Label:information for theuser

Treprostinilo Ferrer 1mg/ml solution for EFG infusion

Treprostinilo Ferrer 2,5mg/ml solution for EFG infusion

Treprostinilo Ferrer 5mg/ml solution for EFG infusion

Treprostinilo Ferrer 10mg/ml solution for EFG infusion

Read this label carefully before starting to use this medication,because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor.
• This medication has been prescribed only to you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

1.What isTreprostinilo Ferrerand how is it used

2.What you need to know before starting to use Treprostinilo Ferrer

3.How to use Treprostinilo Ferrer

4.Possible adverse effects

5.Storage of Treprostinilo Ferrer

6.Contents of the package and additional information

What is treprostinilo

The active ingredient of Treprostinilo Ferrer is treprostinilo.

Treprostinilo belongs to a group of medications whose action is similar to that of natural prostacyclins. Prostacyclins are substances similar to hormones that reduce blood pressure by relaxing blood vessels, allowing blood to flow more easily. Prostacyclins can also prevent blood coagulation.

What is treprostinilo used for

Treprostinilo is used to treat idiopathic or hereditary pulmonary arterial hypertension (PAH) in patients with moderate symptoms. Pulmonary arterial hypertension is a disease in which blood pressure is too high in the blood vessels between the heart and lungs. This causes difficulty breathing, dizziness, fatigue, fainting, palpitations or abnormal heartbeats, dry cough, chest pain, and swelling of the ankles or legs.

Treprostinilo Ferrer is initially administered through continuous subcutaneous infusion (under the skin). Some patients may not tolerate this administration because it causes local pain and swelling. The doctor will decide if they can administer Treprostinilo Ferrer through continuous intravenous infusion (directly into a vein). This technique requires inserting a central venous catheter (central line) that is usually placed in the neck, chest, or groin.

How treprostinilo works

Treprostinilo reduces blood pressure in the pulmonary artery by improving circulation and reducing heart workload. Improved blood circulation increases oxygen supply to the body and requires less effort from the heart, making it work more efficiently. Treprostinilo improves symptoms associated with PAH and exercise capacity in patients with reduced activity.

No use Treprostinilo Ferrer:

-if you are allergic to treprostinilo or any of the other components of this medication (listed in section 6);;

-if you have been diagnosed with a disease called "pulmonary veno-occlusive disease". In this disease, the blood vessels that transport blood through the lungs become swollen and blocked, increasing the pressure in the blood vessels between the heart and the lungs;

-if you have severe liver failure;

-if you have a heart problem, for example:

-if you have a high risk of bleeding, for example, due to active stomach ulcers, injuries, or other bleeding disorders;

-if you have had a stroke in the last three months, or any interruption of blood supply to the brain.

Warnings and precautions

Consult your doctor before starting to use Treprostinilo Ferrer:

-if you have any liver disease

-if you have been advised that you are clinically obese (BMI greater than 30 kg/m2)

-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 the way blood circulates through it

-if you are on a low-sodium diet

During treatment with this medication, inform your doctor:

• if your blood pressure drops (hypotension)
• if you experience rapid worsening of breathing difficulties or persistent cough (may be related to pulmonary congestion, asthma, or other diseases),consult your doctor immediately.
• if you experience excessive bleeding, as treprostinilo may increase the risk of bleeding by preventing blood clotting.
• if you experience fever while receiving treprostinilo intravenously, or if the intravenous administration site becomes red, swollen, or painful to the touch, as it may be a sign of infection

Use of Treprostinilo Ferrer with other medications

Inform your doctor or pharmacist if you are using, have used recentlyor may need to useany other medication.

Inform your doctor if you are taking:

-medications to treat high blood pressure (antihypertensive medications or other vasodilators)

-medications used to increase the amount of urine excreted (diuretics), including furosemide

-medications that interrupt blood clotting (anticoagulants), such as warfarin products, heparin, or nitric oxide

-any non-steroidal anti-inflammatory drug (NSAID) (such as aspirin or ibuprofen)

-medications that may increase or decrease the effect of treprostinilo (such as gemfibrozil, rifampicin,trimetoprima, deferasirox, phenytoin, carbamazepine, phenobarbital, St. John's wort), as your doctor may need to adjust the dose of treprostinilo.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medication.

