Testosteronum prolongatum Ielfa

Package Leaflet: Information for the Patient

TESTOSTERONUM PROLONGATUM JELFA, 100 mg/ml, Solution for Injection

Testosterone Enanthate

Read the Leaflet Carefully Before Using the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medication has been prescribed for a specific person. Do not pass it on to others. The medication may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not mentioned in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Testosteronum Prolongatum Jelfa and what is it used for
• 2. Important information before using Testosteronum Prolongatum Jelfa
• 3. How to use Testosteronum Prolongatum Jelfa
• 4. Possible side effects
• 5. How to store Testosteronum Prolongatum Jelfa
• 6. Contents of the pack and other information

1. What is Testosteronum Prolongatum Jelfa and what is it used for

Testosteronum Prolongatum Jelfa contains a synthetic derivative of testosterone, a male sex hormone (androgen). Testosterone 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 sperm formation and maturation), and initiates the development of secondary and tertiary sex characteristics.
Testosterone has an anabolic effect, leading to the growth of skeletal muscles, increases bone mineral density, stimulates the production of erythropoietin (a hormone that affects red blood cell production) in the kidneys, and increases hemoglobin levels (red blood pigment).

Indications for Use

Testosteronum Prolongatum Jelfa is used in adult men as testosterone replacement therapy for the treatment of various diseases resulting from testosterone deficiency (male hypogonadism). To confirm the disease, two independent testosterone level measurements 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

2. Important Information Before Using Testosteronum Prolongatum Jelfa

When Not to Use Testosteronum Prolongatum Jelfa:

• if the patient is allergic to testosterone enanthate or any other component of this medication (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 androgen-dependent prostate cancer;
• if the patient has breast cancer;
• if the patient has or has had liver cancer;
• in pregnant or breastfeeding women.

Warnings and Precautions

Before starting treatment with Testosteronum Prolongatum Jelfa, discuss it with your doctor or pharmacist.
Inform your doctor and exercise special caution:

• if the patient has a tumor, especially with bone metastases - due to the increased risk of hypercalcemia (elevated calcium levels in the blood), the doctor should order additional blood tests; if necessary, the doctor may decide to discontinue the medication;
• if the patient has severe heart, liver, or kidney disease, the use of Testosteronum Prolongatum Jelfa may cause serious complications, which will manifest as water retention in the body, and sometimes (congestive) heart failure;
• if the patient has kidney or liver function disorders;
• if the patient has high blood pressure or is taking medications for hypertension, as testosterone may cause an increase in blood pressure.
• if the patient has acquired or congenital blood coagulation disorders
• thrombophilia (abnormalities in blood coagulation, increasing the risk of thrombosis - the formation of blood clots in blood vessels).
• factors increasing 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 fainting, severe abdominal pain, sudden loss of vision. If the patient experiences any of these symptoms, they should seek medical help immediately.
• if the patient has epilepsy or migraine - Testosteronum Prolongatum Jelfa may exacerbate symptoms. Medical examinations and laboratory tests Before starting treatment, the doctor will order tests to rule out prostate cancer (prostate cancer). During treatment, the doctor will regularly order additional tests, especially for elderly patients (over 65 years old). The following blood tests should be ordered by the doctor before and during treatment: testosterone level in the blood, full blood count. Due to the variability of laboratory results, all testosterone level measurements should be performed in the same laboratory. Misuse of Testosteronum Prolongatum Jelfa and dependence on the medication This medication should always be used in accordance with the doctor's or pharmacist's recommendations. Misuse 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 health. People who have misused testosterone may become dependent and may experience withdrawal symptoms after significantly reducing the dose or abruptly stopping the medication. Do not misuse this medication alone or in combination with other anabolic-androgenic steroids, as it poses a serious health risk (see "Possible side effects"). Other warnings and precautions Testosteronum Prolongatum Jelfa may accelerate the development of asymptomatic prostate cancer

and benign prostatic hyperplasia.
Rarely, liver tumors have been reported in patients receiving testosterone replacement therapy.
Certain clinical symptoms, such as irritability, nervousness, weight gain, prolonged or frequent erections, may indicate excessive testosterone doses. The doctor should consider changing the dosage. If symptoms of androgen excess persist or recur during treatment with recommended doses, the doctor may decide to discontinue Testosteronum Prolongatum Jelfa.
During treatment, sleep apnea may worsen.
In athletes treated with testosterone, doping test results may be positive.
Using testosterone as a doping agent can cause serious side effects.
Androgens are not suitable for accelerating muscle development in healthy individuals or for increasing physical fitness.

Children and Adolescents

Testosteronum Prolongatum Jelfa is not recommended for use in children and adolescents under 18 years of age.
The efficacy and safety of the medication in children and adolescents have not been adequately determined.
Androgen therapy should be used with caution in patients with delayed puberty. The doctor should monitor treatment by assessing bone age every 6 months.

Testosteronum Prolongatum Jelfa and Other Medications

Inform your doctor or pharmacist about all medications you are currently taking or have recently taken, as well as any medications you plan to take.
Inform your doctor if you are taking any of the following medications:

• oral anticoagulants - the doctor should order additional blood tests to assess the coagulation system, especially during the initiation of treatment or when discontinuing Testosteronum Prolongatum Jelfa;
• insulin - during concomitant use of Testosteronum Prolongatum Jelfa, blood glucose levels may decrease, and insulin requirements may decrease;
• adrenocorticotropic hormone (ACTH) or corticosteroids - during concomitant use with Testosteronum Prolongatum Jelfa, the risk of edema increases, especially in patients with heart or liver disease or a tendency to edema;
• oxyphenbutazone (a pain reliever and anti-inflammatory medication) - during concomitant use with Testosteronum Prolongatum Jelfa, oxyphenbutazone levels may increase.

