TREPROSTINIL 1 mg /Ml Roztwór Do Infuzji

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1. Treprostinil Tillomed 1 mg/ml, 2.5 mg/ml, 5 mg/ml, 10 mg/ml solution for infusion
   1. What is Treprostinil Tillomed and what is it used for
   2. What you need to know before using Treprostinil Tillomed
   3. How to use Treprostinil Tillomed
   4. Possible side effects
   5. How to store Treprostinil Tillomed
   6. Package contents and other information

Treprostinil Tillomed 1 mg/ml, 2.5 mg/ml, 5 mg/ml, 10 mg/ml solution for infusion

treprostinil

Equivalent medicinal product

Read this leaflet carefully before you start to use this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 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

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

What is Treprostinil Tillomed
The active ingredient of Treprostinil Tillomed is treprostinil.
Treprostinil belongs to a class of medicines that act similarly to
natural prostacyclins. Prostacyclins are hormone-like substances that reduce
blood pressure by causing relaxation, and therefore dilation, of blood
vessels and facilitating blood flow. Prostacyclins can also prevent blood
clotting.
What is Treprostinil Tillomed used for
Treprostinil Tillomed is used for the treatment of idiopathic or hereditary pulmonary arterial hypertension
(PAH) in patients with moderate symptoms.
Pulmonary arterial hypertension is a disease in which the pressure is too high in
the blood vessels between the heart and the lungs and causes shortness of breath, dizziness,
fatigue, fainting, palpitations or heart arrhythmias, dry cough, chest pain and
swelling of the ankles or legs.
Treprostinil Tillomed is initially administered as a continuous subcutaneous
(under the skin) infusion. Some patients may no longer be able to tolerate it due to
local pain and swelling. If necessary, the doctor will decide whether Treprostinil
Tillomed can instead be administered via continuous intravenous (directly into
vein) infusion. This will require the insertion of a central venous tube (catheter) generally inserted into the neck, chest or groin.
How does Treprostinil Tillomed work
Treprostinil Tillomed reduces blood pressure in the pulmonary artery, improving
blood circulation and reducing the workload on the heart. Improved blood flow leads to
better oxygen supply to the body and a reduction in strain on the heart
allowing the heart itself to function more efficiently. Treprostinil improves
symptoms associated with PAH and the mobility of patients with limited ability.

2. What you need to know before using Treprostinil Tillomed

Do not use Treprostinil Tillomed

• 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 vessels that carry blood to the lungs become swollen and obstructed, causing an increase in pressure in the blood vessels between the heart and the lungs.
• If you have severe liver disease.
• If you have a heart problem, such as:
• myocardial infarction (a heart attack) in the last six months
• serious changes in heart rate
• severe coronary heart disease or unstable angina
• you have been diagnosed with a heart defect, such as a valve defect that causes heart failure
• any heart disease that is not treated or not under strict medical control.
• If you have a specific high risk of bleeding - for example, in case of active gastric ulcers, lesions or other bleeding conditions.
• If you have had a stroke in the last three months or any other condition that has interrupted blood flow to the brain.

Warnings and precautions
Talk to your doctor or pharmacist before using Treprostinil Tillomed

• If you suffer from liver disease
• If you suffer from kidney disease
• If you are obese (BMI greater than 30 kg/m)
• If you have a human immunodeficiency virus (HIV) infection
• If you suffer from high pressure in the hepatic veins (portal hypertension)
• If you have a congenital heart defect that affects blood circulation
• If you are following a low-sodium diet.

During treatment with Treprostinil Tillomed, inform your doctor:

• If your blood pressure drops (hypotension).
• If you experience a rapid increase in difficulty breathing or persistent cough (this may be due to pulmonary congestion, asthma or other conditions), seekimmediate medical attention.
• In case of excessive bleeding, as treprostinil may increase this risk, preventing blood clotting.
• If you develop a fever during intravenous administration of treprostinil or if the intravenous infusion site becomes red, swollen and/or painful to the touch, as this may be a sign of infection.

Other medicines and Treprostinil Tillomed
Tell your doctor if you are taking, have recently taken or might take
any other medicine.
Tell your doctor if you are taking:

• medicines used to treat high blood pressure(antihypertensive drugs or other vasodilators)
• drugs used to increase urineproduction (diuretics) including furosemide
• medicines that prevent blood clotting(anticoagulants) such as warfarin, heparin or products based on nitric oxide
• any non-steroidal anti-inflammatory drug (NSAIDs) (e.g. acetylsalicylic acid, ibuprofen)
• medicines that can 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 the dose of treprostinil.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are
breastfeeding, ask your doctor or pharmacist for advice before taking
this medicine.
The use of treprostinil is not recommended if you are pregnant, planning a
pregnancy, or think you may be pregnant, unless your doctor considers it necessary. The
safety regarding the use of this medicine during pregnancy has not been established.
The use of treprostinil is not recommended during breastfeeding, unless your
doctor considers it necessary. If you are prescribed treprostinil, it is advisable to
stop breastfeeding, as it is not known whether this medicine is excreted in
breast milk.
The effect of treprostinil on human fertility is currently unknown, therefore
the use of a contraceptive method is strongly recommended during treatment with
treprostinil.

