Omnadren 250

Leaflet attached to the packaging: information for the user

Warning! Keep the leaflet! Information on the immediate packaging 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

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 necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• 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. See section 4.

Table of contents of the leaflet:

• 1. What is Omnadren 250 and what is it 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 packaging and other information

1. What is Omnadren 250 and what is it 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 androgen hormone produced in men in the Leydig cells of the testes. It plays a major role in stimulating and maintaining male sexual functions.
It causes the growth of the testes, prostate, seminal vesicles, affects spermatogenesis (the process of formation and maturation of sperm), initiates the development of secondary and tertiary sexual characteristics.
Testosterone, both in men and women, has an anabolic effect, leading to the growth of skeletal muscles, increases bone mineral density, stimulates the production of erythropoietin (a hormone that affects the production of red blood cells) in the kidneys, and increases hemoglobin levels (red blood pigment).

Indications for use

In men
Omnadren 250 is used in adult men as testosterone replacement therapy for the treatment of various diseases resulting from testosterone deficiency (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 libido
• fatigue
• depressive mood
• bone mass loss caused by low hormone levels.

The medicine may also be used in: delayed puberty, post-castration syndrome, impotence caused by testosterone deficiency, and spermatogenesis disorders.
In women
It may be used exceptionally in women with hyperestrogenism-related disorders (excessive amounts 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 any of the other ingredients of this medicine (listed in section 6);
• if the patient is allergic to peanuts or soy;
• 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 to use Omnadren 250, you should discuss it with your doctor. Omnadren 250 is intended for intramuscular injection only.
The following blood tests should be ordered by the doctor before and during treatment:
testosterone levels in the blood, full blood count.
You should tell your doctor:

• if the patient has breast cancer - due to the increased risk of hypercalcemia (elevated calcium levels in the blood), it is necessary to monitor calcium levels in the urine and blood;
• if the patient is taking large doses of the medicine - it is recommended to monitor liver function, as liver plaques or tumors may occur;
• if the patient develops hepatitis - it may be necessary to discontinue the use of the medicine and determine the cause of hepatitis;
• if the patient has severe heart, liver, or kidney disease, the use of Omnadren 250 may cause serious complications, which will manifest as water retention in the body and sometimes (congestive) heart failure;
• if the patient has high blood pressure or is taking medications for hypertension, as testosterone may cause an increase in blood pressure;
• coagulation disorders;
• thrombophilia (abnormalities in blood coagulation that increase the risk of thrombosis - the formation of blood clots in blood vessels);
• factors that increase the risk of blood clots in the vein: previously occurring blood clots in the vein; smoking; obesity; cancer; immobilization; 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); the patient's advanced age.

How to recognize the occurrence of a blood clot: painful swelling of one leg or sudden change in skin color, e.g., pallor, redness, or cyanosis, 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 the patient experiences any of these symptoms, they should immediately seek medical help.
Elderly patients
Experience with the safety and efficacy of Omnadren 250 in patients over 65 years of age is limited.
In elderly patients, the risk of developing prostatic hyperplasia, benign prostatic hyperplasia, or prostate cancer increases. Therefore, in these patients, the doctor may perform prostate examinations and recommend additional laboratory tests - PSA (prostate-specific antigen) measurement.
(Incorrect) use of the medicine in sports
The use of testosterone as a doping agent can cause serious side effects.
Overuse and dependence on Omnadren 250
This medicine should always be used in accordance with the doctor's or pharmacist's recommendations. Overuse of testosterone and other anabolic-androgenic steroids can lead to serious side effects, including those related to the heart and blood vessels (which can lead to death), mental health, and (or) liver. People who have overused testosterone may become dependent and may experience withdrawal symptoms after significantly reducing the dose or abruptly stopping the use of the medicine. You should not overuse this medicine used alone or in combination with other anabolic-androgenic steroids, as it poses a serious risk to health (see "Possible side effects").
Warning: in case of painful erection, you should stop using the medicine.

Children and adolescents

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

Omnadren 250 and other medicines

You should tell your doctor or pharmacist about all the medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
During concomitant use of Omnadren 250 with:

• oral anticoagulants - it is necessary to monitor the coagulation system, especially when starting or stopping the use of Omnadren 250;
• insulin - it may lead to a decrease in blood glucose levels and a decrease in insulin requirements;
• ACTH (adrenal hormone) or corticosteroids - the risk of edema increases, especially in people with liver or heart disease;
• oxyphenbutazone (a pain reliever and anti-inflammatory drug) - it may lead to an increase in oxyphenbutazone levels;
• drugs that stimulate the activity of enzymes involved in drug metabolism, such as rifampicin (a drug used, among other things, to treat tuberculosis), barbiturates (sedatives, sleeping pills, and anticonvulsants), carbamazepine (an antiepileptic drug), salicylates (drugs with analgesic and anti-inflammatory effects), phenytoin (an antiepileptic drug), or primidone (an antiepileptic drug) - it may lead to a decrease in the efficacy of Omnadren 250.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, suspects that they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before using this medicine.
Omnadren 250 is contraindicated in pregnant or breastfeeding women. In men, the use of Omnadren 250, especially in large doses, may lead to a decrease in sperm count in the semen, and in women to menstrual disorders or amenorrhea (see section 4).

Driving and using machines

Omnadren 250 does not affect psychophysical fitness, the ability to drive vehicles, or operate machinery.

Omnadren 250 contains benzyl alcohol and arachis oil

Omnadren 250 contains 50 mg of benzyl alcohol in each 1 ml, which corresponds to 50 mg/ml. Benzyl alcohol may cause allergic reactions.
Patients with liver or kidney disease should contact their doctor before using the medicine, as a large amount of benzyl alcohol may accumulate in their body and cause side effects (so-called metabolic acidosis).
The medicine may cause mild local irritation.
The medicine contains arachis oil (from peanuts). Do not use if you are hypersensitive to peanuts or soy.

