Who can use TESTOGEL®

• Only men can use TESTOGEL®
• Young men under the age of 18 years should not use this medicine.
• This medicine should not be used by females of any age.
• Do not allow women (especially women that are pregnant or breast-feeding) or children to come into contact with TESTOGEL® or the areas of skin where TESTOGEL® has been applied.

Do not use this medicine

• 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

Your doctor will do the necessary tests before you can use this medicine and do follow-up checks by carrying out periodic blood tests.

Talk to your doctor or pharmacist before using this medicine, if you have or ever had any of the following:

• you have difficulty in passing water (urinating) due to an enlarged prostate gland
• you have bone cancer – your doctor will check your calcium levels
• you have high blood pressure, or if you are treated for high blood pressure, as this medicine may cause a rise in blood pressure
• you have severe heart, liver or kidney disease, as treatment with this medicine may cause severe complications in the form of water retention in your body sometimes accompanied by (congestive) heart failure (fluid overload in the heart)
• you have ischaemic heart disease (which affects the supply of blood to the heart)
• 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.

• you have epilepsy
• you have migraines
• you have breathing difficulties when you sleep – these are more likely to happen if you are overweight or have long term lung problems

If any of the above apply to you (or you are not sure), talk to your doctor before using this medicine as using this medicine may make these conditions worse.

If you develop reactions on your skin where you applied this medicine, go back to your doctor to seek advice. It may be necessary to stop the treatment with this medicine.

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.

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 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.

This medicine 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).

Information on additional monitoring

The following blood checks should be carried out by your doctor before and during the treatment: testosterone blood level, full blood count.

You will have regular check-ups (at least once a year and twice a year if you are elderly or if your doctor considers you as a risk patient) during treatment.

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.

Children and adolescents

This medicine is not recommended for children, as no clinical information is available for boys under 18 years

Possible transfer of testosterone

During close skin-to-skin contact testosterone may be transferred to another person and could result in the other person showing signs of increased testosterone (see below).

The following precautions are recommended to protect against transfer:

For the patient:

• wash your hands with soap and water after applying the gel
• cover the application area with clothing once the gel has dried
• wash the application area before making close skin-to-skin contact with another person 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 (man, woman or child), this person should:

• wash the area of skin onto which may have been affected immediately with soap and water
• contact a doctor if they get signs such as acne, changes in the growth or pattern of hair on their body or face, deepening of the voice, changes in their menstrual cycle.
• For children signs of early puberty and genital enlargment shoud also be looked out for.

You should preferably wait at least 1 hour before showering or bathing after applying this medicine.

Other medicines and this medicine

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, particularly the following:

• oral anticoagulants (medicines used to thin the blood)
• corticosteroids (medicines used to reduce inflammation)
• insulin (medicines used to control your blood sugar levels in diabetes). You may need to reduce your dose of insulin when using this medicine.
  If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before using this medicine.

These particular medicines may lead to your dose of this medicine being adjusted.

Pregnancy, breast-feeding and fertility

This medicine is not to be used by women.

Sperm production may be reversibly suppressed with this medicine.

If your partner is or becomes pregnant or is planning to have a baby you must follow the advice regarding avoiding transfer of the testosterone gel (see “Possible transfer of testosterone” above).

Pregnant women must avoid any contact with this medicine’s application sites. This medicine may cause damage to the unborn baby.

In the event of contact, your partner must wash the area of contact as soon as possible with soap and water.

Driving and using machines

This medicine has no influence on the ability to drive or use machines.

This medicine contains alcohol (ethanol)

This medicine contains 1.81 g alcohol (ethanol) in each sachet.

It may cause burning sensation on damaged skin.

This product is flammable until dry.