Omnadren 250

Package leaflet: Information for the user

Warning! Keep the leaflet. The information on the immediate packaging is in a foreign language!
OMNADREN 250
(30 mg + 60 mg + 60 mg + 100 mg)/ml, solution for injection
Testosterone propionate + Testosterone phenylpropionate + Testosterone isocaproate + Testosterone
decanoate
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• 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 or pharmacist. See section 4.

Contents of the leaflet:

1. What Omnadren 250 is and what it is used for
2. Important information before using Omnadren 250
3. How to use Omnadren 250
4. Possible side effects
5. How to store Omnadren 250
6. Contents of the package and other information

1. What Omnadren 250 is and what it is used for

Omnadren 250 is a mixture of the following testosterone esters: propionate,
phenylpropionate, isocaproate, and decanoate. The medicine is administered intramuscularly in cases
of androgen deficiency in men.
Testosterone is a natural androgenic hormone produced in men by Leydig cells of the testes. It plays a key role in stimulating and maintaining male sexual function.
It causes growth of the testes, prostate gland, and seminal vesicles, influences spermatogenesis
(the process of formation and maturation of spermatozoa), and initiates the development of secondary and tertiary sexual characteristics.
Testosterone exerts anabolic effects in both men and women, promoting skeletal muscle growth, increasing bone mineral density, stimulating erythropoietin production (a hormone affecting red blood cell formation) in the kidneys, and increasing hemoglobin concentration (the red pigment in blood).
Indications
In men
Omnadren 250 is used in adult men as testosterone replacement therapy for the treatment of various conditions resulting from testosterone deficiency (male hypogonadism). Diagnosis requires two independent measurements of testosterone blood levels and the presence of the following clinical symptoms:

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

The medicine may also be used in delayed puberty, post-castration syndrome, impotence due to testosterone deficiency, and disorders of spermatogenesis.
In women
Rarely, it may be used in women for conditions associated with hyperestrogenism (excessive levels of female sex hormones called estrogens).

2. Important information before using Omnadren 250

When not to use Omnadren 250

• if the patient is allergic to the active substances (testosterone propionate, testosterone phenylpropionate, testosterone isocaproate, testosterone decanoate) or to any of the other ingredients of this medicine (listed in section 6);
• if the patient is allergic to peanuts or soya;
• if the patient has nephrotic syndrome;
• if the patient has or is suspected of having prostate cancer;
• if the patient has breast cancer;
• if the patient is pregnant or breastfeeding.

Warnings and precautions
Before starting treatment with Omnadren 250, discuss this with your doctor. Omnadren 250 is intended for intramuscular use only.
The following blood tests should be ordered by the doctor before and during treatment:
blood testosterone levels, complete blood count.
Tell your doctor:

• if the patient has breast cancer – due to an increased risk of hypercalcaemia (elevated calcium levels in the blood), monitoring of calcium levels in urine and blood is necessary;
• if the patient is using high doses of the medicine – liver function should be monitored, as hepatic peliosis or liver tumours may occur;
• if the patient develops hepatitis – administration of the medicine may need to be discontinued and the cause of hepatitis investigated;
• if the patient has severe heart, liver or kidney disease, treatment with Omnadren 250 may lead to serious complications, manifesting as fluid retention and, occasionally, congestive heart failure;
• if the patient has high blood pressure or is taking medications for high blood pressure, because testosterone may increase blood pressure;
• blood clotting disorders;
• thrombophilia (abnormalities in blood coagulation increasing the risk of thrombosis – formation of blood clots in blood vessels);
• factors increasing the risk of venous thrombosis: previous history of venous blood clots; smoking; obesity; cancer; immobilization; if a close family member of the patient had a blood clot in the leg, lung or another organ at a young age (e.g. under 50 years); advanced age of the patient.

How to recognize the occurrence of a blood clot: painful swelling in one leg or sudden change in skin colour, e.g. pallor, redness or cyanosis; sudden unexplained shortness of breath; sudden cough possibly with coughing up blood; sudden chest pain; severe dizziness or vertigo; severe abdominal pain; sudden loss of vision. If any of these symptoms occur, seek immediate medical help.

