TESTEX PROLONGATUM 250 mg/2 ml INJECTABLE SOLUTION

1. What is Testex Prolongatum and what is it used for

Testex Prolongatum contains the active substance testosterone, a male hormone.

Testex Prolongatum is used in adult men for testosterone replacement therapy to treat various health problems caused by a lack of testosterone (male hypogonadism). This should be confirmed by two separate testosterone measurements in the blood and clinical symptoms such as:

• impotence
• infertility
• low sexual appetite
• fatigue
• depressive mood
• bone loss caused by low hormone levels

If you are being treated for infertility, you may need other medications in addition to Testex Prolongatum.

2. What you need to know before you take Testex Prolongatum

Only men can use Testex Prolongatum.

Men under 18 years of age should not use this product. Similarly, women of any age should not use this product.

If you have a severe heart, liver, or kidney disease, treatment with Testex Prolongatum may cause serious complications in the form of fluid retention, which can sometimes be accompanied by congestive heart failure.

Before starting treatment and during treatment, your doctor will check the following parameters in your blood test: testosterone level and complete blood count.

Tell your doctor if you have high blood pressure or if you are being treated for high blood pressure, as testosterone can cause an increase in blood pressure.

Do not takeTestex Prolongatum:

• if you are allergic to testosterone or any of the other components of this medicine (listed in section 6)
• if you have or are suspected of having prostate cancer
• if you have an enlarged prostate (benign prostatic hyperplasia)
• if you have or are suspected of having breast cancer (a rare disease in men).
• if you have or have had liver tumors
• if you have elevated red blood cell levels in your blood (hematocrit) (>50%)

Warnings and precautions

Consult your doctor or pharmacist before starting to use Testex Prolongatum, or if any of the following conditions apply to you:

• you have blood clotting problems known as "thrombophilia" (a blood clotting problem - this increases the risk of developing blood clots in blood vessels ("thrombosis"))
• factors that increase the risk of blood clots in a vein: previous blood clots in a vein; smoking; obesity; cancer; immobility; if a close family member has had a blood clot in the leg, lung, or other organ at a young age (e.g., under 50 years); or as you get older.

How to recognize a blood clot: painful swelling of a leg or sudden change in skin color, such as paleness, redness, or blueness, sudden difficulty breathing, sudden unexplained cough that may bring up blood; or sudden severe chest pain, severe dizziness or fainting, severe stomach pain, sudden loss of vision. Seek urgent medical attention if you experience any of these symptoms.

• if you have difficulty urinating due to an enlarged prostate gland. Your doctor will perform checks to assess the size of the prostate.
• if you have severe heart, kidney, or liver disease; you may develop complications, such as edema (swelling due to fluid retention) with or without heart failure. In this case, you should stop treatment immediately.
• if you have high blood pressure, as Testex Prolongatum may increase it.
• if you have elevated calcium levels in your blood or urine due to bone cancer, your doctor may advise you to undergo regular blood tests.
• if you have high blood pressure.
• if you suffer from epilepsy.
• if you suffer from migraines.
• if you have diabetes.
• if you have difficulty breathing during sleep (sleep apnea); this is more likely to happen if you are overweight or have a chronic lung disease.
• if you are over 65 years old.

These diseases may worsen when using Testex Prolongatum. If you have any of these diseases, consult your doctor again and ask what you should do.

Your doctor should perform the following blood tests before and during treatment: complete blood count, lipid profile (fat level in blood), and liver function tests, as well as testosterone levels in blood. Treatment with testosterone may accelerate the progression of pre-existing prostate cancer. Your doctor will perform the necessary tests before starting treatment and will monitor you with periodic blood tests and prostate exams.

Abuse and dependence

Always take this medicine exactly as your doctor or pharmacist has told you.

Abuse of testosterone, especially if you take too much, alone or with other anabolic androgenic steroids, can cause serious problems in the heart, blood vessels (which can lead to death), mental health, and/or liver.

People who have abused testosterone may become dependent and experience withdrawal symptoms when the dose is significantly changed or stopped abruptly. Do not abuse this medicine alone or with other anabolic androgenic steroids because it carries serious health risks. (See "Side effects").

If you are an athlete, you should know that this product may give a positive result in anti-doping tests.

Testosterone should not be usedto increase muscle mass or improve physical strengthin healthy individuals.

Children

Testex Prolongatum is not indicated in children.

Use ofTestex Prolongatumwith other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Testex Prolongatum may affect the action of these medicines and may need to be adjusted. This is especially important if you are taking:

• insulin and other medicines used to control your blood sugar levels (in diabetes): you may need to decrease the dose of these medicines when used in combination with Testex Prolongatum.

• medicines that make your blood more fluid (anticoagulants): Testex Prolongatum may increase the effects of these medicines.

• medicines used to treat diseases related to immunity or used in transplantation (cyclosporin).

• medicines used to treat thyroid gland disorders (levothyroxine)

• corticosteroids or medicines that can increase the production of these hormones: which can cause your body to retain more water.

