TESTOSTERONE 250 mg /Ml Solution

Contents of the leaflet

1. Leaflet attached to the packaging: information for the user
2. Testosterone enantate EVER Pharma, 250 mg/mL, solution for injection
   1. You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Testosterone enantate EVER Pharma and what is it used for
4. Important information before using Testosterone enantate EVER Pharma
   1. When not to use Testosterone enantate EVER Pharma
   2. Warnings and precautions
   3. Children and adolescents
   4. Elderly patients (65 years or older)
   5. Patients with liver function disorders
   6. Testosterone enantate EVER Pharma and other medicines
   7. Pregnancy and breastfeeding
   8. Effects on fertility
   9. Driving and operating machinery
   10. Testosterone enantate EVER Pharma contains benzyl benzoate
5. How to use Testosterone enantate EVER Pharma
   1. Missing a dose of Testosterone enantate EVER Pharma
   2. Stopping treatment with Testosterone enantate EVER Pharma
6. Possible side effects
   1. Reporting side effects
7. How to store Testosterone enantate EVER Pharma
8. Contents of the packaging and other information
   1. What Testosterone enantate EVER Pharma contains
   2. What Testosterone enantate EVER Pharma looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. This medicine is authorized in the Member States of the European Economic Area under the following names:
   5. Date of last revision of the leaflet: --------------------------------------------------------------------------------------------------------------------

Leaflet attached to the packaging: information for the user

Testosterone enantate EVER Pharma, 250 mg/mL, solution for injection

Testosterone enantate

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Testosterone enantate EVER Pharma and what is it used for
• 2. Important information before using Testosterone enantate EVER Pharma
• 3. How to use Testosterone enantate EVER Pharma
• 4. Possible side effects
• 5. How to store Testosterone enantate EVER Pharma
• 6. Contents of the packaging and other information

1. What is Testosterone enantate EVER Pharma and what is it used for

Testosterone enantate EVER Pharma contains testosterone enantate, a synthetic form of the naturally occurring male sex hormone, testosterone.
The medicine is used in adult men as testosterone replacement therapy for the treatment of various health problems that are caused by a lack of testosterone in the body (male hypogonadism). To confirm the disease, two independent measurements of testosterone levels in the blood and the following clinical symptoms are required:

• impotence
• infertility
• decreased sex drive
• fatigue
• depressive moods
• bone mass loss caused by low hormone levels.

Testosterone enantate EVER Pharma is injected deeply into the buttock muscle, where it can then be stored and gradually released into the bloodstream.

2. Important information before using Testosterone enantate EVER Pharma

When not to use Testosterone enantate EVER Pharma

Testosterone enantate EVER Pharma is notintended for use in women.

Warnings and precautions

Before starting treatment with Testosterone enantate EVER Pharma, the patient should tell their doctor if they have or have had:

• liver problems, including severe upper abdominal problems
• tendency to retain fluid, such as swelling of the ankles
• severe heart, liver, or kidney disease; testosterone treatment may cause serious complications in the form of fluid retention in the body, sometimes with congestive heart failure
• high blood pressure or if the patient is being treated for high blood pressure, as testosterone may cause an increase in blood pressure
• blood clotting problems, such as thrombophilia (blood clotting disorders that increase the risk of thrombosis - the formation of blood clots in blood vessels), as testosterone treatment may increase the risk of thrombosis.
• Factors that increase the risk of blood clots: previous blood clots; smoking; obesity; cancer; immobilization; old age; if someone in the patient's immediate family has had a blood clot in the leg, lung, or other organ at a young age (e.g., under 50 years).
• How to recognize the occurrence of a blood clot: painful swelling of one leg or sudden change in skin color, such as pallor, redness, or cyanosis, sudden shortness of breath, sudden unexplained cough, which may be accompanied by coughing up blood; or sudden chest pain, severe dizziness or fainting, severe abdominal pain, sudden loss of vision. If the patient experiences any of these symptoms, they should seek medical help immediately.

Testosterone enantate EVER Pharma may also affect the results of some laboratory tests (e.g., thyroid function). The doctor or laboratory personnel should be informed about the use of Testosterone enantate EVER Pharma.
Development of muscles and doping tests
Male hormones, such as testosterone enantate, are not a suitable means of accelerating muscle development in healthy individuals or enhancing physical performance.
Testosterone enantate EVER Pharma may give positive results in doping tests.
Abuse of the medicine and dependence on the medicine
This medicine should always be taken as directed by the doctor or pharmacist.
Abuse of testosterone, especially when using excessive amounts of this medicine in monotherapy or in combination with other anabolic androgenic steroids, may cause serious health problems related to the heart and blood vessels (which can lead to death), mental health, and/or liver.

