Treprostinil Zentiva

Leaflet accompanying the packaging: information for the user

Treprostinil Tillomed

1 mg/mL, 2.5 mg/mL, 5 mg/mL, 10 mg/mL, solution for infusion
Treprostinilum

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a doctor.
• This medicine has been prescribed to a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

1.

What is Treprostinil Tillomed and what is it used for

2.

Important information before using Treprostinil Tillomed

3.

How to use Treprostinil Tillomed

4.

Possible side effects

5.

How to store Treprostinil Tillomed

6.

Contents of the packaging and other information

1. What is Treprostinil Tillomed and what is it used for

What is Treprostinil Tillomed

The active substance of Treprostinil Tillomed is treprostinil.
Treprostinil belongs to a group of medicines that work in a similar way to naturally occurring prostacyclins in the body. Prostacyclins are hormone-like substances. They lower blood pressure by relaxing blood vessels, causing them to widen and thus facilitating blood flow. Additionally, prostacyclins may also affect the prevention of blood clotting.

In which diseases is Treprostinil Tillomed used

Treprostinil Tillomed is used to treat idiopathic or hereditary pulmonary arterial hypertension (PAH) in patients with moderate symptoms. Pulmonary arterial hypertension is a condition in which blood pressure is too high in the blood vessels between the heart and lungs, causing shortness of breath, dizziness, fatigue, fainting, palpitations or irregular heartbeat, dry cough, chest pain, and swelling of the ankles or feet.
Treprostinil Tillomed is initially administered as a continuous subcutaneous infusion. Some patients may not be able to tolerate such administration due to local pain and swelling. The doctor will decide whether Treprostinil Tillomed can be administered as a continuous intravenous infusion. This will require the insertion of a central venous catheter in the neck, chest, or groin.

How does Treprostinil Tillomed work

Treprostinil Tillomed lowers blood pressure in the pulmonary artery, improving blood flow and reducing the heart's workload. Improved blood flow leads to better oxygen supply to the body and reduces the strain on the heart muscle, improving the efficiency of the heart's work.
Treprostinil Tillomed alleviates symptoms associated with PAH and improves exercise tolerance in patients who need to limit physical activity.

2. Important information before using Treprostinil Tillomed

When not to use Treprostinil Tillomed:

• if the patient is allergic to treprostinil or any of the other ingredients of this medicine (listed in section 6).
• if the patient has been diagnosed with pulmonary veno-occlusive disease. This is a disease in which the blood vessels in the lungs become swollen and blocked, causing increased blood pressure in the vessels between the heart and lungs.
• if the patient has severe liver disease.
• if the patient has heart disease, such as:
• myocardial infarction (heart attack) in the last six months,
• severe changes in heart rate,
• severe ischemic heart disease or unstable angina,
• diagnosed heart valve disease that impairs heart function,
• heart disease that is not being treated or is not under close medical supervision.
• if the patient is at risk of significant bleeding - e.g., active peptic ulcer, injuries, or other types of bleeding.
• if the patient has had a stroke in the last 3 months or other cerebral circulation disorders.

Warnings and precautions

Before starting treatment with Treprostinil Tillomed, you should tell your doctor:

• if you have liver disease,
• if you have kidney disease,
• if you have been medically diagnosed with obesity (BMI over 30 kg/m),
• if you have HIV infection,
• if you have high blood pressure in the liver veins (portal hypertension),
• if you have a congenital heart defect that affects blood flow through the heart,
• if you are on a low-sodium diet.

During treatment with Treprostinil Tillomed, you should inform your doctor if:

• you experience low blood pressure (hypotension),
• you experience sudden worsening of breathing difficulties or persistent cough (may be related to pulmonary edema, asthma, or other disease), you should contact your doctor immediately,
• you experience excessive bleeding, as treprostinil may increase this risk due to its anti-clotting effect,
• you experience fever or redness, swelling, and (or) tenderness to the touch at the infusion site during intravenous administration of Treprostinil Tillomed, as this may be a sign of infection.

