MENDALUR

Package Leaflet: Information for the User

Mendalur 12.5 mg powder for concentrate for solution for infusion

Levosimendan
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• 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 Mendalur is and what it is used for
  2. What you need to know before using Mendalur
  3. How to use Mendalur
  4. Possible side effects
  5. How to store Mendalur
  6. Contents of the pack and other information

1. What Mendalur is and what it is used for

Mendalur is a powder that must be reconstituted and diluted before being administered as an intravenous infusion.
Mendalur works by increasing the heart's contractile force and promoting relaxation of the blood vessel walls. Mendalur will reduce congestion in your lungs and improve blood and oxygen delivery to the organs. Mendalur will help relieve the shortness of breath caused by severe heart failure.
Mendalur is used for the treatment of heart failure in adult patients who continue to experience breathing difficulties despite receiving other medications to remove excess fluid from the body.

2. What you need to know before using Mendalur

Do not use Mendalur
if you are allergic to levosimendan or to any of the other ingredients of this
medicine (listed in section 6),
if you have very low blood pressure and abnormally fast heart rate,
if you have severe liver or kidney disease,
if you have a heart condition that impairs the heart's ability to fill or empty properly,
if your doctor has told you that you have had an abnormal heart rhythm called torsades de
pointes.

Warnings and precautions
Talk to your doctor or nurse before using Mendalur

• if you have liver or kidney disease,
• if your doctor has told you that you have low levels of potassium in your blood,
• if you have a low red blood cell count (anaemia) and chest pain,
• if you have an abnormally fast heart rate, an abnormal heart rhythm, or if your doctor has diagnosed you with atrial fibrillation.

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Your doctor must use Mendalur with great care.
If you have any of the above-mentioned diseases or symptoms, consult your doctor or nurse before
starting treatment with Mendalur.

Children and adolescents
Mendalur must not be used in children and adolescents under 18 years of age.

Other medicines and Mendalur
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
If you have been given other intravenous heart medications, your blood pressure may drop when
Mendalur is administered.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning a pregnancy, or are breastfeeding,
ask your doctor for advice before taking this medicine. It is not known whether Mendalur could affect your baby.
There is information available regarding the passage of levosimendan into breast milk. You must not breastfeed
during treatment with Mendalur to avoid potential cardiovascular adverse events in the newborn.

Mendalur contains sodium
This medicine contains 60.5 mg of sodium (a key component of table salt) per vial. This is equivalent to 3% of the
recommended maximum daily dietary intake of sodium for an adult.

3. How to use Mendalur

Mendalur will be administered to you as an intravenous infusion (intravenous drip). Therefore, it must be administered only in a hospital where your doctor can monitor you closely.
Your doctor will decide the dose to be administered to you. Your doctor will measure your response to Mendalur (for example, by monitoring your heart rate, blood pressure, ECG, and/or asking how you feel), and if necessary, may adjust the dose for you. Your doctor may wish to monitor you for up to 4-5 days after stopping Mendalur.
Mendalur may be given as a rapid infusion over ten minutes, followed by a slower infusion lasting up to 24 hours.
From time to time, your doctor will check how you are responding to Mendalur. The infusion rate may be reduced if your blood pressure drops suddenly, or if your heart starts beating too fast, or if you do not feel well. Inform your doctor or nurse immediately if you feel your heart beating too fast, if you feel dizzy, or if you feel that the effect of Mendalur is too strong or too weak.
If your doctor considers that you need a higher dose of Mendalur and you are not experiencing side effects, the infusion rate may be increased.
Your doctor will continue the Mendalur infusion for as long as your heart needs support. Usually, the infusion lasts 24 hours.
The effect on the heart will continue for at least 24 hours after the Mendalur infusion has ended. The effect may persist for 7-10 days after the infusion is stopped.
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If you have been given more Mendalur than you should have
If you have been given too much Mendalur, 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, this medicine can cause side effects, although not everybody gets them.

Very common (may affect more than 1 in 10 people)

• Abnormally fast heartbeat
• Headache
• Low blood pressure

Common (may affect up to 1 in 100 people)

• 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
• The heart does not receive enough oxygen
• Nausea
• Constipation
• Diarrhoea
• Vomiting
• Low blood cell count

Not known (frequency cannot be estimated from the available data)

• Hypersensitivity (symptoms may include skin rash and itching).

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 levosimendan.
Inform your doctor or nurse immediately if you experience any side effects. The doctor may reduce the infusion rate of Mendalur or stop it completely.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. 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 Mendalur

Keep this medicine out of the sight and reach of children.
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Do not store above 25°C.
Do not use this medicine after the expiry date stated on the carton after Exp.
Do not use this medicine if you notice formation of particulate matter and/or discoloration of
the reconstituted solution.
The storage time in use after reconstitution and dilution must not exceed 24 hours.

6. Package contents and other information

What Mendalur contains

• The active substance is levosimendan.
• The other components are: sulfobutylether beta-cyclodextrin sodium and sodium hydroxide for pH adjustment.

Description of the appearance of Mendalur and the contents of the pack
The vials are made of clear glass (type I, Ph. Eur.) and closed with bromobutyl rubber stoppers.
Mendalur is packaged in cardboard boxes containing 1 vial each.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
INCA-Pharm S.r.l.
Via Marittima, 38
03100 Frosinone
Italy

Responsible manufacturer for batch release
CBA Chemische Produkte-Beratung und -Analyse GmbH
Konrad-Zuse-Str. 10
66459 Kirkel
Germany

This medicinal product is authorised in the European Economic Area countries
under the following names:
Austria: Levosimendan Carinopharm 12.5 mg Powder for a concentrate for solution for infusion
Germany: Levosimendan Carinopharm 12.5 mg Powder for a concentrate for solution for infusion
Italy: Mendalur 12.5 mg powder for concentrate for solution for infusion
Denmark: Levosimendan Carinopharm 12.5 mg powder for concentrate for infusion solution
Finland: Levosimendan Carinopharm 12.5 mg powder for concentrate for infusion solution
Norway: Levosimendan Carinopharm
Sweden: Levosimendan Carinopharm 12.5 mg powder for concentrate for infusion solution
Slovenia: Levosimendan Carinopharm 12.5 mg powder for concentrate for infusion solution
Spain: Levosimendán Carinopharm 12.5 mg Powder for concentrate for solution for perfusion

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The following information is intended for medical and healthcare professionals only.
Instructions for use and handling of the medicinal product

Mendalur 12.5 mg powder for concentrate for solution for infusion is intended for

single use only.
As with all parenteral medicinal products, the diluted solution should be inspected visually before administration to check for the presence of particles and discoloration.

• To prepare the infusion at 0.025 mg/ml, reconstitute the contents of one vial with 5 ml of water for injections and add the resulting concentrate to 500 ml of 0.9% sodium chloride solution or Ringer's solution.
• To prepare the infusion at 0.05 mg/ml, reconstitute the contents of two vials with 5 ml of water for injections each and add the resulting concentrate to 500 ml of 0.9% sodium chloride solution or Ringer's solution.

Posology and method of administration
Mendalur is for hospital use only. It must be administered in a hospital setting where adequate monitoring equipment and experience in the use of inotropic agents are available.
Mendalur must be reconstituted and 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.
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