Levosimendan altan

Package leaflet: Information for the user

Levosimendan Altan 2.5 mg/ml, concentrate for solution for infusion
Levosimendan
Please read all of this leaflet carefully before this medicine is given, because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further 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 the leaflet

1. What Levosimendan Altan is and what it is used for
2. What you need to know before receiving Levosimendan Altan
3. How Levosimendan Altan is given
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 concentrated medicine that must be diluted before intravenous infusion.
Levosimendan Altan increases the force with which the heart pumps blood and allows blood vessels to relax. As a result, pulmonary congestion is reduced and blood and oxygen flow through the body is improved. Levosimendan Altan helps to relieve breathlessness caused by severe heart failure.
Levosimendan Altan is used for the short-term treatment of acute decompensated chronic heart failure in adult patients who still experience difficulty in breathing despite treatment with other medicines that remove excess fluid from the body.

2. What you need to know before receiving Levosimendan Altan

When not to use Levosimendan Altan:

• if you are allergic (hypersensitive) to levosimendan or any of the other ingredients of this medicine (listed in section 6);
• if you have very low blood pressure and a fast heart rate (tachycardia);
• if you have severe kidney or liver disease;
• if you have a heart condition that impairs filling or emptying of the heart;
• if you have ever been diagnosed by a doctor with a heart rhythm disorder called torsades de pointes.

Warnings and precautions
Talk to your doctor before receiving Levosimendan Altan if you have:

• any kidney or liver disease;
• low red blood cell count (anaemia) and chest pain;
• a fast heart rate (tachycardia), irregular heartbeat, or if your doctor has ever told you that you have atrial fibrillation;
• low blood pressure;
• if you have ever been told by your doctor that you have low potassium levels in your blood; Levosimendan Altan must be used with extreme caution in such cases.

If you have any of the conditions or symptoms listed above, discuss them with your doctor before starting treatment with Levosimendan Altan.

Children and adolescents
Levosimendan Altan must not be given to children and adolescents under 18 years of age.

Levosimendan Altan and other medicines
Tell your doctor about all medicines you are currently taking, have recently taken, or might take.
If you are receiving other intravenous heart medications, treatment with Levosimendan Altan may cause a drop in blood pressure.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor before receiving this medicine. It is not known whether Levosimendan Altan affects the unborn child.
There is evidence that Levosimendan Altan passes into human milk. Therefore, breastfeeding must be avoided during treatment with Levosimendan Altan to prevent potential cardiovascular side effects in the infant.

Levosimendan Altan contains alcohol
This medicine contains 98% v/v ethanol (alcohol), up to 3,925 mg per 5 ml in a vial, equivalent to 99.2 ml of beer or 41.3 ml of wine per 5 ml vial.
Harmful for individuals with alcoholism.
The alcohol content should be taken into account in pregnant or breastfeeding women, children, and patients at high risk, such as patients with liver disease or epilepsy. The alcohol contained in this medicine may affect the action of other medicines.

3. How to use Levosimendan Altan

Levosimendan Altan is intended for hospital use only. The medicine must be administered in a hospital setting where appropriate monitoring equipment and specialist expertise in the use of inotropic agents are available.
Levosimendan Altan will be given as an intravenous infusion (via drip).
The dose and duration of treatment will be adjusted according to the individual clinical condition and the patient's response to treatment.
Typically, the medicine is administered as a rapid infusion (loading dose of 6 to 12 micrograms/kg) over 10 minutes, followed by a slower continuous intravenous infusion (0.1 microgram/kg body weight/min) for up to 24 hours.
Periodically, the doctor will assess the patient's response to Levosimendan Altan (e.g. by measuring pulse or blood pressure, performing an ECG and/or asking about well-being) and, if necessary, adjust the dose.
Inform the doctor or nurse if palpitations or dizziness occur, or if the effect of Levosimendan Altan seems too strong or too weak. The doctor may reduce the infusion rate if the patient experiences a drop in blood pressure, increased heart rate, or general discomfort.
If the doctor considers a higher dose of Levosimendan Altan necessary and no adverse effects are present, the infusion rate may be increased.
The doctor will continue the Levosimendan Altan infusion for as long as cardiac support is required. This usually lasts 24 hours.
The cardiac effect of Levosimendan Altan persists for at least 24 hours after the end of the infusion. The effect may last up to 9 days after the infusion ends. Therefore, Levosimendan Altan must be used only in a hospital where the doctor can monitor the patient's condition for 4–5 days after the infusion has ended.

