LEVOSIMENDAN ALTAN

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Levosimendan Altan 2.5 mg concentrate for solution for infusion

Levosimendan
Generic medicine
Read this 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, consult your doctor.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor. See section 4.

Contents of this leaflet:

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

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

Levosimendan Altan is a concentrate medicine that must be diluted before being administered to you as an intravenous infusion.
Levosimendan Altan works by increasing the heart's contractile force and promoting relaxation of the blood vessel walls. Levosimendan Altan will reduce congestion in your lungs and improve blood and oxygen supply to the organs. Levosimendan Altan will help relieve shortness of breath caused by severe heart failure.
Levosimendan Altan is indicated for the short-term treatment of an acute worsening of existing heart failure in adult patients who continue to experience breathing difficulties despite taking medications that remove excess body fluids.

2. What you need to know before using Levosimendan Altan

Do not use Levosimendan Altan:

• if you are allergic (hypersensitive) to levosimendan or to any of the other ingredients of Levosimendan Altan (listed in section 6),
• if you have very low blood pressure or an abnormally fast heartbeat (tachycardia),
• if you have severe kidney or liver disease,
• if you have a heart condition that makes it difficult for the heart 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 have a low red blood cell count (anemia) and chest pain,
• if you have an abnormally fast heartbeat (tachycardia), an abnormal heart rhythm, or if your doctor has told you that you have atrial fibrillation,
• if you have low blood pressure,
• if your doctor has told you that you have abnormally low levels of potassium in your blood, your doctor must administer Levosimendan Altan with great caution.

If you have any of the above conditions or symptoms, speak with your doctor before starting
Levosimendan Altan.
Levosimendan Altan must not be administered to children and adolescents under 18 years of age.
Other medicines and Levosimendan Altan
Inform your doctor if you are taking or have recently taken any other medicines.
If you have been given other intravenous heart medications, your blood pressure may drop when
Levosimendan Altan is administered.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding,
ask your doctor for advice before using this medicine. It is not known whether Levosimendan Altan
could affect your baby.
There is no information available on whether Levosimendan Altan passes into breast milk. Therefore,
you must not breastfeed during treatment with Levosimendan Altan to avoid potential cardiovascular
side effects in the newborn.
Levosimendan Altan contains alcohol
This medicine contains 98 vol% ethanol (alcohol), e.g. up to 3925 mg per 5 ml vial, equivalent to
99.2 ml of beer or 41.3 ml of wine per 5 ml vial.
It may be harmful for alcoholics.
The amount of alcohol in this medicine may affect your ability to drive or operate machinery.
This is because it may impair your judgment and reaction speed.
If you have epilepsy or liver problems, consult your doctor or pharmacist before taking this medicine.
The amount of alcohol in this medicine may alter the effects of other medicines. Talk to your doctor or
pharmacist if you are taking other medicines.
If you are pregnant or breastfeeding, speak to your doctor or pharmacist before taking this medicine.
If you are alcohol-dependent, speak 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 Altan

Levosimendan Altan 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 Altan will be given to you as an intravenous infusion (drip).
The dose and duration of treatment will be tailored according to your clinical condition and response.
Normally, you will receive a rapid infusion (loading dose of 6–12 micrograms/kg) over 10 minutes, followed by a slower infusion (continuous infusion of 0.1 micrograms/kg/min) for up to 24 hours.
Your doctor will periodically check how you are responding to Levosimendan Altan (for example, by measuring your heart rate, blood pressure, ECG and/or asking how you feel). If necessary, your doctor may adjust the dosage.
Tell your doctor or nurse if you feel your heart beating too fast, if you feel dizzy, or if you feel that the effect of Levosimendan Altan is too strong or too weak. Your doctor may reduce your infusion if your blood pressure drops suddenly, or if your heart starts beating too fast, or if you feel unwell.
If your doctor determines that you need a higher dose of Levosimendan Altan and you are not experiencing side effects, the infusion rate may be increased.
Your doctor will continue the Levosimendan Altan infusion for as long as cardiac support is needed. Usually, the infusion lasts 24 hours.
The effect on your heart function will continue for at least 24 hours after the Levosimendan Altan infusion has ended. The effect may last up to 7–10 days after the infusion is stopped. This is why Levosimendan Altan must be administered only in hospital, where your doctor can monitor you for up to 4–5 days after the infusion is discontinued.