Elderly patients
Experience regarding the safety and efficacy of Omnadren 250 in patients over 65 years of age is limited.
In elderly patients, the risk of benign prostatic hyperplasia, benign prostatic enlargement or prostate cancer increases. Therefore, the doctor may perform prostate examinations and recommend additional laboratory tests – measurement of PSA levels (prostate-specific antigen, a protein produced exclusively by prostate cells).

(Inappropriate) use of the medicine in sports
Using testosterone as a doping agent may lead to serious adverse effects.

Misuse and dependence on Omnadren 250
This medicine should always be used according to the doctor's or pharmacist's instructions. Misuse of testosterone and other anabolic-androgenic steroids may lead to severe adverse effects, including those affecting the heart and blood vessels (which may lead to death), mental health and (or) the liver. Individuals who misuse testosterone may become dependent and may experience withdrawal symptoms after a significant dose reduction or abrupt discontinuation of the medicine. Do not misuse this medicine alone or in combination with other anabolic-androgenic steroids, as this poses a serious health risk (see "Possible side effects").

Note: if painful penile erection occurs, discontinue use of the medicine.

Children and adolescents
The safety and efficacy of Omnadren 250 in children and adolescents have not been adequately established.

Omnadren 250 and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken or plan to take.

During concomitant use of Omnadren 250 with:

• oral anticoagulants – coagulation system monitoring is necessary, especially when starting or stopping Omnadren 250;
• insulin – blood glucose (sugar) levels may decrease, reducing insulin requirements;
• ACTH (adrenocorticotropic hormone) or corticosteroids – increased risk of oedema, especially in patients with liver or heart disease;
• oxyphenbutazone (an analgesic and anti-inflammatory medicine) – oxyphenbutazone levels may increase;
• drugs that induce the activity of enzymes involved in drug metabolism, such as rifampicin (used, among others, in tuberculosis treatment), barbiturates (sedatives, hypnotics and anticonvulsants), carbamazepine (antiepileptic), salicylates (analgesic and anti-inflammatory agents), phenytoin (antiepileptic) or primidone (antiepileptic) – the effectiveness of Omnadren 250 may be reduced.

Pregnancy, breastfeeding and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Omnadren 250 is contraindicated in pregnant or breastfeeding women.
In men, use of Omnadren 250, especially at high doses, may lead to reduced sperm count in semen, and in women to menstrual cycle disturbances or amenorrhoea (see section 4).

Driving and using machines
Omnadren 250 has no effect on psycho-motor performance, ability to drive motor vehicles or operate machinery.

Omnadren 250 contains benzyl alcohol and arachis oil
Omnadren 250 contains 50 mg of benzyl alcohol in each 1 ml, equivalent to 50 mg/ml.
Benzyl alcohol may cause allergic reactions.
Patients with liver or kidney disease should consult a doctor before using this medicine, as large amounts of benzyl alcohol may accumulate in their body and cause adverse effects (so-called metabolic acidosis).
The medicine may cause mild local irritation.
The medicine contains arachis oil (from peanuts). Do not use if hypersensitivity to peanuts or soya has been diagnosed.

3. How to use Omnadren 250

This medicine should always be used exactly as prescribed by the doctor.
If in doubt, consult your doctor or pharmacist.
Omnadren 250 is administered intramuscularly.
Injections should be given deep into the gluteal muscle.
The doctor will determine the dose individually for each patient.
The usual dose is 1 vial of Omnadren 250 every 4 weeks.
Male primary hypogonadism (anorchism, Klinefelter's syndrome, castration syndrome, testicular atrophy).
Depending on the degree of impairment of gonadal function (based on clinical evaluation and laboratory results), the medicine is administered every 7, 14, or 21 days.
Other indications
In certain cases of male infertility (azoospermia – absence of sperm in semen, oligospermia – low sperm count in semen), two injections of Omnadren 250 are given at two-week intervals.
Omnadren 250 is exceptionally used in gender transition in various forms of intersex conditions.
Use of a higher than recommended dose of Omnadren 250
Overdose of Omnadren 250 is unlikely when used as recommended. However, in case of overdose due to excessive dosage or administration more frequently than once a week, men may develop persistent penile erection (priapism), while women may develop hoarseness, which may lead to irreversible voice changes. In such cases, Omnadren 250 should be discontinued.
Missed dose of Omnadren 250
Do not use a double dose to make up for a missed dose.
Stopping treatment with Omnadren 250
Discontinuation is not contraindicated and, apart from a gradual return of symptoms of hypogonadism or ADAM syndrome ("Androgen Deficiency in Aging Men") or PADAM ("Partial Androgen Deficiency in Aging Men"), or loss of libido in some women, no life-threatening or health-threatening symptoms have been reported.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in everyone.
Common adverse effects (may occur in up to 1 in 10 people):

• Blood and lymphatic system disorders: increased number of red blood cells, haematocrit (percentage of red blood cells in the blood), and haemoglobin concentration (a component of red blood cells that carries oxygen), identified in periodic blood tests.
• Investigations: increased haemoglobin concentration (a component of red blood cells that carries oxygen), increased haematocrit (percentage of red blood cells in the blood), increased number of red blood cells, increased prostate-specific antigen (PSA) level.
• Metabolism and nutrition disorders: weight gain.

Adverse effects with unknown frequency (frequency cannot be determined from available data):

• Benign, malignant and unspecified neoplasms (including cysts and polyps): liver tumour.
• Reproductive system and breast disorders:
  • Women: menstrual irregularities, amenorrhoea (absence of menstruation), suppression of gonadotropin secretion, masculinization (development of male characteristics in women);
  • Men: gynaecomastia (enlargement of breast tissue in men), priapism (painful erection), oligospermia (low sperm count in semen) during use of high doses.
• Skin and subcutaneous tissue disorders: hirsutism (excessive male-pattern hair growth in women), male-pattern baldness, acne.
• Gastrointestinal disorders: nausea.
• Hepatobiliary disorders: cholestatic jaundice, liver function abnormalities, hepatic peliosis or liver neoplasia.
• Vascular disorders: deep vein thrombosis, hypertension.
• Respiratory, thoracic and mediastinal disorders: pulmonary embolism.
• Blood and lymphatic system disorders: inhibition of clotting factors II, V, VII and X (substances essential for blood coagulation), bleeding in patients treated with oral anticoagulants, polycythaemia (excessive number of red blood cells in the blood).
• Psychiatric and nervous system disorders: changes in libido (sexual drive), headache, anxiety, paraesthesia (e.g. tingling, numbness).
• Investigations: retention of sodium, chloride, water, potassium, calcium and inorganic phosphates, increased cholesterol concentration.
• General disorders and administration site conditions: inflammation and pain at the injection site.

If any adverse effects occur, including possible adverse effects not listed in this leaflet, consult a doctor or pharmacist.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Omnadren 250

Store below 25°C. Protect from light.
Keep the medicine in a place inaccessible and out of sight of children.
Do not use this medicine after the expiry date stated on the carton and
ampoule. 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 in use. This will help
protect the environment.

6. Contents of the pack and other information

What Omnadren 250 contains
The active substances in this medicine are: testosterone propionate 30 mg, testosterone phenylpropionate 60 mg,
testosterone isocaproate 60 mg, testosterone decanoate 100 mg.
Other components of the medicine are benzyl alcohol 50 mg, arachis oil for injections up to 1 ml.

What Omnadren 250 looks like and contents of the pack
Omnadren 250 is a clear yellow, oily solution.
The pack contains 5 ampoules of 1 ml each, made of colourless glass with a brown stripe, packed in a cardboard box.

For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing authorisation holder in Bulgaria, the country of export:
Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland

Manufacturer:
Jelfa Pharmaceutical Company SA
ul. Wincentego Pola 21
58-500 Jelenia Góra
Poland

Parallel importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland
SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
Poland

Marketing authorisation number in Bulgaria, the country of export: 20030700
Parallel import authorisation number: 215/23