Label: Information for the User

Testosterona SIT 1000 mg/4ml injectable Solution EFG

Testosterone undecanoate

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor.
• This medication has been prescribed only to you, 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 any adverse effects, consult your doctor, even if they are not listed in this label. See section 4.

Testosterona SIT contains testosterone, a male hormone, as the active ingredient.

Testosterona SIT is administered via injection through intramuscular injection; the administered medication is released over time.

Testosterone is used in adult men for testosterone replacement therapy to treat various health problems resulting from 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.

No use Testosterona SIT

• If you are allergic to undecanoate testosterone or any of the other components of this medication (listed in section 6)
• If you have androgen-dependent cancer or suspect you may have prostate or breast cancer
• If you have or have had liver tumors

Testosterona is not indicated for use in women.

Warnings and precautions

Consult your doctor before starting to use testosterone if you have or have ever had:

• Epilepsy
• Heart, liver, or kidney problems
• Migraine
• Obstructive sleep apnea, as it may worsen with treatment
• Cancer, as it will be necessary to determine blood calcium levels
• High blood pressure or if you are being treated for hypertension, as testosterone may cause an increase in blood pressure
• Bleeding disorders
• • Bleeding disorders (e.g., hemophilia)
  • Thrombophilia (blood clotting disorder that increases the risk of thrombosis - blood clots in blood vessels)
  • Factors that increase the risk of venous blood clots: previous blood clots in a vein, smoking, obesity, cancer, inactivity, if a direct relative has had a blood clot in a leg, lung, or other organ at an early age (e.g., approximately below 50 years of age), or as you age.

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

If you have severe heart, liver, or kidney failure, testosterone treatment may cause severe complications in the form of fluid retention, which may be accompanied by heart failure (congestive) in some cases.

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

If your liver does not function

No formal studies have been conducted in patients with liver failure. If you have ever had a liver tumor, you will not be prescribed this medication (see "Do not use Testosterona SIT").

Children and adolescents

Testosterona is not indicated for use in children and adolescents. There is no available information on the use of this medicationin male individuals under 18 years of age.

Older adults (65 years or older)

No dose adjustment is necessary if you are over 65 years old (see "Medical examination/follow-up").

Use in athletes, bodybuilding, and doping tests

Testosterona is not indicated for increasing muscle mass in healthy individuals or for increasing physical resistance. Testosteronamayproduce a positive result in doping control tests.

Drug abuse and dependence

Use this medication exactly as your doctor or pharmacist has instructed you.

The abuse of testosterone, especially if you take too much of this medication either alone or in combination with other anabolic androgenic steroids, may cause severe health problems to your heart and blood vessels (which may cause death), your mental health, and/or your liver.

Individuals who have abused testosterone may become dependent and may experience withdrawal symptoms when the dose changes significantly or when use is suddenly stopped. Do not abuse this medication because it may cause severe health problems, whether used alone or in combination with other anabolic androgenic steroids (see "Possible adverse effects").

Medical examination / follow-up

Male hormones may increase the growth of prostate cancer or increase the size of the prostate gland (benign prostatic hyperplasia). Before starting testosterone treatment, your doctor must perform a medical examination to exclude the risk of existing prostate cancer.

Your doctor must perform regular and careful follow-up of the prostate and breasts, especially in older adults. Your doctor will also perform regular blood tests.

There have been reports of benign (non-cancerous) and malignant (cancerous) liver tumors in patients treated with hormone products such as androgenic compounds.

Other medications and Testosterona SIT

Inform your doctor or pharmacist if you are using or have used recently or may need to useany other medication, including those purchased without a prescription. Your doctor may need to adjust the dose if you are taking other medications, such as:

• Adrenocorticotropic hormone (ACTH) or corticosteroids (used to treat various diseases such as rheumatism, arthritis, allergic reactions, and asthma). Testosterone may increase the risk of fluid retention, especially if you have heart or liver problems.
• Medications that make blood thinner (oral anticoagulants, coumarin derivatives) as they may increase the risk of bleeding. Your doctor will check your dose.
• Medications for the treatment of diabetes. You may need to adjust the dose of your antidiabetic medication. Like other androgens, testosterone may increase the effect of insulin.

Inform your doctor if you have any bleeding disorders,as it is essential for your doctor to know this information to decide if you can be treated with testosterone.

