Testosterone enantate ever pharma

Package leaflet: Information for the user

Testosterone enantate EVER Pharma, 250 mg/mL, solution for injection
Testosteroni enantas
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Leaflet contents

1. What Testosterone enantate EVER Pharma is and what it is used for
2. Important information before using Testosterone enantate EVER Pharma
3. How to use Testosterone enantate EVER Pharma
4. Possible side effects
5. How to store Testosterone enantate EVER Pharma
6. Contents of the pack and other information

1. What Testosterone enantate EVER Pharma is and what it is used for

Testosterone enantate EVER Pharma contains testosteroni enantas, a synthetic form of the naturally occurring male sex hormone, testosterone.
This medicine is used in adult men as testosterone replacement therapy for the treatment of various health problems resulting from low testosterone levels in the body (male hypogonadism). The diagnosis of this condition requires two independent measurements of testosterone concentrations in the blood, together with the clinical symptoms listed below:

• impotence
• infertility
• reduced sexual desire
• fatigue
• depressive moods
• loss of bone mass caused by low hormone levels.

Testosterone enantate EVER Pharma is administered by deep intramuscular injection, typically into the gluteal muscle, from where it can be stored and gradually released into the bloodstream.

2. Important information before using Testosterone enantate EVER Pharma

When not to use Testosterone enantate EVER Pharma

• if the patient is allergic to testosterone enantate or any of the other ingredients of this medicine (listed in section 6)
• if the patient has androgen-dependent cancer or suspected cancer of the prostate gland or breast
• if the patient has high calcium levels in the blood
• if the patient has or has had liver tumours
• if the patient has benign prostatic hyperplasia (enlargement of the prostate gland).

Testosterone enantate EVER Pharma is not intended for use in women.
Warnings and precautions
Before starting treatment with Testosterone enantate EVER Pharma, tell your doctor if the patient has or has ever had:

• liver problems, including severe discomfort in the upper abdomen
• a tendency to retain fluid, for example, ankle swelling
• severe heart, liver or kidney disease; testosterone treatment may cause serious complications due to fluid retention, sometimes leading to congestive heart failure
• high blood pressure or if the patient is being treated for hypertension, because testosterone may increase blood pressure
• blood clotting disorders, such as thrombophilia (abnormalities in blood clotting that increase the risk of thrombosis – formation of blood clots in blood vessels), because testosterone treatment may increase the risk of thrombosis.
  • Factors increasing the risk of venous blood clots: previous history of blood clots in veins; smoking; obesity; cancer; immobilisation; advanced age; if someone in the patient's immediate family has had a blood clot in the leg, lung or another organ at a young age (e.g. under 50 years).
  • How to recognize a blood clot: painful swelling of one leg or sudden skin colour change, such as pallor, redness or cyanosis; sudden shortness of breath; sudden unexplained cough, possibly accompanied by coughing up blood; or sudden chest pain, severe dizziness or vertigo, severe abdominal pain, sudden loss of vision. If the patient experiences any of these symptoms, seek medical help immediately.
• if the patient has epilepsy, migraine, diabetes or a bone tumour.
• if the patient has sleep apnoea (pauses in breathing during sleep), as sleep apnoea may worsen.

Testosterone enantate EVER Pharma may also affect the results of certain laboratory tests (e.g. thyroid function). Inform your doctor or laboratory personnel that the patient is taking Testosterone enantate EVER Pharma.
Muscle development and anti-doping tests
Androgenic hormones, such as testosterone enantate, are not appropriate for accelerating muscle development in healthy individuals or for enhancing physical performance.
Testosterone enantate EVER Pharma may lead to positive results in anti-doping tests.
Misuse and dependence
This medicine should always be taken according to the doctor's or pharmacist's instructions.
Misuse of testosterone, especially when excessive doses are used alone or in combination with other anabolic androgenic steroids, may cause serious health problems affecting the heart and blood vessels (which may lead to death), mental health and (or) the liver.
Individuals misusing testosterone may become dependent, which may lead to withdrawal symptoms following a significant dose reduction or abrupt discontinuation. Do not misuse this medicine either alone or in combination with other anabolic androgenic steroids, as this is associated with serious health risks.
Medical examination/consultation
Androgenic hormones may accelerate the development of prostate cancer and may cause enlargement of the prostate gland (benign prostatic hyperplasia). Before administering Testosterone enantate EVER Pharma, the doctor will examine the patient to ensure that there is no prostate cancer.
In elderly patients, there is an increased risk of prostate enlargement during treatment with Testosterone enantate EVER Pharma. As a precaution, the doctor will regularly examine the prostate gland in men, especially in elderly patients.
For long-term androgen therapy, periodic blood tests should be performed (see section 4 "Possible side effects").
Cases of benign (non-cancerous) and malignant (cancerous) liver tumours have been observed with the use of hormonal substances such as androgens. Although the occurrence of a tumour is unlikely, such tumours may pose a health risk.
Therefore, immediate medical help should always be sought if severe abdominal pain occurs. Not all unusual sensations in the upper abdomen should be considered possible signs of tumours. However, if unusual pains do not resolve quickly, they should be reported to a doctor.
Additional information for specific patient groups
Children and adolescents
Testosterone enantate EVER Pharma is not intended for use in children and adolescents.
The safety and efficacy of this medicine in children and adolescents have not been adequately established.
Elderly patients (65 years of age or older)
Available limited data do not indicate the need for dose adjustment in elderly patients.
Patients with liver function disorders
Studies have not been conducted in patients with impaired liver function. If the patient has ever had a liver tumour, Testosterone enantate EVER Pharma will not be prescribed (see "When not to use Testosterone enantate EVER Pharma").
Testosterone enantate EVER Pharma and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including those obtained without a prescription.
In particular, inform the doctor if any of the following medicines are being used, as Testosterone enantate EVER Pharma may affect them or they may affect Testosterone enantate EVER Pharma:

