Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

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•    Keep this leaflet. You may need to read it again.

•    If you have further questions please ask your doctor or your 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.

What is in this leaflet:

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

2.    What you need to know before Sustanon 250 is administered

3.    How Sustanon 250 is administered

4.    Possible side effects

5.    How to store Sustanon 250

6.    Contents of the pack and other Information

Sustanon 250 is a clear pale yellow solution for injection containing the active ingredient testosterone in 4 (250 mg/ml) separate forms. The active substances of Sustanon 250 (see section 6 "What Sustanon 250 contains" are turned into testosterone by your body Testosterone is a natural m ' an androgen.

In men, testosterone is produced by the testicles It is ne growth, development and function of the male sex organs an sex characteristics It is necessary for the growth of body hair, the de of bones and muscles, and it stimulates the production of red blood cells It also makes men's voices deepen.

Sustanon 250 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 and bone loss caused by low hormone levels

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

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Do not take Sustanon 250:

•    If you are pregnant or think you may be pregnant (see section 2 "Pregnancy, breast-feeding and fertility").

•    If you have or have had a tumour of your prostate or breast, or are suspected to have one of these tumours

•    In children under the age of 3 years.

•    If you are allergic to one or more of the ingredients of this medicine (listed in section 6 "What Sustanon 250 contains").If you are allergic to peanuts or soya (see Section 2 "Important information about some of the ingredients of Sustanon 250").

Take special care with Sustanon 250:

If you notice any signs of masculinisation (for instance lowenng of the voice or increase in body or facial hair), consult your doctor immediately Treatment with male hormones like testosterone may increase the size of the prostate gland, especially in elderly men. Therefore your doctor will examine your prostate gland at regular intervals by digital rectal examination (DRE) and blood tests for prostate-specific antigen (PSA).

Additionally, at regular intervals blood tests will be done to check the oxygencarrying substance in your red blood cells (haemoglobin). In very rare cases the number of red blood cells will increase too much leading to complications.

The following blood checks should be carried out by your doctor before and dunng the treatment: testosterone blood level, full blood count.

Medical checks may also be necessary    ore

you start using this medicine you must tell your doctor or pharmacist if you ever had, still have or are suspected to have:

•    Breast cancer which has spread to the bones;

•    Kidney or lung cancer

•    Heart, disease;

•    Kidney disease;

•    Liver disease;

•    High blood pressure;

•    Diabetes mellitus;

•    Epilepsy;

•    Migraine, headaches;

•    Prostatic complaints, such as problems with passing urine.

If you are suffering from severe heart, liver or kidney disease, treatment with Sustanon 250 may cause severe complications in the form of water retention in your body sometimes accompanied by (congestive) heart failure.

Tell your doctor if you have high blood pressure or if you are treated for high blood pressure as testosterone may cause a rise in blood pressure.

If you have sleep apnoea (temporarily stopping breathing during your sleep), it may get worse if you are using testosterone-containing products. Let your doctor know if you are worried about this. Extra supervision by your doctor may be necessary in case you are overweight or suffer from chronic lung disease.

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.

•    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.

Children and adolescents

The safety and efficacy of this medicine has not been adequately determined in children and adolescents.

Extra supervision by your doctor is necessary in the treatment of children and adolescents since testosterone administration in general may cause early sexual development and limits growth (see section 4 "Children and adolescents").

Blood tests may be affected.

For female-to-male transsexuals, Sustanon 250 may be given as part of a programme of treatment, including suigery.

Other medicines and Sustanon 250

•    Please tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines - even those not prescribed.

Other medicines may influence the effects of Sustanon 250, or Sustanon 250 may affect other medicines Therefore you must tell your doctor or pharmacist if you are using, or are about to use:

•    Insulin and/or other medicines to control blood sugar levels;

•    Medicines to reduce the clotting of your blood (anti-coagulants);

•    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.

The use of androgens like Sustanon 250 may lead to a reduction of the doses of these medicines

Also tell your doctor or pharmacist if you are using or about to use the hormone ACTH or corticosteroids (used to treat various conditions such as rheumatism, arthritis, allelic conditions and asthma). The use of androgens like Sustanon 250 may increase the risk of water retention especially if your heart and liver are not working property.

Androgens may also affect the results of some laboratory tests (e g. thyroid gland). Therefore you must tell your doctor or the laboratory staff performing the tests that you are using this medicine Using Sustanon 250 with food and drink

This medicine can be injected without taking consideration of meals and drinks Pregnancy, breast-feeding and fertility

Sustanon 250 must not be taken by women who are pregnant or think they are pregnant (see section 2 "Do not use Sustanon 250"), or by women who are breast-feeding.

In men, treatment with Sustanon 250 can lead to fertility disorders by repressing sperm formation.

In women, treatment with this medicine can lead to an irregular or absent menstrual cycle

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice taking this medicine Driving and using machines

As far as is known this medicine has no influence on driving and using machines.

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