Leaflet: information for the user

Epoprostenol SUN 0.5 mg powder for solution for infusion

Epoprostenol SUN 1.5 mg powder for solution for infusion

epoprostenol

Read this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

1. What is Epoprostenol SUN and what it is used for

2. What you need to know before starting to use Epoprostenol SUN

3. How to use Epoprostenol SUN

4. Possible side effects

5. Storage of Epoprostenol SUN

6. Contents of the pack and additional information

Epoprostenol Sun contains the active ingredient epoprostenol, which belongs to a group of medications called prostaglandins, that prevent blood coagulation and dilate blood vessels.

Epoprostenol Sun is used to treat a lung disease known as "pulmonary arterial hypertension". This occurs when the blood pressure in the blood vessels of the lungs is high. Epoprostenol Sun dilates the blood vessels to reduce blood pressure in the lungs.

Epoprostenol Sun is also used to prevent blood coagulation during renal dialysis in emergency situations where heparin cannot be used.

No use Epoprostenol Sun

• if you are allergicto epoprostenol or to any of the other components of this medication (listed in section 6)
• if you haveheart failure.
• if you start to develop fluid accumulation in the lungs that causes difficulty breathing after starting treatment.

If you consider that any of these situations apply to you,do not use Epoprostenol Sununtil you have consulted your doctor.

Warnings and precautions

Consult your doctor before starting to use Epoprostenol Sun

• ifyou bleedeasily (for example, from the nose).

Skin and injection site lesions

Epoprostenol Sun is injected into a vein. It is essential that the medication does not leak or filter out of the vein into the surrounding tissues. If it does, it may damage the skin. The symptoms are:

• sensitivity
• burning
• itching
• swelling
• redness.

This may be followed by the formation of blisters and skin peeling. It is essential that you monitor the injection site while being treated with Epoprostenol Sun.

Contact the hospital immediatelyif the injection site becomes painful, itches, or becomes inflamed, or if you notice any blister formation or skin peeling.

Effect of Epoprostenol Sun on blood pressure and heart rate

Epoprostenol Sun may accelerate or slow down heart rate. Your blood pressure may also become very low. While being treated with Epoprostenol Sun, your heart rate and blood pressure will be monitored. Symptoms of low blood pressure includedizzinessandblackouts.

Inform your doctorif you experience any of these symptoms. You may need to reduce your dose or discontinue infusion.

Children and adolescents

The safety and efficacy of Epoprostenol Sun in children have not been established.

Use of Epoprostenol Sun with other medications

Inform your doctor or nurse if you are using, have used recently, or may need to use any other medication.

Some medications may affect the functioning of Epoprostenol Sun or make it more likely that its adverse effects will increase.

Epoprostenol Sun may also affect the functioning of other medications if taken at the same time. These include:

• medications usedto treat high blood pressure
• medications used toprevent blood clot formation
• medications used todissolve blood clots
• medications used totreat inflammation or pain(also known as NSAIDs), for example ibuprofen
• digoxin (used to treatcardiac disorders).

Inform your doctor or nurseif you are taking any of these medications.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

It is unknownwhether the components of Epoprostenol Sun can pass into breast milk.You should stop breastfeeding while being treated with Epoprostenol Sun.

Driving and operating machinery

The treatment may affect your ability to drive and operate machinery.

Do not drive or operate machineryif you do not feel well.

Epoprostenol Sun contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per dose; this is, essentially "sodium-free".

The diluted solution of Epoprostenol Sun (pH 12) should not be used with administration materials that contain polyethylene terephthalate (PET) or polyethylene terephthalate glycol (PETG).

Follow exactly the administration instructions of this medication as indicated by your doctor, nurse, or pharmacist. In case of doubt, consult your doctor or nurse again.

Epoprostenol Sun comes as a powder in a small glass vial. The powder must be dissolved before use.

Epoprostenol Sun should not be administered as a rapid injection into a vein. It must be administered always as an intravenous infusion (drip).

Your doctor will indicate how much Epoprostenol Sun is suitable for you. The amount you are administered is based on your body weight and the type of disease. Your dose may be increased or decreased depending on how well you respond to treatment.

Epoprostenol Sun is administered through a slow infusion (drip) into a vein.

Pulmonary Arterial Hypertension

The first treatment will be administered in a hospital. This is because the doctor needs to monitor you and identify the best dose for you.

Start with an infusion of Epoprostenol Sun. The dose will be increased until your symptoms are relieved and any adverse effects are controlled. Once the best dose is identified, a permanent catheter (line) will be placed in one of your veins. You will then be treated using a pump for infusion.

Renal Dialysis

Epoprostenol Sun infusion will be administered during the duration of your dialysis.

