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The product code(s) for this leaflet is: PL16853/0116.
Testosterone Enantate Ampoules
Testosterone Enantate 250mg/ ml Solution for Injection
Testosterone Enantate
1. What Testosterone Enantate is and what it is used for
2. What you need to know before you use Testosterone Enantate
3. How to use Testosterone Enantate
4. Possible side effects
5. How to store Testosterone Enantate
6. Contents of the pack and other information
Testosterone Enantate is a manufactured version of the naturally occurring male sex hormone, testosterone.
It is used in adult men for testosterone replacement to treat various health problems caused by a lack of testosterone (male hypogonadism). This should be confirmed by two separate blood testosterone measurements and also include clinical symptoms such as:
Talk to your doctor before using Testosterone Enantate if you:
Testosterone Enantate should not be used in women because they may develop signs of virilisation, e.g. acne, increased hair growth on the face or body and voice changes.
Male hormones such as Testosterone Enantate are not suitable for increasing muscular development in healthy people or for increasing physical ability.
Male hormones may increase the growth of prostate cancer and enlarged prostate glands (benign prostatic hypertrophy). Before your doctor injects Testosterone Enantate, s/he will examine you to check that you do not have prostate cancer. If you are older, you may be at an increased risk for the development of prostate enlargement when using Testosterone Enantate. Although there is no clear evidence that sex hormones such as Testosterone Enantate actually generate cancer of the prostate, they can enhance the growth of any existing cancer of the prostate.
As a precaution, regular examinations of the prostate are recommended in men, especially if you are elderly.
If you are on long-term androgen therapy blood tests should be carried out periodically (see section "Possible side effects").
The following blood checks should be carried out by your doctor before and during the treatment:
Following the use of hormonal substances such as androgen compounds, cases of benign (non-cancerous) and malignant (cancerous) liver tumours have been observed to occur. Although it is improbable that a tumour will occur, these would present a health concern. In isolated cases, internal bleeding could occur from these tumours, which might endanger life.
Thus you should always seek the immediate emergency attention of a doctor when you suffer severe abdominal pains. Not all unusual sensations you might feel in your upper abdomen can be counted as a possible sign of tumour or bleeding. Those that do not disappear within a short time should however better be brought to your doctor's attention.
Children and adolescents
Testosterone Enantate is not indicated for use in children and adolescents (see “Warnings and precautions”).
In children and adolescents, earlier development of male secondary sex characteristics (masculinisation) may occur. Testosterone can affect bone growth and in some cases reduce final height.
Safety and efficacy have not been adequately determined in children and adolescents.
Elderly patients (65 years or older)
Limited data do not suggest the need for a dosage adjustment in elderly patients (see “Warnings and precautions”).
Patients with impaired liver function
No formal studies have been performed in patients with liver impairment. The use of Testosterone Enantate is contraindicated in men with past or present liver tumours (see “Do not use Testosterone Enantate”).
Patients with impaired kidney function
No formal studies have been performed in patients with kidney impairment.
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, tell your doctor if you are having any of the following as they may be affected or affect Testosterone Enantate:
Testosterone Enantate is intended for use by men only. It is not indicated in pregnant or breast-feeding women. Testosterone Enantate should not be used during pregnancy due to the possibility of virilisation (development of male sex characteristics) of the female foetus.
Treatment with high doses of testosterone preparations may reversibly reduce sperm production (see “Possible side effects”).
Testosterone Enantate should not affect your ability to drive or use machinery.
Testosterone Enantate contains 342 mg benzyl benzoate per ampoule. Benzyl benzoate can be metabolised into benzyl alcohol and benzoic acid once the medicine is administered. Benzyl alcohol may cause allergic reactions. Ask your doctor or pharmacist for advice if you have a liver or kidney disease. This is because large amounts of benzyl alcohol can build-up in your body and may cause side effects (called “metabolic acidosis”).
Testosterone Enantate must not be given to premature babies or neonates.
Always take this medicine exactly as your doctor or pharmacist has told you.
Abuse of testosterone, especially if you take too much of this medicine alone or with other anabolic androgenic steroids, can cause serious health problems to your heart and blood vessels (that can lead to death), mental health and/or the liver.
Individuals who have abused testosterone may become dependent and may experience withdrawal symptoms when the dosage changes significantly or is stopped immediately. You should not abuse this medicine alone or with other anabolic androgenic steroids because it carries serious health risks. (See “Side effects”).
Testosterone Enantate may cause toxic reactions and allergic reactions in infants and children up to 3 years old.
Testosterone Enantate is administered by a doctor or nurse.
It is given by very slow injection into a muscle, usually every 2 to 3 weeks. The injections are continued for as long as your doctor considers necessary, depending on your individual circumstances. Men receiving long term treatment may later be given injections at 3 to 6 week intervals.
Your doctor will measure your blood testosterone levels before starting treatment and occasionally during the treatment at the end of an injection interval and adjust your dose as necessary.
During treatment, it is advisable for men to have a regular prostate check by a doctor.
As Testosterone Enantate is administered in hospital by a healthcare professional it is most unlikely that you will be given the wrong dose.
If you have any concerns about your dose or the use of this product speak to your doctor.
Please adhere to the timelines on the injection intervals agreed with your doctor for optimal efficacy of the treatment.
When Testosterone Enantate is stopped, symptoms of testosterone deficiency may reoccur.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some people may be allergic to Testosterone Enantate. If you experience an allergic reaction you should stop using Testosterone Enantate and tell your doctor straight away or contact the accident and emergency department of your nearest hospital. Signs of an allergic reaction may include:
Common side effects include:
May affect up to 1 in 10 patients
Not known: frequency cannot be estimated from the available data:
Injections of oily liquid such as Testosterone Enantate have been associated with reactions such as cough, shortness of breath, chest pain. There may be other signs and symptoms including feeling generally unwell, excessive sweating, dizziness, “pins and needles”, or fainting.
If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the internet at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
The information in Sections 5 and 6 is primarily for healthcare professionals.
Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that month.
Testosterone Enantate ampoules should be stored away from light.
Testosterone Enantate should be inspected visually prior to administration and only clear solution free from particles should be used.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
The active substance is Testosterone Enantate. Each 1 ml ampoule contains 250 mg testosterone enantate (the equivalent of about 180mg testosterone) in oily solution. The other ingredients are: benzyl benzoate and castor oil refined.
Testosterone Enantate is a clear, yellowish oily liquid.Each ampoule is clear glass and contains 1 ml of solution for injection.
They are supplied in packs of 3 ampoules.
This leaflet was last revised in November 2022
Alliance and associated devices are registered trade marks of Alliance Pharmaceuticals Limited.
© Alliance Pharmaceuticals Limited 2022.
Testosterone PIL UK 009