Prospecto:Information for the User

Treprostinilo Dr. Reddys 1 mg/ml Solution for Infusion EFG

Treprostinilo Dr. Reddys 2.5 mg/ml Solution for Infusion EFG

Treprostinilo Dr. Reddys 5 mg/ml Solution for Infusion EFG

Treprostinilo Dr. Reddys 10 mg/ml Solution for Infusion EFG

Treprostinilo

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

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor.

-This medicine has been prescribed only to you, and you must 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, pharmacist, or nurse, even if they are not listed in this prospectus. See section 4.

1.What is Treprostinilo Dr. Reddys and what is it used for

2.What you need to know before starting to use Treprostinilo Dr. Reddys

3.How to use Treprostinilo Dr. Reddys

4.Possible adverse effects

5Storage of Treprostinilo Dr. Reddys

6.Contents of the package and additional information

The active ingredient of this medication 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 them to expand and 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 Dr. Reddys 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 whether to administer Treprostinilo Dr. Reddys through continuous intravenous infusion directly into a vein with the insertion of a central venous catheter (central line) connected to an external pump or, depending on their condition, a surgically implanted pump under the skin of their abdomen. The doctor will determine the best option for you.

How treprostinilo works

Treprostinilo reduces blood pressure in the pulmonary artery by improving circulation and reducing the workload of the heart. 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 Dr. Reddys:

• 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 condition 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 lungs;
• if you have severe liver failure;
• if you have a heart problem, for example:
• • a heart attack (heart attack) in the last six months
  • severe changes in heart rate
  • severe coronary heart disease or unstable angina
  • a heart defect diagnosed, such as a faulty heart valve that causes the heart to malfunction
  • any untreated or closely monitored heart disease;

-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 Dr. Reddys:

• 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

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 disease),consult your doctor immediately.
• if you experience excessive bleeding, as treprostinilo may increase the risk by preventing blood coagulation.
• 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 Dr. Reddys with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any 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 coagulation (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, trimethoprim, 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 Dr. Reddys may cause low blood pressure, dizziness, and fainting. In this case, do not drive or operate machinery and consult your doctor.

Treprostinilo Dr. Reddys contains sodium

This medication contains up to 78.4 mg of sodium (main component of table salt/for cooking) in each vial. This is equivalent to 3.9% of the maximum daily sodium intake recommended for an adult.

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

Treprostinilo Dr. Reddys 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.

For subcutaneous infusion, the product must be administered undiluted.

For intravenous infusion, the product must be diluted according to the prescriber's instructions and can only be diluted with sterile injection water or with a 0.9% (p/v) sodium chloride injection solution.

In both cases, Treprostinilo Dr. Reddys will be pumped through the tube by a portable pump placed outside the body (external).

Before leaving the hospital or clinic, the doctor will instruct you on how to prepare Treprostinilo Dr. Reddys and at what speed the pump should administer Treprostinilo Dr. Reddys.

Flush the infusion tube while connected may cause accidental overdose.

Alternatively, Treprostinilo Dr. Reddys can be administered intravenously through an implantable infusion pump that is usually surgically inserted under the skin of the abdomen. In this case, the pump and tube are completely inside the body (internal) and you will need to visit the hospital periodically (e.g., every 4 weeks) for the internal reservoir to be refilled.

In any case, you must also be given information on how to use the pump correctly and what to do if it stops working. The information should also indicate who to contact in case of an emergency.

Treprostinilo Dr. Reddys is only diluted when administered with a continuous intravenous infusion:

For intravenous infusion with a portable external pump:You should only dilute your Treprostinilo Dr. Reddys solution with sterile injection water or 0.9% (p/v) sodium chloride injection solution as indicated by your doctor.

For intravenous infusion with an implantable infusion pump:You should visit the hospital periodically (e.g., every 4 weeks) where the doctor must dilute your Treprostinilo Dr. Reddys solution with 0.9% (p/v) sodium chloride injection solution and refill the internal reservoir.

