ANDROGEL 50 mg, gel in sachet Testosterone
What ANDROGEL is and what it is used for This medicine contains testosterone, a male hormone produced naturally in the body. ANDROGEL 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, – bone loss caused by low hormone levels, – regression of masculine characteristics, – reduced lean body mass, – inability to have/maintain an erection.
What you need to know before you use ANDROGEL Do not use ANDROGEL – If you are allergic to testosterone or 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. Warning and precautions Take special care with ANDROGEL Before starting any treatment with ANDROGEL, 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.
ANDROGEL 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.
If you are suffering from severe heart, liver or kidney disease, treatment with ANDROGEL may cause severe complications in the form of water retention in your body sometimes accompanied by congestive heart failure.
The following blood checks should be carried out by your doctor before and during the treatment: testosterone blood level, full blood count.
Thrombophilia (an abnormality of blood coagulation that increases the risk of thrombosis – blood clots in blood vessels).
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.
Worsening of breathing problems during sleep have been reported during treatment with testosterone in some people, particularly those who are very overweight or are already suffering from breathing difficulties.
If you have cancer that affects your bones, you may develop increased levels of calcium in your blood or urine. ANDROGEL may further affect these calcium levels. Your doctor may wish to check these calcium levels using blood tests during your treatment with ANDROGEL.
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.
ANDROGEL must be used with caution if you are suffering from epilepsy and/or from migraine as these conditions may be made worse.
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 ANDROGEL.
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.
Possible transfer of testosterone During close and relatively long periods of skin contact testosterone may be transferred to another person unless you cover the treated area. This could cause your partner to show the signs of increased testosterone such as more hair on the face and body and a deepened voice. It may cause changes in the menstrual cycle of women. Wearing clothes covering the application area or showering before contact protects against such transfer.