OMNADREN 30 mg/60 mg /60 Mg/100 Mg Solution

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.
   1. You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
3. What is Omnadren 250 and what is it used for
   1. Indications for use
4. Important information before using Omnadren 250
   1. When not to use Omnadren 250
   2. Warnings and precautions
   3. Children and adolescents
   4. Omnadren 250 and other medicines
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and operating machinery
   7. Omnadren 250 contains benzyl alcohol and arachis oil.
5. How to use Omnadren 250
   1. Use of a higher dose of Omnadren 250 than recommended
   2. Missing a dose of Omnadren 250
   3. Stopping the use of Omnadren 250
6. Possible side effects
   1. Reporting side effects
7. How to store Omnadren 250
8. Contents of the packaging and other information
   1. What Omnadren 250 contains
   2. What Omnadren 250 looks like and what the packaging contains
   3. Marketing authorization holder in Bulgaria, the country of export:
   4. Manufacturer:
   5. Parallel importer:
   6. Repackaged by:
   7. Parallel import authorization number: 199/22 Date of leaflet approval: 6.05.2022

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

OMNADREN 250(ОМНАДРЕН)
(30 mg + 60 mg + 60 mg +100 mg)/ml, solution for injection
Testosterone propionate + Testosterone phenylpropionate + Testosterone isocaproate + Testosterone decanoate

OMNADREN 250 and ОМНАДРЕН are different trade names for the same drug written in Polish and Bulgarian.

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 one person. It should not be given to others. The medicine may harm another person even if the symptoms of their illness are the same.
• 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 formation of secondary and tertiary sex 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 moods
• 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 disorders of spermatogenesis.
In women
It may be used exceptionally in women with hyperestrogenism (excessive amounts of female sex hormones called estrogens).

2. Important information before using Omnadren 250

When not to use Omnadren 250

Warnings and precautions

Before starting treatment with 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:

• blood clotting disorders;
• thrombophilia (abnormalities in blood clotting, increasing 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 attention.
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) level determination.
(Incorrect) use of the medicine in sports
The use of testosterone as a doping agent can cause serious side effects.
Overuse of the medicine 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 severe 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 medicine. You should not overuse this medicine, either 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 erections, 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 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 blood coagulation, especially when starting or stopping Omnadren 250;
• insulin - it may lead to a decrease in blood glucose levels and a decrease in insulin requirements;
• ACTH (pituitary hormone) or corticosteroids - the risk of edema increases, especially in people with liver or heart disease;
• oxyphenbutazone (a pain-relieving and anti-inflammatory medicine) - it may lead to an increase in oxyphenbutazone levels;
• medicines that stimulate the activity of enzymes involved in drug metabolism, such as rifampicin (a medicine used, among other things, to treat tuberculosis), barbiturates (sedatives, sleeping pills, and anticonvulsants), carbamazepine (an antiepileptic medicine), salicylates (medicines with analgesic and anti-inflammatory effects), phenytoin (an antiepileptic medicine), or primidone (an antiepileptic medicine) - it may lead to a decrease in the efficacy of Omnadren 250.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, suspects 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 disorders of menstruation or amenorrhea (see section 4).

Driving and operating machinery

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

Omnadren 250 contains benzyl alcohol and arachis oil.

Due to the content of:

• benzyl alcohol - the medicine should not be administered to premature infants or newborns. The medicine may cause poisoning and allergic reactions in infants and children under 3 years of age. Benzyl alcohol may cause allergic reactions. Patients with liver or kidney disease should consult their doctor before using the medicine, as large amounts of benzyl alcohol may accumulate in their body and cause side effects (metabolic acidosis). Omnadren 250 contains 50 mg of benzyl alcohol in each 1 ml, which corresponds to 50 mg/ml. The medicine contains arachis oil (from peanuts). It should not be used in case of known hypersensitivity to peanuts or soybeans.

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 select 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 - absence of sperm in the semen, oligospermia - low sperm count in the semen), 2 injections of Omnadren 250 are administered at 2-week intervals.
Omnadren 250 is used exceptionally in cases of sex reassignment in various forms of hermaphroditism.

Use of 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 administration of the medicine more frequently than once a week in men, it may lead to persistent erections (priapism), while in women, it may lead to hoarseness, which can result in irreversible voice changes.
In this case, you should stop using Omnadren 250.

Missing a dose of Omnadren 250

You should not take 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 symptoms 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), 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, this medicine can cause side effects, although not everybody gets them.
Common 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.
• Metabolism and nutrition disorders:weight gain.

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

• 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 erections), oligospermia (low sperm count in the semen) 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.
• Metabolism and nutrition disorders:sodium, chloride, water, potassium, calcium, and inorganic phosphate retention, increased cholesterol levels.
• Gastrointestinal disorders:nausea.
• Hepatobiliary disorders:obstructive jaundice, liver function disorders, liver plaques or liver tumors.
• Blood and lymphatic system disorders:inhibition of blood clotting factors II, V, VII, and X (substances necessary for blood clotting), bleeding in patients treated with oral anticoagulants, polycythemia (excessive red blood cell count in the blood).
• Nervous system disorders:changes in libido (sexual desire), headaches, anxiety, paresthesia (including tingling, numbness).
• 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 your 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, tel.: +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 out of sight and reach of children.
You should not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. You should 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 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 packaging contains

Omnadren 250 is a clear yellow, oily solution.
The packaging contains 5 ampoules of 1 ml each, 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 the 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:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Bulgaria, the country of export:20030700

Parallel import authorization number: 199/22 Date of leaflet approval: 6.05.2022

[Information about the trademark]