Testosterone enanthate Sit

Package leaflet: Information for the user

Testosterone enantato SIT 250 mg/ml solution for injection

Testosterone enantato
Equivalent medicine
Please read this leaflet carefully before using this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

1. What Testosterone enantato SIT is and what it is used for

Testosterone enantato SIT contains testosterone enantate, a synthetic form of the natural male sex hormone, testosterone.
It is used to replace testosterone in adult men for the treatment of various health problems caused by testosterone deficiency (male hypogonadism). This condition must be confirmed by two separate blood measurements of testosterone and must include clinical symptoms such as:

• impotence
• infertility
• low sexual desire
• fatigue
• depressed mood
• loss of bone tissue due to low hormone levels.

Testosterone enantato SIT must be injected deeply into the gluteal muscle, where it accumulates and can be gradually released into the bloodstream.

2. What you need to know before using Testosterone enantato SIT

Do not use Testosterone enantato SIT:

• if you are allergic to testosterone enantate or to any of the other ingredients of this medicine (listed in section 6),
• if you have androgen-dependent (steroid hormone-dependent) cancer of the prostate or breast gland,
• if you have high levels of calcium in the blood,
• if you have or have had a liver tumour,
• if you have benign enlargement (adenoma) of the prostate. Testosterone enantato SIT is not intended for use in women. 1 of 6

Warnings and precautions
Talk to your doctor before using Testosterone enantato SIT if you currently have or have previously had:

• liver problems, including severe upper abdominal pain,
• a tendency to retain fluids, which may cause, for example, swelling of the ankles,
• a serious heart, liver or kidney disease; treatment with testosterone may cause serious complications such as fluid retention in the body, sometimes accompanied by heart failure (congestion),
• high blood pressure or if you are being treated for high blood pressure, since testosterone may increase blood pressure,
• blood clotting disorders, such as thrombophilia (a blood clotting abnormality that increases the risk of thrombosis, i.e. blood clots in blood vessels), as treatment with testosterone may increase the risk of thrombosis. Factors that increase the risk of blood clots in a vein: previous blood clots in a vein; smoking; obesity; cancer; sedentary lifestyle; aging; if one of your close relatives had a blood clot in a leg, lung or other organ at a young age (e.g. under approximately 50 years of age). How to recognize a blood clot: painful swelling of one leg or sudden change in skin colour, for example becoming pale, red or blue; sudden shortness of breath; sudden unexplained cough, possibly causing you to cough up blood; sudden chest pain; severe mental confusion or dizziness; severe stomach pain; sudden loss of vision. Seek immediate medical attention if any of these symptoms occur.
• epilepsy, migraine, diabetes mellitus or bone cancer.
• sleep apnoea (temporary interruptions in breathing during sleep), as this condition may worsen. Testosterone enantato SIT may also affect the results of certain laboratory tests (e.g. thyroid). Inform your doctor or laboratory staff if you are taking Testosterone enantato SIT.

Muscle development and anti-doping tests
Male hormones such as testosterone enantate are not suitable for muscle building in healthy individuals or for increasing physical performance.
Testosterone enantato SIT may lead to positive results in anti-doping tests.

Misuse of the medicine and dependence
Always take the medicine exactly as prescribed by your doctor or pharmacist.
Abuse of testosterone, especially when taken in excessive amounts alone or in combination with other anabolic androgenic steroids, may cause serious health problems affecting the heart and blood vessels (which may lead to death), mental health and/or the liver.
Individuals who have abused testosterone may develop dependence and may experience withdrawal symptoms when dosage is significantly changed or abruptly stopped.
Do not misuse this medicine alone or in combination with other anabolic androgenic steroids, as it poses serious health risks.