Individuals who abuse testosterone may become dependent, which can lead to withdrawal symptoms after significant dose changes or sudden discontinuation of treatment. This medicine should not be abused, either in monotherapy or in combination with other anabolic androgenic steroids, as it is associated with serious health risks.
Medical examination/consultation
Male hormones can accelerate the development of prostate cancer and cause prostate enlargement (benign prostatic hyperplasia). Before administering Testosterone enantate EVER Pharma, the doctor will examine the patient to ensure that they do not have prostate cancer.
In elderly patients, there is an increased risk of developing prostate enlargement during treatment with Testosterone enantate EVER Pharma. As a precaution, the doctor will regularly examine the prostate in men, especially in elderly patients.
During long-term androgen therapy, regular blood tests should be performed (see section 4 "Possible side effects").
Due to the use of hormonal substances such as androgens, cases of benign (non-cancerous) and malignant (cancerous) liver tumors have been observed. Although the occurrence of a tumor is unlikely, they can pose a health risk.
In this regard, medical help should always be sought immediately in case of severe abdominal pain. Not all unusual sensations in the upper abdomen should be considered a possible symptom of a tumor. However, if unusual pains do not subside within a short period, they should be reported to the doctor.
Additional information for specific patient groups

Children and adolescents

Testosterone enantate EVER Pharma is notintended for use in children and adolescents.
The safety and efficacy of the use of this medicine in children and adolescents have not been adequately demonstrated.

Elderly patients (65 years or older)

Limited available data do not indicate a need to adjust the dosage in elderly patients.

Patients with liver function disorders

No studies have been conducted in patients with liver function disorders. If the patient has ever had a liver tumor, Testosterone enantate EVER Pharma will not be prescribed (see "When not to use Testosterone enantate EVER Pharma").

Testosterone enantate EVER Pharma and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, including those that are available without a prescription.
In particular, the doctor should be informed if the patient is taking any of the following medicines, as Testosterone enantate EVER Pharma may affect them or they may affect Testosterone enantate EVER Pharma:

• Painkillers and anti-inflammatory drugs (e.g., oxyfenbutazone)
• Anticoagulant tablets used to thin the blood, such as warfarin
• Medicines used to treat diabetes, such as metformin. It may be necessary to adjust the dose of the medicine that lowers blood sugar levels.

Pregnancy and breastfeeding

Testosterone enantate EVER Pharma is not intended for use in women and should not be used in pregnant or breastfeeding women.

Effects on fertility

Treatment with testosterone preparations in high doses may reversibly stop or reduce sperm production (see section 4 "Possible side effects").

Driving and operating machinery

Testosterone enantate EVER Pharma should not affect the ability to drive and operate machinery.

Testosterone enantate EVER Pharma contains benzyl benzoate

This medicine contains 342 mg of benzyl benzoate in a 1 mL ampoule.

3. How to use Testosterone enantate EVER Pharma

Testosterone enantate EVER Pharma is administered by a healthcare professional.
The medicine is administered in a very slow injection into the buttock muscle, usually every 2 to 3 weeks. The medicine will be administered for as long as the doctor considers it necessary, depending on individual circumstances. Men treated long-term may have injections administered at intervals of 3 to 6 weeks after some time.
The doctor will assess testosterone levels in the blood before starting treatment and periodically during treatment at the end of the interval between injections and, if necessary, adjust the dose.
During long-term treatment of men, the doctor will regularly examine the prostate.

Missing a dose of Testosterone enantate EVER Pharma

To ensure optimal treatment efficacy, the scheduled injection dates should be followed as agreed with the doctor.

Stopping treatment with Testosterone enantate EVER Pharma

After stopping treatment, the symptoms of testosterone deficiency may return.
If the patient has any further doubts about the use of this medicine, they should consult a 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 an allergic reaction occurs, the use of Testosterone enantate EVER Pharma should be stopped and the doctor or emergency department of the nearest hospital should be informed immediately. The symptoms of an allergic reaction may include:

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

Common side effects(may occur in less than 1 in 10 patients):

• Increased red blood cell count, hematocrit (percentage of red blood cells in the blood), and hemoglobin (a component of red blood cells that carries oxygen); these are determined in periodic blood tests
• Increased body weight.

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

• Liver tumors have been observed. The doctor should be informed if the patient notices any previously unseen stomach pain, especially if it is severe or persistent.
• Increased red blood cell count (polycythemia), blood circulation problems, high levels of calcium in the blood
• Abnormal liver function test results, yellowing of the skin and eyes (jaundice), liver enlargement
• Acne, hair loss, skin reactions, such as rash, hives (raised red patches), itching, "tingling", or baldness
• Various types of injection site reactions, including pain, itching, hardening, swelling, and inflammation
• Increased prostate-specific antigen (PSA) levels
• Increased or decreased interest in sex, abnormal breast development in men, prostate problems, accelerated puberty (Testosterone enantate EVER Pharma is not indicated for use in children - see section 2 "Warnings and precautions")
• Fluid retention in the body, and even ankle swelling in case of high doses or prolonged use.
• Reduced sperm count and frequent or prolonged erections in men (in case of such an erection, it is essential to inform the doctor, as it may cause penis damage)
• Headache, weakness, depression, anxiety
• Bone growth disorders (increased or premature closure)
• Gastrointestinal problems, nausea. Injections of oily solutions, such as Testosterone enantate EVER Pharma, have been associated with reactions such as coughing, shortness of breath, and chest pain. Other symptoms may occur, including general malaise, excessive sweating, dizziness, "tingling", or fainting.

