Levosimendan Reig Jofre

Package leaflet: Information for the user

Levosimendan Reig Jofre 2.5 mg/mL concentrate for solution for infusion

Read all of this leaflet carefully before you start 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 or nurse.
• If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of this leaflet

1. What Levosimendan Reig Jofre is and what it is used for
2. What you need to know 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 Levosimendan Reig Jofre is and what it is used for

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

2. What you need to know before using Levosimendan Reig Jofre

Do not use Levosimendan Reig Jofre

• 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 or an 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 and empty properly;
• if your doctor has diagnosed you with an abnormal heart rhythm called Torsades de Pointes.

Warnings and precautions
Talk to your doctor or nurse before using Levosimendan Reig Jofre:

• if you have low blood pressure;
• if you are in a state of reduced blood volume (hypovolemia);
• if you have liver or kidney disease;
• if you have a low red blood cell count and experience chest pain;
• if you have an abnormally fast heart rate, an irregular heart rhythm, or if your doctor has diagnosed you with atrial fibrillation or low blood potassium levels, your doctor must administer Levosimendan Reig Jofre with great caution.

Children and adolescents
Levosimendan Reig Jofre must not be administered to children and adolescents under 18 years of age.

Other medicines and Levosimendan Reig Jofre
Tell your doctor if you are taking, have recently taken, or might take any other medicines, including those that do not require a prescription.
If you are receiving other intravenous heart medications, your blood pressure may drop further when Levosimendan Reig Jofre is administered.
Inform your doctor if you are taking isosorbide mononitrate, as using Levosimendan Reig Jofre may cause a greater drop in blood pressure when standing up.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, or breastfeeding, consult your doctor before using this medicine. It is not known whether Levosimendan Reig Jofre could affect your baby. Your doctor will assess whether the benefit to you outweighs the potential risks to your baby.
Available data indicate that Levosimendan Reig Jofre passes into breast milk. You must not breastfeed during treatment with Levosimendan Reig Jofre to avoid potential cardiovascular risks to the newborn.

Levosimendan Reig Jofre contains alcohol
This medicine contains 3925 mg of alcohol (anhydrous ethanol) in each 5 mL vial, equivalent to approximately 98% vol. The amount of alcohol in one 5 mL vial of this medicine is equivalent to 99.2 mL of beer or 41.3 mL of wine.
The alcohol content in this medicine may affect your ability to drive or operate machinery, as it may impair your judgment and reaction speed.
If you have epilepsy or liver problems, talk to your doctor or pharmacist before taking this medicine.
The alcohol content in this medicine may alter the effects of other medicines. Consult your doctor or pharmacist if you are taking other medications.
If you are pregnant or breastfeeding, consult your doctor or pharmacist before taking this medicine.
If you are alcohol-dependent, talk to your doctor or pharmacist before taking this medicine.
Since this medicine is usually administered slowly over 24 hours, the effects of the alcohol may be reduced.

3. How to use Levosimendan Reig Jofre

Levosimendan Reig Jofre will be administered to you by intravenous infusion (intravenous drip). This is why
Levosimendan Reig Jofre must be given only in a hospital setting where your doctor can monitor you. Your
doctor will decide how much Levosimendan Reig Jofre you should receive. Your doctor will measure your
response to Levosimendan Reig Jofre (for example, by monitoring your heart rate, blood pressure, ECG, and
by assessing how you feel). If necessary, your doctor may then adjust the dosage. Your doctor may wish to
monitor you for up to 4-5 days after stopping Levosimendan Reig Jofre.
You may be given a rapid infusion over ten minutes, followed by a slower infusion lasting up to 24 hours.
Your doctor must assess your response to Levosimendan Reig Jofre each time it is administered. The infusion
rate may be reduced if your blood pressure drops suddenly, or if your heart starts beating too fast, or if you
feel unwell. Inform your doctor or nurse if you feel your heart beating too fast, if you feel dizzy, or if you feel
the effect of Levosimendan Reig Jofre is too strong or too weak.
If your doctor considers that you need a higher dose of Levosimendan Reig Jofre and you are not
experiencing side effects, the infusion rate may be increased.
Your doctor will continue the Levosimendan Reig Jofre infusion for as long as your heart needs support.
Typically, the infusion lasts for 24 hours.
The effect on your heart function will continue for at least 24 hours after the Levosimendan Reig Jofre
infusion has ended. The effect may last for 7-10 days after the infusion is completed.

