PATIENT INFORMATION LEAFLET

TESTEX PROLONGATUM 100 MG/2 ML INJECTABLE SOLUTION

Testosterone, cyclopentylpropionate

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

- Keep this leaflet, as you may need to read it again.

- If you have any questions, ask 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before you start taking Testex Prolongatum

3. How to take Testex Prolongatum

4. Possible side effects

5. Storage of Testex Prolongatum

6. Contents of the pack and additional information

Testex Prolongatum contains testosterone as its active ingredient, a male hormone.

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

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

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

Only men can useTestex Prolongatum.

Males 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 severe complications in the form of fluid retention, which may be accompanied by congestive heart failure at times.

Before starting treatment and during treatment, your doctor will check the following parameters in your blood test: testosterone level 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 takeTestex Prolongatum:

• if you are allergic to testosterone or any of the other components of this medication (listed in section 6)
• if you have or suspect you may have prostate cancer
• if you have an enlarged prostate (benign prostatic hyperplasia)
• if you have or suspect you may have breast cancer (a rare disease in men)
• if you have or have had liver tumors
• if you have elevated red blood cell levels 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:

• you have blood clotting problems known as "thrombophilia" (a blood clotting problem - this increases the risk of developing blood clots in the 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 (for example, under 50 years); or as you age.

How to recognize a blood clot: painful swelling of a leg or sudden change in skin color, for example, paleness, redness, or blue, sudden difficulty breathing, sudden and inexplicable cough that may cause bleeding; or sudden chest pain, intense dizziness, or intense stomach pain, sudden loss of vision. Seek urgent medical attention if you experience one of these symptoms.

• if you have difficulty urinating due to prostate gland enlargement. Your doctor will perform checks to evaluate the size of the prostate.
• if you have severe heart, 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.
• if you have high blood pressure (hypertension), as Testex Prolongatum may increase it.
• if you have elevated calcium levels in the 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 experience difficulty breathing during sleep (sleep apnea); this is more likely to occur if you are overweight or have a chronic lung disease.
• if you are over 65 years old.

These diseases may worsen when usingTestex Prolongatum. If you have any of the mentioned diseases, 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 level), liver function analysis, and blood testosterone levels. Treatment with testosterone may accelerate the progression of existing prostate cancer. Your doctor will perform the necessary tests before starting treatment and will monitor you through periodic blood tests and prostate exams.

Abuse and dependence

Always take this medication exactly as your doctor or pharmacist has instructed.

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

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

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

Testosteroneshould not be usedtoincrease muscle mass or improve physical strengthin healthy individuals.

Children

Testex Prolongatumis not indicated for use in children.

Use ofTestex Prolongatumwith other medications

Inform your doctor or pharmacist if you are taking,have takenrecentlyor may need to take any other medication.

Testex Prolongatummay affect the action of these medications and may require adjusting your dose. This is especially important if you are taking:

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

• blood-thinning medications (anticoagulants):Testex Prolongatummay increase the effects of these medications.

• medications used to treat immune system-related diseases or used in transplantation (ciclosporina).

• medications used to treat thyroid gland-related conditions (levotiroxina)

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

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

Interaction with laboratory tests: treatment with testosterone may alter the levels of thyroid hormones in your body. The thyroid gland is located in the neck and is involved in regulating your 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 women or breastfeeding women.

Use of testosterone may cause a reduction in sperm production, which is reversible. This may involve modifying the dose of Testex Prolongatum. Your doctor will advise you on how to proceed.

Driving and operating machinery

Testex Prolongatum does not affect your ability to drive and operate machinery.

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

Before starting treatment and during the first part of it, your doctor will measure your blood testosterone levels through a blood test. This will determine the dose of testosterone that your doctor will prescribe. The usual dose of Testex Prolongatum is 1 ampule administered intramuscularly, every 2-4 weeks.

Testex Prolongatum must only be administered intramuscularly. It is recommended to administer it in the buttock. Special care must be taken to avoid injecting the product into a blood vessel.

If you think the effect of Testex Prolongatum is too intense 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 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. Inform your doctor and he will tell you what to do.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

If you consider that any of the side effects you experience are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Side effectsfrequent, that is, which probably affect up to 1 in 10 people using Testex Prolongatum:

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

Side effectsinfrequent, that is, which probably affect less than 1 in 100 people using Testex Prolongatum:

• Hot flashes or redness.
• Greasy skin, itching, hair loss, increased body hair.
• Water retention (edema).

• Redness, rash, or other reactions at the application site.
• Headache, nervousness, aggression, irritability, depression.
• Increased cholesterol in the blood.
• Labored breathing during sleep (sleep apnea).
• Diarrhea, nausea, increased appetite.
• Urinary tract alterations (e.g., decreased urine flow, urinary retention, urgent need to urinate at night).
• Prostate alterations (e.g., prostatic intraepithelial neoplasia, prostate hardening or inflammation), sexual appetite alterations, prolonged erections, and testicular pain, breast pain 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).
• Alterations in liver test results: increased levels of liver enzymes (GOT), increased bilirubin in the blood.
• Azoospermia (negative sperm count).

Side effects of unknown frequency, that is, the frequency 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 (increased blood pressure above the normal level), or behavioral disorders, such as anxiety.
• Increased levels of calcium in the blood and urine.
• Hyperthyroidism.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not mentioned 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.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Once the ampule is opened, it must be administered immediately. The medication is for single use, and unused solution must be discarded. The solution to be administered must be visually inspected, and only clear solutions free of particles should be used.

Medications should not be thrown into the drains or trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Composition of Testex Prolongatum

• The active principle is cyclopentylpropionate of testosterone.One vial contains 100 mg of cyclopentylpropionate of testosterone (corresponding 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 packaging

Testex Prolongatum is an oily solution, transparent and slightly yellowish. It is presented in an amber glass vial, containing a volume of 2 ml of injectable solution.

Each package contains 1 vial.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Desma Pharmaceutical Laboratory, S.L.

Paseo de la Castellana 121, right staircase, 6th floor

28046 Madrid,

Spain

Responsible for manufacturing:

B. Braun Medical, S.A.

Ronda de Los Olivares, plot 11,

Los Olivares Industrial Estate,

Jaén 23009

Spain

Last review date of this leaflet:February 2020

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS).

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