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

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!
3. OMNADREN 250
   1. You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.
4. What is Omnadren 250 and what is it used for
   1. Indications for use
5. 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 using machines
   7. Omnadren 250 contains benzyl alcohol and arachis oil
6. How to use Omnadren 250
   1. Using a higher dose of Omnadren 250 than recommended
   2. Missing a dose of Omnadren 250
   3. Stopping the use of Omnadren 250
7. Possible side effects
   1. Reporting side effects
8. How to store Omnadren 250
9. Contents of the pack and other information
   1. What Omnadren 250 contains
   2. What Omnadren 250 looks like and contents of the pack
   3. Marketing authorization holder in Bulgaria, the country of export:
   4. Manufacturer:
   5. Parallel importer:
   6. Repackaged by:
   7. Date of approval of the leaflet: 03.10.2023

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

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 you need to.
• If you have 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 you experience any side effects, including those not listed in this leaflet, you should tell your 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 pack 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 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 spermatogenesis disorders.
In women
It may be used exceptionally in women with hyperestrogenism-related diseases (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 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:

• 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 liver tumors may occur;
• if the patient has hepatitis - it may be necessary to discontinue 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;
• 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); advanced age of the patient.

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 the above 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 prostate 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 health risk (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.
When using Omnadren 250 concomitantly with:

• oral anticoagulant medicines - it is necessary to monitor blood clotting, 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 (pituitary hormone) or corticosteroids - the risk of edema increases, especially in people with liver or heart disease;
• oxyphenbutazone (a pain reliever 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, in the treatment of 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 effectiveness of Omnadren 250.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your 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 large amounts 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 administration of the medicine more frequently than once a week in men, it may lead to the occurrence of persistent erection (priapism), while in women it may lead to hoarseness, which can cause irreversible changes in voice. 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, this medicine 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, increased hematocrit, 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):liver tumor.
• 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 male type in women), male-pattern baldness, acne.
• Gastrointestinal disorders:nausea.
• Hepatobiliary disorders:obstructive jaundice, liver function disorders, liver plaques or liver 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 clotting), bleeding in patients treated with oral anticoagulant medicines, polycythemia (excessive red blood cell count in the blood).
• Psychiatric and nervous system disorders:changes in libido, 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 those not listed in this leaflet, you should consult your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including those 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 inaccessible to 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 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 pack 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 contents of the pack

Omnadren 250 is a clear yellow, oily solution.
The pack 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 SA
ul. Wincentego Pola 21
58-500 Jelenia Góra
Poland

Parallel importer:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
Marketing authorization number in Bulgaria, the country of export: 20030700
Parallel import authorization number: 215/23

Date of approval of the leaflet: 03.10.2023

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