Renal impairment
Caution should be exercised when administering Levosimendan Altan to patients with mild or moderate renal impairment. The medicine should not be used in patients with severe renal impairment (creatinine clearance < 30 ml/min) (see section 2. Important information before using Levosimendan Altan).

Hepatic impairment
Caution should be exercised when administering Levosimendan Altan to patients with mild or moderate hepatic impairment, although dose adjustment is not required in these patients. The medicine should not be used in patients with severe hepatic impairment (see section 2. Important information before using Levosimendan Altan).

Overdose of Levosimendan Altan
If a patient receives more Levosimendan Altan than recommended, a decrease in blood pressure and increased heart rate may occur. The doctor will provide appropriate treatment based on the patient's condition.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Very common (occur in more than 1 in 10 patients):

• abnormally rapid heartbeat
• headache
• reduced blood pressure

Common (occur in no more than 1 in 10 patients):

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

In patients receiving Levosimendan Altan, heart rhythm disorders called ventricular fibrillation (a part of the heart flutters instead of beating properly) have been reported.
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If adverse reactions occur, inform your doctor or nurse immediately. The doctor may reduce the infusion rate or discontinue the infusion of Levosimendan Altan.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, tell your doctor or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Levosimendan Altan

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the vial or carton.
The expiry date refers to the last day of the stated month.
Store at 2°C – 8°C (in a refrigerator). Do not freeze.
After dilution
Chemical and physical stability has been demonstrated for the prepared solution used within
24 hours at 25°C.
From a microbiological point of view, unless the method of opening, reconstitution or dilution
excludes the risk of microbiological contamination, the product should be used immediately.
If the product is not used immediately, the user is responsible for the duration and conditions of
storage prior to use.
As with all medicinal products for parenteral administration, the prepared solution should be
inspected visually for particulate matter and discoloration before use.
Medicines must 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 Altan contains

• The active substance is levosimendan 2.5 mg/ml. Each ml of concentrate contains 2.5 mg of levosimendan.
• The other ingredients are: povidone, citric acid and denatured alcohol (ethanol).

What Levosimendan Altan looks like and contents of the pack
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The concentrate is a clear, yellow to orange solution for dilution before administration,
packed in colourless type I glass vials with a chlorobutyl rubber stopper coated with a fluoropolymer layer and an aluminium seal.
Pack sizes: 1 vial (type I glass) with a capacity of 5 ml, in a cardboard box.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Altan Pharma Ltd.
The Lennox Building
50 South Richmond Street
Dublin 2, D02 FK02
Ireland

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 under the following names:
Austria: Levosimendan Altan 2.5 mg/ml Konzentrat zur Herstellung einer Infusionslösung
Belgium: Levosimendan Altan 2.5 mg/ml solution à diluer pour perfusion
Spain: Levosimendan Altan 2.5 mg/ml concentrado para solución para perfusión EFG
France: Levosimendan Altan 2.5 mg/ml solution à diluer pour perfusion
Germany: Levosimendan Altan 2.5 mg/ml Konzentrat zur Herstellung einer Infusionslösung
Poland: Levosimendan Altan 2.5 mg/ml koncentrat do sporządzania roztworu do infuzji
Portugal: Levosimendan Altan 2.5 mg/ml concentrado para solução para infusão
Italy: Levosimendan Altan
Finland: Levosimendan Altan 2.5 mg/ml infuusiokonsentraatti, liuosta varten
Norway: Levosimendan Altan 2.5 mg/ml konsentrat for infusjonsvæske, oppløsning
Sweden: Levosimendan Altan 2.5 mg/ml koncentrat till infusionsvätska, lösning

Information intended exclusively for healthcare professionals:

Levosimendan Altan 2.5 mg/ml, concentrate for solution for infusion
Instructions for use and handling
Levosimendan Altan 2.5 mg/ml, concentrate for solution for infusion is intended exclusively for single use. As with all parenteral products, the diluted solution should be inspected visually for particulate matter and discoloration prior to administration.

Levosimendan Altan 2.5 mg/ml concentrate for solution for infusion must not be diluted to a concentration exceeding 0.05 mg/ml, as described in the instructions below; otherwise opalescence and precipitation may occur.

To prepare an infusion solution with a concentration of 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 solution with a concentration of 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 administration
Levosimendan Altan is intended exclusively for hospital use. The medicinal product must be administered in a hospital setting where appropriate monitoring equipment and experienced personnel in the administration of inotropic drugs are available.

Levosimendan Altan must be diluted before administration.

The solution is intended exclusively for intravenous infusion and may be administered either peripherally or centrally.

For dosage information, refer to the Summary of Product Characteristics.