• paclitaxel (a medicine used for cancer): Testex Prolongatum may increase the adverse effects of this medicine.

Interaction with laboratory tests: treatment with testosterone may alter thyroid hormone levels in your body. The thyroid gland is a gland located in the neck and is involved in regulating the body's metabolism and growth. Thyroid function is not affected by these minor changes in thyroid hormone levels.

Pregnancy, breastfeeding, and fertility

Testex Prolongatum is not indicated for use in women and should not be used in pregnant or breastfeeding women.

The use of testosterone may result in reduced sperm production, which is reversible. This may involve a modification of the Testex Prolongatum dose. Your doctor will tell you how to proceed.

Driving and using machines

Testex Prolongatum does not affect your ability to drive or use machines.

3. How to take Testex Prolongatum

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.

Before starting treatment and during the first part of treatment, your doctor will measure your testosterone levels in the blood. This will determine the dose of testosterone that your doctor will prescribe. The usual dose of Testex Prolongatum is 1 ampoule by intramuscular route, every 2-4 weeks.

Testex Prolongatum should be administered only by intramuscular route. It is recommended to administer it in the buttock. Special care should be taken not to inject the product into a blood vessel.

If you think that the effect of Testex Prolongatum is too strong or too weak, tell your doctor.

Use in children and adolescents

Testex Prolongatum is not recommended for use in children and adolescents under 18 years of age due to the lack of efficacy and safety data in this population.

If you take more Testex Prolongatum than you should

The symptoms of having received too much Testex Prolongatum include irritability, nervousness, weight gain, frequent or prolonged erections. No special measures are necessary, except to interrupt treatment or reduce the dose. Tell your doctor and he will tell you what to do.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or go to the nearest hospital or call the Toxicology Information Service, phone 915620420, indicating the medicine and the amount taken.

4. Possible side effects

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

If you think any of the side effects you are experiencing are serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

Common side effects, i.e., those that may affect up to 1 in 10 people who use Testex Prolongatum:

• worsening of hypertension (increase in blood pressure above the normal range).
• increase in Prostate-Specific Antigen (PSA), identified by periodic blood tests. PSA is a protein produced in the prostate that can be used to detect prostate disease.
• increase in red blood cell count, hematocrit (percentage of red blood cells in the blood), and hemoglobin (part of red blood cells that carries oxygen), identified in periodic blood tests.
• weight gain.
• acne.

Uncommon side effects, i.e., those that may affect less than 1 in 100 people who use Testex Prolongatum:

• hot flashes or reddening.
• oily skin, itching, hair loss, increased body hair.
• fluid retention (edema).

• redness, rash, or other reactions at the injection site.
• headache, nervousness, aggressiveness, irritability, depression.
• increased cholesterol levels in the blood.
• breathing difficulties during sleep (sleep apnea).
• diarrhea, nausea, increased appetite.
• urinary tract disorders (e.g., decreased urine flow, urinary retention, urgent need to urinate at night).
• prostate disorders (e.g., prostatic intraepithelial neoplasia, hardening or inflammation of the prostate), disorders of sexual desire, prolonged or painful erections, testicular pain, breast pain or hardening, or enlargement, or increased levels of male and female hormones. Reversible decrease in sperm production.
• muscle problems (e.g., spasms, pain, or stiffness, or muscle cramps).
• liver function test abnormalities: increased liver enzyme levels (GOT), increased bilirubin levels in the blood.
• azoospermia (zero sperm count).

Side effects of unknown frequency, i.e., cannot be estimated from the available data:

• changes in electrolyte levels in the blood (e.g., sodium, chloride, potassium, calcium, inorganic phosphate) that can cause edema (swelling due to fluid retention), hypertension (increase in blood pressure above the normal range), or behavioral disorders, such as anxiety.
• increased calcium levels in the blood and urine.
• hyperthyroidism.

Reporting of side effects

If you experience any side effects, tell your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) through the website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Testex Prolongatum

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

Once the ampoule is opened, it should be administered immediately. The medicine is for single use and any unused solution should be discarded. The contents to be administered should be visually inspected and only clear and particle-free solutions should be used.

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to a pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Testex Prolongatum

• The active substance is testosterone cyclopentylpropionate. One ampoule contains 250 mg of testosterone cyclopentylpropionate (corresponding to 174.8 mg of testosterone), in 2 ml of solution.
• The other ingredients (excipients) are: ethyl oleate and olive oil.

Appearance and packaging of the product

Testex Prolongatum is a clear, slightly yellowish oily solution. It is presented in a 2 ml amber glass ampoule containing the injectable solution.

Each pack contains 1 ampoule.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Desma Laboratorio Farmacéutico, S.L.

Paseo de la Castellana 121, Escalera Izquierda, 3ºB

28046 Madrid,

Spain

Manufacturer:

• Braun Medical, S.A.

Ronda de Los Olivares, parcela 11,

Polígono Industrial Los Olivares,

Jaén 23009.

Spain

Date of last revision of this leaflet:April 2025

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS).

http://www.aemps.gob.es/