Testosterone undecanoate ever pharma

Package leaflet: Information for the user

Testosterone Undecanoate EVER Pharma, 1000 mg/4 mL, solution for injection
Testosteroni undecanoas
Please read all of this leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor. See section 4.

Contents of the leaflet:

1. What Testosterone Undecanoate EVER Pharma is and what it is 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 pack and other information

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

Testosterone Undecanoate EVER Pharma contains testosterone as the active substance, a male hormone. Testosterone Undecanoate EVER Pharma is administered by intramuscular injection, after which it may be stored in the muscle and gradually released over a certain period of time. Testosterone Undecanoate EVER Pharma is used in adult men as testosterone replacement therapy for the treatment of various conditions resulting from testosterone deficiency in the body (male hypogonadism). Diagnosis of the condition requires two independent measurements of testosterone blood levels, together with the following clinical symptoms:

• impotence
• infertility
• reduced libido
• fatigue
• depressive mood
• loss of bone mass due to low hormone levels

2. Important information before using Testosterone Undecanoate EVER Pharma

When NOT to use Testosterone Undecanoate EVER Pharma

• if the patient has an allergy (hypersensitivity) to testosterone undecanoate or to any of the other ingredients of this medicine (listed in section 6)
• if the patient has androgen-dependent cancer or suspected cancer of the prostate gland or breast
• if the patient currently has or has previously had liver tumour. Testosterone Undecanoate EVER Pharma is not intended for use in women.

Warnings and precautions
Before starting treatment with Testosterone Undecanoate EVER Pharma, you should inform
your doctor if the patient currently has or has ever had:

• epilepsy
• heart, kidney or liver problems
• migraine
• periodic breathing interruptions during sleep (apnoea), as these may worsen
• cancer, therefore regular monitoring of blood calcium levels may be required
• high blood pressure or if the patient is being treated for hypertension, as testosterone may increase blood pressure
• blood clotting disorders
• bleeding disorders (such as haemophilia)
• thrombophilia (abnormalities in blood clotting, increasing the risk of thrombosis – formation of blood clots in blood vessels)
• factors increasing the risk of venous blood clots: previous venous blood clots; smoking; obesity; cancer; immobilisation; if a close family member of the patient has had a blood clot in the leg, lung or another organ at a young age (e.g. under 50 years); advanced patient age. How to recognize a blood clot: painful swelling in one leg or sudden skin colour change, such as pallor, redness or cyanosis; sudden shortness of breath; sudden unexplained cough, possibly with coughing up blood; sudden chest pain; severe dizziness or vertigo; severe abdominal pain; sudden loss of vision. If the patient experiences any of the above symptoms, medical help should be sought immediately. If the patient has severe heart, liver or kidney disease, treatment with Testosterone Undecanoate EVER Pharma may cause serious complications, manifesting as fluid retention and, occasionally, congestive heart failure. The following blood tests should be ordered by the doctor before and during treatment: blood testosterone levels, complete blood count. Use in patients with liver function disorders Studies have not been conducted in patients with liver function disorders. Testosterone Undecanoate EVER Pharma must not be prescribed if the patient currently has or has previously had liver tumour (see section "When not to use Testosterone Undecanoate EVER Pharma"). Children and adolescents Testosterone Undecanoate EVER Pharma is not intended for use in children and adolescents. There is no data on the use of this medicine in males under 18 years of age. Elderly patients (over 65 years of age) There is no need to change the dosage in patients over 65 years of age (see section Medical examination/Monitoring). Muscle development and anti-doping tests Testosterone Undecanoate EVER Pharma is not an appropriate agent for accelerating muscle development in healthy individuals or for enhancing physical performance. Testosterone Undecanoate EVER Pharma may result in positive findings in anti-doping tests.

Misuse and dependence
This medicine should always be taken exactly as prescribed by the doctor.
Misuse of testosterone, especially when excessive doses are used, either alone or in combination
with other anabolic androgenic steroids, may lead to serious health problems affecting the heart
and blood vessels (which may result in death), mental health and/or the liver.
Individuals misusing testosterone may become dependent, which may lead to withdrawal symptoms
following a significant dose reduction or abrupt discontinuation. This medicine should not be misused,
either alone or in combination with other anabolic androgenic steroids, as this is associated with
serious health risks (see section "Possible side effects").

