Epoprostenol 1.5 mg powder for solution for infusion

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

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

• if you are allergic to epoprostenol or any of the other ingredients of this medicine (listed in section6)
• if you have heart failure
• if you start to develop a build-up of fluid in your lungs causing breathlessness after starting this treatment.

If you think any of these apply to you, don’t use Epoprostenol until you have checked with your doctor.

Talk to your doctor before treatment with Epoprostenol

• if you bleed easily (for example from your nose).

Epoprostenol is injected into a vein. It is important that the medicine does not leak out of the vein into the surrounding tissue. If it does, the skin could be damaged. The symptoms of this are:

• tenderness
• burning
• stinging
• swelling
• redness.

This may be followed by blistering and shedding of the skin. While you are being treated with Epoprostenol, it is important that you check the injection area.

Contact the hospital immediately for advice if the area becomes sore, painful or swollen or you notice any blistering or shedding of the skin.

Epoprostenol can cause your heart to beat faster or slower. Also your blood pressure can become too low. While you are being treated with Epoprostenol your heart rate and blood pressure will be checked. The symptoms of low blood pressure include dizziness and fainting.

Tell your doctor immediately if you get these symptoms. Your dose may need to be reduced or your infusion stopped.

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

Tell your doctor or nurse if you are using, have recently used or might use any other medicines.

Some medicines may affect how Epoprostenol works, or make it more likely that you’ll have side effects.

Epoprostenol can also affect how some other medicines work if taken at the same time. These include:

• medicines used to treat high blood pressure
• medicines used to prevent blood clots
• medicines used to dissolve blood clots
• medicines to treat inflammation or pain (also called ‘NSAIDs’), for example ibuprofen
• digoxin (used to treat heart disease).

Tell your doctor or nurse if you are taking any of these.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before treatment with this medicine.

It is not known whether the ingredients of Epoprostenol can pass into breast-milk. You should stop breastfeeding your child during treatment with Epoprostenol.

Your treatment may have an effect on the ability to drive or use machinery.

Don’t drive or use machines if you’re feeling unwell.

This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium- free’.

The diluted solution of Epoprostenol (pH 12) must not be used with administration materials containing polyethylene terephthalate (PET) or polyethylene terephthalate glycol (PETG).

Your first treatment will be given to you in a hospital. This is because your doctor needs to monitor you and find the best dose for you.

You will start with an infusion of Epoprostenol. The dose will be increased until your symptoms are relieved and any side effects are manageable. Once the best dose has been found, a permanent tube (line) will be fitted into one of your veins. You can then be treated using an infusion pump.

You will be given an infusion of Epoprostenol for the duration of your dialysis.

If you are treating yourself at home, your doctor or nurse will show you how to prepare and use Epoprostenol. They will also advise you how to stop treatment if necessary. Stopping Epoprostenol must be done gradually. It is very important that you follow all their instructions carefully.

Epoprostenol comes as a powder in a glass vial. Before use, the powder needs to be dissolved in a liquid. The liquid does not contain a preservative. If you have any of the liquid left over, it must be thrown away.

If you have been fitted with a ‘line’ into a vein it is very important to keep this area clean, otherwise you could get an infection. Your doctor or nurse will show you how to clean your ‘line’ and the area around it. It is very important that you follow all of their instructions carefully. It is also very important that you carefully follow all instructions regarding the change of the pump drug delivery reservoir (cassette) and that you always use an extension set with an in-line filter, as instructed by your doctor to reduce the risk of an infection.

Seek urgent medical attention if you think you have used or been given too much Epoprostenol. Symptoms of overdose may include headache, nausea, vomiting, fast heart rate, warmth or tingling, or feeling like you might pass out (feeling faint/dizziness).

Do not use a double dose to make up for a forgotten dose.

Stopping Epoprostenol must be done gradually. If the treatment is stopped too quickly you may get serious side effects, including dizziness, feeling weak and breathing difficulties. If you have problems with the infusion pump or an injection line that stops or prevents treatment with Epoprostenol, contact your doctor, nurse or hospital immediately.

• You feel that your heart is beating faster, or you have chest pain or shortness of breath
• You feel dizzy or feel faint, especially on standing
• You have fevers or chills
• You have more frequent or longer periods of bleeding, for example nose bleeding
• The injection site becomes sore, painful or swollen or you notice any blistering or shedding of the skin (see Section 2).

Very common (may affect more than 1 in 10 people)

• headache
• jaw pain
• pain
• being sick (vomiting)
• feeling sick (nausea)
• diarrhoea
• redness of your face (flushing).

Common (may affect up to 1 in 10 people)

• infection of the blood (septicaemia)
• heart beating faster
• slow heart beat
• low blood pressure
• bleeding at various sites and bruising more easily than normal, for example from the nose or gums
• stomach discomfort or pain
• chest pain
• joint pain
• feeling anxious, feeling nervous
• rash
• pain at the injection site
• decrease in the number of blood platelets (cells that help the blood to clot). This may show up in blood tests.

Uncommon (may affect up to 1 in 100 people)

• sweating
• dry mouth.

Rare (may affect up to 1 in 1000 people)

• infection at the injection site.

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

• feeling of tightness around the chest
• feeling tired, weak
• feeling agitated
• pale skin
• redness at the injection site
• overactive thyroid gland
• blockage of the injection catheter.

Not known (frequency cannot be estimated from the available data)

• enlarged or overactive spleen
• build up of fluid in the lungs (pulmonary oedema)
• increase in sugar (glucose) in the blood
• swelling due to build up of fluid around the stomach
• too much pumping of blood from the heart leading to shortness of breath, fatigue, swelling of the legs and abdomen due to fluid build-up, persistent cough.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

Epoprostenol 0.5 mg, powder for solution for infusion:

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

Epoprostenol 1.5 mg, powder for solution for infusion:

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

The other ingredients are glycine, sucrose and sodium hydroxide (for pH adjustment).

White to off-white powder in a clear glass vial with a rubber stopper and an aluminium flip-off cap.

Each pack contains one vial holding 0.5 mg powder.

Each pack contains one vial holding 1.5 mg powder.

Not all pack sizes may be marketed.