Omnadren 250

Package leaflet: Information for the user

Warning! Keep this 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
Testosteroni propionas + Testosteroni phenylpropionas + Testosteroni isocaproas + Testosteroni decanoas
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 doubts, 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 effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents:

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, and seminal vesicles, influences spermatogenesis
(the process of sperm formation and maturation), and initiates the development of secondary and tertiary sexual characteristics.
Testosterone exhibits anabolic effects in both men and women, leading to skeletal muscle growth, increased bone mineral density, stimulation of erythropoietin (a hormone affecting red blood cell production) in the kidneys, and increased 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 blood testosterone concentrations, along with the clinical symptoms listed below:

• impotence
• infertility
• decreased 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
Exceptionally, it may be used in women for disorders associated with hyperestrogenism (excessive levels 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 administration only.
The following blood tests should be ordered by the doctor before and during treatment:
blood testosterone concentration, complete blood count.

Tell 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 monitoring is recommended, as peliosis hepatis or liver tumours may occur;
• if the patient develops hepatitis – discontinuation of the medicine and identification of the cause of hepatitis may be necessary;
• if the patient has severe heart, liver or kidney disease, treatment with Omnadren 250 may lead to serious complications, including fluid retention and, occasionally, (congestive) heart failure;
• if the patient has high blood pressure or is taking medicines for high blood pressure, because 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 blood clots: previous history of venous thrombosis; smoking; obesity; cancer; immobility; if a blood clot in the leg, lung or another organ occurred at a young age (e.g. under 50 years) in a close family member of the patient; advanced age of the patient.

How to recognize a blood clot: painful swelling in one leg or sudden skin colour change, e.g. pallor, redness or cyanosis; sudden shortness of breath; sudden unexplained cough, possibly with coughing up blood; sudden chest pain; severe dizziness or vertigo; severe abdominal pain; sudden loss of vision. If any of these symptoms occur, seek immediate medical help.

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 prostate hypertrophy, benign prostatic hyperplasia 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
Using testosterone as a doping agent may lead to serious adverse effects.

Misuse and dependence on Omnadren 250
This medicine should always be used according to the doctor's or pharmacist's instructions. Misuse 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 misuse testosterone may become dependent and may experience withdrawal symptoms after a significant dose reduction or abrupt discontinuation of the medicine. Do not misuse 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
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken or 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 – risk of oedema is increased, 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 (antiepileptic), salicylates (analgesic and anti-inflammatory medicines), phenytoin (antiepileptic) or primidone (antiepileptic) – the effect 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 psycho-physical performance, ability to drive mechanical vehicles or operate machinery.

Omnadren 250 contains benzyl alcohol and arachis oil
Omnadren 250 contains 50 mg of benzyl alcohol in each 1 ml, equivalent to 50 mg/ml.
Benzyl alcohol may cause allergic reactions.
Patients with liver or kidney disease should consult a doctor before using this medicine, as large amounts of benzyl alcohol may accumulate in their bodies and cause adverse effects (so-called metabolic acidosis).
The medicine may cause mild local irritation.
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 as directed by the physician.
In case of any doubts, consult your doctor or pharmacist.
Omnadren 250 is administered intramuscularly.
Injections should be given deeply into the gluteal muscle.
The physician will individually determine the dose for each patient.
The usual dose is 1 vial of Omnadren 250 every 4 weeks.
Male primary hypogonadism (anorchism, Klinefelter’s syndrome, castration syndrome, testicular atrophy).
Depending on the degree of impairment of gonadal function (based on clinical evaluation and laboratory results), the medicine is 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 given at two-week intervals.
Omnadren 250 is exceptionally used in 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 excessive dosage or administration 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.
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. 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 doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

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

• Blood and lymphatic system disorders: increase in red blood cell count, haematocrit (percentage of red blood cells in blood), and haemoglobin concentration (a component of red blood cells responsible for oxygen transport), identified in periodic blood tests.
• Investigations: increased haemoglobin concentration (a component of red blood cells responsible for oxygen transport), increased haematocrit (percentage of red blood cells in blood), increased red blood cell count, increased prostate-specific antigen (PSA) level.
• Metabolism and nutrition disorders: weight gain.

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

• Benign, malignant and unspecified neoplasms (including cysts and polyps):
• Reproductive system and breast disorders:
• Women: menstrual disorders, amenorrhoea (absence of menstruation), suppression of gonadotropin secretion, masculinization (development of male characteristics in women);
• Men: gynaecomastia (enlargement of breast tissue in men), 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.
• Gastrointestinal disorders: nausea.
• Hepatobiliary disorders: cholestatic jaundice, liver function abnormalities, hepatic peliosis or hepatic tumours.
• 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 essential for blood clotting), bleeding in patients treated with oral anticoagulants, polycythaemia (excessive number of red blood cells in blood).
• Psychiatric and nervous system disorders: changes in libido (sexual desire), headache, anxiety, paraesthesia (e.g. tingling, numbness).
• Investigations: retention of sodium, chloride, water, potassium, calcium and inorganic phosphates, increased cholesterol concentration.
• General disorders and administration site conditions: inflammation and pain at the injection site.

If any adverse effects occur, including possible adverse effects not listed in this leaflet, consult a doctor or pharmacist.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the 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
Reporting adverse effects 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 inaccessible and out of sight of 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 stated month.
Medicines must not be disposed of via the sewage system or household waste. Ask
your pharmacist how to dispose of medicines no longer required. Such measures will help
protect the environment.

6. Contents of the package and other information

What Omnadren 250 contains
The active substances are: testosterone propionate 30 mg, testosterone phenylpropionate 60 mg,
testosterone isocaproate 60 mg, testosterone decanoate 100 mg.
The other components 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 stripe, in a cardboard box.

For more detailed information, please contact the Marketing Authorisation Holder or the Parallel Importer.

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

Manufacturer:
Jelfa S.A. Pharmaceutical Company
ul. Wincentego Pola 21, 58-500 Jelenia Góra
Poland

Parallel Importer:
Aga Kommerz spol. s r.o.
Frydecka 2006
737 01 Český Těšín
Czech Republic

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

Marketing Authorisation Number in Bulgaria, the country of export: 20030700
Parallel Import Authorisation Number: 99/24