Testex Prolongatum 250 mg/2 ml solution for injection

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

TESTEX PROLONGATUM 250 MG/2 ML INJECTABLE SOLUTION

Testosterone, cyclopentylpropionate

Read the entire leaflet carefully before starting to take this medicine, as it contains important information for you.

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

Leaflet contents:

1. What Testex Prolongatum is and what it is used for
2. What you need to know before taking Testex Prolongatum
3. How to take Testex Prolongatum
4. Possible adverse effects
5. Storage of Testex Prolongatum
6. Package contents and additional information

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

Testex Prolongatum contains as its 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 must be confirmed by two separate blood tests measuring testosterone levels, together with the presence of clinical symptoms such as:

• impotence
• infertility
• low sex drive
• fatigue
• depressive mood states
• bone loss caused by low hormone levels

If you are being treated for infertility, you may require additional medications alongside Testex Prolongatum.

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

Only men can use Testex Prolongatum.

Men under 18 years of age should not use this product. Likewise, 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 in the body, which may sometimes be accompanied by heart failure (congestive).

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

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

Do not take Testex Prolongatum:

• if you are allergic to testosterone or to 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 condition in men)
• if you have or have had liver tumors
• if you have elevated levels of red blood cells in the 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 disorders known as "thrombophilia" (a blood clotting disorder – 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 any of your immediate family members have had a blood clot in the leg, lung, or another organ at an early age (e.g., under 50 years); or as you get older.

How to recognize a blood clot: painful swelling of one leg or sudden change in skin color, for example paleness, redness or blueness; sudden shortness of breath; sudden and unexplained cough that may produce blood; or sudden chest pain, severe dizziness or fainting, severe stomach pain, sudden loss of vision. Seek urgent medical attention if you experience any of these symptoms.

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

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

Your doctor must perform the following blood tests before and during treatment: complete blood count, lipid profile (blood fat levels), liver function tests, and blood testosterone levels. Testosterone treatment may accelerate the progression of pre-existing prostate cancer. Your doctor will perform the necessary tests before starting treatment and will subsequently monitor you through periodic blood tests and prostate examinations.

Abuse and dependence

Always take this medicine exactly as prescribed by your doctor or pharmacist.

Abuse of testosterone, especially if taken in excess, alone or with other anabolic androgenic steroids, may cause serious problems affecting the heart, blood vessels (which may lead to death), mental health, and/or the liver.

Individuals who have abused testosterone may become dependent and experience withdrawal symptoms when the dose is significantly reduced or abruptly stopped. Do not abuse this medicine alone or with other anabolic androgenic steroids, as it carries serious health risks. (See "Adverse reactions").

If you are an athlete, you should be aware that this product may result in a positive anti-doping test.

Testosterone must not be used to increase muscle mass or improve physical strength in healthy individuals.

Children

Testex Prolongatum is not indicated for use in children.

Use of Testex Prolongatum with other medicines

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

Testex Prolongatum may affect the action of these medicines, and dosage adjustments may be necessary. This is especially important if you are taking:

• medicines used to treat diabetes. It may be necessary to adjust the dose of your blood sugar-lowering medication. Like other androgens, testosterone may enhance the effect of insulin. Taking SGLT-2 inhibitors (such as empagliflozin, dapagliflozin, or canagliflozin) together with testosterone may increase the number of red blood cells in the blood. Your doctor may need to monitor your blood more frequently.

• blood-thinning drugs (anticoagulants): Testex Prolongatum may enhance the effects of these drugs.

• drugs used to treat immune-related conditions or used in transplantation (cyclosporine).

• drugs used to treat thyroid gland disorders (levotiroxine).

• corticosteroids or drugs that may increase the production of these hormones: as they may cause your body to retain more water.

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

Interaction with laboratory tests: treatment with testosterone may alter thyroid hormone levels in your body. The thyroid is a gland located in the neck 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 must not be used by pregnant or breastfeeding women.

