PATIENT INFORMATION LEAFLET

TESTEX 25 MG/ML INJECTABLE SOLUTION

Testosterone propionate

Read this 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if they have similar symptoms, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before you start taking Testex 25

3. How to take Testex 25

4. Possible side effects

5. Storage of Testex 25

6. Contents of the pack and additional information

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

Testex 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 accompanied by 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 toTestex.

Only men can use Testex.

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

If you have a serious heart, liver, or kidney disease, Testex treatment 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 take Testex:

• 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 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 and intense 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 experience 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 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 using Testex. If you experience any of the mentioned diseases, consult your doctor again and ask what to 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. Testex treatment 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 the 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 a serious risk to your health. (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 is not indicated for use in children.

Use of Testex with other medications

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

Testex may 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 your dose of these medications when using it in combination with Testex.

• blood thinners (anticoagulants): Testex may 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 may increase the adverse effects of this medication.

Interaction with laboratory tests: Testex treatment 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 is not indicated for use in women and should not be used in pregnant women or breastfeeding women.

Testosterone use may cause a reduction in sperm production, which is reversible. This may involve modifying the Testex dose. Your doctor will instruct you on how to proceed.

Driving and operating machinery

Testex 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. If in 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 is 1 ampule administered intramuscularly, 2-4 times a week.

Testex 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 is too intense or too weak, inform your doctor.

Use in Children and Adolescents

Testex 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 Than You Should

The symptoms of having taken too much Testex include irritability, nervousness, weight gain, frequent or prolonged erections.No special measures are necessary, except to stop treatment or reduce the dose. Inform your doctor and they 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 medications, this medication may cause side effects, although not everyone will experience them.

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

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

• 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 may affect fewer than 1 in 100 people using Testex:

• 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 blood cholesterol.
• Labored breathing during sleep (sleep apnea).
• Diarrhea, nausea, increased appetite.
• Urinary tract alterations (e.g., decreased urine flow, urinary retention, nocturia).
• Prostate alterations (e.g., prostatic intraepithelial neoplasia, prostate hardening or inflammation), sexual desire alterations, prolonged erections, and testicular pain, breast pain or tenderness, or increased levels of male and female hormones. Reversible decrease in sperm production.
• Muscle problems (e.g., spasms, pain, stiffness, or muscle cramps).
• Alterations in liver test results: increased liver enzyme levels (GOT), increased bilirubin in the blood.
• Azoospermia (negative sperm count).

Side effects of unknown frequency, that is, the frequency cannot be estimated from available data:

• Changes in blood electrolyte levels (e.g., sodium, chloride, potassium, calcium, inorganic phosphate) that may cause edema, hypertension, or behavioral disorders, such as anxiety.
• Increased calcium levels in the blood and urine.
• Hyperthyroidism.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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 disposed of through drains or in the trash. Deposit the packaging and unused medications at the SIGRE point of your pharmacy. Ask your pharmacist how to dispose of packaging and medications that you no longer need. By doing so, you will help protect the environment.

Composition of Testex

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

Appearance of the product and contents of the packaging

Testex is an oily solution, transparent and slightly yellowish. It is presented in amber glass vials, containing 1 ml of injectable solution.

Each package contains 4 vials.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Desma Pharmaceutical Laboratory SL

Paseo de la Castellana 121,Left Staircase 3rd B

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:May 2024

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

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