SUSTANON 250 250MG/ML SOLUTION FOR INJECTION

Active substance: TESTOSTERONE PROPIONATE

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(testosterone propionate, testosterone phenylpropionate,
testosterone isocaproate, testosterone decanoate)

SUSTANON 250
250MG/ML SOLUTION FOR INJECTION

XXXXXXX/XXXXXX-X

UV58-05-2013

Read all of this leaflet carefully before you are given this
medicine.

For Position Only

• 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 gets 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 Sustanon 250 is and what it is used for
2. Before you are given Sustanon 250
3. How you are given Sustanon 250
4. Possible side effects
5. How to store Sustanon 250
6. Further Information

• have prostate cancer or breast cancer
• are allergic to peanuts or soya (see “important information
about some of the ingredients of Sustanon”)
Take special care with Sustanon 250:
 your doctor if you have ever had:
Tell
• 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
• if you are a female-to-male transsexual, you should have
special assessments, including psychiatric assessment,
before treatment is started.

Sustanon 250 is a solution for injection containing the active
ingredient testosterone in 4 (250 mg/ml) separate forms. The
active substances in Sustanon 250 are turned into testosterone
by your body. Testosterone is a natural male hormone known as
an androgen which controls normal sexual development in men.

Extra supervision may be necessary in some cases, particularly:
• the elderly
• in the treatment of young boys since male hormones may
cause early sexual development and delay growth.
• if you are having long-term treatment.
• if you are a female-to-male transsexual and have a
personal or family history of breast
• cancer and a personal history of endometrial cancer.

Sustanon 250 is used to replace testosterone in the body in
men with low or no natural testosterone (a condition known as
hypogonadism).

Children and adolescents
Safety and efficacy have not been adequately determined in
children and adolescents

Sustanon 250 may also be used as supportive therapy for
female-to-male transsexuals.

Blood tests may be affected.

1. What Sustanon 250 is and what it is used for

2. Before you are given Sustanon 250
Do not use Sustanon 250 if you:
• are allergic (hypersensitive) to testosterone propionate,
testosterone phenylpropionate, testosterone isocaproate,
testosterone decanoate or any of the ingredients of
Sustanon 250

For female-to-male transsexuals, Sustanon 250 may be given
as part of a programme of treatment, including surgery.
Sustanon 250 should not be used to enhance ability in sports
as it carries serious health risks.
Taking other medicines
Other medicines may affect how Sustanon 250 works or
Sustanon 250 may affect how they work.

These include:
• Certain medicines that change the amount of enzymes to
be made in the liver eg. 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 or frequency of your Sustanon 250 injections.
• Certain medicines that thin the blood (anti-coagulants).
Your doctor may need to adjust the dose of your
anti-coagulant.
• Medicines for diabetes. Your doctor may need to adjust the
dose of your medicine for diabetes.

Please tell your doctor or pharmacist if you are taking
or have recently taken any other medicines, including
medicines obtained without a prescription.
Pregnancy and breast-feeding
Sustanon 250 must not be taken during pregnancy or when
you are breast feeding. Ask your doctor or pharmacist for
advice before taking any medicine.
Driving and using machines
As far as is known Sustanon 250 has no adverse effect on
alertness or concentration.
Important information about some of the ingredients of
Sustanon 250
Sustanon 250 also contains:
Arachis oil (peanut oil) - If you are allergic to peanut or soya,
do not use this medicinal product.
Benzyl alcohol (0.1 mg per ml of Sustanon 250) - Products
containing benzyl alcohol must not be given to premature
babies or neonates. Benzyl alcohol may cause toxic reactions
and allergic reactions in infants and children up to 3 years old.
3. How you are given Sustanon 250
Sustanon 250 is normally given by a doctor or nurse. It will be
given as an injection deep into a muscle. The dose depends on
your illness and how bad it is. Your doctor will decide the dose.

XXXXXXX/XXXXXX-X

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Adults (male)
Sustanon 250:
usually one injection of 1ml every three weeks.
Adults (female-to-male transsexuals)
Sustanon 250:
doses vary from one injection of 1ml every two weeks to one injection
of 1ml every four weeks.
If you are given more Sustanon 250 than you should:
 you do think you have been given too much Sustanon 250, tell
If
your doctor straight away. The following effects may happen:
• frequent erections in men
• changes in your red blood cells (polycythaemia), which your doctor
may monitor for.
4. Possible side effects
Like all medicines, Sustanon 250 can have side effects, although not
everybody gets them.
These 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 results of liver function tests
• changes in your red blood cells (polycythaemia)
• changes in cholesterol levels
• muscle pain (myalgia)
• feeling sick
• changes in mood, feelings of depression or nervousness

For Position Only

In young boys, it may cause:
• early sexual development
• erections occurring more often than normal
• enlarged penis
• delayed growth.

Manufacturer:
NV Organon
PO Box 20
5340 BH Oss
The Netherlands

 any of the side effects gets serious, or if you notice any side
If
effects not listed in this leaflet, please tell your doctor or
pharmacist.

This leaflet was updated in May 2013.

5. How to store Sustanon 250
Keep out of the reach and sight of children.
Store below 30°C.
Do not refrigerate or freeze.
Store in the original package.in order to protect from light.
Do not use Sustanon 250 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 Sustanon 250 contains
The active ingredients in Sustanon 250 are:
• testosterone propionate, 30 mg
• testosterone phenylpropionate, 60 mg
• testosterone isocaproate, 60 mg
• testosterone decanoate, 100 mg
The other ingredients are: Benzyl Alcohol and Arachis Oil.
What Sustanon 250 looks like and contents of the pack
Sustanon 250 is a clear, pale yellow solution for deep intramuscular
injection.
Sustanon 250 is packed in a 1 ml glass ampoule and comes in packs of
1 ampoule, 3 ampolues and 6 ampoules.
Not all pack sizes are marketed.
Marketing Authorisation Holder
Organon Laboratories Ltd,
Cambridge Science Park,
Milton Road, Cambridge, CB4 0FL, UK

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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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