Pregnancy, Breastfeeding, and Fertility

Testosteronum Prolongatum Jelfa is contraindicated in women and must not be used in pregnant or breastfeeding women.
Testosteronum Prolongatum Jelfa, especially when administered in high doses, inhibits spermatogenesis (see section 4).

Driving and Operating Machines

The medication does not affect psychophysical abilities, the ability to drive vehicles, or operate machines.

Testosteronum Prolongatum Jelfa Contains Benzyl Alcohol and Arachis Oil.

Testosteronum Prolongatum Jelfa contains 50 mg of benzyl alcohol per 1 ml, which corresponds to 50 mg/ml.
Benzyl alcohol may cause allergic reactions.
Patient with liver or kidney disease should consult their doctor before using the medication, as large amounts of benzyl alcohol may accumulate in their body and cause side effects (metabolic acidosis).
The medication may cause mild local irritation.
The medication contains arachis oil (from peanuts). Do not use if you are allergic to peanuts or soy.

3. How to Use Testosteronum Prolongatum Jelfa

This medication should always be used in accordance with the doctor's recommendations. In case of doubts, consult a doctor or pharmacist.
Intramuscular injection.
The dose is determined by the doctor.
The recommended dose is: from 100 mg to 200 mg, and if necessary up to 300 mg, once a week. After improvement: 100 mg every 2-4 weeks.
Method of administration
The medication is intended for intramuscular injection only. Injections should be administered deep into the gluteal muscle.
Experience indicates that short-term reactions (cough reflex, coughing fits, breathing difficulties), which rarely occur during or immediately after injection of oily solutions, can be avoided by injecting the solution very slowly.

Use in Children and Adolescents

Testosteronum Prolongatum Jelfa is not recommended for use in children and adolescents under 18 years of age.
The efficacy and safety of the medication in children and adolescents have not been adequately determined.

Using More Than the Recommended Dose of Testosteronum Prolongatum Jelfa

Overdose is unlikely when used as recommended.
A symptom of overdose due to excessive dose or too frequent administration may lead to persistent erections (priapism) in men.
In this case, the medication should be discontinued.

Missing a Dose of Testosteronum Prolongatum Jelfa

Missing a dose (a 1- or 2-day interval) should not affect the course of treatment. The medication should be administered as soon as possible. Subsequent doses should be administered according to the doctor's recommendation. Do not take a double dose to make up for a missed dose.
In case of any further doubts about using this medication, consult a doctor or pharmacist.

4. Possible Side Effects

Like all medications, Testosteronum Prolongatum Jelfa 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, identified in periodic blood tests.
• Metabolism and nutrition disorders:weight gain.
• Diagnostic tests:increased hemoglobin levels, increased hematocrit, increased red blood cell count, increased prostate-specific antigen levels.
• Side effects with unknown frequency(frequency cannot be estimated from available data):
• Benign, malignant, and unspecified tumors (including cysts and polyps):liver tumors.
• Reproductive system and breast disorders: gynecomastia (breast enlargement in men), priapism (prolonged, painful erections), oligospermia (low sperm count) during high-dose treatment.
• Skin and subcutaneous tissue disorders: male pattern baldness, hirsutism (excessive hair growth in women), acne.
• Diagnostic tests: sodium, chloride, water, potassium, calcium, and inorganic phosphate retention.
• Gastrointestinal disorders: nausea.
• Hepatobiliary disorders: congestive jaundice, liver function disorders, liver spots or liver tumors. Long-term use of high doses may cause liver spots or liver tumors. Occurring liver inflammation is a reason to discontinue androgen use and determine the cause of the changes. The doctor will monitor liver function.
• Blood and lymphatic system disorders: inhibition of blood clotting factors II, V, VII, and X, bleeding in patients treated with oral anticoagulants, polycythemia.
• Nervous system disorders: changes in libido, headaches, anxiety, paresthesia (tingling).
• Vascular disorders:deep vein thrombosis, arterial hypertension.
• Respiratory, thoracic, and mediastinal disorders: pulmonary embolism.
• General disorders and administration site conditions: inflammation and pain at the injection site (the most common observed side effect).

Reporting Side Effects

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

5. How to Store Testosteronum Prolongatum Jelfa

Keep the medication out of sight and reach of children.
Store in a temperature below 25°C. Do not freeze. Store in the original packaging to protect from light.
Do not use this medication after the expiration date stated on the ampoules and carton. The expiration date refers to the last day of the specified month. A decrease in transparency of the solution or the appearance of "needles" (crystals) does not indicate that the medication is expired. Turbidity can be eliminated by warming the ampoule in warm water.
Medications should not be disposed of in wastewater or household waste. Ask your pharmacist how to dispose of unused medications. This will help protect the environment.

6. Contents of the Pack and Other Information

What Testosteronum Prolongatum Jelfa Contains

• The active substance of the medication is testosterone enanthate. 1 ml of the solution for injection contains 100 mg of testosterone enanthate.
• Other ingredients of the medication are: benzyl alcohol 50 mg and arachis oil up to 1 ml.

What Testosteronum Prolongatum Jelfa Looks Like and What the Pack Contains

Testosteronum Prolongatum Jelfa is a clear yellow, oily solution.
Packaged in ampoules and cardboard boxes.
5 ampoules of 1 ml each

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

Date of Last Update of the Leaflet: