Omnadren 250

Package leaflet: Information for the patient

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.
OMNADREN 250 (OMNADREN)
(30 mg + 60 mg + 60 mg + 100 mg)/ml, solution for injection
Testosteroni propionas + Testosteroni phenylpropionas + Testosteroni isocaproas + Testosteroni
decanoas
OMNADREN 250 and ОМНАДРЕН are different trade names of the same medicinal product written in
Polish and Bulgarian.
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 pack 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, seminal vesicles, influences spermatogenesis
(the process of sperm formation and maturation), and initiates the development of secondary and tertiary sexual characteristics.
Testosterone, both in men and women, exhibits anabolic effects, leading to skeletal muscle growth, increases bone mineral density, stimulates erythropoietin production (a hormone affecting red blood cell formation) in the kidneys, and increases 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, along with the clinical symptoms listed below:

• impotence
• infertility
• reduced libido
• fatigue
• depressive moods
• loss of bone mass caused by 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 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 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.
Inform 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 blood and urine is necessary;
• if the patient is receiving high doses of the medicine – liver function should be monitored, as hepatic peliosis or liver tumours may occur;
• if the patient develops hepatitis – treatment with 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, including fluid retention and possibly (congestive) heart failure;
• if the patient has high blood pressure or is taking antihypertensive medicines, as 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; immobilisation; if a close family member of the patient has 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 recognise the occurrence of a blood clot: painful swelling of one leg or sudden change in skin colour, e.g. paleness, redness or blueness; sudden shortness of breath; sudden unexplained cough, possibly with coughing up of blood; sudden chest pain; severe dizziness or vertigo; severe abdominal pain; sudden loss of vision. If the patient experiences any of the above symptoms, seek medical help immediately.
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 developing benign prostatic hyperplasia, benign prostatic hypertrophy or prostate cancer is increased. Therefore, the doctor may perform prostate examinations and recommend additional laboratory tests – measurement of PSA levels (a protein produced exclusively by prostate cells).
(Mis)use of the medicine in sports
The use of testosterone as a doping agent may lead to serious adverse effects.
Abuse and dependence on Omnadren 250
This medicine should always be used according to the doctor's or pharmacist's instructions. Abuse 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 have abused testosterone may become dependent and may experience withdrawal symptoms after a significant dose reduction or abrupt discontinuation of the medicine. Do not abuse this medicine, either alone or in combination with other anabolic-androgenic steroids, as this poses a serious health risk (see "Possible side effects").
Warning: 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
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines you plan to take.
During concomitant use of Omnadren 250 with:

• oral anticoagulants – monitoring of the coagulation system is necessary, especially when starting or stopping treatment with 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;
• medicines 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 (an antiepileptic), salicylates (analgesic and anti-inflammatory medicines), phenytoin (an antiepileptic) or primidone (an 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 disorders or absence of menstruation (see section 4).
Driving and operating machinery
Omnadren 250 has no effect on psychomotor performance, ability to drive mechanical 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 a doctor before using the medicine, as large amounts of benzyl alcohol may accumulate in their bodies and cause adverse effects (so-called metabolic acidosis). Omnadren 250 contains 50 mg of benzyl alcohol in each 1 ml, equivalent to 50 mg/ml. 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 your 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 of the medicine individually for each patient.
The usual dose is 1 vial of Omnadren 250 every 4 weeks.
Primary male hypogonadism (anorchism, Klinefelter's syndrome, castration syndrome, testicular atrophy).
Depending on the degree of impairment of gonadal function (as assessed clinically and by laboratory tests), the medicine may be 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 administered at two-week intervals.
Omnadren 250 is exceptionally used in cases of 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 cases of overdose due to administration of too high a dose or injections given 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 immediately.
Missed dose of Omnadren 250
Do not administer a double dose to make up for a missed dose.
Discontinuation of 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 questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Common adverse reactions (may occur in up to 1 in 10 people):

• Blood and lymphatic system disorders: increased number of red blood cells, haematocrit (the proportion of red blood cells in the blood), and haemoglobin concentration (the oxygen-carrying component of red blood cells), identified in periodic blood tests.
• Metabolism and nutrition disorders: weight gain.

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

• Reproductive system and breast disorders:
• In women: menstrual disorders, absence of menstruation, suppression of gonadotropin secretion, masculinization (development of male characteristics in women);
• In men: gynaecomastia (enlargement of the male breast), priapism (painful erection), oligospermia (low sperm count in semen) when high doses are used.
• Skin and subcutaneous tissue disorders: hirsutism (excessive male-pattern hair growth 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: cholestatic jaundice, liver function disorders, peliosis hepatis or hepatic neoplasms.
• Blood and lymphatic system disorders: inhibition of clotting factors II, V, VII, and X (substances essential for blood clotting), bleeding in patients treated with oral anticoagulants, polycythaemia (excessive number of red blood cells in the blood).
• Nervous system disorders: changes in libido (sexual drive), headache, anxiety, paraesthesia (e.g. tingling, numbness).
• General disorders and administration site conditions: inflammation and pain at the injection site.

If any adverse reactions occur, including possible adverse reactions not listed in the leaflet, consult a doctor or pharmacist.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in the leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Omnadren 250

Store below 25°C. Protect from light.
Keep the medicine in a place invisible and inaccessible to children.
Do not use this medicine after the expiry date stated on the packaging. 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 package and other information

What Omnadren 250 contains
The active substances in this medicine are: testosteronum propionicum 30 mg, testosteronum phenylpropionicum 60 mg,
testosteronum isocaproicum 60 mg, testosteronum decanoicum 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 band, packed in a cardboard box.

For further detailed information, please contact the responsible party or the parallel importer.

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

Manufacturer:
Jelfa Pharmaceutical Company 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
Poland

Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

Marketing Authorisation Number in Bulgaria, country of export: 20030700
Parallel Import Authorisation Number: 199/22