Trepulmix 5 mg/ml solution for infusion

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor.
• 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 Trepulmix is and what it is used for
2. What you need to know before you use Trepulmix
3. How to use Trepulmix
4. Possible side effects
5. How to store Trepulmix
6. Contents of the pack and other information

The active ingredient of Trepulmix is treprostinil.

Treprostinil belongs to a group of medicines which work in a similar way to the naturally occurring prostacyclins. Prostacyclins are hormone-like substances which reduce blood pressure by relaxing blood vessels, causing them to widen, which allows the blood to flow more easily. Prostacyclins can also have an influence in preventing blood from clotting.

Trepulmix is used for the treatment of adult patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH), or persistent or recurrent CTEPH after surgical treatment (severity classified WHO Functional Class (FC) III or IV), to improve exercise capacity and symptoms of the disease. Chronic thromboembolic pulmonary hypertension is a condition where your blood pressure is too high in the blood vessels between the heart and the lungs causing shortness of breath, dizziness, tiredness, fainting, palpitations or abnormal heartbeat, dry cough, chest pain and swollen ankles or legs.

Trepulmix lowers blood pressure within the pulmonary artery by improving blood flow and reducing the amount of work for the heart. Improved blood flow leads to an increased supply of oxygen to the body and reduced strain on the heart, causing it to function more effectively. Trepulmix improves the symptoms associated with CTEPH and the ability to exercise in patients who are limited in terms of activity.

• if you are allergic to treprostinil or any of the other ingredients of this medicine (listed in section 6).
• if you have been diagnosed with a disease called “pulmonary veno-occlusive disease”. This is a disease in which the blood vessels that carry blood through your lungs become swollen and clogged resulting in a higher pressure in the blood vessels between the heart and the lungs.
• if you have severe liver disease
• if you have a heart problem, for example:
  • a heart attack (myocardial infarction) within the last six months
  • severe changes in heart rate
  • severe coronary heart disease or unstable angina
  • a heart defect has been diagnosed, such as a faulty heart valve that causes the heart to work poorly
  • any disease of the heart which is not being treated or not under close medical observation
• if you are at a specific high risk of bleeding – for example active stomach ulcers, injuries or other bleeding conditions
• if you have had a stroke within the last 3 months, or any other interruption of blood supply to the brain

Talk to your doctor before using Trepulmix if you:

• suffer from any liver disease
• suffer from kidney disease
• have been advised that you are medically obese (BMI greater than 30 kg/m2)
• are on a low sodium diet

During your treatment with Trepulmix, tell your doctor:

• if your blood pressure decreases (hypotension)
• if you experience a rapid increase in breathing difficulties or persistent cough (this can be related to congestion in the lungs or asthma or other condition), consult your doctor immediately.
• if you have excessive bleeding as treprostinil may increase the risk, by preventing your blood from clotting

Trepulmix must not be used in children and adolescents.

Tell your doctor if you are taking/using, have recently taken/used or might take/use any other medicines. Please tell your doctor if you are taking:

• medicines used to treat high blood pressure (antihypertensive medicines or other vasodilators)
• medicines used to increase the rate of urination (diuretics) including furosemide
• medicines that stop blood clotting (anticoagulants) such as warfarin, heparin or nitric oxide based products
• any non-steroidal anti-inflammatory (NSAID) medicines (e.g. acetylsalicylic acid, ibuprofen)
• medicines which may enhance or weaken the effects of Trepulmix (e.g. gemfibrozil, rifampicin, trimethoprim, deferasirox, phenytoin, carbamazepine, phenobarbital, St. John's wort.), as your doctor may need to adjust the dosage of Trepulmix.

Trepulmix is not recommended if you are pregnant, planning to become pregnant, or think that you might be pregnant, unless considered essential by your doctor. The safety of this medicine for use during pregnancy has not been established.

Contraception is strongly recommended during Trepulmix treatment.