Renal impairment
Levosimendan Reig Jofre should be used with caution in patients with mild to moderate renal impairment.
Levosimendan Reig Jofre must not be used in patients with severe renal impairment (see section 2).

Hepatic impairment
Levosimendan Reig Jofre should be used with caution in patients with mild to moderate hepatic impairment,
although dose adjustment does not appear to be necessary for these patients. Levosimendan Reig Jofre must
not be used in patients with severe hepatic impairment (see section 2).

If you have been given more Levosimendan Reig Jofre than you should have
If you have been given too much Levosimendan Reig Jofre, your blood pressure may drop suddenly and
your heart rate may increase. 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 rapid heartbeat
Headache
Low blood pressure

Common: may affect up to 1 in 10 people
Low blood potassium levels
Insomnia
Dizziness
An abnormal heart rhythm called atrial fibrillation (a part of the heart moves rapidly and irregularly instead of beating properly)
Extrasystoles
Heart failure
Inadequate oxygen supply to the heart
Nausea
Constipation
Diarrhoea
Vomiting
Low blood count

Abnormal heart rhythm called ventricular fibrillation (a part of the heart moves rapidly and irregularly instead of beating properly) has been reported in patients treated with Levosimendan Reig Jofre.

If you experience any side effects, inform your doctor immediately. Your doctor may reduce the infusion rate of Levosimendan Reig Jofre or stop it completely.

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or nurse. You can also report side effects directly via the Italian Medicines Agency (Agenzia Italiana del Farmaco), 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 Levosimendan Reig Jofre

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 this medicine after the expiry date stated on the container. The expiry date refers to the last day of that month.
The colour of the concentrate may become more orange during storage, but this does not imply a loss of efficacy, and the medicine can therefore be used up to the expiry date indicated, provided the storage instructions are followed.

After dilution
Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C.
From a microbiological standpoint, the product should be used immediately. If not used immediately, the period and conditions of storage prior to use are the responsibility of the user and normally should not exceed 24 hours at a temperature between 2°C and 8°C, unless dilution has been carried out under well-controlled and validated aseptic conditions. Storage and duration of use after dilution must never exceed 24 hours.

Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Levosimendan Reig Jofre contains

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

Description of the appearance of Levosimendan Reig Jofre and contents of the pack
The concentrate is a yellow or orange transparent solution for dilution before administration.
Pack sizes

• 1, 4, 10 vials (glass vials with chlorobutyl rubber stopper, closure cap and aluminium seal) of 5 mL
  Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Laboratorio Reig Jofre S.A.
Gran Capitán, 10
08970 Sant Joan Despí – Barcelona
Spain
This medicinal product is authorised in the European Economic Area and the United Kingdom (Northern Ireland) under the following names:
Denmark Levosimendan "Bioglan"
Germany Levosimendan Reig Jofre 2.5 mg/mL, concentrate for solution for infusion
Finland Levosimendan Bioglan 2.5 mg/mL infuusiokonsentraatti, liuosta varten
France Levosimendan Reig Jofre 2.5 mg/mL, solution à diluer pour perfusion
Italy Levosimendan Reig Jofre 2.5 mg/mL concentrate for solution for infusion
Norway Levosimendan Bioglan
Poland Levosimendan Reig Jofre
Portugal Levossimendano Reig Jofre 2.5 mg/mL concentrado para solução para perfusão
Sweden Levosimendan Bioglan 2.5 mg/mL koncentrat till infusionsvätska, lösning
Spain Levosimendan Sala 2.5 mg/mL concentrate for solution for infusion EFG

The following information is intended exclusively for healthcare professionals:

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.
Levosimendan Reig Jofre 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, visually inspect the diluted solution prior to administration to check for the presence of particles and discoloration.

• To prepare the 0.025 mg/mL infusion, mix 5 mL of Levosimendan Reig Jofre 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 Levosimendan Reig Jofre 2.5 mg/mL concentrate for solution for infusion with 500 mL of 5% glucose solution.

Dosage and method of administration
Levosimendan Reig Jofre 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 Reig Jofre must be diluted prior to 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.