Testosterone Undecanoate Ever Pharma

Leaflet attached to the packaging: information for the user

Testosterone Undecanoate EVER Pharma, 1000 mg/4 mL, solution for injection

Testosterone undecanoate

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor.
• 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. See section 4.

Table of contents of the leaflet:

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

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

Testosterone Undecanoate EVER Pharma contains the active substance testosterone, a male hormone. Testosterone Undecanoate EVER Pharma is injected into a muscle, where it is then stored and released gradually over a certain period. Testosterone Undecanoate EVER Pharma is used in adult men as testosterone replacement therapy to treat various diseases that result from a deficiency of testosterone in the body (male hypogonadism). To diagnose 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

2. Important information before using Testosterone Undecanoate EVER Pharma

When NOT to use Testosterone Undecanoate EVER Pharma

notintended for use in women.

Warnings and precautions

Before starting treatment with Testosterone Undecanoate EVER Pharma, tell your doctorif you have or have had:

• epilepsy
• heart, kidney, or liver problems
• migraine
• periodic breathing pauses during sleep (apnea), as they may worsen
• cancer, as regular blood calcium level tests may be required
• high blood pressure or if you are being treated for hypertension, as testosterone may increase blood pressure
• bleeding disorders
• coagulation disorders (such as hemophilia)
• thrombophilia (blood coagulation disorders that increase the risk of blood clots)
• factors that increase the risk of blood clots in the vein: previous blood clots in the vein; smoking; obesity; cancer; immobilization; if someone in your immediate family has had a blood clot in the leg, lung, or other organ at a young age (e.g., under 50); advanced age. How to recognize a blood clot: painful swelling of one leg or sudden change in skin color, e.g., pallor, redness, or bruising, sudden shortness of breath, sudden unexplained cough, which may produce bloody sputum; sudden chest pain, severe dizziness or fainting, severe abdominal pain, sudden loss of vision. If you experience any of these symptoms, seek medical help immediately. If you have severe heart, liver, or kidney disease, using Testosterone Undecanoate EVER Pharma may cause serious complications, which will manifest as water retention in the body, and sometimes (congestive) heart failure. The following blood tests should be ordered by your doctor before and during treatment: testosterone level in the blood, full blood count.

Use in patients with liver function disorders

No studies have been conducted in patients with liver function disorders. Testosterone Undecanoate EVER Pharma should not be prescribed if the patient has or has had liver tumors (see "When not to use Testosterone Undecanoate EVER Pharma").

Children and adolescents

Testosterone Undecanoate EVER Pharma is notintended for use in children and adolescents. There is no data on the use of the medicine in men under 18 years of age.

Elderly patients (over 65 years)

There is no need to change the dosage in patients over 65 years of age (see "Medical examination/Observation").

Muscle development and doping tests

Testosterone Undecanoate EVER Pharma is nota suitable means of accelerating muscle development in healthy individuals or enhancing physical performance. Testosterone Undecanoate EVER Pharma may give positive results in doping tests.

Drug abuse and dependence

This medicine should always be taken as directed by your doctor. Abuse of testosterone, especially when using excessive amounts of this medicine alone or in combination with other anabolic androgenic steroids, can cause serious health problems related to the heart and blood vessels (which can lead to death), mental health, and/or liver. People who abuse testosterone may become dependent, which can lead to withdrawal symptoms after a significant change in dose or sudden cessation of treatment. Do not abuse this medicine, either alone or in combination with other anabolic androgenic steroids, as it is associated with serious health risks (see "Possible side effects").

Medical examination/Observation

Male hormones can accelerate the development of prostate cancer and cause prostate enlargement (benign prostatic hyperplasia). Before administering Testosterone Undecanoate EVER Pharma, your doctor will examine you to ensure you do not have prostate cancer. Your doctor will regularly examine your prostate and breasts, especially in elderly patients, and order blood tests. With the use of hormonal substances such as androgens, cases of benign (non-cancerous) and malignant (cancerous) liver tumors have been observed.

Testosterone Undecanoate EVER Pharma and other medicines

Tell your doctor or pharmacist about all medicinesyou are currently taking or have recently taken, including those available without a prescription. Your doctor may decide to change the dosage if you are taking the following medicines:

• adrenocorticotropic hormone (ACTH) or corticosteroids (used in various diseases, such as rheumatism, arthritis, allergy, and asthma): Testosterone Undecanoate EVER Pharma may increase the risk of water retention in the body, especially in patients with impaired heart and liver function
• blood-thinning tablets (oral anticoagulants, coumarin derivatives), as this may increase the risk of bleeding. Your doctor will check the dosage.
• medicines used to treat diabetes. It may be necessary to adjust the dosage of the medicine that lowers blood sugar levels. Like other androgens, testosterone can enhance the effect of insulin. Tell your doctor if you have a bleeding disorder, as this information is important for your doctor to decide on the administration of Testosterone Undecanoate EVER Pharma.

