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.
x Keep this leaflet. You may need to read it again.
x If you have any further questions, ask your doctor or pharmacist.
x 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.
2.
3.
4.
5.
6.

What Testosterone Enantate is and what it is used for
What you need to know before you are given Testosterone Enantate
How Testosterone Enantate is administered
Possible side effects
How to store Testosterone Enantate
Contents of the pack and other information

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 men when natural levels of this hormone are low, which can
cause loss of interest in sex, low fertility and other problems.

2. What you need to know before you are given Testosterone Enantate
Do not use Testosterone Enantate:
x if you are allergic to Testosterone Enantate or any of the other
ingredients of this medicine (listed in section 6)
x if you suffer from androgen (steroid hormone) dependent prostate
cancer or breast cancer
x if you have high calcium levels in your blood
x if you have or have had tumours of the liver
x if you have kidney disease (nephrosis)
Warnings and precautions

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Talk to your doctor before using Testosterone Enantate if you:
x have a tendency to retain fluid causing, for example, swelling of the
ankles
x suffer from sleep apnoea (interrupted breathing during sleep), as this
may get worse
x suffer from heart disease, high blood pressure, 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").
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”).
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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:
x
x
x

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.
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.

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 longterm
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.

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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.
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:
x severe rash
x swallowing or breathing problems
x swelling of your lips, face, throat or tongue
x weakness, feeling dizzy or faint
x nausea.
Other side effects:
x
x
x
x
x
x
x

x
x
x
x

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.

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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 call Freephone 0808 100 3352. 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 July 2013
Alliance and associated devices are registered trade marks of Alliance
Pharmaceuticals Limited.
© Alliance Pharmaceuticals Limited 2013.

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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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