Use of Epoprostenol Sun at Home (only for the treatment of Pulmonary Arterial Hypertension)

If you are being treated at home, your doctor or nurse will teach you how to prepare and use Epoprostenol Sun. They will also instruct you on how to interrupt treatment if necessary. Stopping Epoprostenol Sun should be done gradually. It is very important that you carefully follow all instructions.

Epoprostenol Sun comes as a powder in a glass vial. Before using it, the powder must be dissolved in a liquid. The liquid does not contain preservatives. You should discard any unused liquid.

Care of the Catheter

If you have had a "line" placed in a vein, it is very important to keep that area clean; if not, it could become infected. Your doctor or nurse will teach you how to clean the "line" and the surrounding area. It is very important that you carefully follow all instructions. It is also very important that you carefully follow all instructions related to changing the medication administration container of the pump (cassette) and that you always use an extension set with an internal filter, as indicated by your doctor in order to reduce the risk of infection.

If you use more Epoprostenol Sun than you should

Seek urgent medical attentionif you think you have used or have been administered too much Epoprostenol Sun. Symptoms of overdose may include headache, nausea, vomiting, rapid heartbeat, heat or tingling, or a sensation of dizziness (vertigo).

If you forgot to use Epoprostenol Sun

Do not use a double dose to compensate for the missed doses.

If you interrupt treatment with Epoprostenol Sun

Stopping Epoprostenol Sun should be done gradually. If you stop treatment too quickly, you may experience severe adverse effects, including dizziness, weakness, and difficulty breathing. If you have problems with the infusion pump or catheter, because it stops or prevents treatment with Epoprostenol Sun,contact your doctor, nurse, or hospital immediately.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Inform your doctor or nurse immediately if you experience any of the following signs of blood infection, low blood pressure, or severe bleeding:

-You feel your heart beating faster, or you have chest pain or difficulty breathing.

-You feel dizzy or experience dizziness, especially when standing.

-You have a fever or chills.

-You bleed more frequently or for longer periods, for example from the nose.

-The injection site becomes painful, itches, or becomes inflamed, or you notice any blistering or peeling on the skin (see section 2).

Other possible side effects

Very common (affects more than 1 in 10 people)

-Headache

-Mandibular pain

-Unspecified pain

-Nausea (feeling sick)

-Vomiting

-Diarrhea

-Facial flushing (redness of the face).

Common (may affect up to 1 in 10 people)

-Blood infection (septicemia)

-Fast heart rate

-Bradycardia (slow heart rate)

-Low blood pressure

-Bleeding in various locations and increased tendency to bruise, for example bleeding from the nose or gums

-Abdominal discomfort or pain

-Chest pain

-Joint pain

-Anxiety or nervousness

-Rash

-Pain at the injection site

• Decreased platelet count in the blood (blood cells that help with clotting). This may be detected in blood tests.

Rare (may affect up to 1 in 1,000 people)

-Infection at the injection site.

Very rare (may affect up to 1 in 10,000 people)

-Chest pressure sensation

-Fatigue, weakness

-Agitation

-Pallor

-Redness at the injection site

-Hyperthyroidism

-Catheter occlusion

Unknown frequency (with the available data, the frequency cannot be estimated)

-Enlargement or hyperactivity of the spleen

-Pulmonary edema (fluid accumulation in the lungs)

-Increased blood sugar (glucose)

-Abdominal swelling due to fluid accumulation around the stomach.

-Excessive blood pumping from the heart leading to difficulty breathing, fatigue, swelling of the legs and abdomen due to fluid retention, persistent cough.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report side effects directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use Epoprostenol Sun after the expiration date that appears on the vial label and on the box after CAD. The expiration date is the last day of the month indicated.

Do not freeze.

Store the vial in the outer container to protect it from light.

The reconstituted solution must be diluted to the final concentration within the first hour from reconstitution (seeInformation for Healthcare Professionals).

To consult the storage conditions after reconstitution and dilution of the medication, seeInformation for Healthcare Professionals.

Do not use this medication if you notice the presence of particles in the reconstituted solution.

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

Composition of Epoprostenol Sun

Epoprostenol SUN 0.5 mg, powder for solution for infusion:

-The active ingredient is epoprostenol (as epoprostenol sodium).
Each vial contains 0.531 mg of epoprostenol sodium equivalent to 0.5 mg of epoprostenol.
One ml of reconstituted solution contains 0.1 mg of epoprostenol (as epoprostenol sodium).

Epoprostenol SUN 1.5 mg, powder for solution for infusion:

-The active ingredient is epoprostenol (as epoprostenol sodium).
Each vial contains 1.593 mg of epoprostenol sodium equivalent to 1.5 mg of epoprostenol.
One ml of reconstituted solution contains 0.3 mg of epoprostenol (as epoprostenol sodium).