Medical examinations/monitoring
Male hormones may promote the growth of prostate cancer and enlarged prostate gland (benign prostatic hyperplasia). Before administering Testosterone enantato SIT, your doctor will examine you to ensure you do not have prostate cancer.
If you are elderly, you may have a higher risk of developing prostate enlargement with the use of Testosterone enantato SIT. As a precaution, regular prostate examinations are recommended in men, especially in the elderly.
If you are on long-term androgen therapy, periodic blood tests should be performed (see section 4 “Possible side effects”).
Benign (non-cancerous) and malignant (cancerous) liver tumours have been observed following the use of hormonal substances such as androgenic compounds. Although the occurrence of a tumour is unlikely, it would represent a health concern.
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Therefore, you should always seek immediate medical attention if you experience severe abdominal pain. Not all unusual sensations in the upper abdomen should be considered possible signs of a tumour, but those that do not resolve quickly should be reported to your doctor.

Additional information on special populations
Children and adolescents
Testosterone enantato SIT must not be used in children and adolescents. Safety and efficacy have not been adequately established in children and adolescents.

Elderly patients (65 years or older)
Limited data do not suggest the need for dose adjustment in elderly patients.

Patients with impaired liver function
No formal studies have been conducted in patients with impaired liver function.
Testosterone enantato SIT will not be prescribed to you if you have previously had liver cancer (see “Do not use Testosterone enantato SIT”).

Other medicines and Testosterone enantato SIT
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
In particular, inform your doctor if you are taking any of the following medicines, as they may be affected by or may affect Testosterone enantato SIT:

• medicines used to treat pain or inflammation (e.g. oxyphenbutazone),
• anticoagulant tablets used to thin the blood, such as warfarin,
• medicines used to treat diabetes. It may be necessary to adjust the dose of your blood sugar-lowering medicine. 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 perform blood tests more frequently.

Pregnancy and breastfeeding
The use of Testosterone enantato SIT is not indicated in women and the medicine must not be used during pregnancy or breastfeeding.

Fertility
Treatment with high doses of testosterone preparations may reversibly block or reduce sperm production (see section “Possible side effects”).

Driving and using machines
Testosterone enantato SIT has no known effects on the ability to drive vehicles or operate machinery.

Testosterone enantato SIT contains benzyl benzoate
This medicine contains 342 mg of benzyl benzoate in each 1 ml vial.

Doping
For individuals engaged in sports: using this medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.

3. How to use Testosterone enantato SIT

Testosterone enantato SIT is administered by a healthcare professional.
It is given by slow intramuscular injection, usually every 2 or 3 weeks. Injections will continue for as long as the doctor considers necessary, depending on individual circumstances. Men receiving long-term treatment may subsequently receive injections at intervals of 3–6 weeks.
The doctor will measure testosterone levels in the blood before starting treatment and occasionally during treatment, at the end of an injection interval, adjusting the dose as needed.
During treatment, men are advised to have regular prostate examinations by a physician.
If you forget to take Testosterone enantato SIT
Follow the injection interval schedule agreed upon with your doctor to ensure optimal treatment effectiveness.
If you stop using Testosterone enantato SIT
When treatment is stopped, symptoms of testosterone deficiency may reappear.
If you have any doubts about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some people may be allergic to testosterone enantate. If you experience an allergic reaction, you must stop using Testosterone enantato SIT and contact your doctor immediately or go to the nearest hospital emergency department. Signs of an allergic reaction may include:

• severe skin rash
• difficulty swallowing or breathing
• swelling of the lips, face, throat, or tongue
• weakness, dizziness, or fainting
• nausea

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

• increase in red blood cells, haematocrit (percentage of red blood cells in the blood), and haemoglobin (the component of red blood cells that carries oxygen); these are detected by periodic blood tests
• weight gain

Other side effects (frequency cannot be determined from available data):

