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TESTOSTERONE ENANTATE AMPOULES

Active substance: 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.
• 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 are given
Testosterone Enantate
3. How Testosterone Enantate is administered
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 are
given 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 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.
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
In children, earlier development of male secondary sex
characteristics (masculinisation) may occur. Testosterone can
affect bone growth and in some cases reduce final height.
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.

Additional information on special populations
Children and adolescents
Testosterone Enantate is not indicated for use in children and
adolescents (see “Warnings and precautions”).
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:
• Phenobarbital which is used in the treatment of epilepsy
• 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.

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3. How Testosterone Enantate is
administered
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.
If you think you have been given 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.

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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.

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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. Testosterone Enantate ampoules should be
stored away from light.

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 December 2014
Alliance and associated devices are registered trade marks
of Alliance Pharmaceuticals Limited.
© Alliance Pharmaceuticals Limited 2014.

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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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