Simdax

Package Leaflet: Information for the User

Simdax, 2.5 mg/mL, Concentrate for Solution for Infusion

Levosimendan

Read All of This Leaflet Carefully Before Using This Medicine.

• Keep This Leaflet. You May Need to Read It Again.
• If You Have Any Further Questions, Ask Your Doctor or Nurse.
• If You Get Any Side Effects, Talk to Your Doctor or Nurse. See Section 4.

Table of Contents of the Leaflet

• 1. What Simdax Is and What It Is Used For
• 2. Important Information Before You Use Simdax
• 3. How to Use Simdax
• 4. Possible Side Effects
• 5. How to Store Simdax
• 6. Contents of the Pack and Other Information

1. What Simdax Is and What It Is Used For

Simdax Is a Medicine That Must Be Diluted Before Intravenous Infusion.
Simdax Increases the Force with Which the Heart Pumps Blood and Allows Blood Vessels to Relax.
This Reduces Congestion in the Lungs and Improves Blood and Oxygen Flow in the Body. It Helps
Relieve Shortness of Breath Caused by Severe Heart Failure.
Simdax Is Used as Additional, Short-Term Treatment for Acute Episodes of Decompensated Severe
Chronic Heart Failure in Adult Patients Who Still Have Difficulty Breathing Despite Taking Other
Medicines to Remove Excess Fluid from the Body.

2. Important Information Before You Use Simdax

When Not to Use Simdax:

• If You Are Allergic to Levosimendan or Any of the Other Ingredients of This Medicine (Listed in Section 6);
• If You Have Very Low Blood Pressure and a Fast Heart Rate;
• If You Have Heart Disease That Makes It Difficult for the Heart to Fill or Empty;
• If You Have Severe Kidney Disease;
• If You Have Severe Liver Disease;
• If You Have Ever Been Told by a Doctor That You Have an Abnormal Heart Rhythm Called Torsades de Pointes.

Warnings and Precautions

• If You Have Low Blood Pressure;
• If You Have Decreased Blood Volume (Hypovolemia);
• If You Have Any Kidney or Liver Disease;
• If You Have Ever Been Told by a Doctor That You Have Low Potassium Levels in Your Blood;
• If You Have a Low Number of Red Blood Cells (Anemia) and Chest Pain;
• If You Have a Fast Heart Rate, Abnormal Heart Rhythm, or Have Been Told by a Doctor That You Have Atrial Fibrillation; Simdax Should Be Used with Caution.

If You Have Any of These Conditions or Symptoms, You Should Discuss Them with Your Doctor or Nurse Before Starting Simdax.

Children and Adolescents

The Safety and Efficacy of Simdax in Children and Adolescents Below 18 Years of Age Have Not Been Established.

Simdax and Other Medicines

Tell Your Doctor About All Medicines You Are Taking or Have Recently Taken, as Well as Any Medicines You Plan to Take.
If You Are Taking Other Intravenous Heart Medicines, Using Simdax May Cause a Drop in Blood Pressure.

Pregnancy and Breast-Feeding

If You Are Pregnant or Breast-Feeding, Think You May Be Pregnant, or Are Planning to Have a Baby, Ask Your Doctor for Advice Before Taking This Medicine. It Is Not Known Whether Simdax Affects the Unborn Child. Animal Studies Have Shown Some Harmful Effects on Reproduction. Therefore, Simdax Should Not Be Used During Pregnancy or in Women Who May Become Pregnant and Are Not Using Contraception.
It Has Been Shown That Simdax Passes into Human Milk. You Should Not Breast-Feed While Taking Simdax to Avoid Any Possible Effect on the Baby's Heart and Blood Vessels.

Simdax Contains Alcohol

This Medicine Contains 3925 Mg of Alcohol (Anhydrous Ethanol) in Each 5 Ml Vial, Which Is Equivalent to 98% V/V Alcohol. This Amount of Alcohol May Affect Your Ability to Drive or Use Machines, as It May Affect Your Judgment and Reaction Time.
If You Have Epilepsy or Liver Problems, You Should Consult Your Doctor or Pharmacist Before Taking Simdax.
The Amount of Alcohol in This Medicine May Change the Effect of Other Medicines. If You Are Taking Other Medicines, You Should Consult Your Doctor or Pharmacist.
If You Are Pregnant or Breast-Feeding, You Should Consult Your Doctor or Pharmacist Before Taking Simdax.
If You Are Alcohol-Dependent, You Should Consult Your Doctor or Pharmacist Before Taking Simdax.
Since This Medicine Is Usually Given Slowly Over More Than 24 Hours, the Effect of Alcohol May Be Reduced.