Treprostinil Tillomed and other medicines

You should tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
You should inform your doctor if you are taking:

• medicines used to treat high blood pressure(antihypertensive or other vasodilating medicines),
• medicines used to increase urine production(diuretics), including furosemide,
• medicines that prevent blood clotting(anticoagulants) such as warfarin, heparin, or nitric oxide
• any non-steroidal anti-inflammatory drugs ( NSAIDs) (e.g., acetylsalicylic acid, ibuprofen),
• medicines that may increase or decrease the effect of Treprostinil Tillomed (e.g., gemfibrozil, rifampicin, trimethoprim, deferasirox, phenytoin, carbamazepine, phenobarbital, St. John's Wort), as the dose of Treprostinil Tillomed may need to be adjusted by your doctor.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor before using this medicine.
Treprostinil Tillomed is not recommended for women who are pregnant, plan to become pregnant, or suspect they are pregnant, unless the doctor considers it necessary.
The safety of using Treprostinil Tillomed in pregnant women has not been established.
Treprostinil Tillomed is not recommended for women who are breastfeeding, unless the doctor considers it necessary. If Treprostinil Tillomed is prescribed to a breastfeeding woman, breastfeeding should be discontinued, as it is not known whether the medicine passes into breast milk.
The effect of treprostinil on human fertility is not currently known, so during treatment with treprostinil, it is strongly recommended to use contraception.

Driving and using machines

Treprostinil Tillomed may cause low blood pressure with dizziness and fainting.
In such cases, do not drive or operate machinery and consult your doctor for advice.

Treprostinil Tillomed contains sodium

You should inform your doctor if you are on a controlled sodium diet.
The doctor will consider that one vial of Treprostinil Tillomed contains the amount of sodium listed below.

Treprostinil Tillomed 1 mg/ml, solution for infusion

This medicine contains 74.16 mg of sodium (main component of common salt) per vial. This corresponds to 3.71% of the recommended maximum daily sodium intake in the diet for an adult.

Treprostinil Tillomed 2.5 mg/ml, solution for infusion

This medicine contains 75.08 mg of sodium (main component of common salt) per vial. This corresponds to 3.75% of the recommended maximum daily sodium intake in the diet for an adult

Treprostinil Tillomed 5 mg/ml, solution for infusion

This medicine contains 78.16 mg of sodium (main component of common salt) per vial. This corresponds to 3.91% of the recommended maximum daily sodium intake in the diet for an adult

Treprostinil Tillomed 10 mg/ml, solution for infusion

This medicine contains 75 mg of sodium (main component of common salt) per vial. This corresponds to 3.75% of the recommended maximum daily sodium intake in the diet for an adult

3. How to use Treprostinil Tillomed

You should always use this medicine exactly as your doctor has told you. If you are not sure, ask your doctor.
Treprostinil Tillomed is administered as a continuous infusion:

• subcutaneously using a small tube (cannula) inserted under the skin of the abdomen or thigh of the patient or
• intravenously using a venous catheter in the neck, chest, or groin.

In both cases, Treprostinil Tillomed is pumped through a drain using a portable pump.
Before leaving the hospital, the doctor will inform the patient how to prepare Treprostinil Tillomed and at what rate the pump should deliver it. Additionally, the patient will receive information on how to properly use the pump and what to do in case of pump failure. The provided information should also include instructions on who to contact in an emergency.
Flushing the connected infusion line may cause accidental overdose.
Treprostinil Tillomed is diluted only in the case of intravenous administration:
Only in the case of intravenous administration:The patient must dilute the Treprostinil Tillomed solution with sterile water for injection or 0.9% sodium chloride for injection (as instructed by the doctor), only if the medicine is administered as a continuous intravenous infusion.
Adult patients
Treprostinil Tillomed is available as a 1 mg/mL, 2.5 mg/mL, 5 mg/mL, or 10 mg/mL solution for infusion. The doctor will determine the infusion rate and dose suitable for the patient's clinical condition.
Patients with obesity
If the patient has obesity (body weight exceeds ideal body weight by 30% or more), the doctor will determine the initial dose and subsequent doses based on the target body weight. See also section 2 "Warnings and precautions"
Elderly patients
The doctor will determine the infusion rate and dose suitable for the patient's clinical condition.
Children and adolescents
There are limited data available on the use of the medicine in children and adolescents.
Dose adjustments
The infusion rate can be decreased or increased individually only under medical supervision.
The goal of adjusting the infusion rate is to establish an effective maintenance dose that alleviates PAH symptoms while minimizing side effects.
If symptoms worsen or the patient requires complete rest or is limited to bed or chair rest, or if any physical exertion causes discomfort, and symptoms occur at rest, the dose should not be increased without consulting a doctor.
Treprostinil Tillomed may not be sufficient to treat the condition, and the use of other medicines may be indicated.
The maximum administered dose depends on the patient's clinical condition and various concomitant diseases.