Treprostinilo is not recommended for use during pregnancy, unless your doctor considers it essential. The safety of this medication for use during pregnancy has not been determined.

Treprostinilo is not recommended for use during breastfeeding, unless your doctor considers it essential. We recommend stopping breastfeeding if you are prescribed treprostinilo, as it is unknown whether this medication is excreted in breast milk.

It is highly recommended to use contraceptive methods during treatment with treprostinilo.

Driving and operating machinery

Treprostinilo Ferrer may cause low blood pressure, dizziness, and fainting. In this case, do not drive or operate machinery and consult your doctor.

Treprostinilo Ferrer contains sodium

This medication contains up to 78.4 mg (3.41 mmol) of sodium (main component of table salt/for cooking) in each 20 ml. This is equivalent to 4% of the maximum daily sodium intake recommended for an adult.

Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor again.

Treprostinilo Ferrer is administered as a continuous infusion:

• Subcutaneously (under the skin) through a small tube (cannula) placed in the abdomen or thigh; or,
• Intravenously through a tube (catheter) that is usually placed in the neck, chest, or groin.

In both cases, a portable pump pumps treprostinilo through the tube.

Before leaving the hospital or clinic, your doctor will indicate how to prepare Treprostinilo Ferrer and at what rate the pump should administer Treprostinilo Ferrer. You should also be provided with information on how to use the pump correctly and what to do if it stops working. The information should also include emergency contact persons.

Flush the infusion tube while it is connected may cause an accidental overdose.

Treprostinilo Ferrer is only diluted when administered intravenously:

For intravenous infusion only:Only dilute the Treprostinilo Ferrer solution with sterile injectable water or in a 0.9%sodium chloride solution for infusion if it is to be administered through continuous intravenous infusion.

Adult patients

Treprostinilo Ferrer is available as a solution for infusion of 1mg/ml, 2.5mg/ml, 5mg/ml or 10mg/ml. Your doctor will determine the infusion rate and the appropriate dose for your disease.

Patients with obesity

If you are obese (you weigh 30% or more of your ideal body weight), your doctor will determine the initial and subsequent doses based on your ideal body weight.See section 2, "Warnings and precautions".

Older patients

Your doctor will determine the infusion rate and the appropriate dose for your disease.

Dose adjustment

The infusion rate in each individual patient may be reduced or increased only under medical supervision.

The goal of adjusting the infusion rate is to establish an effective maintenance rate that improves PAH symptoms while minimizing adverse effects.

If your symptoms worsen or if you need absolute rest, or are confined to bed or a chair, or if any physical activity causes discomfort and your symptoms appear at rest, do not increase the dose without consulting your doctor. It is possible that treprostinilo is no longer sufficient to treat your disease and you need another treatment.

How can bloodstream infections be prevented during the intravenous administration of treprostinilo?

Like all long-term intravenous treatments, there is a risk of contracting a bloodstream infection. Your doctor will indicate how to prevent them.

Use in childrenand adolescents

There is limited data in children and adolescents.

If you use more Treprostinilo Ferrer than you should

If an accidental overdose of treprostinilo is administered, you may experience nausea, vomiting, diarrhea, low blood pressure (dizziness, drowsiness, or fainting), redness or headache.

If any of these symptoms become severe, you should contact your doctor or hospital immediately. The doctor may reduce the dose or stop administration until the symptoms disappear. Then, the administration of treprostinilo will be resumed with the recommended dose by your doctor.

In case of overdose, consult your doctor immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

If you interrupt treatment with Treprostinilo Ferrer

Always use treprostinilo as indicated by your doctor or hospital specialist. Do not stop using treprostinilo unless your doctor tells you to.