3. How to Use Simdax

Simdax Is for Hospital Use Only. The Medicine Should Be Given in a Hospital Setting Where Appropriate Monitoring Equipment and Specialist Knowledge of Inotropic Medicines Are Available.
Simdax Will Be Given to You as an Intravenous Infusion (Drip).
The Dose and Duration of Treatment Will Be Adjusted According to Your Individual Clinical Condition and Response to Treatment.
Usually, the Medicine Is Given as a Rapid Infusion (Loading Dose of 6 to 12 Micrograms/Kg) Over 10 Minutes. Then, You Will Receive a Slower Intravenous Infusion (Continuous Infusion of 0.1 Micrograms/Kg/Min) for Up to 24 Hours. Your Doctor Will Determine the Appropriate Dose of Simdax Based on Your Body Weight and Kidney and Liver Function.
From Time to Time, Your Doctor Will Assess Your Response to Simdax (for Example, by Measuring Your Pulse or Blood Pressure, Performing an ECG, and/or Asking About Your Well-Being) and Adjust the Dose as Needed.
Tell Your Doctor or Nurse If You Experience a Feeling of a Racing Heart, Dizziness, or If It Seems That the Effect of Simdax Is Too Strong or Too Weak. If You Experience a Drop in Blood Pressure, a Faster Heart Rate, or Feel Unwell, Your Doctor May Reduce the Infusion Rate.
Your Doctor May Increase the Infusion Rate If They Consider That a Higher Dose of Simdax Is Needed and You Are Not Experiencing Any Side Effects.
Your Doctor Will Continue the Simdax Infusion for as Long as Heart Support Is Needed. This Is Usually for 24 Hours.
The Effect of Simdax on the Heart Lasts for at Least 24 Hours After the End of the Infusion. The Medicine May Still Be Active for Up to 9 Days After the End of the Infusion. Therefore, Simdax Should Only Be Used in a Hospital Setting Where Your Doctor Can Monitor Your Condition for 4-5 Days After the End of the Infusion.
Kidney Problems
Caution Should Be Exercised When Using Simdax in Patients with Mild or Moderate Kidney Problems. The Medicine Should Not Be Used in Patients with Severe Kidney Problems (Creatinine Clearance <30 ml min) (see section 2. important information before using simdax).
Liver Problems
Caution Should Be Exercised When Using Simdax in Patients with Mild or Moderate Liver Problems, Although No Dose Adjustment Is Needed in These Patients. The Medicine Should Not Be Used in Patients with Severe Liver Problems (See Section 2. Important Information Before Using Simdax).

Overdose of Simdax

If You Receive Too Much Simdax, You May Experience a Drop in Blood Pressure and a Faster Heart Rate. Your Doctor Will Provide Appropriate Treatment Based on Your Condition.
If You Have Any Further Questions on the Use of This Medicine, Ask Your Doctor or Nurse.

4. Possible Side Effects

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

• Abnormally Fast Heart Rate
• Headache
• Decreased Blood Pressure

Common (Affects Up to 1 in 10 People):

• Low Potassium Levels in the Blood
• Insomnia
• Dizziness
• Abnormal Heart Rhythms, 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 Simdax, Abnormal Heart Rhythms, Called Ventricular Tachycardia (Part of the Heart Quivers Instead of Beating Properly), Have Been Observed.
If You Experience Any Side Effects, Tell Your Doctor or Nurse Immediately. Your Doctor May Reduce the Infusion Rate or Stop the Simdax Infusion.

Reporting Side Effects

If You Experience Any Side Effects, Including Any Not Listed in This Leaflet, Tell Your Doctor or Nurse. You Can Also Report Side Effects Directly to the Department of Medicinal Product Monitoring, 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
You Can Also Report Side Effects to the Marketing Authorization Holder.
By Reporting Side Effects, You Can Help Provide More Information on the Safety of This Medicine.

5. How to Store Simdax

Keep This Medicine Out of the Sight and Reach of Children.
Do Not Use This Medicine After the Expiry Date Stated on the Vial or Carton.
The Expiry Date Refers to the Last Day of the Month Stated.
Store in a Refrigerator (2°C - 8°C). Do Not Freeze.
During Storage, the Concentrate May Change Color to Orange, but It Does Not Lose Its Potency and Can Still Be Used Until the Expiry Date, Provided the Storage Conditions Have Been Observed.
After Dilution
Chemical and Physical Stability Has Been Demonstrated for 24 Hours at 25°C and for 24 Hours at 2°C to 8°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 User Is Responsible for the Storage Conditions Prior to Use.
As with All Parenteral Medicines, the Prepared Solution Should Be Inspected Visually for Particulate Matter and Discoloration Prior to 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 Other Information

What Simdax 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, Anhydrous Citric Acid, and Anhydrous Ethanol.

What Simdax Looks Like and Contents of the Pack

The Concentrate Is a Clear, Yellow to Orange Solution, for Dilution Prior to Administration.

• 1 Vial (Colorless Glass Type I) of 5 Ml, in a Carton

Marketing Authorization Holder

Orion Corporation
Orionintie 1
Fi-02200 Espoo
Finland

Manufacturer

Orion Corporation, Orion Pharma
Orionintie 1
Fi-02200 Espoo
Finland
To Obtain More Detailed Information on This Medicine, Please Consult the Local Representative of the Marketing Authorization Holder:
Orion Pharma Poland Sp. z o. o.
[email protected]

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

Austria, France: Zimino
Denmark, Belgium, Estonia, Poland: Simdax
Date of Last Revision of the Leaflet:27.02.2022

Information Intended for Healthcare Professionals Only:

Instructions for Use and Handling

Simdax 2.5 Mg/Ml, Concentrate for Solution for Infusion Is for Single Use Only.
Simdax Should Not Be Diluted to a Concentration Greater Than 0.05 Mg/Ml, as Specified in the Instructions Below, Otherwise Opalescence and Precipitation May Occur.
As with All Parenteral Medicines, the Prepared Solution Should Be Inspected Visually for Particulate Matter and Discoloration Prior to Administration.

• To Prepare an Infusion Solution of 0.025 Mg/Ml, 5 Ml of Simdax 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 Simdax Concentrate for Solution for Infusion Should Be Mixed with 500 Ml of 5% Glucose Solution.

Dosage and Administration

Simdax Is for Hospital Use Only. The Medicine Should Be Given in a Hospital Setting Where Appropriate Monitoring Equipment and Specialist Knowledge of Inotropic Medicines Are Available.
Simdax Should Be Diluted Before Administration.
The Solution Is for Intravenous Infusion Only and May Be Administered Peripherally or Centrally.
For Information on Dosage, Refer to the Summary of Product Characteristics.