Skip to Content

SUSTANON 250 250MG/ML SOLUTION FOR INJECTION

Active substance: TESTOSTERONE PROPIONATE

View full screen / Print PDF » Download PDF ⇩
Transcript
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 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
1. WHAT SUSTANON 250 IS AND WHAT IT IS USED FOR
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 male hormone known as
an androgen.
In men, testosterone is produced by the testicles. It is necessary for the normal
growth, development and function of the male sex organs and for secondary male
sex characteristics. It is necessary for the growth of body hair, the development
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.

(testosterone esters)

Sustanon 250,
250 mg/ml, solution for injection

Package Leaflet: Information for the patient

XXXXXXX/XXXXXX-X

2. WHAT YOU NEED TO KNOW BEFORE SUSTANON 250 IS ADMINISTERED
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 lowering 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
during the treatment: testosterone blood level, full blood count.
Medical checks may also be necessary in some other conditions. Therefore, before
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 surgery.
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
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 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, allergic 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 properly.
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.

XXXXXXX/XXXXXX-X

Important information about some of the ingredients of Sustanon 250
This medicine also contains:
• Arachis oil (peanut oil) - If you are allergic to peanut or soya, do not use this
medicinal product (see “Do not use Sustanon 250”).
• Benzyl alcohol (100 mg per ml of solution) - 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.
Improper use
If you are a patient who participates in competitions governed by the World Anti-Doping
Agency (WADA), then you should consult the WADA-code before using this medicine as
Sustanon 250 can interfere with anti-doping testing.
The misuse of this medicine to enhance ability in sports carries serious health risks and is
discouraged.
3. HOW SUSTANON 250 IS ADMINISTERED
This medicine should only be given by a doctor or a nurse. The injections are given deeply
into a muscle (for instance in the buttock, upper leg or upper arm). The dose depends on your
illness and how bad it is. Your doctor will decide the dose.
Usually, the dosage is one injection of 1 ml every three weeks.
If you have the impression that the effect of this medicine is too strong or too weak, talk to
your doctor or nurse immediately.
Use in children and adolescents
The safety and efficacy of this medicine have not been adequately determined in children
and adolescents. Pre-pubertal children using this medicine will be monitored by your doctor
(see section 2 “Take special care with Sustanon 250”).
If you use more Sustanon 250 than you should
Your doctor or nurse will inject this medicine into you. If you have the impression that the
effect of this medicine is too strong then please talk to your doctor or nurse immediately.
The following effects may happen:
• Frequent erections in men;
• Changes in your red blood cells (polycythaemia), which your doctor may monitor you for.
If you forgot to get your injection of Sustanon 250
Your doctor or nurse will inject this medicine into you. Should you miss a scheduled injection
then please talk to your doctor or nurse as soon as possible. No double dose should be
injected to make up for forgotten individual doses.
Effects when treatment with Sustanon 250 is stopped
The effects of this medicine do not stop immediately after discontinuation, but gradually
subside.
When treatment with this medicine is stopped, complaints such as those experienced before
treatment may re-occur within a few weeks.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Adults (female-to-male transsexuals)
Sustanon 250:
Doses vary from one injection of 1 ml every two weeks to one injection of 1 ml every four weeks.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Sustanon 250 can have side effects although not everybody gets them.
In general the side effects which are reported with testosterone therapy include:
Common (may affect up to 1 in 10 people)
• Increase in red blood cell count (the cells which carry the oxygen in your blood);
haematocrit (percentage of red blood cells in blood) and haemoglobin (the component of
red blood cells that carries oxygen), identified by periodic blood tests.
Not known (cannot be estimated from available data)
• Itching (pruritus);
• Acne;
• Nausea;
• Changes in liver function tests;
• Changes in cholesterol levels (changes in lipid metabolism);
• Depression, nervousness, mood alterations;
• Muscle pain (myalgia);
• Fluid retention in the tissues, usually marked by swelling of ankles or feet;
• High blood pressure (hypertension);
• Changes in sexual desire;
• Prolonged abnormal, painful erection of the penis;
• Ejaculation disorder;
• Disturbed formation of sperm;
• Feminisation (gynaecomastia);
• Prostatic growth to a size representative for the concerned age group;
• Increased levels of a blood marker which is associated with prostate cancer (PSA
increased);
• Increased growth of a small prostate cancer which has not been detected yet (progression
of a sub-clinical prostatic cancer).
Due to the nature of Sustanon 250, side effects cannot be quickly reversed by discontinuing
medication. Injectables in general, may cause local reaction at the injection site.
Side effects in women:
In women, this product may induce signs of masculinisation (for example, lowering of the
voice, and increase in body or facial hair.)
Children and adolescents:
The following side effects have been reported in pre-pubertal children using androgens:
• Early sexual development;
• Penis enlargement;
• An increased frequency of erections;
• Growth limitation (limited body height)
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card
Scheme 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 SUSTANON 250
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or label after the term
“exp” (expiry date). The expiry date refers to the last day of that month.
Store below 30°C. Do not refrigerate or freeze.
Store in the original package in order to protect from light.
Do not throw away any medicines via wastewater or household waste. Ask your Pharmacist
how to throw away medicines you no longer use. These measures will help to protect the
environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Sustanon 250 contains
The active substance is:
Each milliliter of the oily solution contains the following
- testosterone propionate,
30 mg
- testosterone phenylpropionate,
60 mg
- testosterone isocaproate,
60 mg
- testosterone decanoate,
100 mg
All four compounds are esters of the natural hormone testosterone. The total amount of
testosterone per ml is 176 mg.
The other ingredients are:
The solution for injection contains Arachis oil and Benzyl Alcohol.
What Sustanon 250 looks like and contents of the pack
Sustanon 250 is a clear, pale yellow solution for deep intramuscular injection.
Each colourless glass ampoule is filled with 1 ml of Sustanon 250.
A box of Sustanon 250 contains 1 ampoule.
Not all pack sizes are marketed.
If you have any further questions or require the full prescribing information for this medicine
please consult your doctor or pharmacist.
Marketing Authorisation Holder
Aspen Pharma Trading Limited
3016 Lake Drive,
Citywest Business Campus,
Dublin 24,
Ireland
Manufacturer:
NV Organon
PO Box 20
5340 BH Oss
The Netherlands
This leaflet was updated in February 2015

Expand view ⇕

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.

Hide