Levosimendan TilloMed

PACKAGE LEAFLET

Package leaflet: information for the user

Levosimendan Tillomed 2.5 mg/ml concentrate for solution for infusion

Equivalent medicinal product
Please read this entire 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, ask your doctor.
• If you experience any side effects, including those not listed in this leaflet, inform your doctor or nurse. See section 4.

What this leaflet contains:

1. What Levosimendan Tillomed is and what it is used for
2. What you need to know before using Levosimendan Tillomed
3. How to use Levosimendan Tillomed
4. Possible side effects
5. How to store Levosimendan Tillomed
6. Contents of the pack and other information

1. What Levosimendan Tillomed is and what it is used for

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

2. What you need to know before using Levosimendan Tillomed

Do not use Levosimendan Tillomed

• if you are allergic (hypersensitive) to levosimendan or to any of the other ingredients of this medicine (listed in section 6),
• if you have very low blood pressure or an abnormally fast heartbeat,
• if you have severe kidney or liver disease,
• if you have a heart condition that impairs the heart's ability to fill and empty properly,
• if your doctor has told you that you have had an abnormal heart rhythm called Torsades de Pointes.

Warnings and precautions

• if you have any kidney or liver disease,
• if you also have low blood cell counts and chest pain,
• if you have an abnormally fast heartbeat, an irregular heart rhythm, or if your doctor has diagnosed you with atrial fibrillation or low potassium levels in the blood, your doctor must administer levosimendan with great caution.

If you have any of the above conditions or symptoms, talk to your doctor before starting treatment with
Levosimendan Tillomed.
Children and adolescents
This medicine must not be given to children and adolescents under 18 years of age.
Other medicines and Levosimendan Tillomed
Tell your doctor if you are taking, have recently taken, or might take any other medicines, including those
not requiring a prescription.
If you have been given other intravenous heart medications, your blood pressure may drop further if
levosimendan is administered.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding,
ask your doctor for advice before taking this medicine.
It is not known whether levosimendan may affect your unborn child. Your doctor must assess whether the
benefit to you outweighs the potential risks to your unborn child.
There is information indicating that levosimendan passes into breast milk. You must not breastfeed during
treatment with levosimendan to avoid potential cardiovascular adverse events in the newborn.
Levosimendan Tillomed contains alcohol
This medicine contains 98% alcohol by volume, i.e. up to 3848 mg per 5 ml vial, equivalent to 98 ml of beer or 41 ml of wine.
The amount of alcohol in this medicine may impair your ability to drive or operate machinery, as it may affect your judgment or reaction speed.
If you have epilepsy or liver disease, talk to your doctor or pharmacist before taking this medicine.
The amount of alcohol in this medicine may alter the effects of other medicines. Consult your doctor or pharmacist before taking other medicines.
If you are pregnant or breastfeeding, consult your doctor or pharmacist before taking this medicine.
If you are alcohol-dependent, consult 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 Levosimendan Tillomed

Levosimendan Tillomed will be administered to you as an intravenous infusion (intravenous drip). For this reason,
Levosimendan Tillomed must be given only in a hospital setting where your doctor can monitor you.
Your doctor will decide how much Levosimendan Tillomed you should receive. Your doctor will monitor your
response to Levosimendan Tillomed (for example, by measuring your heart rate, blood pressure, ECG, and by assessing how you feel).
Your doctor may adjust your dosage if necessary. Your doctor may wish to monitor you for up to 4–5 days after discontinuation of levosimendan.
Levosimendan may be administered as a rapid infusion over ten minutes, followed by a slower infusion lasting up to 24 hours.
Your doctor will periodically assess your response to levosimendan. The infusion rate may be reduced if your blood pressure drops sharply, if your heart begins to beat too quickly, or if you feel unwell. Inform your doctor or nurse immediately if you feel your heart beating too fast, if you feel dizzy, or if you think the effect of levosimendan is too strong or too weak.
If your doctor considers that you require a higher dose of levosimendan and you are not experiencing adverse effects, the infusion rate may be increased.
Your doctor will continue the levosimendan infusion for as long as necessary to support your heart function. Usually, the infusion lasts 24 hours.
The effect on the heart continues for at least 24 hours after the levosimendan infusion has ended.
This effect may persist for 7–10 days after the infusion is completed.
If you have been given more Levosimendan Tillomed than you should have
If you have been given too much Levosimendan Tillomed, your blood pressure may drop sharply and your heart may beat faster.
Your doctor knows how to treat you according to your condition.
If you have any doubts about the use of this medicine, consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences 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 10 people)