Trepulmix is not recommended for use in breast-feeding, unless considered essential by your doctor. You are advised to stop breast-feeding if Trepulmix is prescribed for you, because it is not known whether this medicine passes into breast milk.

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

Trepulmix may induce low blood pressure with dizziness or fainting. In such a case do not drive or operate machinery and ask your doctor for advice.

Please tell your doctor if you are on a controlled sodium diet. They will take into account:

Trepulmix 1 mg/ml solution for infusion

This medicine contains 36.8 mg sodium (main component of cooking/table salt) in each vial. This is equivalent to 1.8% of the recommended maximum daily dietary intake of sodium for an adult.

Trepulmix 2.5 mg/ml solution for infusion

This medicine contains 37.3 mg sodium (main component of cooking/table salt) in each vial. This is equivalent to 1.9% of the recommended maximum daily dietary intake of sodium for an adult.

Trepulmix 5 mg/ml solution for infusion

This medicine contains 39.1 mg sodium (main component of cooking/table salt) in each vial. This is equivalent to 2.0% of the recommended maximum daily dietary intake of sodium for an adult.

Trepulmix 10 mg/ml solution for infusion

This medicine contains 37.4 mg sodium (main component of cooking/table salt) in each vial. This is equivalent to 1.9% of the recommended maximum daily dietary intake of sodium for an adult.

If you accidentally overdose Trepulmix, you may experience nausea, vomiting, diarrhoea, low blood pressure (dizziness, light-headedness or fainting), skin flushes and/or headaches.

If any of these effects become severe you should contact your doctor or hospital immediately. Your doctor may reduce or discontinue the infusion until your symptoms have disappeared. Trepulmix solution for infusion will then be reintroduced at a dose level recommended by your doctor.

Always use Trepulmix as directed by your doctor or hospital specialist. Do not stop using Trepulmix unless your doctor has advised you to.

Abrupt withdrawal or sudden reductions in the dose of Trepulmix may cause the pulmonary arterial hypertension to return with the potential for rapid and severe deterioration in your condition.

If you get any side effects, talk to your doctor. 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 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.

The active substance is treprostinil.

Trepulmix 1 mg/ml solution for infusion

Each ml of solution contains 1 mg treprostinil (as sodium salt).

Each 10 ml vial of solution contains 10 mg treprostinil (as sodium salt).

Trepulmix 2.5 mg/ml solution for infusion

Each ml of solution contains 2.5 mg treprostinil (as sodium salt)

Each 10 ml vial of solution contains 25 mg treprostinil (as sodium salt).

Trepulmix 5 mg/ml solution for infusion

Each ml of solution contains 5 mg treprostinil (as sodium salt).

Each 10 ml vial of solution contains 50 mg treprostinil (as sodium salt).

Trepulmix 10 mg/ml solution for infusion

Each ml of solution contains 10 mg treprostinil (as sodium salt).

Each 10 ml vial of solution contains 100 mg treprostinil (as sodium salt).

The other ingredients are:

Sodium citrate, sodium chloride, sodium hydroxide, hydrochloric acid, metacresol and water for injections. See section 2, “Trepulmix contains sodium”.

Trepulmix is a clear colourless to slightly yellow solution, available in a 10 ml clear glass vial sealed with a rubber stopper and a colour coded cap:

Trepulmix 1 mg/ml solution for infusion

Trepulmix 1 mg/ml solution for infusion has a yellow rubber cap.

Trepulmix 2.5 mg/ml solution for infusion

Trepulmix 2.5 mg/ml solution for infusion has a blue rubber cap.

Trepulmix 5 mg/ml solution for infusion

Trepulmix 5 mg/ml solution for infusion has a green rubber cap.

Trepulmix 10 mg/ml solution for infusion

Trepulmix 10 mg/ml solution for infusion has a red rubber cap.

Each carton contains one vial.

Not all pack sizes may be marketed.