• Painkillers and anti-inflammatory medicines (e.g. oxyphenbutazone)
• Anticoagulant tablets used to thin the blood, e.g. warfarin
• Medicines used to treat diabetes, e.g. metformin. Dose adjustment of blood glucose-lowering medicines may be necessary.

Pregnancy and breastfeeding
Testosterone enantate EVER Pharma is not intended for use in women and must not be used in pregnant or breastfeeding women.
Effect on fertility
Treatment with testosterone preparations in high doses may reversibly suppress or reduce sperm production (see section 4 "Possible side effects").
Driving and operating machinery
Testosterone enantate EVER Pharma is not expected to affect the ability to drive or operate machinery.
Testosterone enantate EVER Pharma contains benzyl benzoate
This medicine contains 342 mg of benzyl benzoate per 1 mL ampoule.

3. How to use Testosterone enantate EVER Pharma

Testosterone enantate EVER Pharma is administered by a qualified healthcare professional.
The medicine is given as a very slow intramuscular injection into the buttock muscle, usually every 2 to 3 weeks. The treatment will be continued for as long as the doctor considers it necessary, depending on individual circumstances. Men receiving long-term treatment may, after some time, receive injections at intervals of 3 to 6 weeks.
Your doctor will assess your blood testosterone levels before starting treatment and periodically during treatment, towards the end of the interval between injections, and will adjust the dose if necessary.
During long-term treatment of men, your doctor will regularly examine the prostate gland.
Missing a dose of Testosterone enantate EVER Pharma
To ensure optimal effectiveness of treatment, it is important to adhere to the injection schedule agreed with your doctor.
Stopping Testosterone enantate EVER Pharma
If treatment is stopped, symptoms of testosterone deficiency may return.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Some individuals may be allergic to testosterone enanthate. If an allergic reaction occurs, treatment with Testosterone enantate EVER Pharma should be discontinued immediately and a doctor should be informed or contact the emergency department of the nearest hospital. Symptoms of an allergic reaction may include:

• severe rash
• difficulty swallowing or breathing
• swelling of the lips, face, throat or tongue
• weakness, dizziness or fainting
• nausea.

Frequent adverse reactions (may occur in less than 1 in 10 patients):

• Increase in red blood cell count, haematocrit (proportion of red blood cells in the blood) and haemoglobin (component of red blood cells that carries oxygen); these are monitored during periodic blood tests
• Increase in body weight.

Other adverse reactions (frequency cannot be determined from available data):

• Liver tumours have been observed. Patients should inform their doctor if they notice any new abdominal pain, especially if it is severe or persistent.
• Increased red blood cell count (polycythaemia), circulatory problems, high calcium levels in the blood
• Abnormal liver function tests, yellowing of the skin and eyes (jaundice), liver enlargement
• Acne, hair loss, skin reactions such as rash, urticaria (raised red patches), itching, tingling, androgenic alopecia
• Various injection site reactions including pain, itching, induration, swelling and inflammation
• Increased prostate-specific antigen (PSA) levels
• Increased or decreased interest in sex, abnormal excessive breast development in males, prostate gland problems, accelerated maturation (Testosterone enantate EVER Pharma is not indicated for use in children – see section 2 "Warnings and precautions")
• Excessive fluid retention in the body, and even ankle swelling when the medicine is used in high doses or for prolonged periods
• Decreased sperm count and prolonged or frequent erections in males (if such erection(s) occur, it is important to inform the doctor, as this may lead to penile damage)
• Headache, fatigue, depression, anxiety
• Bone growth disorders (increase or premature cessation)
• Gastrointestinal problems, nausea. Injections of oily solutions such as Testosterone enantate EVER Pharma have been associated with reactions such as cough, shortness of breath and chest pain. Other symptoms may also occur, including general malaise, excessive sweating, dizziness, tingling or fainting.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, they should be reported to a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Testosterone enantate EVER Pharma

