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

Contents of the leaflet

1. Package Leaflet: Information for the User
   1. Read the package leaflet carefully before using the medicine, as it contains important information for the patient.
2. What is Omnadren 250 and what is it used for
   1. Indications for use
3. 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
4. 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
5. Possible side effects
   1. Reporting side effects
6. How to store Omnadren 250
7. 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
   4. Manufacturer

Package Leaflet: Information for the User

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

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform 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, 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 due to low hormone levels.

The medicine may also be used in: delayed puberty, post-castration syndrome, impotence caused by testosterone deficiency, disorders of spermatogenesis.
In women
It may be used 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, 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.
Tell your doctor:

• bleeding disorders;
• thrombophilia (abnormalities in blood clotting, increasing the risk of thrombosis - the formation of blood clots in blood vessels);
• factors increasing the risk of blood clots in the vein: previous 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 fainting, severe abdominal pain, sudden loss of vision. If the patient experiences any of the above 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 prostate hyperplasia, benign prostatic hypertrophy, 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 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. Do not overuse this medicine, either 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 priapism, discontinue the medicine.

Children and adolescents

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

Omnadren 250 and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
When using 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 (pain 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 others, 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 efficacy of Omnadren 250.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.
Omnadren 250 is contraindicated in women who are pregnant or breastfeeding.
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 using machines

Omnadren 250 does not affect psychophysical abilities, 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 consult their doctor before using the medicine, as large amounts of benzyl alcohol may accumulate in their body and cause side effects (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, consult your doctor or pharmacist.
Omnadren 250 is administered intramuscularly.
Injections should be performed deep into the gluteal muscle.
The doctor will determine 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 occasionally 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 persistent priapism, while in women it may lead to hoarseness, which can result in irreversible voice changes.
Then, discontinue the use of Omnadren 250.

Missing a dose of Omnadren 250

Do 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 in aging men") or PADAM ("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 regarding the use of this medicine, consult your 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 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) when using large 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 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, 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, please inform your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Omnadren 250

Store in a temperature below 25°C. Store in the original packaging to protect from light.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after: Expiry Date (EXP:). The expiry date refers to the last day of the month.
Medicines should not be disposed of 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 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.

Marketing authorization holder

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
Polska
Date of last revision of the leaflet: