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1. Testosterone enantate SIT 250 mg/ml injectable solution
   1. What is Testosterone enantate SIT and what is it used for
   2. What you need to know before using Testosterone Enanthate SIT
   3. How to use Testosterone enantate SIT
   4. Possible side effects
   5. How to store Testosterone enantate SIT
   6. Content of the pack and other information

Testosterone enantate SIT 250 mg/ml injectable solution

Testosterone enantate

Equivalent medicine

Important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even if not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

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

Testosterone enantate 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 due to
testosterone deficiency (male hypogonadism). This condition must be confirmed with two
separate testosterone measurements in the blood 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 enantate SIT must be injected deep into the gluteal muscle, where it remains accumulated
and can be gradually released into the bloodstream.

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

Do not use Testosterone Enanthate SIT:

• if you are allergic to testosterone enanthate or any of the other ingredients of this medicine (listed in section 6),
• if you have androgen-dependent cancer (hormone steroid-dependent) of the prostate or mammary gland,
• if you have high levels of calcium in the blood,
• if you have or have had a liver tumor
• if you have a benign growth (adenoma) of the prostate. Testosterone Enanthate SIT is notintended for use in women. 1 of 6

Warnings and precautions
Talk to your doctor before using Testosterone Enanthate SIT if you suffer from or have suffered in the past from:

• liver problems, including severe upper abdominal discomfort
• a tendency to retain fluids, which causes, for example, swelling of the ankles
• a severe heart, liver or kidney disease; treatment with testosterone may cause serious complications in the form of fluid retention in the body, sometimes accompanied by congestive heart failure.
• high blood pressure or if you are being treated for high blood pressure, as testosterone may cause an increase in blood pressure
• alterations in blood coagulation, such as thrombophilia (an abnormality of blood coagulation 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; inactivity; aging; if one of your close relatives has had a blood clot in a leg, lung or other organ at a young age (e.g. under about 50 years of age). How to recognize a blood clot: painful swelling of a leg or a sudden change in skin color which for example becomes pale, red or blue, sudden shortness of breath, unexplained sudden cough that may cause bleeding; or sudden chest pain, severe dizziness or lightheadedness, 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 apnea (temporary interruptions of breathing during sleep), because this condition may worsen. Testosterone Enanthate SIT may also affect the results of some laboratory tests (e.g. thyroid). Inform your doctor or laboratory personnel if you are taking Testosterone Enanthate SIT.

Muscle development and anti-doping tests
Male hormones such as testosterone enanthate are not suitable for developing muscles in healthy people or for increasing physical capacity.
Testosterone Enanthate SIT may result in positive anti-doping tests.

Drug abuse and dependence
Always take the medicine exactly as directed by your doctor or pharmacist.
Abuse of testosterone, especially if you take too much on your own or with other anabolic androgenic steroids, can cause serious health problems with the heart and blood vessels (which can lead to death), mental health and/or the liver.
Individuals who have abused testosterone may develop dependence and may experience withdrawal symptoms when the dosage is changed significantly or is abruptly discontinued. Do not abuse this medicine on your own or with other anabolic androgenic steroids because it causes serious health risks.

Medical examinations/checks
Male hormones can promote the growth of prostate cancer and enlarged prostate gland (benign prostatic hyperplasia). Before injecting Testosterone Enanthate SIT, your doctor will examine you to make sure you do not have prostate cancer.
If you are elderly, you may be at greater risk of developing an enlarged prostate with the use of Testosterone Enanthate SIT. As a precaution, regular prostate exams are recommended in men, especially if they are elderly.
If you are undergoing long-term therapy with androgens, blood tests should be performed periodically (see section 4 “Possible side effects”).
The onset of benign (non-cancerous) and malignant (cancerous) liver tumors has been observed following the use of hormonal substances such as androgenic compounds. Although a tumor is unlikely to occur, this would be a health problem.
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Therefore, you should always seek immediate medical attention if you experience severe abdominal pain. Not all unusual sensations you may experience in the upper abdomen are to be considered a possible sign of a tumor, but those that do not disappear in a short time should be brought to the attention of the doctor.
Further information on special populations

Children and adolescents
Testosterone Enanthate SIT must notbe used in children and adolescents. Safety and efficacy have not been adequately established in children and adolescents.

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

Patients with impaired liver function
Formal studies have not been conducted in patients with impaired liver function.
Testosterone Enanthate SIT will not be prescribed to you if you have had a liver tumor in the past (see

“Do not use Testosterone Enanthate SIT”).

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

• medicines used to treat pain or inflammation (e.g. oxyphenbutazone)
• tablet anticoagulants, used to thin the blood, e.g. warfarin
• medicines used to treat diabetes, e.g. metformin. It may be necessary to adjust the dosage of your blood sugar-lowering medicine.

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

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

Driving and operating machinery
Testosterone Enanthate SIT has no known effects on the ability to drive vehicles or operate machinery.

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

Doping
For those who engage in sports: the use of the drug without therapeutic need constitutes doping and may still result in a positive doping test.

3. How to use Testosterone enantate SIT

Testosterone enantate SIT is administered by a healthcare professional.
It is administered by very slow injection into the gluteal muscle, usually every 2 or 3
weeks. Injections will be continued for as long as deemed necessary by the doctor, depending on
individual circumstances. Men receiving long-term treatment may be
administered injections subsequently at intervals of 3-6 weeks.
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The doctor will measure testosterone levels in the blood before starting treatment and occasionally
during treatment at the end of an injection interval and will adjust the dose as needed.
During treatment, men should regularly undergo a prostate check by a doctor.

If you forget to take Testosterone enantate SIT
Respect the timings on the injection intervals agreed with your doctor for optimal
treatment effectiveness.

If you stop using Testosterone enantate SIT
When treatment is stopped, symptoms of testosterone deficiency may reappear.
If you have any doubts about the use of this medicine, ask 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 enanthate. If you develop an allergic reaction
you should stop using Testosterone enanthate SIT and immediately inform your doctor or contact
the emergency room of the nearest hospital. The 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):

• increased red blood cells, hematocrit (percentage of red blood cells in the blood) and hemoglobin (the component of red blood cells that carries oxygen); these are identified by periodic blood tests
• weight gain

Other side effects(frequency cannot be estimated based on available data):

• Liver tumors have been observed. Inform your doctor if you notice new stomach pain that is severe or persistent.
• High levels of red blood cells (polycythemia), blood circulation problems, high levels of calcium in the blood
• Abnormal liver function test results, yellowing of the skin and eyes (jaundice), enlargement of the liver
• Acne, hair loss, skin reactions such as rashes, hives (raised red spots), itching, tingling, male pattern baldness
• Various types of reactions at the injection site including pain, itching, hardening, swelling and inflammation
• Increased prostate specific antigen (PSA)
• Increased or decreased interest in sex, abnormal excessive development of the breast in men, prostate problems, early onset of puberty (Testosterone enanthate SIT is not indicated for use in children - see section 2 “Warnings and precautions”)
• At high doses or for a long period of time, too much water may be retained and even swelling of the ankles may occur
• Men may develop a decrease in the number of sperm and frequent or persistent erections (if this happens, it is important to inform your doctor as this could damage the penis)
• Headache, weakness, depression, anxiety
• Changes in bone growth (increase or premature stopping) 4 of 6
• Stomach problems, feeling unwell. Injections of oily liquids such as Testosterone enanthate SIT have been associated with reactions such as coughing, shortness of breath and chest pain. There may be other signs and symptoms including a general feeling of being unwell, excessive sweating, dizziness, tingling or fainting.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor, pharmacist or nurse. You can also report side effects directly through
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 enantate 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 which is stated on the packaging. The expiry date
refers to the last day of that month.
Testosterone enantate SIT must be visually inspected before administration and only a clear solution, free of particles, must
be used.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Content of the pack and other information

What Testosterone enantate SIT contains

• The active ingredient is testosterone enantate. Each 1 ml vial contains 250 mg of testosterone enantate (corresponding 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 transparent, yellowish 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.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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

This medicinal product is authorised in the Member States of the European Economic Area under the following
denominations:

• Sweden: Testosteronenantat SIT 250 mg/ml Injektionsvätska, lösning
• France: TESTOSTERONE DESMA 250 mg/1 ml, solution injectable5 of 6

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The following information is intended for healthcare professionals only:
Under conditions of 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 brought to room or body temperature before use.
The injectable solution for intramuscular use must be visually inspected before use;
only clear solutions free from suspended particles must be used.
The contents of one vial must be injected intramuscularly immediately after opening.
The medicine is for single use only; any unused solution must be discarded.
Administration:
For intramuscular injection only. Care must be taken to inject Testosterone enantate SIT deeply into the gluteal muscle following the usual precautions for intramuscular administration.
Particular care must be taken to avoid intravascular injection.
As with all oily solutions, Testosterone enantate SIT must be injected strictly intramuscularly and very slowly (over two minutes). The formation of pulmonary microemboli of
oily solutions can, in rare cases, lead to signs and symptoms such as cough, dyspnea, malaise, hyperhidrosis,
chest pain, feeling of instability, paresthesia or syncope. These reactions may occur during
or immediately after the injection and are reversible. Treatment is usually supportive, consisting, for
example, in the administration of oxygen.
Cases of suspected anaphylactic reaction have been reported after injection of Testosterone enantate SIT.
Warning:
Patients receiving testosterone therapy must be subjected to careful and
regular monitoring, according to recommended methods, of the prostate gland (rectal exploration and serum PSA determination) and breasts, at least once a year and twice a year for elderly
patients and those at risk (those with clinical or family factors).
In patients undergoing long-term androgen therapy, in addition to laboratory tests relating to
testosterone concentration, the following laboratory parameters must be checked periodically:
hemoglobin, hematocrit, and liver function tests and lipid profile.
In patients with severe heart, liver or kidney failure or ischemic heart disease, the
treatment with testosterone may induce serious complications, characterized by edema with or without
congestive heart failure. In such cases, treatment must be discontinued immediately.

Notes on handling the OPC (One-Point Cut) vial:
Below the colored point, the vial has a pre-score, which eliminates the need to use
a saw for opening it. Before opening, make sure that any solution present
in the upper part of the vial has descended into the lower part. Use both hands to open; holding
the lower part of the vial with one hand, detach the upper part with the other hand, in the direction
opposite to the colored point.

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