Testosterone Undecanoate EVER Pharma may also affect the results of certain laboratory tests (e.g., evaluating thyroid function). You should inform your doctor or laboratory staff that you are taking Testosterone Undecanoate EVER Pharma.

Pregnancy and breastfeeding

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

Fertility

Systematic treatment with high doses of testosterone may reversibly stop or reduce sperm production (see also "Possible side effects").

Driving and using machines

Testosterone Undecanoate EVER Pharma does not affect the ability to drive and use machines.

Testosterone Undecanoate EVER Pharma contains benzyl benzoate

This medicine contains 2000 mg of benzyl benzoate in each ampoule/vial of 4 mL solution, which corresponds to 500 mg/mL of solution.

3. How to use Testosterone Undecanoate EVER Pharma

Your doctor will prescribe the injection of Testosterone Undecanoate EVER Pharma (1 ampoule/vial) very slowly into the muscle. The injection will be repeated every 10 to 14 weeks. This is enough to maintain the testosterone level at the right level, without causing the hormone to accumulate in the blood. Testosterone Undecanoate EVER Pharma is intended for intramuscular injection only. The person administering the injection will make sure not to inject the medicine into a blood vessel; see "Method of administration".

Starting treatment

Your doctor will assess your blood testosterone level before starting treatment and in the early stages of treatment. Your doctor may prescribe the next injection after 6 weeks to quickly achieve the right testosterone level. This will depend on the symptoms you are experiencing and your testosterone levels.

Maintaining testosterone levels during treatment

The intervals between injections should be within the recommended period of 10 to 14 weeks. Your doctor will regularly check your blood testosterone level at the end of the injection interval to ensure it is correct. If the level is too low, your doctor may decide to administer the medicine more frequently. If the level is too high, your doctor may decide to administer the medicine less frequently. Remember to attend each injection. Otherwise, it will not be possible to maintain the optimal testosterone level. If you feel that the effect of Testosterone Undecanoate EVER Pharma is too strong or too weak, consult your doctor.

Using a higher dose of Testosterone Undecanoate EVER Pharma than recommended

Symptoms of using a higher dose of Testosterone Undecanoate EVER Pharma may include:

• irritability
• nervousness
• weight gain
• prolonged or frequent erections If you experience any of these symptoms, consult your doctor. Your doctor will decide to administer injections less frequently or stop treatment.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The most common side effectsare acne and pain at the injection site. Common side effects(may affect up to 1 in 10 people):

• increased red blood cell count
• weight gain
• hot flashes
• acne
• prostate enlargement and related problems
• various reactions at the injection site (e.g., pain, bruising, or irritation)

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

• allergic reaction
• increased appetite, changes in blood test results (e.g., increased sugar or fat levels in the blood)
• depression, emotional disorders, insomnia, anxiety, aggression, or irritability
• headache, migraine, or tremor
• cardiovascular disorders, high blood pressure, or dizziness
• bronchitis, sinusitis, cough, shortness of breath, snoring, or voice problems
• diarrhea, nausea
• changes in liver function test results
• excessive hair loss (alopecia) or various skin reactions (e.g., itching, redness, or dryness of the skin)
• joint pain, limb pain, muscle problems (e.g., cramp, pain, or stiffness), or increased creatine phosphokinase activity in the blood
• urinary disorders (e.g., reduced urine flow, urinary retention, nocturia)
• prostate disorders (e.g., prostatic dysplasia, hardening, or inflammation), changes in sex drive, testicular pain, pain, hardening, or enlargement of the breasts, or increased levels of male and female sex hormones
• fatigue, general weakness, excessive sweating, or night sweats

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

• The oily solution of Testosterone Undecanoate EVER Pharma may enter the lungs (pulmonary oil microembolism), which can rarely cause symptoms such as: cough, shortness of breath, feeling unwell, excessive sweating, chest pain, dizziness, tingling, or fainting. These reactions may occur during or immediately after injection and are reversible. After testosterone administration, anaphylactic reactions have been observed.