Keep this medicine out of the sight and reach of children.
There are no special storage instructions for this medicine.
Do not use this medicine after the expiry date stated on the label. The expiry date refers to the last day of the stated month.
Testosterone enantate should be inspected visually before administration. Only clear solutions free from particulate matter should be used.
Medicines must not be disposed of via wastewater 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 pack and other information

What Testosterone enantate EVER Pharma contains

• The active substance is testosterone enantate. Each ampoule contains 1 mL of solution containing 250 mg of testosterone enantate (equivalent to 180 mg of testosterone) in an oily solution.
• The other ingredients are benzyl benzoate and purified castor oil.

What Testosterone enantate EVER Pharma looks like and contents of the pack
Testosterone enantate EVER Pharma is a clear, yellowish oily solution.
Each ampoule is made of amber glass and contains 1 mL of injectable solution.
The medicine is available in packs containing 1, 3, 5 or 10 ampoules.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
EVER Valinject GmbH
Oberburgau 3
4866 Unterach am Attersee
Austria

Manufacturer
EVER Pharma Jena GmbH
Brüsseler Str. 18
07747 Jena
Germany

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
EVER Pharma Poland Sp. z o.o.
e-mail: [email protected]

This medicine is authorised for marketing in the European Economic Area under the following names:
Austria Testosteron enantat EVER Pharma 250 mg/ml Injektionslösung
France Testosterone enantate EVER Pharma 250 mg/ml solution injectable
Poland Testosterone enantate EVER Pharma
Sweden Testosterone enantate EVER Pharma 250 mg/ml injektionsvätska, lösning

Information intended exclusively for healthcare professionals:
During storage at low temperatures, the properties of this oily solution may temporarily change (e.g. increased viscosity, cloudiness). If the medicinal product has been stored at low temperature, it should be brought to room temperature or body temperature before use.
The intramuscular solution should be inspected visually before administration. Only clear solutions free from solid particles should be used.
The contents of the ampoule should be administered intramuscularly immediately after opening.
This medicinal product is for single use only, and any unused solution should be discarded.

Method of administration
For intramuscular use only. Care must be taken to inject Testosterone enantate EVER Pharma deeply into the gluteal muscle, observing standard precautions for intramuscular injections. Particular care should be taken to avoid intravenous injection.
Like all oily solutions, Testosterone enantate EVER Pharma should be administered intramuscularly and very slowly (over more than two minutes). Pulmonary microemboli caused by oily solutions may, in rare cases, lead to symptoms such as cough, dyspnoea, malaise, excessive sweating, chest pain, dizziness, paraesthesia or fainting. These reactions may occur during or immediately after injection and are reversible. Treatment is usually supportive, e.g. by administering oxygen.
Suspected anaphylactic reactions have been observed after administration of Testosterone enantate EVER Pharma.

Warnings
In patients treated with testosterone, the prostate and breasts should be carefully and regularly examined in accordance with recommended procedures (digital rectal examination and measurement of serum PSA concentration). These examinations should be performed at least once a year, and in elderly patients or those at increased risk (clinical or familial factors), twice a year.
In patients receiving long-term androgen therapy, in addition to monitoring testosterone concentrations, the following laboratory parameters should be regularly monitored: haemoglobin, haematocrit, liver function tests and lipid profile.
In patients with severe heart, liver or renal insufficiency or ischaemic heart disease, testosterone therapy may cause serious complications in the form of oedema, with or without congestive heart failure. In such cases, treatment should be discontinued immediately.

Instructions for preparing/opening the ampoule OPC ( One-Point-Cut ):
Below the coloured dot on the ampoule, there is a score mark eliminating the need for scoring the neck. Before opening, ensure that the solution has flowed from the upper part of the ampoule to the lower part. To open the ampoule, use both hands: hold the lower part of the ampoule with one hand, and with the other hand break off the upper part of the ampoule away from the coloured dot.