Renal impairment
Levosimendan Altan should be used with caution in patients with mild to moderate renal impairment. Levosimendan Altan must not be used in patients with severe renal impairment (creatinine clearance <30 ml/min) (see section 2 “What you need to know before using Levosimendan Altan”).

Hepatic impairment
Levosimendan Altan should be used with caution in patients with mild to moderate hepatic impairment, although dose adjustment does not appear to be necessary in these patients. Levosimendan Altan must not be administered to patients with severe hepatic impairment (see section 2 “What you need to know before using Levosimendan Altan”).

If you have been given more Levosimendan Altan than you should
If you have been given too much Levosimendan Altan, 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 everyone gets them.
Very common (may affect more than 1 in 10 people):

• Abnormally fast heartbeat
• Headache
• Drop in 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 moves rapidly and irregularly instead of beating properly)
• Extrasystoles
• Heart failure
• The heart does not receive enough oxygen
• Nausea
• Constipation
• Diarrhea
• 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 immediately if you experience any side effects. Your doctor may reduce the infusion rate of Levosimendan Altan or stop it completely.
Reporting of side effects
If you get any side effects, including any not listed in this leaflet, talk to your doctor or nurse. You can also report side effects directly via the national reporting system at http://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 Altan

Keep this medicine out of the sight and reach of children.
Do not use Levosimendan Altan after the expiry date stated on the vial or carton.
The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C–8 °C). Do not freeze.

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 unless the opening/reconstitution/dilution process excludes the risk of microbiological contamination. If not used immediately, the duration and conditions of storage prior to use are the responsibility of the user.

As with all parenteral medicinal products, visually inspect the diluted solution before administration to ensure there are no particles or discoloration.

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

6. Package contents and other information

What Levosimendan Altan contains
The active substance is levosimendan 2.5 mg/ml.
Each ml of concentrate contains 2.5 mg of levosimendan.
The other components are: povidone, citric acid and ethanol.

Description of the appearance of Levosimendan Altan and package contents
The concentrate is a yellow or orange transparent solution that must be diluted before administration. It is supplied in clear type I glass vials with a chlorobutyl rubber closure lined with fluoropolymer and an aluminium cap.
Packaging
1 vial of 5 ml.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Altan Pharmaceuticals, S.A.
C/ Cólquide Nº 6, Portal 2, 1st Floor, Office F. Edificio Prisma
Las Rozas, 28230 Madrid, Spain

Manufacturer
Altan Pharmaceuticals S.A.
Polígono Industrial de Bernedo,
s/n, Bernedo, 01118 Álava (Spain)
Altan Pharmaceuticals S.A.
Avda. de la Constitución, 198-199, Polígono Industrial Monte Boyal,
Casarrubios del Monte, 45950 Toledo (Spain)

This medicinal product is authorised in the European Economic Area countries with the following names:
AT Levosimendan Altan 2.5 mg/ml concentrate for infusion solution
IT Levosimendan Altan
ES Levosimendan Altan 2.5 mg/ml concentrate for perfusion solution EFG
FR Levosimendan Altan 2.5 mg/ml solution to be diluted for infusion
DE Levosimendan Altan 2.5 mg/ml concentrate for infusion solution
PT Levosimendan Altan 2.5 mg/ml concentrate for infusion solution
FI Levosimendan Altan 2.5 mg/ml infusion concentrate, for solution
NO Levosimendan Altan 2.5 mg/ml concentrate for infusion solution, solution
SE Levosimendan Altan 2.5 mg/ml concentrate for infusion solution, solution

The following information is intended exclusively for physicians or healthcare professionals:
Levosimendan Altan 2.5 mg/ml concentrate for solution for intravenous infusion
Instructions for use and handling
Levosimendan Altan 2.5 mg/ml concentrate for solution for infusion is intended for single use only.
As with all parenteral medicines, the diluted solution should be visually inspected before administration to check for the presence of particles and discoloration.
Levosimendan Altan 2.5 mg/ml concentrate for solution for infusion must not be diluted to a concentration higher than 0.05 mg/ml according to the instructions below, as opalescence and precipitation may occur.

To prepare an infusion at 0.025 mg/ml, mix 5 ml of Levosimendan Altan 2.5 mg/ml concentrate for solution for infusion with 500 ml of 5% glucose solution.
To prepare an infusion at 0.05 mg/ml, mix 10 ml of Levosimendan Altan 2.5 mg/ml concentrate for solution for infusion with 500 ml of 5% glucose solution.

Dosage and method of administration
Levosimendan Altan 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 Altan must be diluted before 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.