1. What TESTOGEL® (testosterone ) is and what it is used for
This medicine testogel contains testosterone, a male hormone produced naturally in the body.
TESTOGEL® 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:
– low sex drive,
– depressive moods,
– bone loss caused by low hormone levels,
– regression of masculine characteristics,
– reduced lean body mass,
– inability to have/maintain an erection.
2. What you need to know before you use
Do not use
– If you are allergic to testosterone or to any of the ingredients of this medicine. (listed in section 6),
– If you are suffering from prostate cancer,
– If you are suffering from breast cancer.
Warnings and precautions
Talk to your doctor before using
– if you are suffering from epilepsy and/or from migraine, as these conditions may be made worse
– 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 are suffering from severe heart, liver or kidney disease, treatment with that medicine may cause severe complications in the form of water retention in you body sometimes accompanied by (congestive) heart failure
– as worsending of breathing problems during sleep have been reported during treatment with testosterone in some people, particulalry those who are very overweight or are already suffering from breathing difficulties.
– if you have cancer that affects your bones, as you may develop increased levels of calcium in your blood or urine. TESTOGEL may further affect these calcium levels. Your doctor may with to check these calcium levels using blood tests during your treatment with TESTOGEL (testosterone )
– have or ever had blood clotting problems
– thrombophilia (an abnormality of blood coagulation that increases the risk of thrombosis – blood clots in blood vessels)
Before starting any treatment with TESTOGEL®, your testosterone deficiency must be clearly demonstrated by clinical signs (regression of masculine characteristics, reduced lean body mass, weakness or fatigue, reduced sexual desire/drive, inability to have/maintain an erection, etc.) and confirmed by laboratory tests carried out in the same laboratory.
TESTOGEL® is not recommended for:
– The treatment of male sterility or impotence,
– Children as no clinical information is available for boys under 18 years,
– By women because of possibly developing male characteristics.
Androgens may increase the risk of an enlarged prostate gland (benign prostatic hypertrophy) or prostate cancer. Regular examinations of the prostate gland before the beginning and during therapy should be performed to follow your doctor’s recommendations.
The following blood checks should be carried out by your doctor before and during the treatment: testosterone blood level, full blood count.
If you receive testosterone replacement treatment over long periods of time you may develop an abnormal increase in the number of red blood cells in your blood (polycythaemia). You will need regular blood tests to check that this is not happening.
In case of severe skin reactions, treatment should be reviewed and stopped if necessary.
The following may indicate you are taking too much of the product: irritability, nervousness, weight gain, frequent or prolonged erections. Report any of these to your doctor who will adjust the daily dose of TESTOGEL®.
Before starting treatment your doctor will perform a full examination. He/she will need to take blood samples on 2 visits to measure your levels of testosterone before you are given this medicine. You will have regular check-ups (at least once a year and twice a year if you are elderly or an at risk patient) during treatment.