Driving and using machines
Treprostinil can cause a lowering of blood pressure with dizziness or
fainting. If this happens, do not drive vehicles or use machines and ask your
doctor for advice.

Treprostinil Tillomed contains sodium
Tell your doctor if you are on a low-sodium diet. Your doctor will be aware
that one vial of Treprostinil Tillomed contains the amounts of sodium indicated
below.

Treprostinil Tillomed 1 mg/ml solution for infusion
This medicine contains 74.16 mg of sodium (the main component of table salt)
in each vial, which corresponds to 3.71% of the maximum recommended daily intake of sodium for an adult.

Treprostinil Tillomed 2.5 mg/ml solution for infusion
This medicine contains 75.08 mg of sodium (the main component of table salt)
in each vial, which corresponds to 3.75% of the maximum recommended daily intake of sodium for an adult.

Treprostinil Tillomed 5 mg/ml solution for infusion
This medicine contains 78.16 mg of sodium (the main component of table salt)
in each vial, which corresponds to 3.91% of the maximum recommended daily intake of sodium for an adult.

Treprostinil Tillomed 10 mg/ml solution for infusion
This medicine contains 75 mg of sodium (the main component of table salt) in
each vial, which corresponds to 3.75% of the maximum recommended daily intake
of sodium for an adult.

3. How to use Treprostinil Tillomed

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have any doubts, ask your doctor.
Treprostinil Tillomed is administered by continuous infusion:

• or by the subcutaneous route (under the skin) through a thin tube (cannula) inserted into the abdomen or thigh
• or intravenously through a tube (catheter) generally inserted into the neck, chest or groin. In both cases, treprostinil is pushed into the tube through a portable pump.

Before leaving the hospital or clinic, your doctor will tell you how to prepare treprostinil and at
what rate the pump must deliver the dose of treprostinil. You should also be
provided with information on the correct use of the pump and what to do in case of a
malfunction. Among the information that will be provided to you, you will also be told to whom
to contact in case of emergency.
Flushing the infusion cannula while it is connected may cause an accidental overdose
of the medicine.
Treprostinil is diluted only when administered intravenously:

Only for intravenous infusion:the treprostinil solution must be diluted only with
sterile water for injection or with 0.9% sodium chloride solution for injection (as prescribed
by the doctor) if administered by continuous intravenous infusion.
Adult patients
Treprostinil Tillomed is available in the form of an infusion solution of 1 mg/ml,
2.5 mg/ml, 5 mg/ml, 10 mg/ml. The doctor will determine the infusion rate and the appropriate dose
for your condition.
Overweight patients
If you are overweight (30% or more above your ideal body weight) the
doctor will determine the initial and subsequent doses based on your ideal body weight.
See also section 2 “Warnings and precautions”.
Elderly patients
The doctor will determine the infusion rate and the appropriate dose for your condition.
Children and adolescents
The available data relating to the use of the medicine in children and adolescents are limited.
Dosage adjustment
The infusion rate may be increased or decreased on an individual basis only
under medical supervision.
The purpose of adjusting the infusion rate is to establish an effective maintenance rate, capable of improving the symptoms of pulmonary arterial hypertension
and at the same time minimizing any unwanted effects.
If your symptoms worsen, or if you need to rest completely or if you are confined to
bed or armchair, or if any physical activity increases your discomfort or if symptoms occur even when you are at rest, do not increase the dosage without consulting your doctor. It
is possible that treprostinil is no longer sufficient to treat the disease and may be
necessary another treatment.
The maximum dose to be administered depends on various comorbidities and the patient's
clinical conditions.

How can bloodstream infections be prevented during
treatment with treprostinil by intravenous route?
As with any long-term intravenous treatment, there is a risk of
bloodstream infections. Your doctor will instruct you on how to avoid this.

If you use more Treprostinil Tillomed than you should
If you accidentally take more treprostinil than you should, you may develop nausea,
vomiting, diarrhea, low blood pressure (dizziness, confusion or fainting),
skin flushing and/or headache.
If any of these effects become severe, you should contact your doctor
or hospital immediately. The doctor may reduce or stop the infusion until the symptoms disappear. The Treprostinil Tillomed infusion solution will then be restored to a
dose level recommended by the doctor.