Testosterone may also affect the results of laboratory tests (e.g., thyroid gland). Inform your doctor or laboratory staff that you are being treated with testosterone.

Pregnancy and lactation

Testosterona is not indicated for use in women and should not be used in pregnant women or breastfeeding women.

Fertility

High-dose testosterone treatment may interrupt or reduce sperm production in a reversible manner (see also "Possible adverse effects").

Driving and operating machinery

No effect has been observed on the ability to drive and operate machinery.

Testosterona SIT contains benzyl benzoate

Testosterona SIT contains 2000 mg of benzyl benzoate in each 4 ml ampoule/vial equivalent to 500 mg/ml.

Your doctor will inject this medication (1 ampoule/vial) intramuscularly, very slowly. The treatment will be repeated every 10-14 weeks, long enough to maintain testosterone levels without accumulation in the blood.

Testosterone should only be administered intramuscularly. Special care must be taken to avoid injecting the product into a blood vessel (see "Administration").

Starting Treatment

Before starting treatment and during the first part of it, your doctor will determine your blood testosterone levels. Your doctor may administer a second injection, as soon as possible, 6 weeks after the first injection, in order to quickly reach the necessary level of testosterone. This will depend on your symptoms and testosterone levels.

Maintaining Testosterone SIT Levels During Treatment

The interval between injections should be kept within the recommended range of 10 to 14 weeks. Your doctor will regularly measure your testosterone levels at the end of an injection interval to ensure that the levels are correct. If the levels are very low, your doctor may increase the frequency of injections. If your levels are very high, your doctor may decrease the frequency of injections. Do not forget your treatment days, as otherwise, your testosterone levels will not be correctly controlled.

If you think the effect of testosterone is too intense or too weak, inform your doctor..

If You Use More Testosterona SIT Than You Should

The symptoms of having received too much testosterone include:

• irritability
• nervousness
• weight gain
• frequent or prolonged erections.

Inform your doctor if you have any of the above symptoms. Your doctor will reduce the frequency of injections or suspend treatment.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount used.

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

Themost common side effectsare acne and pain at the injection site.

Common side effects(may affect up to 1 in 10 people):

• Abnormally high levels of red blood cells
• Weight gain
• Hot flashes
• Acne
• Enlargement of the prostate and associated problems
• Diverse reactions at the injection site (e.g., pain, hematomas, or irritation)

Uncommon side effects(may affect up to 1 in 100 people):

• Allergic reaction
• Increased appetite, alterations in some blood test results (e.g., increased sugar or fats)
• Depression, emotional disturbances, insomnia, restlessness, aggression, or irritability
• Headache, migraine, or tremors
• Cardiovascular alterations, high blood pressure, or dizziness
• Bronchitis, sinusitis, cough, shortness of breath, snoring, or voice changes
• Diarrhea or nausea
• Alterations in liver test results
• Hair loss or diverse skin reactions (e.g., itching, redness, or dry skin)
• Pain in the joints or extremities, muscle problems (e.g., spasms, pain, or stiffness) or increased creatine phosphokinase in the blood
• Urinary tract alterations (e.g., decreased urine flow, urinary retention, or nocturia)
• Prostate alterations (e.g., prostatic dysplasia, hardening, or inflammation), sexual appetite alterations, testicular pain, pain, hardening, or enlargement of the breasts, or increased levels of male and female hormones
• Fatigue, generalized weakness, excessive sweating, or nocturnal sweating.

Rare side effects(may affect up to 1 in 1000 people):

• The oily liquid oftestosteronecan reach the lungs (pulmonary microembolism of oily solutions) and in rare cases may cause symptoms such as cough, shortness of breath, general discomfort, excessive sweating, chest pain, dizziness, pins and needles, or fainting. These reactions can occur during or immediately after the injection and are reversible.

Suspected anaphylactic reactions have been reported after injection oftestosterone.

In addition to the previously mentioned effects, the following side effects have been observed after treatment with products containing testosterone: nervousness, hostility, brief interruptions of breathing during sleep (apnea), skin reactions such as dandruff and seborrhea, excessive hair growth, more frequent erections, and in very rare cases, yellowing of the skin and eyes (jaundice).