Adult patients

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

Patients with obesity

If you are obese (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 increasedonly 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 instruct you on how to prevent them.

If you use more Treprostinilo Dr. Reddys than you should

If an accidental overdose of treprostinilo is administered, you may experience nausea, vomiting, diarrhea, low blood pressure (dizziness, fainting, or dizziness), 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 interrupt the 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

If you interrupt the treatment with Treprostinilo Dr. Reddys

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

Brusque interruption or sudden reductions in the dose of Treprostinilo Dr. Reddys may cause the reappearance of pulmonary arterial hypertension, with 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)

• Widening of blood vessels with redness
• Pain or tenderness around the injection site
• Change in skin color 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
• Drowsiness or fainting due to low blood pressure
• Itching or redness of the skin
• Swelling of feet, ankles, legs, or fluid retention
• Bleeding episodes such as nosebleeds, coughing up blood, blood in urine, bleeding gums, or blood in stools
• Pain in joints, muscle pain, or pain in legs and/or arms

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

• Infection at the injection site
• Abscess at the injection site
• Reduction of blood cells responsible for clotting (thrombocytopenia) in the blood
• Bleeding at the injection site
• Bone pain
• Skin eruptions with color change or protuberances
• Cellulitis, an 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

• Vein inflammation (thrombophlebitis)
• Bloodstream bacterial infection (bacteremia)*.See section 3.
• Septicemia (severe bloodstream bacterial infection)

* Fatal and potentially fatal cases of bloodstream bacterial infection have been reported.

Reporting side effects

If you experience any type of side effect, consult your doctor, even if it is a possible side effect not listed 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 Dr. Reddys vials must be discarded 30 days after opening.

During continuous subcutaneous infusion, a single undiluted Treprostinilo Dr. Reddys vial (syringe) should be used within 72 hours.

During continuous intravenous infusion, using portable external pumps, a single undiluted Treprostinilo Dr. Reddys vial (syringe) should be used within 24 hours.

During continuous intravenous infusion using implantable infusion pumps, Treprostinilo Dr. Reddys introduced into the pump reservoir should be used for a maximum of 39 days (chemical, physical, and microbiological stability has been demonstrated in use of the Treprostinilo Dr. Reddys solution administered by intravenous infusion for a maximum of 39 days at 40 °C in diluted concentrations as low as 0.5 mg/ml and, as such, 10 mg/ml in a titanium medication reservoir implantable pump). The healthcare professional at the hospital will tell you the duration of the interval before each next reservoir refill.

The diluted solution that is not used should be discarded.

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

Medications should not be thrown away through drains or in the trash. If in doubt, ask your pharmacist how to dispose of the containers and medications that you do not need.This will help protect the environment.

Composition of Treprostinilo Dr. Reddys

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

The other components are:

Sodium dihydrogen citrate (E331), sodium chloride, metacresol, injection water and, for pH adjustment: sodium hydroxide (E524) and hydrochloric acid (E507).

Appearance of the product and contents of the package

Treprostinilo Dr. Reddys is a transparent, colorless to slightly yellowish solution, available in a transparent glass vial of 20 ml closed with a rubber stopper and a color-coded capsule:

• Treprostinilo Dr. Reddys 1 mg/ml infusion solution has a rubber stopper with ayellowcolor capsule.
• Treprostinilo Dr. Reddys 2.5 mg/ml infusion solution has a rubber stopper with abluecolor capsule.
• Treprostinilo Dr. Reddys 5 mg/ml infusion solution has a rubber stopper with agreencolor capsule.
• Treprostinilo Dr. Reddys 10 mg/ml infusion solution has a rubber stopper with aredcolor capsule.

Each box contains one vial.

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization:

Reddy Pharma Iberia, S.A.

Avda. Josep Tarradellas nº 38

08029 Barcelona (Spain)

Telephone: 93.355.49.16

Fax: 93.355.49.61

Responsible for manufacturing:

betapharm Arzneimittel GmbH,

Kobelweg 95,

86156 Augsburg

Germany

This medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of thisleaflet:July 2023

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