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

The active ingredient of Treprostinil Tillomed 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.

What Treprostinil Tillomed is used to treat

Treprostinil Tillomed is used to treat idiopathic or heritable pulmonary arterial hypertension (PAH) in patients with moderate severity of the symptoms. Pulmonary arterial 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.

Treprostinil Tillomed is initially administered as a continuous subcutaneous (under the skin) infusion. Some patients may become unable to tolerate this because of local site pain and swelling. Your physician will decide whether Treprostinil Tillomed can be administered by continuous intravenous infusion directly into a vein with the insertion of a central venous tube (catheter) that is connected to an external pump. Your doctor will determine what is the best option for you.

How Treprostinil Tillomed works

Treprostinil Tillomed 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 improved supply of oxygen to the body and reduced strain on the heart, causing it to function more effectively. Treprostinil improves the symptoms associated with PAH and the ability to exercise in patients who are limited in terms of activity.

• if you are allergic (hypersensitive) 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 myocardial infarction (heart attack) 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 Treprostinil Tillomed:

• if you suffer from any liver disease
• if you suffer from kidney disease
• if you have been advised that you are medically obese (BMI greater than 30 kg/m²)
• if you have Human Immunodeficiency Virus (HIV) infection
• if you have high blood pressure in your liver veins (portal hypertension)
• if you have a birth defect in your heart which affects the way your blood flows through it.

During your treatment with Treprostinil Tillomed, 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
• if you develop a fever whilst receiving intravenous treprostinil or the intravenous infusion site becomes red, swollen and / or painful to touch, as this could be a sign of infection.

Tell your doctor if you are taking, have recently taken, or might take any other medicines.

Please tell your doctor if you are taking:

• medicines used to treat high blood pressure (antihypertensive drugs or other vasodilators)
• drugs 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 Drugs (NSAID) (e.g. acetylsalicylic acid, ibuprofen)
• medicines that may increase or decrease the effect of treprostinil (e.g. gemfibrozil, rifampicin, trimethoprim, deferasirox, phenytoin, carbamazepine, phenobarbital, St. John’s Wort) as your doctor may need to adjust your dose of treprostinil.

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.

Treprostinil 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.

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

Contraception is strongly recommended during treatment with treprostinil.

Treprostinil 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.

Treprostinil Tillomed 1 mg/ml solution for infusion

This medicine contains 74.16 mg sodium (main component of cooking/table salt) in each 20 ml vial. This is equivalent to 3.71% of the recommended maximum daily dietary intake of sodium for an adult.

This medicine contains 75.08 mg sodium (main component of cooking/table salt) in each 20 ml vial. This is equivalent to 3.75% of the recommended maximum daily dietary intake of sodium for an adult.

This medicine contains 78.16 mg sodium (main component of cooking/table salt) in each 20 ml vial. This is equivalent to 3.91% of the recommended maximum daily dietary intake of sodium for an adult.

This medicine contains 75 mg sodium (main component of cooking/table salt) in each 20 ml vial. This is equivalent to 3.75% of the recommended maximum daily dietary intake of sodium for an adult.

As with any long-term intravenous treatment, there is a risk of getting blood stream infections. Your doctor will train you on how to avoid this.

If you accidentally overdose on treprostinil, 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 then you should contact your doctor or hospital immediately. Your doctor may reduce or discontinue the infusion until your symptoms have disappeared. Treprostinil Tillomed solution for infusion will then be reintroduced at a dose level recommended by your doctor.

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

Abrupt withdrawal or sudden reductions in the dose of treprostinil 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 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.

The active substance is treprostinil 1 mg/ml, 2.5 mg/ml, 5 mg/ml, 10 mg/ml.

The other ingredients in Treprostinil Tillomed are:

Sodium chloride, metacresol, sodium citrate, sodium hydroxide, hydrochloric acid; concentrated, water for injection.

Treprostinil Tillomed 1 mg/ml solution for infusion

Clear colourless to slightly yellow solution, practically free from visible particles filled in 20 ml clear glass vial stoppered with 20 mm dark grey bromobutyl rubber stopper with four marks equally spaced 90° apart and with ring at the centre and sealed with 20 mm yellow matte finish flip-off seal.

Treprostinil Tillomed 2.5 mg/ml solution for infusion

Clear colourless to slightly yellow solution, practically free from visible particles filled in 20 ml clear glass vial stoppered with 20 mm dark grey bromobutyl rubber stopper with four marks equally spaced 90° apart and with ring at the centre and sealed with 20 mm blue matte finish flip-off seal.

Treprostinil Tillomed 5 mg/ml solution for infusion

Clear colourless to slightly yellow solution, practically free from visible particles filled in 20 ml clear glass vial stoppered with 20 mm dark grey bromobutyl rubber stopper with four marks equally spaced 90° apart and with ring at the centre and sealed with 20 mm green matte finish flip-off seal.

Treprostinil Tillomed 10 mg/ml solution for infusion

Clear colourless to slightly yellow solution, practically free from visible particles filled in 20 ml clear glass vial stoppered with 20 mm dark grey bromobutyl rubber stopper with four marks equally spaced 90° apart and with ring at the centre and sealed with 20 mm red matte finish flip-off seal.

The vials are packaged in an outer carton.

Pack size: 1 vial/pack

Marketing Authorisation Holder

Manufacturer