Prospecto: information for the user

Levosimendan Altan 2.5 mg/ml concentrate for infusion solutionEFG

Levosimendan

Read this prospect carefully before starting to use this medicine, because it contains important information for you.

- Keep this prospect, as you may need to read it again.
- If you have any doubts, consult your doctor.

- This medicine has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.

- If you experience any adverse effects, consult your doctor, even if they are not listed in this prospect. See section 4.

1. What isLevosimendan Altanand for what it is used

2. What you need to know before starting to useLevosimendan Altan

3. How to useLevosimendan Altan

4. Possible adverse effects

5. Storage ofLevosimendan Altan

6. Contents of the package and additional information

Levosimendan Altan is presented in a concentrated form that must be diluted before administration via intravenous infusion.

Levosimendan Altan acts by increasing the heart's pumping force and allowing blood vessel relaxation. Levosimendan reduces pulmonary congestion and facilitates blood and oxygen circulation throughout the body. Levosimendan Altan helps alleviate severe heart failure respiratory difficulty.

Levosimendan is indicated for the treatment of heart failure in individuals who continue to experience breathing difficulties despite taking other medications to remove fluids from the body.

Do not use Levosimendan Altan

- If you are allergic (hypersensitive) to levosimendan or to any of the other components of this medication (see section 6)

- If you have very low blood pressure or an abnormally high heart rate (tachycardia).

- If you have severe kidney or liver damage.

- If you have a heart disease that makes it difficult to fill and empty the heart

- If your doctor has told you that you have had a type of irregular heartbeat called Torsades de Pointes.

Be especially careful with Levosimendan Altan

- If you have liver or kidney disease.

- If you have anemia and chest pain at the same time.

- If you have an abnormally high heart rate (tachycardia), or if your doctor has told you that you have atrial fibrillation

- If you have low blood pressure.

- If you have abnormally low levels of potassium in your blood, your doctor should use Levosimendan Altan with great caution.

Consult your doctor before starting treatment with Levosimendan Altan if you have any of the diseases or symptoms mentioned above.

Levosimendan Altan should not be administered to children and adolescents under 18 years old.

Other medications and Levosimendan Altan

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

If you have been given other intravenous cardiac medications, the administration of Levosimendan Altan may cause a drop in blood pressure.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor before using this medication. The effects of Levosimendan Altan on the child are unknown.

There is evidence that Levosimendan Altan passes into breast milk. Do not breastfeed while being treated with Levosimendan Altan, to avoid possible adverse cardiovascular effects in the child.

Levosimendan Altan contains Ethanol

This medication contains 98% by volume of ethanol (alcohol), that is, up to 3925 mg per 5 ml vial, equivalent to 99.2 ml of beer, 41.3 ml of wine per 5 ml vial. If you suffer from epilepsy or liver problems, consult your doctor or pharmacist before taking this medication. The amount of alcohol contained in this medication may alter the effect of other medications. Consult your doctor or pharmacist if you are taking other medications. If you are pregnant or breastfeeding, consult with your doctor or pharmacist before taking this medication.

Levosimendan Altan is for hospital use only. It should be administered in a hospital setting where adequate monitoring facilities and experience with inotropic agents are available.

Levosimendan Altan should be administered via intravenous infusion.

The dose and duration of treatment will be individualized according to your clinical status and response.

Typically, treatment can be initiated with a rapid infusion (loading dose of 6-12 micrograms/kg) over 10 minutes followed by a slow infusion (continuous infusion of 0.1 micrograms/kg/min) for 24 hours.

Your doctor will decide the dose of Levosimendan Altan to administer and will continuously monitor your response to treatment (e.g., by measuring your heart rate, blood pressure, electrocardiogram, and subjective sensations), and adjust the dose as necessary.

Inform your doctor or nurse if you feel your heart is racing, if you feel dizzy, or if you feel that the effect of Levosimendan Altan is too strong or too weak. Your doctor may decrease your infusion if your blood pressure drops or your heart starts beating too quickly or if you are not feeling well.

If your doctor considers that you need a higher dose of Levosimendan Altan and you are not experiencing side effects, they may increase the infusion.

Your doctor will continue the infusion of Levosimendan Altan for as long as they deem necessary to help your heart. Typically, it is recommended to infuse Levosimendan Altan for 24 hours.

The effect on your cardiac function will last for at least 24 hours after the infusion of Levosimendan Altan is stopped. The effect may continue up to 9 days after the infusion is completed. This is why you should only receive Levosimendan Altan in a hospital where your doctor can monitor you for a period of up to 4-5 days after the infusion is completed.

Renal Insufficiency

Levosimendan Altan should be used with caution in patients with mild to moderate renal insufficiency. Levosimendan Altan should not be used in patients with severe renal insufficiency (creatinine clearance <30)

Liver Insufficiency

Levosimendan Altan should be used with caution in patients with mild to moderate liver insufficiency, although dose adjustment may not be necessary in these patients. Levosimendan Altan should not be administered to patients with severe liver insufficiency (see section 2. “What you need to know before using Levosimendan Altan”).

If you use more Levosimendan Altan than you should

A Levosimendan Altan overdose will cause a drop in blood pressure and an increase in heart rate. Your doctor will know how to treat it based on your medical history.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Very frequent (affect more than 1 in 10 people)

- Abnormally high heart rate.

- Headache.

- Hypotension.

Frequent(affect between 1 and 10 in 100 people)

- Decrease in potassium in the blood

- Insomnia

- Dizziness

- Abnormal heart rhythm called atrial fibrillation (consequence of heart palpitations instead of the normal heartbeat).

- Additional heartbeats

- Heart failure

- Decrease in oxygen supply to the heart through the blood

- Nausea

- Constipation

- Diarrhea

- Vomiting.

- Decrease in hemoglobin

Cases of a heart rhythm alteration called ventricular fibrillation (as a consequence of heart palpitations instead of the normal heartbeat) have been reported in patients who received levosimendan

Please inform your doctor immediately if you experience any side effects. Your doctor may reduce or stop the infusion of Levosimendan Altan.

If you consider that any of the side effects you are experiencing is severe or if you notice any side effect not mentioned in this prospectus, inform your doctor or pharmacist

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, even if it is a possible adverse effect not appearing in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use Levosimendan Altan after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Store in refrigerator (between2°Cand8°C).

Do not freeze

After dilution

Chemical and physical stability has been demonstrated for use during 24 hours at 25 ° C.

From a microbiological point of view, unless the opening / reconstitution / dilution method excludes the risk of microbiological contamination, the product should be used immediately. If not used immediately, storage times and conditions in use are the responsibility of the user.

As with other parenteral products, visually inspect the diluted solution to see if there are particles and discoloration before administration.

Medicines should not be disposed of through drains. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

Composition of Levosimendan Altan

• The active principle is levosimendan 2.5 mg/ml. Each ml of concentrate contains 2.5 mg of levosimendan.
• The other components are povidone, anhydrous citric acid, and anhydrous ethanol.

Appearance of the product and contents of the container

The concentrate is a clear yellow or orange solution to be diluted before use, packaged in colourless type I glass vials with a chlorobutyl rubber stopper with fluoropolymer coating and an aluminium flip-off.

Container sizes:

1 vial of 5 ml

Holder of the marketing authorization and responsible for manufacturing

Altan Pharma Limited

The Lennox Building

50 South Richmond Street

Dublin 2

D02 FK02, Ireland

Local representative:

Altan Pharmaceuticals, S.A.

C/ Cólquide, Nº 6, Portal 2, 1ª Planta, Oficina F.

Edificio Prisma, Las Rozas, 28230 Madrid

Spain

Responsible for manufacturing

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)

Last review date of this leaflet:10/2022.

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es

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This information is intended solely for healthcare professionals:

Levosimendan Altan 2.5 mg/ml concentrate for solution for infusion

Instructions for use and handling

The Levosimendan Altan 2.5 mg/ml concentrate for solution for infusion is designed exclusively for single use. As with other parenteral products, visually inspect the diluted solution to see if there are particles and discoloration before administration.

Levosimendan Altan 2.5 mg/ml concentrate for solution for infusion should not be diluted to a concentration higher than 0.05 mg/ml as indicated below, otherwise opalescence and precipitation may occur.

To prepare the infusion 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 the infusion 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 only for hospital use. It should be administered in a hospital unit with monitoring facilities and experience with the use of inotropic agents.

Levosimendan Altan should be diluted before administration

The infusion should be administered exclusively by intravenous route, both by peripheral and central route.

Consult the technical data sheet for information on dosage.