3. How to use Omnadren 250

This medicine should always be used in accordance with the doctor's recommendations.
In case of doubts, you should consult a doctor or pharmacist.
Omnadren 250 is administered intramuscularly.
Injections should be performed deep into the gluteal muscle.
The doctor will choose the dose of the medicine individually for each patient.
Usually, the dose used is 1 ampoule of Omnadren 250 every 4 weeks.
Primary male hypogonadism (anorchism, Klinefelter syndrome, castration syndrome, testicular atrophy).Depending on the degree of sexual gland dysfunction (according to clinical assessment and laboratory results), the medicine is injected every 7-14-21 days.
Other indications
In some cases of male infertility (azoospermia - lack of sperm in the semen, oligospermia - small amount of sperm in the semen), 2 injections of Omnadren 250 are administered at 2-week intervals.
Omnadren 250 is exceptionally used in cases of sex reassignment in various forms of hermaphroditism.

Using a higher dose of Omnadren 250 than recommended

Overdose of Omnadren 250 is unlikely when used as recommended. In case of overdose due to the use of too high a dose or more frequent administration than once a week in men, it may lead to persistent erection (priapism), while in women it may lead to hoarseness, which can result in irreversible voice changes. You should then stop using Omnadren 250.

Missing a dose of Omnadren 250

You should not use a double dose to make up for a missed dose.

Stopping the use of Omnadren 250

It is not contraindicated, and apart from the slow return of hypogonadism or ADAM syndrome ("androgen deficiency syndrome in older men" - Adrenal Deficiency in Aging Men) or PADAM ("partial androgen deficiency syndrome in older men" - Partial Androgen Deficiency in Aging Men) symptoms, or loss of libido in some women, no life-threatening or health-threatening symptoms have been reported.
In case of any further doubts related to the use of this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Omnadren 250 can cause side effects, although not everybody gets them.
Frequent side effects(may occur in up to 1 in 10 people):

• Blood and lymphatic system disorders:increased red blood cell count, hematocrit (percentage of red blood cells in the blood), and hemoglobin levels (red blood cell component that carries oxygen), identified in periodic blood tests.
• Diagnostic tests:increased hemoglobin levels (red blood cell component that carries oxygen), increased hematocrit (percentage of red blood cells in the blood), increased red blood cell count, increased prostate-specific antigen levels.
• Metabolism and nutrition disorders:weight gain.

Side effects with unknown frequency(frequency cannot be estimated from the available data):

• Benign, malignant, and unspecified tumors (including cysts and polyps):
• Reproductive system and breast disorders:
• Women: menstrual disorders, amenorrhea, inhibition of gonadotropin secretion, masculinization (development of male characteristics in women);
• Men: gynecomastia (breast enlargement in men), priapism (painful erection), oligospermia (low sperm count) during the use of high doses.
• Skin and subcutaneous tissue disorders:hirsutism (excessive hair growth of the male type in women), male-pattern baldness, acne.
• Gastrointestinal disorders:nausea.
• Hepatobiliary disorders:obstructive jaundice, liver function disorders, liver plaques or tumors.
• Vascular disorders:deep vein thrombosis, arterial hypertension.
• Respiratory, thoracic, and mediastinal disorders:pulmonary embolism.
• Blood and lymphatic system disorders:inhibition of coagulation factors II, V, VII, and X (substances necessary for blood coagulation), bleeding in patients treated with oral anticoagulants, polycythemia (excessive red blood cell count in the blood).
• Psychiatric and nervous system disorders:changes in libido (sexual desire), headaches, anxiety, paresthesia (including tingling, numbness).
• Diagnostic tests:sodium, chloride, water, potassium, calcium, and inorganic phosphate retention, increased cholesterol levels.
• General disorders and administration site conditions:inflammation and pain at the injection site.

If you experience any side effects, including any side effects not listed in this leaflet, you should consult a doctor or pharmacist.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Phone: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Omnadren 250

Store in a temperature below 25°C. Protect from light.
The medicine should be stored in a place that is invisible and inaccessible to children.
Do not use this medicine after the expiry date stated on the box and ampoule. The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste containers. You should ask your pharmacist how to dispose of medicines that are no longer used. This will help protect the environment.

6. Contents of the packaging and other information

What Omnadren 250 contains

The active substances of the medicine are: testosterone propionate 30 mg, testosterone phenylpropionate 60 mg, testosterone isocaproate 60 mg, testosterone decanoate 100 mg.
The other ingredients of the medicine are benzyl alcohol 50 mg, arachis oil for injection up to 1 ml.

What Omnadren 250 looks like and what the pack contains

Omnadren 250 is a clear yellow, oily solution.
The packaging contains 5 ampoules of 1 ml, made of colorless glass with a brown stripe, in a cardboard box.
To obtain more detailed information, you should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Bulgaria, the country of export:

Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland

Manufacturer:

Przedsiębiorstwo Farmaceutyczne Jelfa S.A.
ul. Wincentego Pola 21, 58-500 Jelenia Góra
Poland

Parallel importer:

Aga Kommerz spol. s r.o.
Frydecka 2006
737 01 Czeski Cieszyn
Czech Republic

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warszawa
Wytwórnia Euceryny Laboratorium Farmaceutyczne COEL S.J. E.Z.M. KONSTANTY
ul. Wł. Żeleńskiego 45
31-353 Kraków

Marketing authorization number in Bulgaria, the country of export: 20030700

Parallel import authorization number: 99/24

Date of leaflet approval: 13.03.2024

[Information about the trademark]