High doses of testosterone treatment generally interrupts or reduces sperm production, although it returns to normal after stopping treatment. Testosterone replacement treatment in cases of low-functioning testicles (hypogonadism) may cause rare cases of persistent and painful erections (priapism). Long-term or high-dose testosterone treatment may occasionally cause an increase in fluid retention and edema (swelling due to fluid retention).

In general, testosterone-based medications have been observed to have a frequent risk of increased red blood cell count, hematocrit (percentage of red blood cells in the blood), and hemoglobin (the component of red blood cells that transports oxygen), identified through periodic blood tests.

Reporting of side effects

If you experience any type of side effect, consult your doctororpharmacist,even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use: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.

This medication does not require special conservation conditions.

Nouse this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicationsshould notbe disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at your local pharmacy's SIGRE point.By doing so, you will help protect the environment. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need.

Testosterone SIT Composition

The active ingredient is testosterone undecanoate 250 mg/ml (corresponding to 157.9 mg of testosterone). A vial contains 1000 mg of testosterone undecanoate (which corresponds to 631.5 mg of testosterone).

The other components are: benzyl benzoate and refined ricin oil.

Product Appearance and Packaging Contents

Testosterone SIT is a oily solution, of a slightly yellow to yellow color.

Testosterone SIT is presented in an amber glass vial or in an amber glass vial with a rubber stopper and an aluminum cap with a plastic flip-off closure.

The contents of the packaging are:

1 amber glass vial / amber glass vial with 4 ml of injectable solution.

Only some packaging sizes may be marketed.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder

Laboratorio Farmaceutico S.I.T. S.r.l.

Via Cavour, 70

27035 Mede (PV)

Italy

Responsible Manufacturer

EVER Pharma Jena GmbH

Brüsseler Str 18

07747 Jena

Germany

For more information about this medication, please contact the local representative of the marketing authorization holder:

Desma Laboratorio Farmacéutico SL

Paseo de la Castellana 121,Escalera Izquierda 3ºB

28046 Madrid

Phone: +34 91 3238792

This medication is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following denominations:

• Netherlands: Testosteron undecanoaat SIT 1000 mg/4 ml, oplossing voor injectie
• Italy: Testosterone undecanoato SIT 1000 mg/4 ml, soluzione iniettabile

Last review date of this leaflet:May 2024

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This information is intended solely for healthcare professionals:

At storage temperatures in the cold, the properties of this oily base solution may change temporarily (e.g. increased viscosity, turbidity). If stored in the cold, the product should be brought to room temperature or body temperature before use.

The injectable solution must be visually inspected before use, only transparent and particle-free solutions should be used.

The contents of a vial should be injected intramuscularly immediately after opening the vial.

The medication is for single use, the unused solution should be discarded.

Administration

Care should be taken to avoid injecting the medication into a blood vessel.

Like all oily solutions, this medicationshould only be injected intramuscularly and very slowly. Pulmonary microembolism related to oily solutions may cause rare signs and symptoms such as cough, dyspnea, discomfort, sweating, chest pain, dizziness, paresthesia or syncope. These reactions may occur during or immediately after injection and are reversible. Supportive treatment, for example, administration of supplemental oxygen, is usually sufficient.

Suspected anaphylactic reactions have been reported after administration of this medication.

Warnings

A regular careful check of the prostate gland and breasts should be performed using established methods (digital rectal examination and serum PSA determination) in patients receiving testosterone treatment, at least once a year and twice a year in elderly patients and those at risk (those with clinical or familial factors).

In addition to laboratory tests to determine blood testosterone concentration in patients receiving long-term androgen therapy, the following laboratory tests should be performed periodically: hemoglobin, hematocrit, liver function tests and lipid profile.

In patients with severe cardiac, hepatic or renal failure or ischemic heart disease, testosterone treatment may cause severe complications, characterized by edema with or without congestive heart failure. In this case, treatment should be discontinued immediately.

Instructions for handling the Testosterone SIT vial with a "One Point Cut" (UPC) opening system

The vial has a mark below the colored point. Before opening, ensure that there is no solution left in the upper part of the vial. Use both hands to open it; while holding the lower part of the vial with one hand, use the other hand to press outwards and break the upper part of the vial in the opposite direction to the colored point.

Instructions for handling the vial:

The vial is for single use. The contents of the vial should be injected intramuscularly immediately after loading the syringe. After removing the plastic cover (A), do not remove the metal ring (B) or the cap of the rim (C).