Levosimendan Reig Iofre

Package Leaflet: Information for the User

Levosimendan Reig Jofre, 2.5 mg/mL, Concentrate for Solution for Infusion

Levosimendan

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• If you experience any side effects, including those not listed in this package leaflet, inform your doctor or nurse. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Levosimendan Reig Jofre and what is it used for
• 2. Important information before using Levosimendan Reig Jofre
• 3. How to use Levosimendan Reig Jofre
• 4. Possible side effects
• 5. How to store Levosimendan Reig Jofre
• 6. Contents of the pack and other information

1. What is Levosimendan Reig Jofre and what is it used for

Levosimendan Reig Jofre is a medicine in the form of a concentrate that must be diluted before administration to the patient as an intravenous infusion.
Levosimendan Reig Jofre increases the strength with which the heart pumps blood and allows blood vessels to relax.
This reduces congestion in the lungs and facilitates blood and oxygen flow in the body.
Levosimendan Reig Jofre helps alleviate shortness of breath caused by severe heart failure.
Levosimendan Reig Jofre is used to treat heart failure in patients who still have difficulty breathing despite taking other medications that remove excess water from the body.
Levosimendan Reig Jofre is used in adults.

2. Important information before using Levosimendan Reig Jofre

When not to use Levosimendan Reig Jofre:

Torsades de Pointes.

Warnings and precautions

Discuss this with your doctor or nurse before starting treatment with Levosimendan Reig Jofre.

Children and adolescents

Levosimendan Reig Jofre should not be used in children and adolescents under 18 years of age.

Levosimendan Reig Jofre and other medicines

Tell your doctor about all medicines you are taking or have recently taken, as well as any medicines you plan to take, including those available without a prescription.
If you are taking other heart medicines administered intravenously, the use of Levosimendan Reig Jofre may cause a drop in blood pressure.
Tell your doctor if you are taking isosorbide mononitrate, as Levosimendan Reig Jofre may enhance the drop in blood pressure when standing up.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before using this medicine.
It is not known whether the use of Levosimendan Reig Jofre affects the child.
The doctor will decide whether the benefits of treatment for the mother outweigh the potential risks for the child.
It has been shown that Levosimendan Reig Jofre passes into human milk.
You should not breastfeed while using Levosimendan Reig Jofre to avoid any potential adverse effect on the baby's cardiovascular system.

Levosimendan Reig Jofre contains alcohol

This medicine contains 3925 mg of alcohol (anhydrous ethanol) per 5 mL vial, which is equivalent to 98% v/v alcohol.
This amount of alcohol may affect your ability to drive or operate machinery, as it may affect your judgment and reaction speed.
If you have epilepsy or liver problems, consult your doctor or pharmacist before using this medicine.
The amount of alcohol in this medicine may alter the effect of other medicines.
If you are taking other medicines, consult your doctor or pharmacist.
If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medicine.
If you are addicted to alcohol, consult your doctor or pharmacist before using this medicine.
Since this medicine is usually administered slowly over more than 24 hours, the effect of alcohol may be reduced.

3. How to use Levosimendan Reig Jofre

Levosimendan Reig Jofre will be administered as an intravenous infusion (drip).
Therefore, Levosimendan Reig Jofre should only be administered in a hospital where the doctor can monitor the patient.
The doctor will decide what dose of the medicine to administer to the patient.
The doctor will assess the patient's response to Levosimendan Reig Jofre (e.g., by measuring pulse, blood pressure, performing an ECG, and asking about well-being).
If necessary, the doctor may then adjust the dose of the medicine administered.
The doctor may want to monitor the patient even after the administration of Levosimendan Reig Jofre has been completed, for up to 4-5 days.
The patient may first receive a rapid infusion lasting 10 minutes, and then the patient will receive a slower intravenous infusion over a period of up to 24 hours.
From time to time, the doctor will assess the patient's response to Levosimendan Reig Jofre.
If the patient experiences a drop in blood pressure, rapid heart rate, or poor well-being, the doctor may reduce the infusion rate.
Tell the doctor or nurse if you experience a feeling of palpitations, dizziness, or if you think the effect of Levosimendan Reig Jofre is too strong or too weak.
The doctor may increase the infusion rate if they consider that a higher dose of Levosimendan Reig Jofre is necessary and the patient does not experience any side effects.
The doctor will continue the infusion of Levosimendan Reig Jofre for as long as it is necessary to support the heart.
Usually, this lasts 24 hours.
The effect of Levosimendan Reig Jofre on the heart lasts for at least 24 hours after the infusion has been completed.
The medicine may work for 7-10 days after the infusion has been completed.
Renal impairment
Caution should be exercised when using Levosimendan Reig Jofre in patients with mild or moderate renal impairment.
Levosimendan Reig Jofre should not be used in patients with severe renal impairment (see section 2).
Hepatic impairment
Caution should be exercised when using Levosimendan Reig Jofre in patients with mild or moderate hepatic impairment, although dose adjustment is not necessary in these patients.
Levosimendan Reig Jofre should not be used in patients with severe hepatic impairment (see section 2).

