SIMDAX 2.5 mg/ml Koncentrat do roztworu infuzyjnego

Treść ulotki

1. SIMDAX 2,5 mg/ml concentrate for solution for infusion
   1. What is Simdax and what is it 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
2. Simdax 2.5 mg/ml concentrate for solution for infusion must not be diluted to a

SIMDAX 2,5 mg/ml concentrate for solution for infusion

levosimendan

Read this leaflet carefully before you start using this medicineas it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor.
• If any side effects occur, 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 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 is Simdax and what is it used for

Simdax is a medicine in concentrated form, which must be diluted before being administered to you
by intravenous infusion.
Simdax works by increasing the force of cardiac contraction and allows the relaxation of the walls of the
blood vessels.
Simdax will reduce congestion in your lungs and facilitate the supply of blood and oxygen to the
organs. Simdax will help you relieve shortness of breath caused by severe heart failure.
Simdax is indicated in the treatment of cardiac decompensation in people who still have
difficulty breathing, despite taking medications that eliminate excess body fluids.

2. What you need to know before using Simdax

Do not use Simdax

• If you are allergic (hypersensitive) to levosimendan or any of the other ingredients of Simdax
• If you have very low blood pressure or if you have a fast heartbeat abnormally.
• If you suffer from severe kidney or liver failure.
• If you have a heart condition that prevents the filling and emptying of the heart.
• If your doctor has told you that you have had an abnormal arrhythmia called torsade de pointes.

Warnings and precautions

• If you suffer from any liver or kidney disease.
• If you have a low red blood cell count and chest pain.
• If you have a fast heartbeat abnormally, if you have an abnormal heart rhythm or if your doctor has told you that you suffer from atrial fibrillation or that you have an abnormally low blood potassium level, your doctor must administer Simdax with great care.

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

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

Other medicines and Simdax
Tell your doctor if you are taking, have recently taken or might take any
other medicines, including those available without a prescription.
If you have been given other medicines for the heart intravenously, your blood
pressure may drop if you are given Simdax.

Special warnings
For those who engage in sporting activities, the use of medicines containing ethyl alcohol may determine
positive doping tests in relation to the alcohol concentration limits indicated by some
sports federations.

Pregnancy and breastfeeding
Ask your doctor for advice before starting treatment with Simdax if you are pregnant or think you might be.
It is not known whether Simdax may have an effect on your child. Your
doctor must assess whether the benefit to you outweighs the potential risks to your child.
There is information on the passage of Simdax into breast milk. You should not breastfeed during
treatment with Simdax to avoid potential adverse cardiovascular events in the newborn.

Simdax contains alcohol
This medicine contains 3.925 mg of alcohol (anhydrous ethanol) in each 5 ml vial, which
is equivalent to approximately 98% of the volume. The amount of alcohol 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 contained in this medicine may affect your ability to drive or operate
machinery. This is because it may affect your judgment and reaction speed.
If you suffer from epilepsy or have liver problems, consult your doctor or pharmacist before taking
this medicine.
The amount of alcohol present in this medicine may alter the effects of other medicines. Talk to
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 dependent on alcohol, talk to 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 (drip). This is why Simdax must
be administered only in hospital where the doctor can monitor you. The doctor will decide how much
Simdax you need to be administered. Your doctor will measure your response to Simdax (for
example by measuring your heart rate, blood pressure, ECG, and will assess how you
feel). If necessary, your doctor may then adjust the dosage. The doctor may want to
monitor you for up to 4-5 days after stopping Simdax.
Simdax can be administered as a fast infusion in ten minutes, followed by
a slower infusion for up to 24 hours.
Your doctor must check how you are responding to Simdax moment by moment. They may reduce
your infusion if your blood pressure drops suddenly or if your heart starts to
beat too fast or if you do not feel well. Tell your doctor or
nurse if you feel your heart beating too fast, if you feel dizzy or if you feel that
the effect of Simdax is too strong or too weak.
If your doctor understands that you need a higher dose of Simdax and you are not experiencing
side effects, they may increase your infusion.
Your doctor will continue the Simdax infusion as long as it is necessary to support your heart. Usually the infusion lasts 24 hours.
The effect on your cardiac function will continue for at least 24 hours after the
Simdax infusion has ended. The effect may continue for 7-9 days after the end of the infusion.

If you have been given too much Simdax
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 everybody gets them.
Very common (affects more than 1 in 10 people)
Abnormally fast heartbeat
Headache
Low blood pressure.
Common (affects up to 1 in 10 people)
Low levels of potassium in the blood
Insomnia
Dizziness
Abnormal heartbeat called atrial fibrillation (a part of the heart moves quickly and irregularly instead of
beating properly)
Extra heartbeats
Heart failure
The heart does not receive enough oxygen
Nausea
Constipation
Diarrhoea
Vomiting
Low blood cell count
In patients who have taken Simdax, abnormal heartbeat called ventricular fibrillation (a part of the
heart moves quickly and irregularly instead of beating properly) has been reported.
Tell your doctor immediately if you experience side effects. Your doctor may reduce the speed of
Simdax infusion or stop it completely.
If any of these side effects gets worse or if you notice any side effect not listed here,
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can
also report side effects directly through the national reporting system 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 which is stated on the pack.
The storage and time in use after dilution must never exceed 24 hours.

6. Contents of the pack and other information

What Simdax contains

• The active ingredient 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 transparent solution of yellow or orange colour to be diluted before
administration.

Pack sizes:

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

Not all pack sizes may be marketed.

Marketing Authorisation Holder
Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland
Distributor 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 medicine, contact the Marketing Authorisation
Holder.
The following information is intended only for doctors and healthcare professionals.

Simdax2.5 mg/ml concentrate for solution for intravenous infusion
Instructions for use and handling of the medicine
Simdax 2.5 mg/ml concentrate for solution for infusion is intended for single use only.

Simdax 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 medicines, visually inspect the diluted solution for the presence of particles and discoloration before administration.
Simdax must be diluted before administration as follows:

• To prepare the 0.025 mg/ml infusion, mix 5 ml of Simdax 2.5 mg/ml concentrate for solution for infusion with 500 ml of 5% glucose solution.
• To prepare the 0.05 mg/ml infusion, mix 10 ml of Simdax 2.5 mg/ml concentrate for solution for infusion with 500 ml of 5% glucose solution.

Dosage and administration route
Simdax is for hospital use only. It must be administered in a hospital environment where
adequate monitoring equipment and experience in the use of inotropic agents are available.
Simdax must be diluted before administration.
The infusion is for intravenous use only and can be administered both peripherally and
centrally.
Refer to the Summary of Product Characteristics for dosage information.