Simdax

PACKAGE LEAFLET: INFORMATION FOR THE USER

SIMDAX 2.5 mg/ml concentrate for solution for infusion

levosimendan
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet:

1. What Simdax is and what it is used for
2. What you need to know before using 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 concentrate medicine that must be diluted before being administered to you as an intravenous infusion.
Simdax works by increasing the heart's contractile force and promoting relaxation of the blood vessel walls.
Simdax will reduce congestion in your lungs and improve blood and oxygen delivery to your organs. Simdax will help relieve shortness of breath caused by severe heart failure.
Simdax is indicated for the treatment of heart failure in patients who still experience breathing difficulties despite taking medications that remove excess fluid from the body.

2. What you should know before using Simdax

Do not use Simdax

• If you are allergic (hypersensitive) to levosimendan or to any of the other excipients in Simdax
• If you have very low blood pressure or if you have abnormally fast heart rate
• If you have severe renal or hepatic impairment
• If you have a heart condition that impairs the heart's ability to fill and empty properly
• If your doctor has diagnosed you with an abnormal heart rhythm called torsades de pointes

Warnings and precautions

• If you have any liver or kidney disease
• If you also have low red blood cell count and chest pain
• If you have abnormally fast heart rate, abnormal heart rhythm, or if your doctor has told you that you have atrial fibrillation or abnormally low blood potassium levels, your doctor must administer Simdax with great caution.

If you have any of the above conditions or symptoms, speak with your doctor before starting treatment.

Children and adolescents
Simdax must not be administered to children and adolescents under 18 years of age.

Other medicines and Simdax
Inform your doctor if you are taking, have recently taken, or might take any other medicines, including those without a prescription.

If you have been given other intravenous heart medications, your blood pressure may drop further if Simdax is administered.

Special warning
For athletes, the use of medicinal products containing ethanol may lead to a positive doping test, depending on the blood alcohol concentration limits set by certain sports federations.

Pregnancy and breastfeeding
Ask your doctor for advice before starting treatment with Simdax if you are pregnant or think you might be pregnant. It is not known whether Simdax may affect your unborn child. Your doctor must assess whether the benefit to you outweighs the potential risks to your unborn child.

There is no information available on whether Simdax passes into breast milk. You must not breastfeed during treatment with Simdax to avoid potential cardiovascular adverse events in the newborn.

Simdax contains alcohol
This medicine contains 3.925 mg of alcohol (anhydrous ethanol) in each 5 ml vial, equivalent to approximately 98% of the volume. The amount of alcohol in one 5 ml vial of this medicine is equivalent to 99.2 ml of beer or 41.3 ml of wine.

The amount of alcohol in this medicine may affect your ability to drive or operate machinery, as it may impair your judgment and reaction speed.

If you have epilepsy or liver problems, consult your doctor or pharmacist before taking this medicine.

The alcohol content in this medicine may alter the effects of other medicines. Speak with your doctor or pharmacist if you are taking other medicines.

If you are pregnant or breastfeeding, talk to your doctor or pharmacist before taking this medicine.

If you are alcohol-dependent, speak with 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 Simdax

Simdax will be administered to you by intravenous infusion (intravenous drip). This is why Simdax must be given only in a hospital setting where your doctor can monitor you. Your doctor will decide how much Simdax you should receive. Your doctor will measure your response to Simdax (for example, by monitoring your heart rate, blood pressure, ECG, and by assessing how you feel). If necessary, your doctor may then adjust the dosage. Your doctor may wish to continue monitoring you for up to 4-5 days after Simdax has been discontinued.
Simdax may be given as a rapid infusion over ten minutes, followed by a slower infusion lasting up to 24 hours.
Your doctor must monitor your response to Simdax continuously. The infusion may be reduced if your blood pressure drops suddenly, or if your heart starts beating too fast, or if you feel unwell. Inform your doctor or nurse if you feel your heart beating too fast, if you feel dizzy, or if you think the effect of Simdax is too strong or too weak.
If your doctor determines that you need a higher dose of Simdax and you are not experiencing side effects, the infusion rate may be increased.
Your doctor will continue the Simdax infusion for as long as needed to support your heart. Usually, the infusion lasts 24 hours.
The effect on your heart function will continue for at least 24 hours after the Simdax infusion has ended. The effect may last for 7-9 days after the infusion is stopped.
If you have been given more Simdax than you should have received
If you have been given too much Simdax, your blood pressure may drop suddenly and your heart may beat faster. Your doctor will know how to treat you based on your condition.

4. Possible side effects

Like all medicines, Simdax can cause side effects, although not everyone gets them.
Very common (affects more than 1 in 10 patients)
Abnormally fast heartbeat
Headache
Drop in blood pressure
Common (affects up to 1 in 10 patients)
Low levels of potassium in the blood
Insomnia
Dizziness
Abnormal heartbeat called atrial fibrillation (a part of the heart moves rapidly and irregularly instead of beating properly)
Extrasystoles
Heart failure
Heart not receiving enough oxygen
Nausea
Constipation
Diarrhoea
Vomiting
Low blood cell count
An abnormal heartbeat called ventricular fibrillation (a part of the heart moves rapidly and irregularly instead of beating properly) has been reported in patients treated with Simdax.
Contact your doctor immediately if you experience any side effects. Your doctor may reduce the infusion rate of Simdax or stop it completely.
If any of the side effects worsen, or if you notice any side effects not listed in this leaflet, inform your doctor.
Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
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.
Store in a refrigerator (2°C-8°C).
Do not freeze.
Do not use Simdax after the expiry date stated on the carton.
Storage and duration of use after dilution must not exceed 24 hours.

6. Package contents and other information

What Simdax contains

• The active substance is levosimendan 2.5 mg/ml.
• The excipients are: povidone, citric acid and ethanol.

Description of the appearance of Simdax and contents of the pack
The concentrate is a yellow or orange transparent solution which must be diluted before
administration.
Pack sizes:

• 1, 4, 10 vials (type I glass) of 5 ml

It is possible that not all pack sizes are marketed.
Marketing Authorisation Holder
Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland
Local representative for sales: Orion Pharma S.r.l. - Milan
Manufacturer
Orion Corporation, Orion Pharma
Orionintie 1
FI-02200 Espoo
Finland
Other information
For any information regarding this medicinal product, please contact the Marketing Authorisation Holder.
The following information is intended for healthcare professionals only.
Simdax 2.5 mg/ml concentrate for solution for intravenous infusion

Instructions for use and handling of the medicinal product

Simdax 2.5 mg/ml concentrate for solution for infusion is for single use only. The 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.

As with all parenteral medicinal products, the diluted solution should be visually inspected before administration for the presence of particles and discoloration.
Simdax must be diluted prior to administration as follows:

• To prepare an infusion of 0.025 mg/ml, mix 5 ml of Simdax 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 Simdax 2.5 mg/ml concentrate for solution for infusion with 500 ml of 5% glucose solution.

Dosage and method of administration
Simdax is intended for hospital use only. It must be administered in a hospital setting where adequate monitoring equipment and expertise in the use of inotropic agents are available.
Simdax must be diluted before administration.
The infusion is for intravenous use only and may be administered via either peripheral or central route.
For dosage, refer to the Summary of Product Characteristics.