If you stop using Treprostinil Tillomed
Always use Treprostinil Tillomed as instructed by your doctor or hospital specialist.
Do not stop treatment with treprostinil unless your doctor
orders it.
Abrupt discontinuation or sudden reductions in the dose of treprostinil may
cause the return of pulmonary arterial hypertension with the possibility of a rapid and
serious deterioration of your condition.
If you have any doubts about the use of this medicine, consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

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

• dilation of blood vessels with redness of the skin
• pain or sensitivity at the infusion site
• change in skin color or bruising at the infusion site
• headache
• skin rashes
• nausea
• diarrhea
• jaw/jawbone pain

Common: (may affect up to 1 in 10 people)

• dizziness
• feeling unwell (vomiting)
• confusion or fainting due to low blood pressure
• itching or redness of the skin
• swelling of feet, ankles or legs or fluid retention
• bleeding episodes such as nosebleeds, coughing up blood, blood in urine, bleeding gums, blood in stools
• joint pain (arthralgia)
• muscle pain (myalgia)
• pain in legs and/or arms

Other possible side effects
Not known (frequency cannot be estimated based on available data)

• infection at the infusion site
• abscess at the infusion site
• decrease in blood cells responsible for coagulation (platelets) (thrombocytopenia)
• bleeding at the infusion site
• bone pain
• skin rashes with discoloration of the skin or formation of papules (maculopapular rash)
• infection of the tissue under the skin (cellulitis)
• excessive pumping of blood from the heart causing shortness of breath, fatigue, swelling of the legs and abdomen due to fluid accumulation, persistent cough. Further side effects associated with the intravenous route of administration
• inflammation of the vein (thrombophlebitis)
• bacterial infection of the bloodstream (bacteremia)* (see section 3)
• septicemia (severe bacterial blood infection)

* potentially life-threatening or fatal cases of bacterial bloodstream infections have been reported

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Treprostinil Tillomed

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after
“EXP.”. The expiry date refers to the last day of that month.
Do not use Treprostinil Tillomed if you notice that the vial is damaged, or if you notice
a change in the colour of the product or other signs of deterioration.
This medicine does not require any particular storage temperature.
Store in the original packaging to protect the medicine from light. Shelf life of
treprostinil after first opening: 30 days.
During continuous subcutaneous infusion, a single reservoir (syringe) of undiluted treprostinil must
be used within 72 hours.

Shelf life during continuous subcutaneous administration
Chemical and physical stability in use has been demonstrated for 72 hours at 37 °C. From a
microbiological point of view, the product must be used immediately, unless the
opening method excludes the risk of microbial contamination. If not used
immediately, the storage times and conditions in use are the responsibility of
the user.
During continuous intravenous infusion, a single reservoir (syringe) of diluted treprostinil
must be used within 24 hours.

Shelf life during continuous intravenous administration
After dilution:
The chemical and physical stability in use of diluted treprostinil has been demonstrated for 48 hours at 2-
8 °C, at 20-25 °C and 40 °C. From a microbiological point of view, the product must be
used immediately, unless the dilution method excludes the risk of
microbial contamination. If not used immediately, the storage times and
conditions in use are the responsibility of the user and generally do not
exceed 24 hours at 2-8 °C, unless the dilution was carried out under controlled and validated
aseptic conditions. Any residual diluted solution must be
discarded.
For instructions for use, refer to paragraph 3 “How to use Treprostinil
Tillomed”.
Do not dispose of any medicine in wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect
the environment.

6. Package contents and other information

What Treprostinil Tillomed contains
The active ingredient is treprostinil 1 mg/ml, 2.5 mg/ml, 5 mg/ml, 10 mg/ml.
The other components of Treprostinil Tillomed are: sodium chloride, metacresol, sodium
citrate, sodium hydroxide, hydrochloric acid, concentrated, water for injections.

Description of the appearance of Treprostinil Tillomed and contents of the pack
Treprostinil Tillomed 1 mg/ml solution for infusion
Transparent solution, from colorless to slightly yellow, practically free of visible
particles contained in a transparent glass vial of 20 ml closed with a gray-dark
bromobutyl rubber stopper of 20 mm with four equidistant markings of 90° and a
circle in the center, and equipped with a 20 mm tear-off seal with an opaque yellow
finish.

Treprostinil Tillomed 2.5 mg/ml solution for infusion
Transparent solution, from colorless to slightly yellow, practically free of visible
particles contained in a transparent glass vial of 20 ml closed with a gray-dark
bromobutyl rubber stopper of 20 mm with four equidistant markings of 90° and a
circle in the center, and equipped with a 20 mm tear-off seal with an opaque blue
finish.

Treprostinil Tillomed 5 mg/ml solution for infusion
Transparent solution, from colorless to slightly yellow, practically free of visible
particles contained in a transparent glass vial of 20 ml closed with a gray-dark
bromobutyl rubber stopper of 20 mm with four equidistant markings of 90° and a
circle in the center, and equipped with a 20 mm tear-off seal with an opaque green
finish.

Treprostinil Tillomed 10 mg/ml solution for infusion
Transparent solution, from colorless to slightly yellow, practically free of visible
particles contained in a transparent glass vial of 20 ml closed with a gray-dark
bromobutyl rubber stopper of 20 mm with four equidistant markings of 90° and a
circle in the center, and equipped with a 20 mm tear-off seal with an opaque red
finish.
The vials are packaged in outer packaging.
Pack: 1 vial/box

Marketing authorization holder and manufacturer
Marketing authorization holder
Tillomed Italia S.r.l.
viale Richard 1, Torre A
20143, Milano
Italy

Manufacturer
MIAS Pharma Limited
Suite 2, Stafford House, Strand Road
Portmarnock, Co. Dublin
Ireland

This medicinal product is authorised in the Member States of the European Economic Area
with the following denomination: