Testosterone Sit 1,000 mg/4 ml solution for injection EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Testosterona SIT 1000 mg/4ml injectable solution EFG

Testosterone undecanoate

Read this entire leaflet carefully before you start using 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, consult your doctor.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Testosterona SIT is and what it is used for
2. What you need to know before using Testosterona SIT
3. How to use Testosterona SIT
4. Possible side effects
5. How to store Testosterona SIT
6. Contents of the pack and other information

1. What Testosterona SIT is and what it is used for

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

Testosterona SIT is administered by intramuscular injection; the medicine is released gradually over time.

Testosterone is used in adult men for testosterone replacement therapy to treat various health problems caused by testosterone deficiency (male hypogonadism). This should be confirmed by two separate blood tests measuring testosterone levels, along with the presence of clinical symptoms such as:

• impotence
• infertility
• low libido
• fatigue
• depressive mood states
• bone loss due to low hormone levels.

2. What you need to know before using Testosterona SIT

Do not use Testosterona SIT

• if you are allergic to testosterone undecanoate or to any of the other ingredients of this medicine (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 a liver tumor.

Testosterone is not indicated for use in women.

Warnings and precautions

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

• epilepsy
• heart, liver, or kidney problems
• migraine
• breathing interruptions during sleep (sleep apnea), as this may worsen with treatment
• cancer, as blood calcium levels will need to be monitored
• high blood pressure or are being treated for hypertension, as testosterone may cause an increase in blood pressure
• blood clotting disorders
  • bleeding disorders (e.g., hemophilia)
  • thrombophilia (a blood clotting disorder that increases the risk of thrombosis – blood clots in blood vessels)
  • factors that increase the risk of blood clots in a vein: previous blood clots in a vein, smoking, obesity, cancer, immobility, a close family member who had a blood clot in a leg, lung, or other organ at an early age (e.g., around under 50 years of age), or as you age.

How to recognize a blood clot: painful swelling of one leg or sudden change in skin color, for example becoming pale, red, or blue; 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.

If you have severe heart, liver, or kidney failure, treatment with testosterone may lead to serious complications such as fluid retention, which may occasionally be accompanied by heart failure (congestive).

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

If your liver does not function properly

Formal studies have not been conducted in patients with hepatic impairment. If you have ever had a liver tumor, this medicine will not be prescribed to you (see "Do not use Testosterona SIT").

Children and adolescents

Testosterone is not indicated for use in children and adolescents. There is no available information on the use of this medicine in males under 18 years of age.

Elderly patients (65 years or older)

Dose adjustment is not necessary if you are over 65 years of age (see "Medical examination/follow-up").

Use in athletes, bodybuilding, and doping tests

Testosterone is not indicated to increase muscle mass in healthy individuals or to enhance physical endurance. Testosterone may result in a positive outcome in doping control tests.

Drug abuse and dependence

Always use this medicine exactly as your doctor or pharmacist has instructed.

Abuse of testosterone, especially when taking excessive amounts either alone or in combination with other anabolic androgenic steroids, may cause serious health problems affecting the heart and blood vessels (which may be fatal), mental health, and/or the liver.

Individuals who have abused testosterone may become dependent and may experience withdrawal symptoms when the dose is significantly changed or when treatment is suddenly stopped. Do not abuse this medicine, as it may cause serious health problems, whether used alone or in combination with other anabolic androgenic steroids (see "Possible side effects").

Medical examination / follow-up

Male hormones may promote 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 rule out the presence of existing prostate cancer.

Your doctor must carry out regular monitoring of the prostate and breasts, especially in elderly patients. Your doctor will also perform periodic blood tests.

Benign (non-cancerous) and malignant (cancerous) liver tumors have been reported in patients treated with hormonal products such as androgenic compounds.

Other medicines and Testosterona SIT

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine, including those obtained without a prescription. Your doctor may need to adjust the dose if you are taking other medicines, such as:

• Adrenocorticotropic hormone (ACTH) or corticosteroids (used to treat various conditions such as rheumatism, arthritis, allergic reactions, and asthma). Testosterone may increase the risk of fluid retention, especially if you have heart or liver problems.
• Medicines that make the blood thinner (oral anticoagulants, coumarin derivatives), as they may increase the risk of bleeding. Your doctor will monitor your dosage.
• Medicines for the treatment of diabetes. The dose of your antidiabetic 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.

Inform your doctor if you have any blood clotting disorder, as it is important for your doctor to know this information when deciding whether testosterone treatment is appropriate.

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

Pregnancy and breastfeeding

Testosterone is not indicated for use in women and must not be used in pregnant or breastfeeding women.

Fertility

Treatment with high doses of testosterone-containing medicines may reversibly suppress or reduce sperm production (see also "Possible side effects").

Driving and using machines

No effects on the ability to drive or use machines have been observed.

Testosterona SIT contains benzyl benzoate

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

3. How to use Testosterone SIT

Your doctor will inject this medicine (1 ampoule/vial) intramuscularly, very slowly. The treatment will be repeated every 10–14 weeks, a sufficient interval to maintain testosterone levels without allowing testosterone to accumulate in the blood.

Testosterone must be administered only by intramuscular route. Particular care must be taken to avoid injecting the product into a blood vessel (see "Administration").

Starting treatment

Before starting treatment and during its initial phase, your doctor will determine your blood testosterone levels. Your doctor may administer a second injection no sooner than 6 weeks after the first injection, in order to rapidly achieve the required testosterone level. This will depend on your symptoms and testosterone levels.

Maintaining Testosterone SIT levels during treatment

The interval between injections should remain within the recommended range of 10 to 14 weeks. Your doctor will regularly measure your testosterone levels at the end of each injection interval to ensure that levels are appropriate. If levels are too low, your doctor may increase the injection frequency. If your levels are too high, your doctor may decrease the injection frequency. Do not miss your treatment appointments, as otherwise your testosterone levels will not be properly controlled.