How to prevent blood infections during intravenous treatment with Treprostinil Tillomed

Treprostinil Tillomed?

As with any long-term intravenous treatment, there is a risk of blood infection. The doctor will train the patient in preventing such infections.

Using a higher dose of Treprostinil Tillomed than recommended

If the patient accidentally overdoses on Treprostinil Tillomed, they may experience nausea, vomiting, diarrhea, low blood pressure (dizziness, feeling of emptiness in the head, or fainting), flushing of the skin, and (or) headache.
If any of these symptoms are severe, the patient should contact their doctor or hospital.
The doctor may reduce the dose or stop the infusion until the symptoms subside. Then, the Treprostinil Tillomed infusion solution will be administered again at the dose prescribed by the doctor.

Stopping treatment with Treprostinil Tillomed

You should always use Treprostinil Tillomed as directed by your doctor or hospital specialist. Do not stop using Treprostinil Tillomed without consulting your doctor.
Sudden withdrawal or reduction of the dose of Treprostinil Tillomed may cause a recurrence of pulmonary arterial hypertension, with possible sudden and severe worsening of the patient's condition.
In case of any doubts related to the use of this medicine, you should consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

• vasodilation with flushing of the skin
• pain or tenderness at the infusion site
• discoloration of the skin or extravasation around the infusion site
• headache
• skin rash
• nausea
• diarrhea
• jaw pain

Common side effects (may affect up to 1 in 10 people)

• dizziness
• vomiting
• low blood pressure (dizziness, feeling of emptiness in the head, or fainting)
• tingling or flushing of the skin
• swelling of the feet, ankles, legs, or fluid retention
• bleeding, e.g., nosebleeds, coughing up blood, blood in urine, bleeding gums, blood in stool
• joint pain
• muscle pain
• pain in the legs and (or) arms

Other possible side effects (frequency not known (frequency cannot be estimated from the available data))

• infection at the infusion site
• abscess at the infusion site
• decreased platelet count (thrombocytopenia)
• bleeding at the infusion site
• bone pain
• skin rash with discoloration or nodules
• infection of the tissue under the skin (cellulitis)
• excessive blood pumped by the heart, leading to shortness of breath, fatigue, swelling of the legs and abdomen, and persistent cough

Additional side effects related to intravenous administration

• phlebitis (thrombophlebitis)
• bacterial infection of the blood (bacteremia)* (see section 3)
• sepsis (severe blood infection).

* life-threatening or fatal bacterial blood infections have been reported

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should tell your doctor. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: + 48 22 49 21 301; Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help provide more information on the safety of this medicine.
Side effects can also be reported to the marketing authorization holder.

5. How to store Treprostinil Tillomed

Keep out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and vial. The expiry date refers to the last day of the month.
Do not use Treprostinil Tillomed if you notice damage to the vial, discoloration, or other signs of deterioration.
There are no special precautions for the storage of the medicinal product. Shelf life of treprostinil after first opening: 30 days
During continuous subcutaneous infusion, one container (syringe) of undiluted Treprostinil Tillomed product must be used within 72 hours.
Shelf life in the case of continuous subcutaneous administration
Physical and chemical stability has been demonstrated under conditions of use for a period of 72 hours, provided the medicine is stored at 37°C. From a microbiological point of view, it should be used immediately, unless the method of opening precludes the risk of microbiological contamination.
If the medicine is not used immediately, the user is responsible for complying with the storage period and conditions after preparation.
During continuous intravenous infusion, to minimize the risk of blood infection, the maximum use time of one container (syringe) of diluted treprostinil should not exceed 24 hours.
Shelf life in the case of continuous intravenous administration
After dilution:
Physical and chemical stability of diluted treprostinil has been demonstrated under conditions of use for a period of 48 hours, provided the medicine is stored at 2–8°C, 20–25°C, and 40°C. From a microbiological point of view, the medicine should be used immediately, unless the method of dilution precludes the risk of microbiological contamination. If the medicine is not used immediately, the user is responsible for complying with the storage period and conditions after preparation, and this period should not normally exceed 24 hours at 2 to 8°C, unless the medicine was diluted in controlled and validated aseptic conditions.
Unused diluted solution should be discarded.
Information on use is provided in section 3 "How to use Treprostinil Tillomed".
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Treprostinil Tillomed contains

The active substance is treprostinil 1 mg/mL; 2.5 mg/mL; 5 mg/mL; 10 mg/mL.
The other ingredients are: sodium chloride, metacresol, sodium citrate, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment), water for injection (up to 1 mL).