Medical examination/monitoring
Androgenic hormones may accelerate the development of prostate cancer and may cause prostate
enlargement (benign prostatic hyperplasia). Before administering Testosterone Undecanoate
EVER Pharma, the doctor will examine the patient to ensure that prostate cancer is not present.
The doctor will regularly examine the prostate and breasts, particularly in elderly patients, and will
order regular blood tests.
Cases of benign (non-malignant) and malignant (cancerous) liver tumours have been observed
following the use of hormonal substances such as androgens.
Testosterone Undecanoate EVER Pharma and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, including those available without a prescription. The doctor may decide to adjust doses if the following medicines are used:

• 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 fluid retention, particularly in patients with impaired heart or liver function
• anticoagulant tablets (oral anticoagulants, coumarin derivatives), as this may increase the risk of bleeding. The doctor will check the dose.
• medicines used in the treatment of diabetes. Adjustment of the dose of blood glucose-lowering medicine may be necessary. Like other androgens, testosterone may enhance the effect of insulin. Concurrent use with SGLT-2 inhibitors (such as empagliflozin, dapagliflozin or canagliflozin) may increase the number of red blood cells in the blood. The doctor may need to order blood tests more frequently. Inform the doctor if the patient has blood clotting disorders, as this information is important for the doctor before deciding to administer the Testosterone Undecanoate EVER Pharma injection.

Testosterone Undecanoate EVER Pharma may also affect the results of certain laboratory tests
(e.g. thyroid function tests). 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 must not be used in pregnant or breastfeeding women.
Effect on fertility
Long-term treatment with preparations containing high doses of testosterone may reversibly suppress or reduce sperm production (see also "Possible side effects").
Driving and operating machinery
Testosterone Undecanoate EVER Pharma has no effect on the ability to drive or operate machinery.
Testosterone Undecanoate EVER Pharma contains benzyl benzoate
This medicine contains 2000 mg of benzyl benzoate per ampoule/vial in 4 mL of solution, equivalent to 500 mg/mL of solution.

3. How to use Testosterone Undecanoate EVER Pharma

Your doctor will administer an 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 sufficient to maintain testosterone concentration at an appropriate level, without causing hormone accumulation in the blood.
Testosterone Undecanoate EVER Pharma is intended for intramuscular injection only. The person administering the injection will take care not to inject the medicine into a blood vessel; see section “Method of administration”.
Starting treatment
Your doctor will assess your blood testosterone levels before starting treatment and in the early phase of treatment. Your doctor may schedule the next injection as early as 6 weeks after the previous one to rapidly achieve an appropriate testosterone concentration. This will depend on your symptoms and testosterone levels.
Maintaining Testosterone Undecanoate EVER Pharma levels during treatment
The intervals between injections should remain within the recommended period of 10 to 14 weeks. Your doctor will regularly check your blood testosterone levels towards the end of the interval between injections to ensure they are within the normal range. If the concentration is too low, your doctor may decide to administer the medicine more frequently. If the concentration is too high, your doctor may decide to administer the medicine less frequently. It is important to attend every scheduled injection appointment. Otherwise, optimal testosterone levels cannot be maintained.
If you feel that the effect of Testosterone Undecanoate EVER Pharma is too strong or too weak, consult your doctor.
Use of a higher than recommended dose of Testosterone Undecanoate EVER Pharma
Symptoms of an overdose of Testosterone Undecanoate EVER Pharma may include:

• irritability
• nervousness
• increased body weight
• prolonged or frequent erections

If any of the above symptoms occur, consult your doctor. Your doctor may decide to administer injections less frequently or discontinue treatment.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
The most commonly occurring adverse reactions are acne and pain at the injection site.
Common adverse reactions (may occur in up to 1 in 10 patients):

• increased number of red blood cells
• weight gain
• hot flushes
• acne
• enlargement of the prostate gland and related problems
• various reactions at the injection site (e.g. pain, bruising or irritation)

Uncommon adverse reactions (may occur in up to 1 in 100 patients):

• allergic reaction

• increased appetite, changes in blood test results (e.g. increased blood sugar or fat levels)

• depression, emotional disturbances, insomnia, anxiety, aggression or irritability

• headache, migraine or tremor

• cardiovascular disorders, high blood pressure or dizziness

• bronchitis, sinusitis, cough, breathlessness, snoring or voice problems

• diarrhoea, 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. cramps, pain or stiffness) or increased creatine kinase activity in the blood

• urinary disorders (e.g. reduced urine flow, urinary retention, need to urinate at night)

• prostate gland disorders (e.g. prostatic dysplasia, sclerosis or prostatitis), changes in sex drive, testicular pain, pain, hardness or enlargement of the breasts, or increased concentrations of male and female sex hormones

• fatigue, general weakness, excessive sweating or night sweats
  Rare adverse reactions (may occur in up to 1 in 1000 patients):

• The oily solution of Testosterone Undecanoate EVER Pharma may reach the lungs (pulmonary oil microembolism), which rarely may cause symptoms such as: cough, breathlessness, feeling of general malaise, excessive sweating, chest pain, dizziness, tingling sensation, fainting. These reactions may occur during or immediately after injection and are reversible. The patient should be observed during each injection and immediately thereafter to enable early detection of objective and subjective symptoms that may indicate pulmonary oil microembolism. Anaphylactic reactions have been observed following testosterone administration.