• low levels of potassium in the blood
• insomnia
• dizziness
• abnormal heartbeat called atrial fibrillation (a part of the heart beats 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

Abnormal heartbeat called ventricular fibrillation (a part of the heart beats rapidly and irregularly instead of beating properly) has been reported in patients treated with levosimendan.
Not known (frequency cannot be estimated from the available data):

• Hypersensitivity (symptoms may include rash and itching)

Immediately inform your doctor if you experience any side effects. Your doctor may reduce the infusion rate of levosimendan or stop it altogether.
If any of the side effects worsens or if you notice any side effect not listed in this leaflet, inform your doctor.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website: 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 Levosimendac Tillomed

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "Expiry". The expiry date refers to the last day of that month.
Storage conditions
Store in a refrigerator (2°C – 8°C). Do not freeze.
The product is a clear, yellow or orange solution, free from visible particles.
Storage conditions after dilution
Chemical and physical in-use stability has been demonstrated for 48 hours at 25°C.
From a microbiological point of view, unless the method of opening/reconstitution/dilution excludes the risk of microbiological contamination, the product should be used immediately.
If not used immediately, the duration and conditions of storage during use are the responsibility of the user.

6. Package contents and other information

What Levosimendan Tillomed contains

• The active substance is Levosimendan.
• One 5 ml vial of concentrate for infusion solution contains 12.5 mg of levosimendan.
• The other components are:

Povidone, Citric acid, Anhydrous ethanol

Description of the appearance of Levosimendan Tillomed and contents of the pack

Pack: 1 colourless vial (Type I glass) of 5 ml.
4 colourless vials (Type I glass) of 5 ml.

Levosimendan Tillomed 2.5 mg/ml concentrate for solution for infusion is available as a clear, yellow or orange solution, free from visible particles, contained in a 6 ml transparent Type I glass vial with a 20 mm rubber stopper and sealed with a 20 mm tamper-evident cap.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Tillomed Italia S.r.l.
Viale G. Richard 1, Tower A
20143 Milan (MI), Italy

Manufacturer
Tillomed Malta Limited
Malta Life Sciences Park,
LS2.01.06 Industrial Estate,
San Gwann, SGN 3000, Malta

This medicinal product is authorised in the European Economic Area countries under the following names:

Austria  Levosimendan Tillomed 2.5 mg/ml concentrate for solution for infusion
Czech Republic  Levosimendan Zentiva
Denmark  Levosimendan Tillomed
Finland  Levosimendaani Tillomed 2.5 mg/ml infuusiokonsentraatti liuosta varten
France  LÉVOSIMENDAN TILLOMED 2.5 mg/ml, solution to be diluted for infusion
Germany  Levosimendan Tillomed 2.5 mg/ml concentrate for solution for infusion
Italy  Levosimendan Tillomed
Norway  Levosimendan Tillomed
Poland  Levosimedan Zentiva
Portugal  Levossimendano Tillomed 2.5 mg/ml concentrado para solução para perfusão
Slovakia  Levosimendan Zentiva 2.5 mg/ml koncentrát na infúzny roztok
Slovenia  Levosimendan Tillomed 2.5 mg/ml koncentrat za raztopino za infundiranje
Spain  Levosimendan Zentiva 2.5 mg/ml concentrado para solución para perfusión EFG
Sweden  Levosimendan Tillomed

The following information is intended exclusively for physicians or healthcare professionals:

Instructions for use and handling

Levosimendan Tillomed 2.5 mg/ml concentrate for solution for infusion is intended for single use only.
Levosimendan Tillomed 2.5 mg/ml concentrate for solution for infusion must not be diluted to a concentration higher than 0.05 mg/ml as specified below, otherwise opalescence and precipitation may occur.
As with all parenteral medicinal products, the diluted solution should be visually inspected before administration to check for the presence of particles and discoloration.

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

Dosage and method of administration
Levosimendan Tillomed is intended 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.
Levosimendan Tillomed must be diluted prior to administration.
The infusion is for intravenous use only and may be administered via either peripheral or central venous route.
For dosage, refer to the Summary of Product Characteristics.