Overdose of Levosimendan Reig Jofre

In case of overdose, Levosimendan Reig Jofre may cause a decrease in blood pressure and an increase in heart rate.
The doctor will administer appropriate treatment based on the patient's 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):

• abnormal heart rhythm
• headache
• decrease in blood pressure.

Common(may affect up to 1 in 10 people):

• low potassium levels in the blood
• insomnia
• dizziness
• heart rhythm disorders, called atrial fibrillation (part of the heart beats instead of beating properly)
• extra heartbeats
• heart failure
• myocardial ischemia
• nausea
• constipation
• diarrhea
• vomiting
• low number of blood cells.

In patients receiving Levosimendan Reig Jofre, heart rhythm disorders, called ventricular fibrillation (part of the heart beats instead of beating properly), have been observed.
If side effects occur, inform your doctor immediately.
The doctor may reduce the infusion rate or stop the infusion of Levosimendan Reig Jofre.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, inform your doctor or nurse.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Levosimendan Reig Jofre

Keep the medicine out of the sight and reach of children.
Store in a refrigerator (2°C-8°C).
Do not freeze.
Do not use this medicine after the expiry date stated on the label or carton after: EXP.
The expiry date refers to the last day of the month stated.
During storage, the concentrate may change color to orange, but the potency does not change and the medicine can still be used until the expiry date, provided that the storage conditions have been observed.
After dilution
Chemical and physical stability has been demonstrated during use of the prepared solution for 24 hours at 25°C.
From a microbiological point of view, the product should be used immediately.
If the product is not used immediately, the responsibility for the storage conditions and duration before use lies with the user.
The product should not be stored for more than 24 hours at a temperature between 2°C and 8°C, unless dilution has been performed under controlled and validated aseptic conditions.
After dilution, the medicine should never be stored and administered for more than 24 hours.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
These measures will help protect the environment.

6. Contents of the pack and other information

What Levosimendan Reig Jofre contains

• The active substance is levosimendan.
  Each mL of concentrate contains 2.5 mg of levosimendan.
  Each 5 mL vial contains 12.5 mg of levosimendan.
• The other ingredients are: povidone, citric acid (to adjust pH), and anhydrous ethanol.

What Levosimendan Reig Jofre looks like and contents of the pack

The concentrate for solution for infusion is a clear, yellow or orange solution that must be diluted before administration.
Pack sizes

• 1, 4, 10 vials (glass vial with a rubber stopper and an aluminum cap and seal) of 5 mL, in a cardboard box.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Reig Jofre Sp. z o.o.
ul. Ostródzka 74N
03-289 Warsaw
Poland
e-mail: [email protected]
Phone: +48 22 487 88 49

Manufacturer

Laboratorio Reig Jofre, S.A.
Gran Capitan, 10
Sant Joan Despí
08970 Barcelona
Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Denmark:
Levosimendan Bioglan
Finland:
Levosimendan Bioglan 2.5 mg/ml infuusiokonsentraatti, liuosta varten
France:
LEVOSIMENDAN REIG JOFRE 2,5 mg/mL, solution à diluer pour perfusion
Spain:
Levosimendan Sala 2,5 mg/ml concentrado para solución para perfusión EFG
Norway:
Levosimendan Bioglan
Poland:
Levosimendan Reig Jofre
Portugal:
Levossimendano Reig Jofre 2,5 mg/ml concentrado para solução para perfusão
Sweden:
Levosimendan Bioglan

Date of last revision of the package leaflet:

Other sources of information

Detailed information on this medicine is available on the website of the Office for Registration of Medicinal Products: www.urpl.gov.pl
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Information intended for healthcare professionals only:

Levosimendan Reig Jofre, 2.5 mg/mL, Concentrate for Solution for Infusion

Instructions for use and handling

Levosimendan Reig Jofre 2.5 mg/mL, Concentrate for Solution for Infusion is intended for single use only.
The product Levosimendan Reig Jofre should not be diluted to a concentration greater than 0.05 mg/mL according to the instructions below, otherwise opalescence and precipitation may occur.
As with all products for parenteral use, the diluted solution should be inspected visually for particulate matter and discoloration prior to administration.

• To prepare an infusion solution with a concentration of 0.025 mg/mL, 5 mL of Levosimendan Reig Jofre 2.5 mg/mL concentrate for solution for infusion should be mixed with 500 mL of 5% glucose solution.
• To prepare an infusion solution with a concentration of 0.05 mg/mL, 10 mL of Levosimendan Reig Jofre 2.5 mg/mL concentrate for solution for infusion should be mixed with 500 mL of 5% glucose solution.

Dosage and administration

Levosimendan Reig Jofre is intended for use in hospitals only.
The medicine should be administered under hospital conditions where appropriate monitoring equipment and personnel experienced in the administration of inotropic agents are available.
Levosimendan Reig Jofre should be diluted before administration.
The solution is intended for intravenous infusion only and may be administered peripherally or centrally.
For information on dosing, refer to the Summary of Product Characteristics.