Product Details

Product Information of Testogel Gel 16.2mg/g Pump

WHAT YOU NEED TO KNOW BEFORE YOU USE TESTOGEL  16.2 MG/G

Do not use TESTOGEL ® 16.2 mg/g – if you have or are suspected of having prostate cancer – if you have or are suspected of having breast cancer – if you are allergic to testosterone or any of the other ingredients of this medicine (listed in section 6) Warnings and precautions Talk to your doctor or pharmacist before using TESTOGEL® 16.2 mg/g. Before starting any treatment with TESTOGEL® 16.2 mg/g, 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. If you are arranging for testing of blood samples while using TESTOGEL® 16.2 mg/g you must ensure that all testosterone measurements are performed in the same laboratory, because of the variability in analytical values among diagnostic laboratories. TESTOGEL® 16.2 mg/g is not recommended for: – the treatment of male sterility or impotence – children, as no clinical information is available for boys under 18 years 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 TESTOGEL® 16.2 mg/g may cause severe complications in the form of water retention in your body, sometimes accompanied by congestive heart failure (fluid overload in the heart). The following blood checks should be carried out by your doctor before and during the treatment: testosterone blood level, full blood count. 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. 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. TESTOGEL® 16.2 mg/g should therefore be used with caution if you are suffering from high 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. TESTOGEL® 16.2 mg/g may further affect these calcium levels. Your doctor may wish to check these calcium levels using blood tests during your treatment with TESTOGEL® 16.2 mg/g. 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. TESTOGEL® 16.2 mg/g must be used with caution if you are suffering from epilepsy and/or from migraine as these conditions may worsen. If have diabetes and use insulin to control your blood sugar levels, testosterone treatment may affect your response to insulin and your antidiabetics’ medication might need adjustment. In case of severe skin reactions, treatment should be reviewed and stopped if necessary. The following signs 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® 16.2 mg/g. Before starting treatment your doctor will perform a full examination. He/she will need to take blood samples on two 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. TESTOGEL® 16.2 mg/g should not be used by women due to possible virilising effects (such as growth of facial or body hair, deepening of the voice or changes in the menstrual cycle). Sportsmen and women The attention of sportsmen and women is drawn to the fact that this proprietary medicine contains an active substance (testosterone) that may produce a positive result in doping control tests. 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, premature puberty and genital enlargement in children. Wearing clothes covering the application area or showering before contact protects against such transfer. The following precautions are recommended: – wash your 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 or if not possible wear clothing such as a shirt or a T-shirt covering the application site during the contact period – wear clothing (such as a sleeved shirt) covering the application site during contact periods with children If you believe testosterone has been transferred to another person (woman or child) – wash the area of skin that may have been affected immediately with soap and water – report any signs such as acne or changes in the growth or pattern of hair on your body or face to your doctor You should preferably wait at least 2 hours between applying the gel and taking a bath or shower. If you occasionally need to bath or shower between 2 and 6 hours after applying the gel it should not significantly change the effects of your treatment. In order to improve the safety of your partner you should wash the area with soap for instance during a shower before having sexual intercourse or, if not possible, wear a T-shirt that covers the application site at the time of contact. You should wear a T-shirt that covers the application site when in contact with children in order to avoid the risk of transferring the gel to the child’s skin. Other medicines and TESTOGEL ® 16.2 mg/g Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, particularly the following: – oral anticoagulants (used to thin the blood) – corticosteroids These particular medicines may lead to your dose of TESTOGEL® 16.2 mg/g being adjusted. Pregnancy, breast-feeding and fertility TESTOGEL® 16.2 mg/g is not to be used by pregnant or breastfeeding women. Pregnant women must avoid any contact with the TESTOGEL® 16.2 mg/g application sites. This medicine may cause the development of unwanted male characteristics in the developing baby. In the event of contact, as recommended above, wash the area of contact as soon as possible with soap and water. 5004703 If your partner becomes pregnant you must follow the advice regarding avoiding transfer of the testosterone gel. Spermatozoid production may be reversibly suppressed with TESTOGEL® 16.2 mg/g. Driving and using machines TESTOGEL® 16.2 mg/g has no influence on the ability to drive or use machines. This medicine contains alcohol (ethanol) This medicine contains 0.9 g alcohol (ethanol) in each dose of 1.25 g gel. It may cause burning sensation on damaged skin. This product is flammable until dry.