Epoprostenol 0.5 mg Powder and Solvent for Solution for Infusion

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• 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 or pharmacist. 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 take Epoprostenol
3. How to take 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 Section 6).
• 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 take Epoprostenol until you have checked with your doctor.

Before you are given Epoprostenol your doctor needs to know:

• If you have any problems with bleeding.

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.

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

Tell your doctor or pharmacist if you are taking, have recently taken or might take 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, NSAID’s)
• Digoxin (used to treat heart disease).

Tell your doctor or pharmacist 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 taking this medicine as your symptoms could worsen during pregnancy.

It is not known whether the ingredients of Epoprostenol can pass into breast-milk. You should stop breast-feeding 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 unless you’re feeling well.

This medicinal product contains 2.43 mmol (or 56 milligram) sodium (salt) per dose. To be taken into consideration by patients on a controlled sodium (salt) diet.

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 the liquid provided. 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.

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 take 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 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.

Talk to your doctor or pharmacist or nurse about any other side effects, including those not listed in this leaflet.

Very common side effects

These 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 side effects

These 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

Common side effects that may show up in blood tests

• decrease in the number of blood platelets (cells that help the blood to clot)

Uncommon side effects

These may affect up to 1 in 100 people:

• Sweating
• Dry mouth

Rare side effects

These may affect up to 1 in 1,000 people:

• Infection at the injection site

Very rare side effects

These 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

It is not known how many people are affected:

• Build up of fluid in the lungs (pulmonary oedema)
• Increase in sugar (glucose) in the blood
• Too much pumping of blood form 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 or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard

By reporting side effects you can help provide more information on the safety of this medicine.

Pulmonary arterial hypertension

Once Epoprostenol powder has been dissolved, and diluted, it should ideally be used immediately. If you are being given Epoprostenol using an infusion pump, a ‘cold pouch’ may be used to maintain the temperature of the solution.

When using a ‘cold pouch’, the solution can be stored in the pump for up to 24 hours at 2-8°C if necessary. The cold pouch must be regularly changed throughout the day, to maintain the temperature of the solution.

If you are not using a ‘cold pouch’, the solution can be stored in the pump:

• for up to 12 hours at 25°C, if it has just been made up
• for a maximum of 8 hours if it was made previously and has been stored at 2-8°C.

Renal Dialysis:

Once Epoprostenol has been dissolved and diluted, any unused solution can be stored at 25°C and used within 12 hours.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

Powder for solution for infusion

• The active substance is Epoprostenol (as Sodium).
  1 vial contains 0.531 milligrams Epoprostenol Sodium, corresponding to 0.5 milligrams Epoprostenol.
• The other ingredients are:
  Powder for solution for infusion: Mannitol, Glycine, Sodium Chloride, Sodium Hydroxide (for pH adjustment)
  Solvent: Glycine, Sodium Chloride, Sodium Hydroxide (for pH adjustment), Water for Injection

When 1 vial with 0.5 mg epoprostenol is reconstituted with 50 ml of sterile buffer, the resultant concentration is 10,000 nanograms per ml.

Solvent

Each vial of solvent contains 50 ml of a sterile glycine buffer solution containing approximately 55 milligram sodium.

Epoprostenol is a white lyophilised powder cake packed in clear glass vials with grey lyo stopper and aluminium caps with blue flip-off inserts. The solvent is a clear, colourless solution packed in clear glass vials.

After reconstitution Epoprostenol is a colourless solution, practically free of particles.

Each pack unit contains

• one vial Epoprostenol 0.5 mg, containing a white freeze-dried powder cake packed in a 15 ml clear glass vial Type I with grey lyo stopper and aluminium caps with blue flip-off inserts.
• one 50ml sterile Glycine buffer solution, pH 10.5 in a clear glass vial
• one single unit sterile filter device for aseptic preparation of infusion solution

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