Testosterone Undecanoate Besins

LEAFLET SUPPLIED WITH THE PACKAGING

Leaflet supplied with the packaging: Information for the user

Testosterone Undecanoate Besins 1000 mg/4 ml, solution for injection

Testosterone undecanoate

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in the leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

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

1. What is Testosterone Undecanoate Besins and what is it used for

Testosterone Undecanoate Besins contains the active substance testosterone, a male hormone.
Testosterone Undecanoate Besins is injected into the muscle, where it is then stored and gradually released over a certain period of time. Testosterone Undecanoate Besins is used in adult men as testosterone replacement therapy for various diseases that result from a deficiency of testosterone in the body (male hypogonadism). To diagnose the disease, two independent determinations of testosterone levels in the blood and clinical symptoms such as:

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

2. Important information before using Testosterone Undecanoate Besins

When not to use Testosterone Undecanoate Besins

• If the patient is allergic to testosterone undecanoate or any of the other ingredients of this medicine (listed in section 6),
• if the patient has androgen-dependent cancer or suspected prostate or breast cancer,
• if the patient has or has had liver tumors

Testosterone Undecanoate Besins is notintended for use in women.

Warnings and precautions

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

• epilepsy,
• heart, kidney, or liver problems,
• migraine,
• periodic breathing pauses during sleep (sleep apnea), as they may worsen,
• cancer, as regular blood calcium level tests may be needed,
• high blood pressure or treatment for hypertension, as testosterone may cause an increase in blood pressure,
• blood clotting problems, bleeding disorders (e.g., hemophilia), or thrombophilia (abnormal blood clotting process that increases the risk of blood clots in blood vessels), or factors that increase the risk of blood clots in veins: previous blood clots in veins; smoking; obesity; cancer; immobilization; confirmed blood clots in the leg, lung, or other organ at a young age (e.g., under 50) in a close family member; older age of the patient.

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 be accompanied by coughing up blood; sudden chest pain, severe dizziness or dizziness, severe abdominal pain, sudden loss of vision. If any of these symptoms occur, contact your doctor immediately.
If the patient has severe heart, liver, or kidney disease,the use of Testosterone Undecanoate Besins may cause serious complications, which will manifest as water retention in the body, and sometimes also (congestive) heart failure.
The following blood tests should be ordered by the doctor before and during treatment:
testosterone levels in the blood, full blood count.

Liver function disorders

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

Children and adolescents

Testosterone Undecanoate Besins is notintended for use in children and adolescents. There are no available data on the use of Testosterone Undecanoate Besins in men under 18 years of age.

Elderly patients (65 years or older)

There is no need to change the dosage in people over 65 years old (see "Medical examination/observation").

Muscle development and doping tests

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

Drug abuse and dependence

This medicine should always be used as directed by your doctor or pharmacist.
Abuse of testosterone, especially when using excessive amounts of this medicine in monotherapy 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.
In people who abuse testosterone, dependence on this medicine may occur, and withdrawal symptoms may appear in case of significant dose changes or sudden discontinuation of treatment. Do not abuse this medicine in monotherapy or 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 injecting Testosterone Undecanoate Besins, the doctor will examine the patient to ensure that they do not have prostate cancer.
The doctor will regularly examine the prostate and breasts, especially in older patients.
They will also regularly order blood tests.
During the use of hormonal substances such as androgen compounds, cases of benign (non-cancerous) and malignant (cancerous) liver tumors have been observed.

Testosterone Undecanoate Besins and other medicines

Tell your doctor or pharmacist about all medicinesyou are currently taking or have recently taken, as well as any medicines you plan to take, including those that are available without a prescription. The doctor may adjust the dose if you are taking any of the following medicines:

• ACTH hormone or corticosteroids (used to treat various diseases, such as rheumatism, arthritis, allergic diseases, and asthma): Testosterone Undecanoate Besins may increase the risk of water retention in the body, especially in patients with abnormal heart and liver function,
• blood-thinning tablets (oral anticoagulant medicines from the coumarin derivative group), as they may increase the risk of bleeding. The doctor will check the doses.
• medicines used to treat diabetes. It may be necessary to adjust the dose of the medicine that lowers blood sugar levels. Like other androgens, testosterone can enhance the effect of insulin.