During treatment with testosterone-containing medicines, in addition to the adverse reactions listed above, the following have also been reported: nervousness, hostility, periodic breathing interruptions 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 suppression or reduction of sperm production in the body. These symptoms resolve after discontinuation of treatment. Testosterone replacement therapy in the treatment of impaired testicular hormonal function (hypogonadism) may rarely cause prolonged, painful erections (priapism). Large doses or prolonged administration of testosterone may occasionally lead to fluid retention and the development of oedema (swelling due to fluid retention).
The use of testosterone-containing products may be associated with a general risk of increased red blood cell count, haematocrit (percentage of red blood cells in the blood), and haemoglobin concentration (oxygen-carrying component of red blood cells), as observed in periodic blood analyses.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Testosterone Undecanoate EVER Pharma

Keep this medicine out of the sight and reach of children.
No special storage instructions apply to this medicine.
Do not use this medicine after the expiry date stated on the carton and vial/ampoule label
after: “Expiry date (EXP)”. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the package and other information

What Testosterone Undecanoate EVER Pharma contains
The active substance is testosterone undecanoate. Each 4 mL vial/ampoule of solution contains 1000 mg of testosterone undecanoate (250 mg/mL).
Other ingredients: 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, pale yellow to yellow oily solution.
Testosterone Undecanoate EVER Pharma is supplied in amber glass ampoules or amber glass vials with a bromobutyl rubber stopper and an aluminium cap with a flip-off seal. The pack is contained in a cardboard carton.
Each pack contains 1 ampoule or 1 vial with 4 mL of solution for injection.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
EVER Valinject GmbH
Oberburgau 3
4866 Unterach am Attersee
Austria

Manufacturer
EVER Pharma Jena GmbH
Brüsseler Strasse 18
07747 Jena
Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
EVER Pharma Poland Sp. z o.o.
e-mail: [email protected]

This medicinal product is authorised in the European Economic Area member states 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

The following information is intended for healthcare professionals only:
During storage at low temperatures, the properties of this oil-based solution may temporarily change (e.g. increased viscosity, cloudiness). If the medicinal product has been stored at low temperature, it should be brought to room temperature or body temperature before use.
The solution for intramuscular injection should be inspected visually before use. Only clear solution free from particulate matter should be used.
The contents of the ampoule/vial should be administered intramuscularly immediately after opening.
Testosterone Undecanoate EVER Pharma is intended for single use only. Any remaining solution should be discarded.

Method of administration:
Extreme caution must be taken to avoid intravascular injection.
Like all oily solutions, the medicinal product Testosterone Undecanoate EVER Pharma must be administered intramuscularly and very slowly. Pulmonary microembolism caused by oily solutions may rarely lead to symptoms such as cough, dyspnoea, malaise, excessive sweating, chest pain, dizziness, paresthesia, and fainting. These reactions may occur during or immediately after injection and are reversible.
Treatment is usually supportive, e.g. by administration of additional oxygen.
Anaphylactic reactions have been observed after administration of testosterone.

Warnings:
In patients treated with testosterone, careful and regular examinations of the prostate and breasts should be performed according to recommended guidelines (digital rectal examination, PSA measurement). These examinations should be carried out at least once a year, and twice a year in elderly patients or those with increased risk (clinical and familial factors).
In addition to laboratory measurements of testosterone levels, the following laboratory parameters should be periodically monitored in patients undergoing long-term androgen therapy: haemoglobin, haematocrit, liver function tests, and lipid profile.
In patients with severe heart, liver or renal failure, or ischaemic heart disease, testosterone treatment may lead to serious complications in the form of oedema, with or without congestive heart failure. In such cases, treatment should be discontinued immediately.

Instructions for preparation and opening of the OPC ampoule (One-Point-Cut):
On the ampoule, below the coloured dot, there is a score line eliminating the need for scoring the neck. Before opening, ensure that the solution from the upper part of the ampoule has flowed down into the lower part.
To open the ampoule, use both hands: hold the lower part of the ampoule with one hand and, with the other hand, snap off the top part in the direction opposite to the coloured dot.

Instructions for preparation of the vial:
The vial is intended for single use. The contents of the vial should be administered intramuscularly immediately after withdrawal into a syringe. After removing the plastic cap (A), do not remove the metal ring (B) or the corrugated cap (C).