Abrupt interruption or sudden reductions in the dose of treprostinilo may cause the reappearance of pulmonary arterial hypertension, with a possible rapid and severe deterioration of your condition.

If you have any other doubts about the use of this medication, ask your doctor.

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

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

• vasodilation with erythema
• pain or tenderness around the injection site
• skin color change or bruising around the injection site
• headaches
• skin eruptions
• nausea
• diarrhea
• jaw pain

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

• dizziness
• vomiting
• lethargy or fainting due to low blood pressure
• pruritus or skin redness
• swelling of feet, ankles, legs, or fluid retention
• bleeding episodes such as nasal bleeding, hemoptysis, hematuria, gingival bleeding, or hematochezia
• joint pain
• muscle pain
• pain in a limb

Other possible side effects (Unknown frequency (cannot be estimated from available data))

• infection at the injection site
• abscess at the injection site

• thrombocytopenia (reduction of platelets in the blood)

• hemorrhage at the injection site
• bone pain
• skin eruptions with color change or papules
• cellulitis (infection of the tissue under the skin)

• excessive blood pumping from the heart causing difficulty breathing, fatigue, swelling of legs and abdomen due to fluid accumulation, persistent cough.

Other side effects associated with intravenous administration

• phlebitis (inflammation of the vein)
• bacteremia (bacterial infection in the bloodstream)*. See section 3.
• septicemia (severe bacterial infection of the blood)

* Fatal and potentially fatal cases of bacteremia have been reported.

Reporting of side effects

If you experience any type of side effect, consult your doctor, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

This medication does not require special storage conditions.

Do not use this medication after the expiration date that appears on the box and vial after CAD. The expiration date is the last day of the month indicated.

Do not use this medication if you observe damage to the vial, change in color or other signs of deterioration.

Treprostinilo Ferrer vials must be discarded 30 days after opening.

During continuous subcutaneous infusion, a single, undiluted Treprostinilo Ferrer vial (syringe) must be used within 72 hours.

During continuous intravenous infusion, a single, diluted Treprostinilo Ferrer vial (syringe) must be used within 24 hours.

Unused diluted solution must be discarded.

To know the usage instructions, consult section 3 "How to use Treprostinilo Ferrer".

Medications should not be thrown away through drains or in the trash. Dispose of containers and unused medications at the SIGRE point of the pharmacy.In case of doubt, ask your pharmacist how to dispose of containers and unused medications. By doing so, you will help protect the environment.

Treprostinilo Ferrer Composition

• The active ingredient is treprostinilo 1mg/ml, 2.5mg/ml, 5mg/ml, 10mg/ml.

• The other components are: sodium citrate (E-331iii), sodium chloride, sodium hydroxide (E-524), hydrochloric acid (E-507), metacresol, and water for injectable preparations.

Appearance of the product and contents of the packaging

Treprostinilo Ferrer is a transparent, colorless to slightly yellowish solution, available in a transparent glass vial of 20ml closed with a rubber stopper and a capsule with a color code:

• Treprostinilo Ferrer 1mg/ml infusion solution has a rubber capsule of yellow color.
• Treprostinilo Ferrer 2.5mg/ml infusion solution has a rubber capsule of blue color.
• Treprostinilo Ferrer 5mg/ml infusion solution has a rubber capsule of green color.
• Treprostinilo Ferrer 10mg/ml infusion solution has a rubber capsule of red color.

Each box contains one vial.

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization:

Ferrer Internacional, S.A.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Responsible for manufacturing

Ferrer Internacional, S.A.

Joan Buscallà, 1-9

08173 - Sant Cugat del Vallès (Barcelona)

Spain

or

Kwizda Pharmadistribution GmbH

Achauerstrasse 2

2333 Leopoldsdorf

Austria

For more information about this medication, please contact the local representative of the marketing authorization holder:

Ferrer Farma, S.A.

Av. Diagonal nº 549 5th floor

08029 Barcelona

Spain

Last approval date of this prospectus: April 2021

Other sources of information

The detailed information about this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).