The other components are glycine, sucrose, and sodium hydroxide (to adjust the pH).

Appearance of Epoprostenol Sun and contents of the package

White or off-white powder in a transparent glass vial with a rubber stopper and an aluminum pressure cap.

Each package contains a vial containing 0.5 mg of powder.

Each package contains a vial containing 1.5 mg of powder.

Only some package sizes may be marketed.

Marketing Authorization Holder and Responsible Manufacturer

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

Netherlands

Local Representative

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya 53-55

08007 Barcelona

Spain

Phone: +34 93 342 78 90

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

GermanyEpoprostenol SUN

FranceEpoprostenol SUN

ItalyEpoprostenolo SUN

NetherlandsEpoprostenol SUN

SpainEpoprostenol SUN

United Kingdom (Northern Ireland)Epoprostenol

Last review date of this leaflet: October 2023

This information is intended solely for medical professionals or healthcare professionals:

Renal dialysis

There is a package available for use in the treatment of renal dialysis:

- A vial containing 0.5 mg of powder.

Reconstitution:

Remove approximately 5 ml of sterile water or 0.9% sodium chloride injection with a sterile syringe, inject it into the vial containing Epoprostenol SUN, and agitate gently until the powder has dissolved. The reconstituted solution should be examined before proceeding with dilution. It is prohibited to use it if it presents particles or discoloration. The disposal of unused reconstituted solution should be carried out in accordance with local regulations.

Dilution:

The reconstituted solution must be diluted to the final concentration within the first hour from reconstitution. Subsequent dilution should be carried out with the same solvent used for reconstitution of the sterile lyophilized powder.

When epoprostenol SUN lyophilisate is reconstituted with sterile water for injection or 0.9% sodium chloride injection, the final injection solution has a pH ranging from 11.5 to 12.

Calculation of perfusion rate:

The perfusion rate can be calculated using the following formula:

Perfusion rate (ml/min) =Dose (ng/kg/min) × body weight (kg)

Concentration of the solution (ng/ml)

Perfusion rate (ml/h) = perfusion rate (ml/min) x 60

Pulmonary arterial hypertension

There are two package sizes available for use in the treatment of pulmonary arterial hypertension:

- A vial containing 0.5 mg of powder.

- A vial containing 1.5 mg of powder.

Reconstitution:

Remove approximately 5 ml of sterile water or 0.9% sodium chloride injection with a sterile syringe, inject it into the vial containing Epoprostenol SUN, and agitate gently until the powder has dissolved. The reconstituted solution should be examined before proceeding with dilution. It is prohibited to use it if it presents particles or discoloration. The disposal of unused reconstituted solution should be carried out in accordance with local regulations.

Dilution:

The reconstituted solution must be diluted to the final concentration within the first hour from reconstitution. Subsequent dilution should be carried out with the same solvent used for reconstitution of the sterile lyophilized powder. When administered chronically, Epoprostenol SUN should be prepared in a suitable drug administration device for the infusion pump.

When the lyophilisate of Epoprostenol SUN is reconstituted with sterile water for injection or 0.9% sodium chloride injection, the final injection solution has a pH ranging from 11.5 to 12.

Among the ambulatory pumps suitable for use in the administration of Epoprostenol SUN are:

- CADD-Legacy 1

- CADD-Legacy PLUS

Manufactured by Smiths Medical.

Among the pump accessories compatible with the administration of Epoprostenol SUN are:

• CADD 50 mL; 100 mL disposable medication cassettes from Smiths Medical.
• Internal filter extension set (internal filter extension set with male Luer, 0.2 micra air eliminator filter, pinch clamp, and integral anti-siphon valve with male Luer) from Smiths Medical.

Only internal filter extension sets with 0.22 micra filters should be used between the infusion pump and the catheter. It is recommended to use filters with a hydrophilic polyethersulfone membrane. The extension set and internal filter should be changed at least every 48 hours.

The Epoprostenol SUN solution diluted to the final concentration in the drug administration device, following the instructions, can be administered immediately at room temperature (25°C) or stored for a maximum of 8 days between 2 and 8°C according to the conditions of use described in Table 2.

Table 2: Maximum duration of administration (hours) at room temperature (25°C) of fully diluted solutions stored in the drug administration device.

Do not expose the fully diluted solution to direct sunlight.

Special precautions for storage

Do not freeze.

The reconstituted solution must be diluted to the final concentration within the first hour from reconstitution.

The reconstitution and dilution should be carried out immediately before use.

The freshly prepared solutions of epoprostenol for the treatment of pulmonary arterial hypertension can be administered immediately at 25°C or stored in the drug administration device to protect them from light for a maximum of 8 days between 2 and 8°C according to the conditions of use described in Table 2.