• Liver tumours have been observed. Inform your doctor if you notice new stomach pain that is severe or persistent.
• High red blood cell count (polycythaemia), circulation problems, high levels of calcium in the blood
• Abnormal liver function tests, yellowing of the skin and eyes (jaundice), liver enlargement
• Acne, hair loss, skin reactions such as rashes, hives (red raised patches), itching, tingling, male-pattern baldness
• Various types of reactions at the injection site including pain, itching, hardening, swelling, and inflammation
• Increase in prostate-specific antigen (PSA)
• Increased or decreased interest in sex, abnormal excessive breast development in men, prostate problems, early onset of puberty (Testosterone enantato SIT is not indicated for use in children – see section 2 “Warnings and precautions”)
• At high doses or with prolonged use, fluid retention and even swelling of the ankles may occur
• Men may develop a reduced sperm count and frequent or prolonged erections (if this occurs, it is important to inform your doctor as this could damage the 4 of 6

penis)

• Headache, weakness, depression, anxiety
• Changes in bone growth (increase or premature arrest)
• Stomach problems, feeling unwell

Rare side effects (may affect up to 1 in 1,000 patients)
Testosterone enantato SIT, which is an oily liquid, may reach the lungs (pulmonary microembolism due to oily solutions), leading in rare cases to 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. The patient should therefore be closely observed during and immediately after each injection to allow for rapid identification of any signs or symptoms of oil-induced pulmonary microembolism.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Testosterone enantato SIT

Keep this medicine out of 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. The expiry date refers to the last day of that month.
Testosterone enantato SIT should be inspected visually before administration and only a clear solution, free from particles, should be used.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Testosterone enantate SIT contains

• The active substance is testosterone enantate. Each 1 ml vial contains 250 mg of testosterone enantate (equivalent to 180 mg of testosterone) in oily solution.
• The other components are benzyl benzoate and refined castor oil.

Description of the appearance of Testosterone enantate SIT and contents of the pack
Testosterone enantate SIT is a yellowish, transparent, oily liquid.
Each vial is made of amber glass and contains 1 ml of injectable solution.
The pack contains 1, 3, 5 or 10 vials.
It is possible that not all pack sizes are 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
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This medicinal product is authorized in the European Economic Area Member States under the following names:

• Sweden: Testosteronenantat SIT 250 mg/ml Injektionsvätska, lösning
• France: TESTOSTERONE DESMA 250 mg/1 ml, solution injectable

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The following information is intended exclusively for healthcare professionals:
Under storage at low temperatures, the properties of this oil-based solution may temporarily change (e.g. increased viscosity, turbidity). If stored at low temperature, the product must be warmed to room or body temperature before use.
The injectable solution for intramuscular use must be visually inspected before administration; only clear solutions free from suspended particles should be used.
The content of one vial must be administered intramuscularly immediately after opening.
The medicinal product is for single use only; any unused solution must be discarded.

Administration:
For intramuscular injection only. Testosterone enantate SIT must be injected deeply into the gluteal muscle, observing standard precautions for intramuscular administration.
Particular care must be taken to avoid intravascular injection.
Like all oily solutions, Testosterone enantate SIT must be administered strictly by intramuscular injection and very slowly (over more than two minutes). The formation of pulmonary microemboli from oily solutions may, in rare cases, 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 oxygen.
Cases of suspected anaphylactic reactions have been reported after administration of Testosterone enantate SIT.

Warning:
Patients receiving testosterone therapy must undergo careful and regular monitoring, according to recommended methods, of the prostate gland (digital rectal examination and serum PSA determination) and breasts, at least once a year, and twice a year for elderly patients and those at risk (patients with clinical or familial risk factors).
In patients undergoing long-term androgen therapy, in addition to laboratory tests for testosterone concentration, the following laboratory parameters should be monitored periodically: hemoglobin, hematocrit, liver function tests, and lipid profile.
In patients with severe heart, liver or renal failure or ischemic heart disease, testosterone treatment may lead to serious complications, characterized by edema with or without congestive heart failure. In such cases, treatment must be immediately discontinued.

Instructions for handling the OPC (One-Point Cut) vial:
Below the colored mark, the vial has a pre-scored line, eliminating the need for a file to open it. Before opening, ensure that any solution present in the upper portion of the vial has flowed down into the lower portion. Use both hands to open: hold the lower part of the vial with one hand and, with the other hand, snap off the top portion in the direction opposite to the colored mark.
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