Description
Package Leaflet: Information for the patient Sustanon 250 mg/ml, solution for injection
(testosterone esters)
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
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.
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 “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 testosterone or to any of the other ingredients of this medicine
Warnings and precautions
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 oxygen-carrying 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.
Talk to your doctor or pharmacist before you start using this medicine 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;
• Blood clotting problems – thrombophilia (an abnormality of blood coagulation that increases the risk of
thrombosis – blood clots in blood vessels).
• Factors that increase your risk for blood clots in a vein: previous blood clots in a vein; smoking; obesity;
cancer; immobility; if one of your immediate family has had a blood clot in the leg, lung or other organ
at a young age (e.g. below the age of about 50); or as you get older.
• How to recognise a blood clot: painful swelling of one leg or sudden change in colour of the skin e.g.
turning pale, red or blue, sudden breathlessness, sudden unexplained cough which may bring up blood; or sudden chest pain, severe light headedness or dizziness, severe pain in your stomach, sudden loss of vision. Seek urgent medical attention if you experience one of these symptoms.
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,
− testosterone phenylpropionate,
− testosterone isocaproate,
− testosterone decanoate,
30 mg 60 mg 60 mg 100 mg
All four compounds are esters of the natural hormone testosterone. The total amount of testosterone per ml is 176 mg.
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.