Testosterone Enantate 250 mg/ ml Solution for Injection Ampoules

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

• if you are allergic to Testosterone Enantate or any of the other ingredients of this medicine (listed in section 6)
• if you suffer from androgen (steroid hormone) dependent prostate cancer or breast cancer
• if you have high calcium levels in your blood
• if you have or have had tumours of the liver
• if you have kidney disease (nephrosis)

Talk to your doctor before using Testosterone Enantate if you:

• have liver problems including severe upper abdominal complaints
• have a tendency to retain fluid causing, for example, swelling of the ankles
• suffer from sleep apnoea (interrupted breathing during sleep), as this may get worse
• are suffering from severe heart, liver or kidney disease; treatment with Testosterone Enantate may cause severe complications in the form of water retention in your body sometimes accompanied by (congestive) heart failure
• have high blood pressure or if you are being treated for high blood pressure as testosterone may cause a rise in blood pressure
• have or have ever had blood clotting problems; thrombophilia (an abnormality of blood coagulation that increases the risk of thrombosis – blood clots in blood vessels)
• factors that increase your risk for blood clots in a vein: previous blood clots in a vein; smoking; obesity; cancer; immobility; if one of your immediate family has had a blood clot in the leg, lung or other organ at a young age (e.g. below the age of about 50); or as you get older.
  How to recognise a blood clot: painful swelling of one leg or sudden change in colour of the skin e.g. turning pale, red or blue, sudden breathlessness, sudden unexplained cough which may bring up blood; or sudden chest pain, severe light headedness or dizziness, severe pain in your stomach, sudden loss of vision. Seek urgent medical attention if you experience one of these symptoms.
• have epilepsy, migraine, diabetes mellitus or cancerous bone disease.

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:

• testosterone blood level and
• full blood count

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:

• Medicines used to treat nervousness and sleep problems (barbiturates or other enzyme inducers)
• Medicines used to treat pain or inflammation (oxyphenbutazone)
• Anticoagulants which are used to thin the blood, e.g. warfarin
• Medicines for the treatment of diabetes, e.g. metformin

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”).

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 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.

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.