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TESTOSTERONE ENANTATE AMPOULES

Active substance(s): TESTOSTERONE ENANTATE

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PATIENT INFORMATION LEAFLET

Testosterone Enantate
250mg/ ml Solution for Injection
Testosterone Enantate
Read all of this leaflet carefully before you start using this
medicine because it contains important information for you.
• 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.
What is in this leaflet
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

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1. What Testosterone Enantate is and what
it is used for
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:
• Impotence
• Infertility
• Low sex drive
• Tiredness
• Depressive moods
• Bone loss caused by low hormone levels.

2. What you need to know before you use
Testosterone Enantate
Do not use Testosterone Enantate:
• 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)
Warnings and precautions
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 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.
Medical examination/consultation
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.
Additional information on special populations
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.
Other medicines and Testosterone Enantate
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)

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3. How to use Testosterone Enantate
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.

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• 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
Pregnancy and breast-feeding
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.
Fertility
Treatment with high doses of testosterone preparations may
reversibly reduce sperm production (see “Possible side effects”).
Driving and using machines
Testosterone Enantate should not affect your ability to drive or use
machinery.
Testosterone Enantate contains benzyl benzoate
Testosterone Enantate contains 342 mg of benzyl benzoate per 1
ml ampoule.
Testosterone Enantate must not be given to premature babies or
neonates.

If you use more Testosterone Enantate than you should
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.
If you forget to use Testosterone Enantate
Please adhere to the timelines on the injection intervals agreed
with your doctor for optimal efficacy of the treatment.
If you stop using Testosterone Enantate
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.

4. Possible side effects
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:
• severe rash
• swallowing or breathing problems
• swelling of your lips, face, throat or tongue
• weakness, feeling dizzy or faint
• nausea.
Common side effects include:
• Increase in red blood cell count, haematocrit (percentage of red
blood cells in blood) and haemoglobin (the component of red
blood cells that carries oxygen); these are identified by periodic
blood tests

Other side effects are:
• Liver tumours have been observed which can cause serious
internal bleeding. Tell your doctor if you notice any new pain in
the stomach that is severe or persists.
• High levels of red blood cells (polycythaemia), blood circulation
problems, high levels of calcium in the blood
• Abnormal liver function test results, yellowing of the skin and
eyes (jaundice), enlarged liver
• Acne, hair loss, skin reactions such as rash, urticaria (raised red
spots), itching, “pins and needles”
• Various kinds of injection site reactions including pain, itching,
hardening, swelling and inflammation
• Increase in a prostatic-specific antigen (increased immune
response)
• Increased or decreased interest in sex, abnormal
overdevelopment of the breasts in a man, prostate problems,
early onset of puberty (Testosterone Enantate is not indicated
for use in children – see section 2 “Warnings and precautions”)
• In high doses or over a long period of time, retention of too
much water, and even swelling of the ankles may occur
• Men may develop reduced sperm count, and frequent or
persistent erections (if this happens, it is important to tell your
doctor as it can injure the penis)
• Headache, weakness, depression, anxiety
• Changes in bone growth (increase or premature stoppage)
• Stomach problems, feeling sick.
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.
Reporting of side effects:
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.

By reporting side effects you can help provide more information on
the safety of this medicine.

5. How to store Testosterone Enantate
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.
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.

6. Contents of the pack and other
information
What Testosterone Enantate contains
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 for injection.
What Testosterone Enantate looks like and contents of pack
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.
Marketing Authorisation Holder
Alliance Pharmaceuticals Limited, Avonbridge House, Bath Road,
Chippenham, Wiltshire, SN15 2BB, UK.
Manufacturer
Bayer Pharma AG, Berlin, Germany.
This leaflet was last revised in November 2015.
Alliance and associated devices are registered trade marks of
Alliance Pharmaceuticals Limited.
© Alliance Pharmaceuticals Limited 2015.
85001671

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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