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Testosterone enantate EVER Pharma

The medicine should be stored out of sight and reach of children.
There are no special storage instructions for this medicine.
The medicine should not be used after the expiry date stated on the label. The expiry date refers to the last day of the stated month.
Testosterone enantate should be inspected before administration. Only clear solutions free from solid particles should be used.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Testosterone enantate EVER Pharma contains

• The active substance of the medicine is testosterone enantate. Each ampoule contains 1 mL of solution containing 250 mg of testosterone enantate (equivalent to 180 mg of testosterone) in an oily solution.
• The other ingredients are benzyl benzoate and purified castor oil.

What Testosterone enantate EVER Pharma looks like and contents of the pack

Testosterone enantate EVER Pharma is a clear, yellowish oily solution.
Each ampoule is made of orange glass and contains 1 mL of solution for injection.
The medicine is available in packs of 1, 3, 5, or 10 ampoules.

Marketing authorization holder and manufacturer

Marketing authorization holder
EVER Valinject GmbH
Oberburgau 3
4866 Unterach am Attersee
Austria
Manufacturer
EVER Pharma Jena GmbH
Brüsseler Str. 18
07747 Jena
Germany
To obtain more detailed information about this medicine, you should contact the local representative of the marketing authorization holder:
EVER Pharma Poland Sp. z o.o.
e-mail: [email protected]

This medicine is authorized in the Member States of the European Economic Area under the following names:

Austria
Testosteron enantat EVER Pharma 250 mg/ml Injektionslösung
France
Testosterone enantate EVER Pharma 250 mg/ml solution injectable
Poland
Testosterone enantate EVER Pharma
Sweden
Testosterone enantate EVER Pharma 250 mg/ml injektionsvätska, lösning

Date of last revision of the leaflet: --------------------------------------------------------------------------------------------------------------------

Information intended exclusively for healthcare professionals:
When stored at low temperatures, the properties of this oil-based solution may temporarily change (e.g., increased viscosity, cloudiness). If the medicinal product is stored at low temperature, it should be brought to room temperature or body temperature before use.
The solution for injection should be inspected before use. Only clear solutions free from solid particles can be used.
The contents of the ampoule should be injected immediately after opening the ampoule.
This medicinal product is intended for single use only, and any remaining solution should be discarded.
Administration method
For intramuscular injection only. Care should be taken to inject the medicinal product Testosterone enantate EVER Pharma deeply into the buttock muscle, following the usual precautions for intramuscular injection. Particular care should be taken to avoid intravenous injection.
As with all oily solutions, the medicinal product Testosterone enantate EVER Pharma should be injected intramuscularly and very slowly (over more than two minutes). Pulmonary microembolism caused by the oily solution may, in rare cases, lead to symptoms such as coughing, shortness of breath, malaise, excessive sweating, chest pain, dizziness, paresthesia, or fainting. These reactions may occur during or immediately after injection and are reversible.
Treatment is usually supportive, e.g., by administering oxygen.
Suspected anaphylactic reactions have been observed after administration of the medicinal product Testosterone enantate EVER Pharma.
Warnings
In patients treated with testosterone, the prostate and breasts should be carefully and regularly examined, in accordance with the recommended procedure (rectal examination and PSA measurement in blood serum). These examinations should be performed at least once a year, and in elderly patients and those at increased risk (clinical or family factors), twice a year.
In patients receiving long-term androgen therapy, in addition to testosterone level measurements, the following laboratory parameters should be regularly monitored: hemoglobin, hematocrit, liver function tests, and lipid profile.
In patients with severe heart, liver, or kidney failure or coronary heart disease, testosterone treatment may cause serious complications in the form of fluid retention in the body, sometimes with congestive heart failure. In such cases, treatment should be discontinued immediately.
Instructions for preparing/opening the One-Point-Cut (OPC) ampoule:
Below the colored mark on the ampoule, there is a notch that eliminates the need to file the neck. Before opening, it should be ensured that the solution from the upper part of the ampoule has flowed to the lower part. To open the ampoule, both hands should be used, holding the lower part of the ampoule with one hand and breaking off the upper part of the ampoule in the direction of the colored mark with the other hand.