TESTEX 25 mg/1 ml INJECTABLE SOLUTION

1. What is Testex 25 and what is it used for

Testex contains the active substance testosterone, a male hormone.

Testex 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 blood tests for testosterone and clinical symptoms such as:

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

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

2. What you need to know before you take Testex

Only men can use Testex.

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 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:

• 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 high red blood cell counts in your blood (hematocrit >50%)

Warnings and precautions

Consult your doctor or pharmacist before starting to use Testex 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 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 may increase it.
• if you have high calcium levels in your blood or urine due to bone cancer, your doctor may advise you to have regular blood tests.
• if you have high blood pressure.
• if you have epilepsy.
• if you have 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. 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 test, 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 is not indicated in children.

Use ofTestexwith other medicines

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

Testex may affect the action of these medicines and may require dose adjustment. 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 your dose of these medicines when used in combination with Testex.

• medicines that make your blood more fluid (anticoagulants): Testex 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 may cause your body to retain more water.

• paclitaxel (a medicine used for cancer): Testex 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 is a gland located in the neck that 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 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 change in the dose of Testex. Your doctor will tell you how to proceed.

Driving and using machines

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

3. How to take Testex

Follow exactly the instructions for administration 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 blood testosterone levels. This will determine the dose of testosterone that your doctor will prescribe. The usual dose of Testex is 1 ampoule by intramuscular injection, 2-4 times a week.

Testex should be administered only by intramuscular injection. 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 is too strong or too weak, tell your doctor.

Use in children and adolescents

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

If you take more Testex than you should

Symptoms of taking too much Testex include irritability, nervousness, weight gain, frequent or prolonged erections. No special measures are needed, except to stop 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:

• 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 by the prostate that can be used to detect prostate disease.
• increase in red blood cell count, hematocrit (percentage of red blood cells in 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:

• flushing or redness.
• oily skin, itching, hair loss, increased body hair.
• fluid retention (edema).

• redness, rash, or other reactions at the injection site.
• headache, nervousness, aggression, irritability, depression.
• increase in blood cholesterol.
• 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, prostate hardening or inflammation), disorders of sex drive, prolonged or painful erections, testicular pain, breast pain or hardening or enlargement, increase in male and female hormone levels. Reversible decrease in sperm production.
• muscle problems (e.g., spasms, pain, or stiffness, or muscle cramps).
• changes in liver test results: increased liver enzyme levels (GOT), increased bilirubin in blood.
• azoospermia (zero sperm count).

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

• changes in electrolyte levels in 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.
• increase in calcium levels in blood and urine.
• hyperthyroidism.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Health Products Agency (AEMPS) 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

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

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month shown.

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 only, and any unused solution should be discarded. The contents to be administered should be visually inspected, and only clear solutions free of particles should be used.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE collection point. 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 other information

Composition of Testex

• The active substance is testosterone propionate. One ampoule contains 25 mg of testosterone propionate (corresponding to 20.9 mg of testosterone), in 1 ml of solution.
• The other ingredients (excipients) are: ethyl oleate and olive oil.

Appearance and packaging of the product

Testex is a clear, slightly yellowish oily solution. It is presented in 1 ml glass ampoules.

Each pack contains 4 ampoules.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Desma Laboratorio Farmacéutico SL

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:May 2024

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

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