution of 0.025 mg/ml, 5 ml of Levosimendan Altan 2.5 mg/ml Concentrate for Solution for Infusion Should be Mixed with 500 ml of 5% Glucose Solution.
To Prepare an Infusion Solution of 0.05 mg/ml, 10 ml of Levosimendan Altan 2.5 mg/ml Concentrate for Solution for Infusion Should be Mixed with 500 ml of 5% Glucose Solution.
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Dosage and Administration

Levosimendan Altan is Intended for Use in a Hospital Setting Only. The Medicinal Product Should be Administered in a Hospital Setting Where Appropriate Monitoring Equipment and Specialist Knowledge in the Use of Inotropic Agents are Available.
Levosimendan Altan Should be Diluted Before Administration.
The Solution is Intended for Intravenous Infusion Only and May be Administered Peripherally or Centrally.
For Information on Dosage, Refer to the Summary of Product Characteristics.
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