Testex Prolongatum 100 mg/2 ml solution for injection

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

TESTEX PROLONGATUM 100 MG/2 ML INJECTABLE SOLUTION

Testosterone, cyclopentylpropionate

Read this entire leaflet carefully before you start taking 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; do not give it to others, 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 such effects are not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What Testex Prolongatum is and what it is used for
2. What you need to know before using Testex Prolongatum
3. How to use 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 resulting from a lack of testosterone (male hypogonadism). This must be confirmed by two separate blood testosterone measurements, along with the presence of clinical symptoms such as:

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

If you are being treated for infertility, you may require additional medications besides 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 tests: testosterone levels and complete blood count.

Inform your doctor if you have high blood pressure or 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 age.

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 lightheadedness, severe stomach pain, sudden loss of vision. Seek urgent medical attention if you experience any of these symptoms.

• you have difficulty urinating due to thickening of the prostate gland. Your doctor will perform checks to assess the size of your prostate.
• you have severe heart (ischemic heart disease), 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 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 old.

These conditions may worsen when using Testex Prolongatum. If you have any of the conditions listed above, 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 discontinued. Do not abuse this medicine alone or with other anabolic androgenic steroids, as it poses 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 your dose may need to be adjusted. This is especially important if you are taking:

• medicines used to treat diabetes. The dose of your blood sugar-lowering medicine may need to be adjusted. 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 medicines (anticoagulants): Testex Prolongatum may increase the effects of these medicines.

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

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

• corticosteroids or medicines 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 medicine.

Interaction with laboratory tests: testosterone treatment may alter the levels of thyroid hormones 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 Testex Prolongatum dose. Your doctor will advise you on how to proceed.

Driving and using machines

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

3. How to take Testex Prolongatum

Follow exactly the instructions for administration of this medicine as given by your doctor or pharmacist. If you are 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 ampoule administered intramuscularly every 2 to 4 weeks.

Testex Prolongatum must only be administered 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 that 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 necessary except stopping treatment or reducing the dose. Inform your doctor, and he or she 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 915620420, indicating the medicine and the amount ingested.

4. Possible adverse effects

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

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect 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), detected through 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, haematocrit (percentage of red blood cells in the blood), and haemoglobin (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 less than 1 in 100 people using Testex Prolongatum:

• Hot flushes or redness.
• Oily skin, itching, hair loss, increased body hair.
• Water retention (oedema).
• Redness, rash, or other reactions at the injection site.
• Headache, nervousness, aggression, irritability, depression.
• Increased blood cholesterol.
• Interrupted breathing during sleep (sleep apnoea).
• Diarrhoea, 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 and hardening or enlargement of the breasts, or increased levels of male and female hormones. Reversible decrease in sperm production.
• Muscle problems (e.g. spasms, pain or stiffness, or muscle cramps).
• Changes in liver function test results: increased levels of liver enzymes (GOT), increased bilirubin in blood.
• Azoospermia (zero sperm count).

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

The oily liquid in Testex Prolongatum may enter 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 injection and are reversible. Therefore, the patient should be observed during and immediately after each injection to allow early identification of 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 oedema (swelling due to fluid retention), hypertension (increase in blood pressure above normal levels), or behavioural disorders 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 via 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 the 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 medicine must be administered immediately. The medicine is for single use only, and any unused solution must be discarded. The solution to be administered should be inspected visually; only clear solutions free from particles should be used.

Medicines must not be disposed of via wastewater or household waste. Deposit unused medicines and their containers at the SIGRE point in your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Testex Prolongatum

• The active substance is testosterone cyclopentylpropionate. One ampoule contains 100 mg of testosterone cyclopentylpropionate (equivalent to 70.0 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 an oily, clear, slightly yellowish 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 medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS).

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