Tell your doctor if you have bleeding disorders,as this information is important for the doctor to decide on the administration of Testosterone Undecanoate Besins.
Testosterone Undecanoate Besins may also affect the results of some laboratory tests (e.g., thyroid function tests). Tell your doctor or laboratory staff that you are using Testosterone Undecanoate Besins.

Pregnancy and breastfeeding

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

Fertility

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

Driving and using machines

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

Testosterone Undecanoate Besins contains benzyl benzoate

Testosterone Undecanoate Besins contains 2000 mg of benzyl benzoate in each 4 ml vial, which corresponds to 500 mg/ml.

3. How to use Testosterone Undecanoate Besins

The doctor will inject Testosterone Undecanoate Besins (1 vial) very slowly into the muscle. They will perform injections every 10 to 14 weeks. This is enough to maintain the testosterone level at the right level, without the effect of hormone accumulation in the blood.
Testosterone Undecanoate Besins is intended for intramuscular injection only.
Particular care should be taken to avoid injecting into a blood vessel (see "Method of administration").

Starting treatment

The doctor will assess the testosterone level in the blood before starting treatment and in its early stages. The doctor may order a second injection after 6 weeks to quickly achieve the necessary testosterone level. This will depend on the symptoms in the patient and the testosterone levels.

Maintaining the level of Testosterone Undecanoate Besins during treatment

The intervals between consecutive injections should always be within the recommended range of 10 to 14 weeks.
The doctor will regularly check the testosterone level in the blood at the end of the interval between injections to ensure it is correct. If the level is too low, the doctor may decide to administer the medicine more frequently. If the level is too high, the doctor may decide to administer the medicine less frequently. It is essential 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 Besins is too strong or too weak, consult your doctor.

Using a higher dose of Testosterone Undecanoate Besins than recommended

Symptoms of using too high a dose of Testosterone Undecanoate Besins are:

• irritability
• nervousness
• weight gain
• prolonged or frequent erections

If any of the above symptoms occur, consult your doctor. The doctor will decide on less frequent injections or discontinue 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):

• abnormally high red blood cell count
• weight gain
• hot flashes
• acne
• enlarged prostate 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, restlessness, aggression, or irritability
• headaches, migraines, or tremors
• cardiovascular disorders, high blood pressure, or dizziness
• bronchitis, sinusitis, cough, shortness of breath, snoring, or voice problems
• diarrhea or nausea
• changes in liver function test results
• hair loss 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 phosphokinase activity in the blood
• urinary disorders (e.g., decreased urine flow, urinary retention, need to urinate at night)
• 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 feeling of weakness, excessive sweating, or night sweats

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

• oil solution of Testosterone Undecanoate Besins may enter the lungs (pulmonary oil microembolism), which in rare cases can cause symptoms such as: cough, shortness of breath, malaise, excessive sweating, chest pain, dizziness, tingling, or fainting. These reactions can occur during or immediately after injection and are reversible.

There have been reports of suspected anaphylactic reactions after injection of Testosterone Undecanoate Besins.
During the use of testosterone preparations, in addition to the above side effects, the following have also been reported: 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).
Treatment with high-dose testosterone preparations often leads to inhibition or reduction of sperm production in the body. These symptoms disappear after the end of treatment.
Testosterone replacement therapy in the treatment of disturbed hormonal function of the testes (hypogonadism) may rarely cause prolonged, painful erections (priapism).
High doses and long-term use of testosterone can occasionally lead to water retention in the body and the occurrence of edema (swelling caused by fluid retention).
The use of testosterone products may be associated with an overall increased risk of increased 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 those not listed in this leaflet, tell your doctor, pharmacist, nurse, or midwife. 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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Testosterone Undecanoate Besins

Keep the medicine out of the sight and reach of children.
There are no special precautions for storing the medicinal product.
Do not usethis medicine after the expiry date stated on the label after the abbreviation "EXP".
The "Lot" abbreviation means batch number. The expiry date refers to the last day of the given month.
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 Besins contains

The active substance of the medicine is testosterone undecanoate 250 mg/ml (which corresponds to 157.9 mg of testosterone). One vial contains 1000 mg of testosterone undecanoate (which corresponds to 631.5 mg of testosterone).
The other ingredients are benzyl benzoate and purified castor oil.

