TESTOSTERONE IMPLANT 200MG

Active substance: TESTOSTERONE

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RA 1530 UK P5 (ref 2.0)

(Testosterone)

Read all of this leaflet carefully before you are given
this medicine.
− Keep this leaflet. You may need to read it again.
− If you have any further questions, ask your doctor or
your pharmacist.
− This medicine has been prescribed for you. Do not pass
it on to others. It may harm them, even if their symptoms
are the same as yours.
− If any of the side effects get serious or if you notice
any side effects not listed in this leaflet, please tell your
doctor or your pharmacist.

In this leaflet:

1

What Testosterone Implants are and what they are
used for

2
3
4
5
6

1

What Testosterone
Implants are and what
they are used for

Testosterone implants are pellets containing 100mg
or 200mg of the active ingredient testosterone. These
implants are used in hormone replacement therapy in
men. Testosterone is a natural male hormone, known as
an androgen, which controls normal sexual development
in men.
Testosterone Implants are used in testosterone
replacement therapy in men with low or no natural
testosterone (a condition known as hypogonadism).

Before you are given Testosterone Implants
How you are given Testosterone Implants
Possible side effects
How to store Testosterone Implants
Further information

2

Before you are given
Testosterone Implants

Do not use Testosterone Implants if you:
- are allergic (hypersensitive) to testosterone
- have prostate cancer or breast cancer
Take special care with Testosterone Implants:
Extra supervision by your doctor may be necessary in
some cases; particularly the elderly.

 Tell your doctor if you have ever had:
- heart disease
- kidney disease
- liver disease
- high blood pressure
- epilepsy
- migraine
- cancer of the bone
- sleep apnea (temporary stopping of breathing during your
sleep). If this gets worse during treatment you should also
tell your doctor.
Blood tests may be affected.
Children and adolescents
Safety and efficacy have not been adequately determined
in children and adolescents.
Extra supervision by the doctor is necessary in the
treatment of young boys since male hormones may cause
early sexual development and delay growth.
Testosterone implants should not be used to enhance
ability in sports as it carries serious health risks.
Taking other medicines
Other medicines may affect how Testosterone Implants
work or Testosterone Implants may affect how they work.
These include:
• Certain medicines that change the amount of enzymes to
be made in the liver e.g. medicines used to treat epilepsy
(phenobarbital). These drugs may affect the levels of
testosterone in your body and your doctor may need to
adjust the dose of your Testosterone Implant.
• Certain medicines that thin the blood (anti-coagulants).
Your doctor may need to adjust the dose of your anticoagulant.
• Medicines for diabetes. Your doctor may need to adjust
the dose of your medicine for diabetes.

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• Other hormone medicines (for example corticosteroids
or ACTH, used to treat various conditions such as
rheumatism, arthritis, allergic conditions and asthma).
 Please tell your doctor or pharmacist if you are taking
or have recently taken any other medicines, including
medicines obtained without a prescription.
Laboratory tests
Testosterone Implants may also affect the results of some
laboratory tests (e.g. thyroid gland and liver function tests).
Tell your doctor or the laboratory staff that you are using
Testosterone Implants.

4 to 5 months. The dose depends on your illness and how
bad it is. Your doctor will decide the dose.
In men a dose of 100-600mg is usual, but this depends on
each individual.
If you are given more Testosterone than you should:
 If you think you have been given too much
Testosterone, tell your doctor straight away, as they
may wish to remove the implant. The following effects may
happen:
• frequent erections in men
• changes in your red blood cells (polycythaemia), which
your doctor may monitor for.

Pregnancy and breast-feeding
Testosterone Implants are not for use in women.
Testosterone Implants must not be taken during pregnancy
or when you are breast feeding.

4

Ask your doctor or pharmacist for advice before taking any
medicine.

Like all medicines, Testosterone Implants can have side
effects, although not everybody gets them.

Driving and using machines
As far as is known Testosterone Implants have no adverse
effect on alertness or concentration.

The most common side effects with the implant are:
• infection, bruising or bleeding at the implantation site
• the implant may start to come out of the implantation site.

3

How you are given
Testosterone Implants

Testosterone Implants are normally given by a doctor.
Testosterone implants are inserted under the skin into the
lower abdominal wall or buttock by your doctor. You are
usually given a local anaesthetic in this area before the
implant is inserted and the small cut made is dressed
with a bandage afterwards. The implant usually lasts for

Possible side effects

The other possible side effects include:
• worsening of the early stages of prostate cancer
• increased levels of a blood marker which is associated
with prostate cancer (PSA increased)
• growth of the prostate gland
• prolonged painful erection
• ejaculation disorder
• increase or decrease in sexual desire
• changes in the sperm formation
• enlargement of the breasts
• acne
• itching (pruritus)
• high blood pressure (hypertension)

• swollen legs or ankles (caused by water retention)
• changes in your red blood cells (polycythaemia)
• changes in cholesterol levels
• muscle pain (myalgia)
• feeling sick
• changes in mood, feelings of depression or nervousness.
• Increased risk of water retention, especially if your heart
and liver are not working properly.
In young boys, it may cause:
• early sexual development
• erections occurring more often than normal
• enlarged penis
• delayed growth.
 If you are having laboratory tests, tell your doctor or
laboratory staff that you are using Testosterone Implants.
 If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell your
doctor or pharmacist.

5

How to store Testosterone
Implants

Keep out of the reach and sight of children.
Do not store above 25°C.
Store in the original package.
Do not use Testosterone Implants after the expiry date
stated on the package, sachet and blister.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.

6

Further information

What Testosterone Implants contain:
100mg Implant:
- The active substance is testosterone 100 mg per implant.
200mg Implant:
- The active substance is testosterone 200 mg per implant.
There are no other ingredients.
What Testosterone Implants look like and contents of
the pack
Testosterone Implants are white to pale yellow moulded
pellets of pure testosterone.
Each sterile implant is supplied singly in a sealed glass
tube, positioned between plugs of non-absorbent wool.
Marketing Authorisation Holder
Organon Laboratories Ltd, Cambridge Science Park,
Milton Road, Cambridge, CB4 0FL, UK
Manufacturer:
Organon (Ireland) Ltd., P O Box 2857,
Drynam Road, Swords, Co Dublin, Eire
This leaflet was last updated in July 2012
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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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