The use of testosterone may cause a reversible reduction in sperm production. This may require adjustment of the dose of Testex Prolongatum. Your doctor will advise you on how to proceed.

Driving and using machines

Testex Prolongatum does not affect the ability to drive or use machinery.

3. How to take Testex Prolongatum

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Before starting treatment and during its initial phase, your doctor will measure your blood testosterone levels through a blood test. This will determine the dose of testosterone your doctor will prescribe. The usual dose of Testex Prolongatum is 1 vial administered intramuscularly every 2–4 weeks.

Testex Prolongatum must be administered only by intramuscular injection. Administration into the gluteal muscle is recommended. Special care must be taken to avoid injecting the product into a blood vessel.

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

Use in children and adolescents

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

If you take more Testex Prolongatum than you should

Symptoms of having received too much Testex Prolongatum include irritability, nervousness, weight gain, frequent or prolonged erections. No special measures are required except stopping treatment or reducing the dose. Inform your doctor, and he will advise you on what to do.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, go to the nearest hospital, or call the Toxicology Information Service at telephone number 915620420, indicating the medicine and the amount ingested.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Frequent adverse effects, i.e. those likely to affect up to 1 in 10 people using Testex Prolongatum:

• worsening of hypertension (increase in blood pressure above the normal range)
• increase in Prostate-Specific Antigen (PSA), identified through periodic blood tests. PSA is a protein produced in the prostate gland 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 (the component of red blood cells that carries oxygen), identified in periodic blood tests
• weight gain
• acne

Uncommon adverse effects, i.e. those likely to affect fewer than 1 in 100 people using Testex Prolongatum:

• hot flushes or redness
• oily skin, itching, hair loss, increased body hair
• fluid retention (edema)
• redness, rash, or other reactions at the application site
• headache, nervousness, aggression, irritability, depression
• increased blood cholesterol
• interrupted breathing 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), changes in sexual appetite, prolonged erections, testicular pain, pain, hardness, or enlargement of the breasts, or increased levels of male and female hormones. Reversible decrease in sperm production
• muscle problems (e.g. spasms, pain, stiffness, or cramps)
• changes in liver function test results: increased liver enzyme levels (GOT), increased bilirrubin in blood
• azoospermia (zero sperm count)

Rare adverse effects (may affect up to 1 in 1,000 patients):

The oily liquid Testex Prolongatum may reach the lungs (pulmonary microembolism of oily solutions), which in rare cases may cause signs and symptoms such as cough, difficulty breathing, general malaise, excessive sweating, chest pain, dizziness, tingling, or fainting. These reactions may occur during or immediately after the injection and are reversible. Therefore, the patient should be observed during and immediately after each injection in order to detect early possible signs and symptoms of pulmonary microembolism of oily solutions.

Adverse effects with unknown frequency, i.e., frequency cannot be estimated from the available data:

• changes in blood levels of salts (electrolytes) (e.g., sodium, chlorides, potassium, calcium, inorganic phosphate) which may cause edema (swelling due to fluid retention), hypertension (increase in blood pressure above normal levels), or behavioral disturbances such as anxiety.
• increased levels of calcium in blood and urine.
• hyperthyroidism.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Testex Prolongatum

Keep this medicine out of sight and reach of children.

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

This medicine does not require any special storage conditions.

After opening the ampoule, the solution must be administered immediately. The medicine is for single use only; any unused solution must be discarded. The solution to be administered should be inspected visually, and only clear solutions free from particles should be used.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly dispose of unused medicines and their packaging. This helps protect the environment.

6. Contents of the pack and other information

Composition of Testex Prolongatum

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

Appearance of the product and contents of the pack

Testex Prolongatum is a slightly yellowish, transparent oily solution. It is supplied in an amber glass ampoule containing 2 ml of injectable solution.

Each pack contains 1 ampoule.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 the most recent revision of this leaflet: February 2026

Detailed and up-to-date 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/