LEVOSIMENDAN 2.5 mg/ml Koncentrat do roztworu infuzyjnego

Treść ulotki

1. Levosimendan Tillomed 2.5 mg/ml concentrate for solution for infusion
   1. What is Levosimendan Tillomed and what is it 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 Levosimenda Tillomed
   6. Package Contents and Other Information

Levosimendan Tillomed 2.5 mg/ml concentrate for solution for infusion

Generic medicine

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, tell 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 you use 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 is Levosimendan Tillomed and what is it used for

Levosimendan Tillomed is a medicine in concentrated form, which must be diluted before being administered to you as an intravenous infusion.
Levosimendan works by increasing the force of cardiac contraction and allows the relaxation of the vessel walls.
Levosimendan will reduce congestion in your lungs and facilitate the supply of blood and oxygen to the organs. Levosimendan will help to relieve shortness of breath caused by severe heart failure.
Levosimendan Tillomed is used for the short-term additional treatment of heart failure in adult patients who still have difficulty breathing, even if they are taking other medicines to eliminate 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 if you have an abnormally fast heartbeat,
• if you have a severe kidney or liver disease,
• 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 heart rhythm called Torsades de Pointes.

Warnings and precautions

• if you have any kidney or liver disease
• if you also have a low blood count and have chest pain
• if you have an abnormally fast heartbeat, an irregular heart rhythm or your doctor has told you that you have atrial fibrillation or have an abnormally low level of potassium in your 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 should not be given to children and adolescents under 18 years of age.

Other medicines and Levosimendan Tillomed
Tell your doctor if you are taking or have recently taken 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 levosimendan.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor for advice before taking this medicine.
It is not known whether levosimendan may have an effect on your child. The doctor must assess whether the benefit
for you outweighs the potential risks to your child.
There is information on the passage of levosimendan into breast milk. You should not breastfeed during
treatment with levosimendan to avoid potential adverse cardiovascular 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 vehicles or operate machinery. This is because it can affect your judgement or the speed at which you react.
If you suffer from 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 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 Levosimendan Tillomed

Levosimendan Tillomed will be administered to you by intravenous infusion (drip). This is why
Levosimendan Tillomed must only be administered in hospital where the doctor can monitor you.
The doctor will decide how much Levosimendan Tillomed you need to be administered. The doctor will measure
your response to Levosimendan Tillomed (for example by measuring your heart rate, your
blood pressure, the ECG and will assess how you feel). The doctor may adjust your dosage, if
necessary. The doctor may want to monitor you for up to 4-5 days after stopping levosimendan.
Levosimendan can be administered as a fast infusion over ten minutes, followed
by a slower infusion for up to 24 hours.
From time to time the doctor must check how you are responding to levosimendan. They may reduce the rate of
infusion if your blood pressure drops suddenly or if your heart starts to beat too
fast or if you do not feel well. Tell the doctor or nurse if you feel your heart
beating too fast, if you feel dizzy or if you feel the effect of levosimendan is too strong or
too weak.
If the doctor thinks you need a higher dose of levosimendan and you are not
experiencing any side effects, they may increase your infusion.
The doctor will continue the levosimendan infusion as long as it is necessary to support your heart. Usually the infusion lasts 24 hours.
The effect on the heart will continue for at least 24 hours after the levosimendan infusion has ended.
The effect may continue for 7-10 days after the infusion has ended.

If you have been given more Levosimendan Tillomed than you should
If you have been given too much Levosimendan Tillomed, your blood pressure may drop
suddenly and your heart beat faster. The doctor will know how to treat you based on your
condition.
If you have any questions about the use of this medicine, ask your doctor.

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 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.

In patients who have taken levosimendan, abnormal heartbeat called
ventricular fibrillation (a part of the heart beats rapidly and irregularly instead of beating
properly) has been reported.
Tell your doctor immediately if you experience any side effects. Your doctor may reduce the rate of
levosimendan infusion or stop it.
If any of the side effects gets worse or if you notice any side effect not

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly
through 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 Levosimenda Tillomed

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after “Exp.” 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 stability has been demonstrated at 25°C for 48 hours.
From a microbiological point of view, unless the opening/reconstitution/dilution method precludes the risk of
microbiological contamination, the product must be used
immediately.
If not used immediately, the storage times and conditions in use are the responsibility
of the user.

6. Package Contents and Other Information

What Levosimendan Tillomed Contains

• The active ingredient is Levosimendan.
• A 5 ml vial of concentrate for infusion solution contains 12.5 mg of levosimendan.
• The other ingredients are: Povidone, Citric acid, Anhydrous ethanol

Description of the Appearance of Levosimendan Tillomed and Package Contents
Package: 1 colorless vial (Type I glass) of 5 ml.
Levosimendan Tillomed 2.5 mg/ml concentrate for infusion solution is available as a
clear, yellow or orange solution, free from visible particles, packaged in a transparent glass vial
of Type I with a 20 mm rubber stopper and sealed with a 20 mm tear-off seal MT.

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

Manufacturer
MIAS Pharma Limited
Suite 2, Stafford House,
Strand Road, Portmarnock,
Co. Dublin, Ireland

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Austria Levosimendan Tillomed 2.5 mg / ml Concentrate for the preparation of an
Infusion solution
Czech Republic Levosimendan Zentiva
Denmark Levosimendan Tillomed
Finland Levosimendaani Tillomed 2.5 mg/ml infusion concentrate for solution
France LÉVOSIMENDAN TILLOMED 2.5 mg/ml, solution for dilution for
infusion
Germany Levosimendan Tillomed 2.5 mg / ml Concentrate for the preparation of an
Infusion solution
Italy Levosimendan Tillomed
Norway Levosimendan Tillomed
Poland Levosimedan Zentiva
Portugal Levossimendano Tillomed 2.5 mg/ml concentrate for solution for
infusion
Slovakia Levosimendan Zentiva 2.5 mg/ml concentrate for infusion solution
Slovenia Levosimendan Tillomed 2.5 mg/ml concentrate for solution for infusion
Spain Levosimendan Tillomed 2.5 mg/ml concentrate for solution for
infusion 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 infusion solution is intended for
single use only.
Levosimendan Tillomed 2.5 mg/ml concentrate for infusion solution should not be diluted to
a concentration greater 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 particles and discoloration
before administration.

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

Dosage and Administration
Levosimendan Tillomed 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.
Levosimendan Tillomed 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.