In addition to the above side effects, the following have been reported during the use of testosterone-containing products: nervousness, hostility, periodic breathing pauses during sleep, various skin reactions, including dandruff and oily skin, accelerated hair growth, more frequent erections, and very rarely, yellowing of the skin and eyes (jaundice). The use of high doses of testosterone often leads to inhibition or reduction of sperm production in the body. These symptoms disappear after treatment is stopped. Testosterone replacement therapy for impaired hormonal function of the testes (hypogonadism) may rarely cause prolonged, painful erections (priapism). High doses or long-term use of testosterone can occasionally lead to water retention in the body and edema (swelling caused by water retention). The use of androgen-containing products may be associated with an overall increased risk of elevated red blood cell count, hematocrit (percentage of red blood cells in the blood), and hemoglobin concentration (a component of red blood cells that carries oxygen), observed in periodic blood tests.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration 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, you can help provide more information on the safety of this medicine.

5. How to store Testosterone Undecanoate EVER Pharma

Keep the medicine out of sight and reach of children. There are no special precautions for storing the medicine. Do not usethis medicine after the expiry date stated on the carton and label of the ampoule/vial after "Expiry date (EXP)". The expiry date refers to the last day of the month stated. Do notthrow away medicines via wastewater or household waste. Ask your pharmacist 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 Undecanoate EVER Pharma contains

The active substance of the medicine is testosterone undecanoate. Each 4 mL ampoule/vial contains 1000 mg of testosterone undecanoate (250 mg/mL). The other ingredients are benzyl benzoate and purified castor oil.

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

Testosterone Undecanoate EVER Pharma is a clear, yellowish oily solution. Testosterone Undecanoate EVER Pharma is provided in orange glass ampoules or vials with a bromobutyl rubber stopper and an aluminum cap with a flip-off cap. The whole is packaged in a cardboard box. Each pack contains 1 ampoule or 1 vial of 4 mL solution for injection. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder EVER Valinject GmbH Oberburgau 3 4866 Unterach am Attersee Austria Manufacturer EVER Pharma Jena GmbH Brüsseler Strasse 18 07747 Jena Germany For more information about this medicine, contact your 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 Testosterone undecanoate 250 mg/ml Injektionslösung Czech Republic Testosteron undekanoát EVER Pharma Netherlands Testosterone undecanoate 250 mg/ml oplossing voor injectie Ireland Testosterone undecanoate EVER Pharma 1000 mg/4 ml solution for injection Poland Testosterone Undecanoate EVER Pharma Romania Testosterone undecanoate 250 mg/ml soluție injectabilă Slovakia Testosteron EVER Pharma 1000 mg/4 ml injekčný roztok Hungary Testosterone undecanoate 250 mg/ml oldatos injekció Date of last revision of the leaflet:01.2025 The following information is intended for healthcare professionals only: When stored at low temperatures, the properties of this oil-based solution may change temporarily (e.g., higher viscosity, cloudiness). If the medicinal product is stored at low temperatures, it should be brought to room temperature or body temperature before use. The solution for intramuscular injection should be inspected before use. Only a clear solution without solid particles can be used. The contents of the ampoule/vial should be injected intramuscularly immediately after opening. Testosterone Undecanoate EVER Pharma is intended for single use only. Any remaining solution should be discarded. Method of administration: Particular care should be taken to avoid injection into a blood vessel. Like all oil solutions, Testosterone Undecanoate EVER Pharma should be injected intramuscularly and very slowly. Pulmonary oil microembolism can rarely lead to symptoms such as: cough, shortness of breath, feeling unwell, excessive sweating, chest pain, dizziness, tingling, or fainting. These reactions may occur during or immediately after injection and are reversible. Treatment is usually supportive, e.g., by administering additional oxygen. After testosterone administration, anaphylactic reactions have been observed. Warnings: In patients treated with testosterone, prostate and breast examinations should be performed carefully and regularly, according to the recommended procedure (rectal examination, PSA measurement). These examinations should be performed at least once a year, and in elderly patients and those at increased risk (clinical and family factors), twice a year. In addition to laboratory tests for testosterone levels, in patients treated long-term with androgens, the following laboratory parameters should be monitored periodically: hemoglobin, hematocrit, liver function tests, and lipid profile. In patients with severe heart, liver, or kidney failure, or coronary heart disease, treatment with testosterone may cause serious complications, including edema, with or without congestive heart failure. In such cases, treatment should be discontinued immediately.

Instructions for preparing/opening the One-Point-Cut (OPC) ampoule:

Instructions for preparing the vial:

On the ampoule, below the colored mark, there is a notch that eliminates the need to cut the neck. Before opening, make sure the solution from the top part of the ampoule has flowed to the bottom part. To open the ampoule, use both hands, holding the bottom part of the ampoule with one hand and breaking off the top part of the ampoule in the opposite direction of the colored mark. The vial is intended for single use. The contents of the vial should be injected intramuscularly immediately after withdrawal into a syringe. After removing the plastic cap

• (A) do not remove the metal ring (B) or the serrated cap (C).