What Treprostinil Tillomed looks like and contents of the pack

Treprostinil Tillomed, 1 mg/mL, solution for infusion

The solution is clear, colorless to slightly yellow, without visible particles, in a 20 mL vial made of type I colorless glass, closed with a bromobutyl rubber stopper with a seal and a flip-off cap, in a cardboard box.

Treprostinil Tillomed, 2.5 mg/mL, solution for infusion

The solution is clear, colorless to slightly yellow, without visible particles, in a 20 mL vial made of type I colorless glass, closed with a bromobutyl rubber stopper with a seal and a flip-off cap, in a cardboard box.

Treprostinil Tillomed, 5 mg/mL, solution for infusion

The solution is clear, colorless to slightly yellow, without visible particles, in a 20 mL vial made of type I colorless glass, closed with a bromobutyl rubber stopper with a seal and a flip-off cap, in a cardboard box.

Treprostinil Tillomed, 10 mg/mL, solution for infusion

The solution is clear, colorless to slightly yellow, without visible particles, in a 20 mL vial made of type I colorless glass, closed with a bromobutyl rubber stopper with a seal and a flip-off cap, in a cardboard box.
Pack size: 1 vial/pack

Marketing authorization holder

For further information on this medicine, please contact the representative of the marketing authorization holder in Poland:

Tillomed Malta Ltd
Tower Business Centre,
2nd floor Tower Street,
Swatar, BIRKIRKARA
BKR4013,
Malta

Importer

SGS Pharma Magyarorszag Kft.
Derkovits Gyula Utca 53
Budapeszt XIX, 1193
Węgry
Tillomed Malta Limited,
Malta Life Sciences Park,
LS2.01.06 Industrial Estate,
San Gwann, SGN 3000, Malta

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Austria
Treprostinil Tillomed 1 mg / ml, 2.5 mg / ml, 5 mg / ml und 10 mg / ml
Infusionslösung
Croatia
Treprostinil Tillomed 1 mg / ml solution for infusion
Treprostinil Tillomed 2.5 mg / ml solution for infusion
Treprostinil Tillomed 5 mg / ml solution for infusion
Treprostinil Tillomed 10 mg / ml solution for infusion
Czech Republic
Treprostinil Tillomed
Finland
Treprostinil Tillomed 1 mg / ml, 2.5 mg / ml, 5 mg / ml ja 10 mg / ml
infusion solution
France
TREPROSTINIL TILLOMED 1 mg/ml, solution for perfusion
TREPROSTINIL TILLOMED 2.5 mg/ml, solution for perfusion
TREPROSTINIL TILLOMED 5 mg/ml, solution for perfusion
TREPROSTINIL TILLOMED 10 mg/ml, solution for perfusion
Germany
Treprostinil Tillomed 1 mg / ml, 2.5 mg / ml, 5 mg / ml und 10 mg / ml
Infusionslösung
Hungary
Treprostinil Tillomed 1 mg / ml, 2.5 mg / ml, 5 mg / ml és 10 mg / ml
infúziós oldat
Italy
Treprostinil Tillomed
Lithuania
Treprostinil Tillomed 1mg / ml, 2.5mg / ml, 5mg / ml ir 10mg / ml infuzinis
tirpalas
Norway
Treprostinil Tillomed
Poland
Treprostinil Tillomed
Portugal
Treprostinil Tillomed
Slovakia
Treprostinil Tillomed 1 mg / ml, 2.5 mg / ml, 5 mg / ml a 10 mg / ml infúzny
roztok
Slovenia
Treprostinil Tillomed Pharma 1mg / ml, 2.5 mg / ml, 5 mg / ml in 10 mg / ml
raztopina za infundiranje
Sweden
Treprostinil Tillomed 1mg / ml, 2.5mg / ml, 5mg / ml och 10mg / ml
infusionsvätska, lösning
United Kingdom
(Northern Ireland)
Treprostinil Tillomed1mg/ml, 2.5mg/ml, 5mg/ml & 10mg/ml solution for
infusion
Date of last revision of the leaflet: April 2025