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

If you use more Testosterone SIT than you should

Symptoms of having received too much testosterone include:

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

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

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number 91 562 04 20, indicating the medicine and the amount used.

4. Possible adverse effects

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

The most common adverse reactions are acne and pain at the injection site.

Frequent adverse effects (may affect up to 1 in 10 people):

• abnormally elevated levels of red blood cells
• weight gain
• hot flushes
• acne
• enlargement of the prostate and associated problems
• various reactions at the injection site (e.g., pain, bruising, or irritation)

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

• allergic reaction
• increased appetite, changes in certain blood test results (such as increased blood sugar or fat levels)
• depression, mood disturbances, insomnia, restlessness, aggression, or irritability
• headache, migraine, or tremors
• cardiovascular disorders, elevated blood pressure, or dizziness
• bronchitis, sinusitis, cough, shortness of breath, snoring, or voice changes
• diarrhea or nausea
• abnormalities in liver function tests
• hair loss or various skin reactions (e.g., itching, redness, or dry skin)
• joint or limb pain, muscle problems (e.g., spasms, pain, or stiffness), or increased blood creatine phosphokinase
• urinary tract disorders (e.g., reduced urine flow, urinary retention, urgent need to urinate at night)
• prostate disorders (e.g., prostatic dysplasia, hardening or inflammation of the prostate), changes in sexual appetite, testicular pain, pain, hardening, or enlargement of the breasts, or increased levels of male and female hormones
• fatigue, general weakness, excessive sweating, or night sweats

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

• The oily liquid of testosterone may reach the lungs (pulmonary microembolism from oily solutions), and in rare cases may cause signs and symptoms such as cough, shortness of breath, general malaise, excessive sweating, chest pain, dizziness, tingling, or fainting. These reactions may occur during or immediately after injection and are reversible. Therefore, patients should be observed during and immediately after each injection to allow early identification of possible signs and symptoms of pulmonary microembolism from oily solutions.

Suspected cases of anaphylactic reactions following testosterone injection have been reported.

In addition to the effects listed above, the following adverse effects have been observed with testosterone-containing products: 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).

Treatment with high doses of testosterone generally interrupts or reduces sperm production, although this returns to normal after stopping treatment. Testosterone replacement therapy in cases of underactive testes (hypogonadism) may rarely cause persistent and painful erections (priapism). Long-term treatment or high-dose testosterone therapy may occasionally lead to increased fluid retention and edema (swelling due to fluid retention).

In general, with testosterone-based medicines, a frequent risk of increased red blood cell count, hematocrit (percentage of red blood cells in the blood), and hemoglobin (the oxygen-carrying component of red blood cells) has been observed, identified through periodic blood tests.

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: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Testosterone SIT

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

This medicine does not require any special storage conditions.

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.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your usual pharmacy. If in doubt, ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Testosterona SIT

The active substance is testosterone undecanoate 250 mg/ml (equivalent to 157.9 mg of testosterone). One ampoule/vial contains 1000 mg of testosterone undecanoate (equivalent to 631.5 mg of testosterone).

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

Appearance of the product and contents of the container

Testosterona SIT is a slightly yellow to yellow oily solution.

Testosterona SIT is supplied in an amber glass ampoule or an amber glass vial with a rubber stopper and an aluminium cap with a plastic flip-off seal.

The pack sizes are:

1 amber glass ampoule / amber glass vial containing 4 ml of injectable solution.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

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

Via Cavour, 70

27035 Mede (PV)

Italy

Manufacturer

EVER Pharma Jena GmbH

Brüsseler Str 18

07747 Jena

Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Desma Laboratorio Farmacéutico SL

Paseo de la Castellana 121, Escalera Izquierda 3ºB

28046 Madrid

Telephone: +34 91 3238792

This medicinal product is authorized in the European Economic Area (EEA) Member States and in the United Kingdom (Northern Ireland) under the following names:

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

Date of most recent revision of this summary: March 2026

This information is intended for healthcare professionals only:

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

The intramuscular injectable solution should be inspected visually before administration; only clear solutions free from particles should be used.

The contents of one ampoule/vial must be injected intramuscularly immediately after opening the ampoule/vial.

The medicine is for single use only; any unused solution should be discarded.

Administration

Caution is required to avoid injecting the medicine into a blood vessel.

Like all oily solutions, this medicine must be administered intramuscularly only and very slowly. Pulmonary microembolism associated with oily solutions may rarely cause signs and symptoms such as cough, dyspnea, malaise, hyperhidrosis, chest pain, dizziness, paresthesia, or syncope. These reactions may occur during or immediately after injection and are reversible. Treatment is usually supportive, for example, administration of supplemental oxygen.

Anaphylactic reactions have been reported following administration of this medicinal product.

Warnings

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

In addition to laboratory tests to determine blood testosterone concentration in patients undergoing long-term androgenic 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 insufficiency or with ischemic heart disease, testosterone treatment may cause serious complications, characterized by edema with or without congestive heart failure. In such cases, treatment must be discontinued immediately.

Instructions for handling the Testosterona SIT ampoule with "One Point Cut" (UPC) opening system

The ampoule has a score mark located below the coloured dot. Before opening, ensure that no solution remains in the upper part of the ampoule. Use both hands to open it: while holding the lower part of the ampoule with one hand, use the other hand to press outward and break off the top of the ampoule in the direction opposite to the coloured dot.

Instructions for handling the vial:

The vial is for single use only. The contents of the vial must be injected intramuscularly immediately after being drawn into the syringe. After removing the plastic cap (A), do not remove the metal ring (B) or the seal from the rim (C).