Each sachet contains 50 mg of the active ingredient testosterone in 5 g of colourless gel.
Excipients/Inactive Ingredients: The other ingredients are: Carbomer 980, isopropyl myristate, ethanol 96%, sodium hydroxide, purified water.
ANDROGEL contains testosterone, a male hormone produced naturally in the body.
ANDROGEL is a hormone treatment. It is used for problems related to testosterone deficiency in men over 18 years.
ANDROGEL is for use by adult men only.
The recommended dosage is 5 g of gel (i.e. 50 mg of testosterone) applied once daily at approximately the same time, preferably in the morning.
The daily dose may be adjusted by the doctor, on an individual patient basis, not exceeding 10 g of gel per day.
The gel must be gently spread onto clean, dry, healthy skin as a thin layer on the shoulders, arms or stomach.
After opening the sachet, the entire contents should be taken out of the sachet and applied immediately onto the skin. Allow the gel to dry for at least 3-5 minutes before dressing. Wash hands with soap and water after applying.
Do not apply to the genital areas (penis and testes) as the high alcohol content may cause local irritation.
Always apply ANDROGEL exactly as instructed by the doctor.
Forgotten application of ANDROGEL: Do not apply a double dose to make up for a forgotten individual dose.
Do not stop therapy with ANDROGEL unless told to do so by the doctor.
If more ANDROGEL has been applied than necessary, seek advice from the doctor.
ANDROGEL must never be used: If allergic to testosterone or to any of the ingredients of the gel; If suffering from prostate cancer; If suffering from breast cancer.
ANDROGEL is not used for the treatment of male sterility or impotence.
ANDROGEL is not to be used by children or women.
ANDROGEL may increase the risk of benign prostatic hypertrophy (enlarged prostate gland) or prostate cancer, and regular examinations of the prostate gland should be performed in accordance with the doctor's recommendations.
In people suffering from severe heart, liver or kidney disease, treatment with ANDROGEL may cause severe complications in the form of oedema (water retention in the body) either accompanied or not accompanied by congestive heart failure (fluid overload in the heart).
As ANDROGEL may cause a rise in blood pressure, it should be used with caution in patients with high blood pressure.
Worsening of breathing problems during sleep has been reported during treatment with testosterone in predisposed individuals, particularly people who are very overweight (obese) or are suffering from respiratory disease.
If the patient is suffering from cancer affecting the bones, the patient may develop increased levels of calcium in the blood or urine. ANDROGEL may further affect these calcium levels. The doctor may wish to check these calcium levels using blood tests during treatment with ANDROGEL.
People receiving testosterone replacement treatment over long periods of time may develop polycythaemia (an abnormal increase in the number of red blood cells in the blood). The patient will have regular blood tests to check that this is not happening.
It may be necessary to adjust treatment doses in people who are receiving oral anticoagulants (used to thin the blood), insulin or corticosteroids, as there is an increased risk of oedema (water retention in the body) if the patient has heart, liver or kidney disease.
In patients with migraine or epilepsy, ANDROGEL must be used with caution, as these conditions may deteriorate.
Before starting treatment, the doctor will perform a full examination. The doctor will need to take blood samples on 2 visits to measure the levels of testosterone before the patient is given ANDROGEL. The patient will have regular check-ups (at least once a year) during treatment.
Testosterone may be transferred to another person during close and relatively prolonged skin contact with the gel application area if no precaution is taken. This could cause the patient's partner to show signs of increased testosterone such as more hair on the face and body and a deepened voice, if contact is made a number of times or for long periods of time.
This may also cause changes in the menstrual cycle of women. Wearing clothes covering the application area or showering before contact allows such transfer to be avoided.
As a result, the following precautions are recommended: wash hands with soap and water after applying the gel; cover the application area with clothing once the gel has dried; take a shower before intimate contact.
For people not being treated with ANDROGEL: in the event of contact with the application area, wash the area of skin onto which testosterone may have been transferred immediately with soap and water; report the development of signs such as acne or changes in the growth or pattern of hair on the body or face to the general practitioner.
Children and women should avoid contact with testosterone application sites on the skin of men who use this product.
The patient should preferably wait at least 6 hours between applying the gel and taking a bath or shower. A bath or shower may occasionally be taken between 1 and 6 hours after applying the gel and should not significantly change the effects of the treatment.
To make sure the patient's partner is not put at risk of receiving testosterone by accident, the patient should leave a long period of time between applying ANDROGEL and having sex. The patient should also either wear a T-shirt during the time when he is in close contact with his partner to cover the area where ANDROGEL has been applied, or have a shower or bath before starting having sexual intercourse.
The patient should also wear a T-shirt covering where ANDROGEL has been applied when he is going to be in close contact with children. This is to avoid any of ANDROGEL being passed onto the children's skin.
Laboratory test interactions: Androgens may decrease levels of thyroxin-binding globulin, resulting in decreased T4 serum concentrations and in increased resin uptake of T3 and T4. Free thyroid hormone levels, however, remain unchanged and there is no clinical evidence of thyroid insufficiency.
Sportsmen and women: The attention of sportsmen and women is drawn to the fact that ANDROGEL contains an active substance (testosterone) which may produce a positive reaction in antidoping tests.
Driving or using machines: Not applicable.
ANDROGEL is not to be used by pregnant or breast-feeding women.
Pregnant women must avoid any contact with ANDROGEL application sites. ANDROGEL may cause the development of unwanted male characteristics in the developing baby. In the event of contact, wash the area of contact as soon as possible with soap and water.
If the patient's partner becomes pregnant, the patient must follow the advice regarding avoiding transfer of the testosterone gel.
Ask the doctor or pharmacist for advice before taking any medicines.
Like all medicines, ANDROGEL may have side effects.
Skin reactions such as irritation, acne, and dry skin may occasionally occur at the application site.
ANDROGEL may cause headaches, hair loss, development of painful, tender or enlarged breasts, changes to the prostate gland, diarrhoea, dizziness, pins and needles, an increase in blood pressure, changes to mood, changes in laboratory tests (increase in the number of red blood cells in the blood, lipids), skin hypersensitivity and stinging.
Gynecomastia (enlarged breasts) may be persistent and is a common finding in patients treated for testosterone deficiency.
Other side effects have been observed during treatment with oral or injectable testosterone: enlarged prostate gland and prostate cancer, itching over the entire body, redness of the face and neck, nausea, yellowing of the skin (jaundice), increased sex drive, depression, nervousness, muscular pain, electrolyte changes (changes of the salts in the blood), oligospermia (reduction in the number of sperm), frequent or prolonged erections, changes in the results of tests.
Certain clinical signs (irritability, nervousness, weight gain, frequent or prolonged erections) may indicate an excessive effect due to the product. Report these to the doctor who will adjust the daily dose of ANDROGEL.
Because of the alcohol this substance contains, frequent applications to the skin may cause irritation and skin dryness.
Tell the doctor or pharmacist if side effects not previously listed are experienced.
Tell the doctor or pharmacist if taking or have recently taken any other medicines, even those not prescribed, but particularly oral anticoagulants (used to thin the blood) and corticosteroids (e.g. cortisone).
Do not use ANDROGEL if signs of substance deterioration are noticed.
There are no special precautions for storage.
G03BA03 - testosterone ; Belongs to the class of 3-oxoandrosten (4) derivative androgens used in androgenic hormone preparations.
Androgel gel 50 mg
30 × 1's
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