SIMDAX 2.5 mg/ml CONCENTRATE FOR INFUSION SOLUTION

Introduction

Package Leaflet: Information for the User

Simdax 2.5 mg/ml Concentrate for Solution for Infusion.

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.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

1. What is Simdax and what is it used for

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

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

Simdax 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 Simdax

Do not use Simdax

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

Warnings and precautions

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

Talk to your doctor before starting Simdax if you have any of the diseases or symptoms mentioned above.

Children and adolescents

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

Other medicines and Simdax

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

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or plan to become pregnant, consult your doctor before using this medicine. Your doctor will decide if the benefit outweighs any possible risk to the baby.

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

Simdax contains alcohol

This medicine contains 3925 mg of alcohol (anhydrous ethanol) in each 5 ml vial, which is equivalent to 98% v. The amount in a 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 and use machines because it can alter your judgment and reaction time.

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

The amount of alcohol in this medicine may alter the effect of other medicines. Consult your doctor or pharmacist before taking this medicine.

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

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 Simdax

Simdax must be administered by intravenous infusion. For this reason, it should only be administered in a hospital where your doctor can monitor you. Your doctor will decide the dose of Simdax to be administered. Your doctor will follow your response to treatment (e.g., by measuring your heart rate, blood pressure, electrocardiogram, and subjective sensations) and modify the dose if necessary. Your doctor may want to monitor you for 4-5 days after the end of the Simdax administration.

Treatment can be started with a rapid infusion for 10 minutes followed by a slow infusion for 24 hours.

Your doctor will assess your response to Simdax at different times. In this way, the infusion can be reduced if your blood pressure drops or your heart rate becomes too fast or you do not feel well. If you feel that your heart is racing, you feel dizzy or have the impression that the effect of Simdax is too strong or too weak, you should inform your doctor or nurse.

If your doctor considers that you need a higher dose of Simdax and you are not experiencing side effects, the infusion can be increased.

Your doctor will continue the Simdax infusion for as long as necessary to help your heart. It is usually recommended to infuse Simdax for 24 hours.

The effect on your heart function will continue for 24 hours after the infusion of the product has ended. The effect may continue for 7-10 days after the end of the infusion.

If you use more Simdax than you should

An overdose of Simdax 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(may affect 1 in 10 patients or more)

Abnormally high heart rate.

Headache.

Low blood pressure.

Common(may affect up to 1 in 10 patients)

Potassium levels in the blood decrease

Insomnia

Dizziness

Abnormal heartbeat called atrial fibrillation (as a consequence of heart palpitations instead of a proper heartbeat).

Extra heartbeats

Heart failure

Decreased oxygen supply to the heart through the blood

Nausea

Constipation

Diarrhea

Vomiting.

Decreased hemoglobin

There have been reports of a heart rhythm disorder called ventricular fibrillation (as a consequence of heart palpitations instead of a proper heartbeat) in patients who received Simdax.

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

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines Agency's website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Simdax

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

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

Do not freeze

Do not use Simdax after the expiry date which is stated on the carton after “EXP”. The expiry date is the last day of the month shown.

Simdax should be used within 24 hours after reconstitution.

6. Contents of the pack and further information

Composition of Simdax

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

Appearance and packaging of the product

The concentrate is a clear orange-yellow solution for dilution before use.

Pack sizes:

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

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Orion Corporation,

Orionintie 1

FI-02200 Espoo

Finland

Manufacturer

Orion Corporation

Orion Pharma

Orionintie 1

FI-02200 Espoo

Finland

Further information

You can obtain more information about this medicine by contacting the local representative of the marketing authorisation holder:

Local representative:

Orion Pharma SL

Telephone: +349 159 9 86 01

Date of last revision of this leaflet: April 2021.

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This information is intended only for healthcare professionals:

Simdax 2.5 mg/ml concentrate for solution for infusion

Instructions for use and handling

Simdax 2.5 mg/ml concentrate for solution for infusion is designed exclusively for single use.

Simdax 2.5 mg/ml concentrate for solution for infusion should not be diluted to concentrations higher than 0.05 mg/ml, as otherwise opalescence and precipitation may occur.

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

• To prepare the 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 the 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.

Posology and method of administration

Simdax is for hospital use only. It should be administered in a hospital unit where there are monitoring facilities and experience with the use of inotropic agents.

Simdax should be diluted before administration

The infusion should be administered exclusively by intravenous route, either by peripheral or central route.

Consult the summary of product characteristics for information on posology.

“Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/”