What Testosterone Undecanoate Besins looks like and contents of the packaging

Testosterone Undecanoate Besins is a clear, yellowish oily liquid. The packaging contains:
A vial made of orange glass with a bromobutyl rubber stopper for injectable products and an aluminum seal of the flip-off type with an orange plastic disc, in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder
Besins Healthcare Ireland Limited
Plaza 4, Level 4 Custom House Plaza
Harbourmaster Place, IFSC
Dublin 1, D01 A9N3
Ireland
Manufacturer
Laboratorios Farmalán, S.A.
Calle La Vallina, s/n,
Polígono Industrial Navatejera
24193 Villaquilambre, León, Spain

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Belgium, Luxembourg:
Testosterone Besins 1000 mg/4 ml solution injectable
Czech Republic:
Testosteron undecanoát Besins
France:
Testosterone Besins 1000 mg/4 ml solution injectable
Germany:
Testosteron Besins 1000 mg/4 ml Injektionslösung
Ireland:
Testosterone Besins 1000 mg/4 ml solution for injection
Italy:
Testosterone undecanoato Besins
Poland:
Testosterone Undecanoate Besins
Portugal:
Androject 1000 mg/4ml Solução injetável
Romania:
Androject 1000 mg/4ml Soluţie injectabilă
Slovakia:
Androject 1000 mg/4ml Injekčný roztok
Spain:
Teneone
Sweden:
Testosterone Besins 1000 mg/4 ml Injektionsvätska, lösning
To obtain more detailed information about this medicine, contact the local representative of the marketing authorization holder.
Besins Healthcare Poland Sp. z o.o.
ul. Wiśniowa 40B/4
02-520 Warsaw
e-mail: info.poland@besins-healthcare.com

Date of last revision of the leaflet:

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Information intended for healthcare professionals only:

When stored at low temperatures, the properties of this oil-based solution may temporarily change (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 injection should be inspected before use; only clear solutions without solid particles can be used.
The contents of the vial should be injected intramuscularly immediately after opening.
Testosterone Undecanoate Besins is intended for single use only, and any unused solution should be discarded.
Method of administration
Particular care should be taken to avoid intravascular injection.
Like all oil solutions, Testosterone Undecanoate Besins should be injected intramuscularly and very slowly. Pulmonary oil microembolism can rarely lead to symptoms such as: cough, shortness of breath, malaise, excessive sweating, chest pain, dizziness, tingling, or fainting. These reactions can occur during or immediately after injection and are reversible. Treatment is usually supportive, e.g., by administering additional oxygen.
There have been reports of suspected anaphylactic reactions after injection of Testosterone Undecanoate Besins.
Warnings
In patients treated with testosterone, careful and regular monitoring of the prostate and breasts is necessary, in accordance with the recommended procedure (rectal examination and determination of prostate-specific antigen (PSA) levels in serum). This should be done at least once a year and twice a year in older patients and those at high risk (with clinical or family factors).
In addition to laboratory tests for testosterone levels, the following laboratory parameters should be periodically monitored in patients treated with androgens for a long time: hemoglobin, hematocrit, liver function tests, and lipid profile.
In patients with severe heart, liver, or kidney failure or coronary artery disease, treatment with testosterone may cause serious complications, such as edema with or without congestive heart failure. In such cases, treatment should be discontinued immediately.

Notes on handling the vial:

The vial is intended for single use only. The contents of the vial should be injected intramuscularly immediately after drawing into the syringe. After removing the plastic cap (A), do not remove the metal ring (B) or the cap (C).