TREPROSTINIL DR REDDYS 5 mg/mL SOLUTION FOR INFUSION

2. What you need to know before taking Treprostinil Dr. Reddys

Do not use Treprostinil Dr. Reddys:

• if you are allergic to treprostinil or any of the other components of this medicine (listed in section 6);
• if you have been diagnosed with a disease called "pulmonary veno-occlusive disease". In this disease, the blood vessels that carry blood through the lungs become swollen and blocked, increasing pressure in the blood vessels between the heart and lungs;
• if you have severe liver failure;
• if you have a heart problem, such as:
• • a heart attack in the last six months
  • severe changes in heart rate
  • severe coronary heart disease or unstable angina
  • a diagnosed heart defect, such as a defective heart valve that causes the heart to malfunction
  • any untreated or closely monitored heart disease;

• if you have a high specific risk of bleeding, such as 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 Treprostinil Dr. Reddys:

• if you have any liver disease
• if you have been told that you are clinically obese (BMI over 30 kg/m2)
• if you have a human immunodeficiency virus (HIV) infection
• if you have high blood pressure in the liver veins (portal hypertension)
• if you have a congenital heart defect that affects how blood circulates through it

During treatment with this medicine, inform your doctor:

• if your blood pressure drops (hypotension)
• if you experience a rapid increase in 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 treprostinil can increase the risk by preventing blood clotting.
• if you have a fever while receiving treprostinil intravenously, or if the intravenous administration site becomes red, swollen, or painful to the touch, as it may be a sign of infection.

Using Treprostinil Dr. Reddys with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medicine.

Tell your doctor if you are taking:

• medicines to treat high blood pressure(antihypertensive medicines or other vasodilators)
• medicines used to increase the amount of urine excreted(diuretics), including furosemide
• medicines that interrupt blood clotting(anticoagulants), such as warfarin, heparin, or nitric oxide
• any non-steroidal anti-inflammatory (NSAID) (such as acetylsalicylic acid or ibuprofen)
• medicines that may increase or decrease the effect of treprostinil (such as gemfibrozil, rifampicin, trimethoprim, deferasirox, phenytoin, carbamazepine, phenobarbital, St. John's Wort), as your doctor may need to adjust the dose of treprostinil.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

Treprostinil is not recommended during pregnancy, unless your doctor considers it essential. The safety of this medicine for use during pregnancy has not been established.

Treprostinil is not recommended during breastfeeding, unless your doctor considers it essential. You are advised to stop breastfeeding if you are prescribed treprostinil, as it is unknown whether this medicine is excreted in breast milk.

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

Driving and using machines

Treprostinil Dr. Reddys may cause low blood pressure, with dizziness and fainting. In this case, do not drive or operate machinery and consult your doctor.

Treprostinil Dr. Reddys contains sodium

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

3. How to use Treprostinil Dr. Reddys

Follow the administration instructions of this medicine exactly as indicated by your doctor. If in doubt, consult your doctor again.

Treprostinil 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 normally placed in the neck, chest, or groin.

For subcutaneous infusion, the product should be administered undiluted.

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

In both cases, Treprostinil Dr. Reddys will be driven through the tube by a portable pump that is placed outside your body (external).

Before leaving the hospital or clinic, your doctor will indicate how to prepare Treprostinil Dr. Reddys and at what speed the pump should administer Treprostinil Dr. Reddys.

Flushing the infusion tube while connected can cause an accidental overdose.

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

In any case, you will 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.

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

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

For intravenous infusion with implantable infusion pump:You should go to the hospital periodically (e.g., every 4 weeks) where your doctor will dilute your Treprostinil Dr. Reddys solution with 0.9% sodium chloride injection solution and refill the internal reservoir.

Adult patients

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

Overweight patients

If you are overweight (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".

Elderly patients

Your doctor will determine the infusion rate and suitable 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 side 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 may be that treprostinil is no longer sufficient to treat your disease and you need another treatment.

How can bloodstream infections be avoided during intravenous administration of treprostinil?

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

If you use more Treprostinil Dr. Reddys than you should

If treprostinil is accidentally administered in excess, you may experience nausea, vomiting, diarrhea, low blood pressure (dizziness, drowsiness, or fainting), flushing, or headache.

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

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

If you stop treatment with Treprostinil Dr. Reddys

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

Sudden interruption or rapid reduction of the dose of Treprostinil Dr. Reddys can cause PAH to recur, with possible rapid and severe deterioration of your condition.

If you have any other questions about the use of this medicine, ask your doctor.

4. Possible side effects

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

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

• vasodilation with flushing
• pain or pain on palpation around the administration site
• skin discoloration or bruising around the administration site
• headaches
• skin rash
• 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, blood in stool
• joint pain, muscle pain, pain in legs and/or arms

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

• infection at the administration site
• abscess at the administration site
• reduction of platelets in the blood (thrombocytopenia)
• bleeding at the administration site
• bone pain
• skin rash with discoloration or bumps
• infection of the tissue under the skin (cellulitis)
• excessive blood flow from the heart that causes difficulty breathing, fatigue, swelling of legs and abdomen due to fluid accumulation, persistent cough.

Other side effects associated with intravenous administration

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

• There have been reports of fatal and potentially fatal cases of bacterial infection in the bloodstream.

Reporting side effects

If you experience any side effects, consult your doctor, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Conservation of Treprostinil Dr. Reddys

Keep this medicine out of sight and reach of children.

This medicine does not require special storage conditions.

Do not use this medicine after the expiration date shown on the box and vial after EXP. The expiration date is the last day of the month indicated.

Do not use this medicine if you notice damage to the vial, color change, or other signs of deterioration.

Treprostinil Dr. Reddys vials should be discarded 30 days after opening.

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

During continuous intravenous infusion with external portable pumps, a single container (syringe) of diluted Treprostinil Dr. Reddys should be used within 24 hours.

During continuous intravenous infusion using implantable infusion pumps, Treprostinil 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 the use of the Treprostinil 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 an implantable pump with a titanium drug reservoir). The healthcare professional at the hospital will tell you the duration of the interval before each subsequent reservoir refill.

The diluted solution that is not used should be discarded.

For instructions for use, see section 3 "How to use Treprostinil Dr. Reddys".

Medicines should not be disposed of through wastewater or household waste. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Container Content and Additional Information

Composition of Treprostinil Dr. Reddys

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

The other components are:

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

Appearance of the Product and Container Content

Treprostinil Dr. Reddys is a clear, colorless to slightly yellowish solution, available in a 20 ml transparent glass vial closed with a rubber stopper and a colored cap:

• Treprostinil Dr. Reddys 1 mg/ml solution for infusion has a yellow rubber cap.
• Treprostinil Dr. Reddys 2.5 mg/ml solution for infusion has a blue rubber cap.
• Treprostinil Dr. Reddys 5 mg/ml solution for infusion has a green rubber cap.
• Treprostinil Dr. Reddys 10 mg/ml solution for infusion has a red rubber cap.

Each box contains one vial.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder:

Reddy Pharma Iberia, S.A.

Avda. Josep Tarradellas nº 38

08029 Barcelona (Spain)

Phone: 93.355.49.16

Fax: 93.355.49.61

Manufacturer:

betapharm Arzneimittel GmbH,

Kobelweg 95,

86156 Augsburg

Germany

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

Date of the Last Revision of thisProspectus:July 2023

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/