Testim gel (testosterone)

How does it work?

Testim gel contains the active ingredient testosterone, which is the same as the naturally occurring male hormone testosterone.

Testosterone is known as an androgen. It is produced by the testicles and is the main hormone essential for normal growth and development of the male sex organs and male sexual characteristics.

The natural production of testosterone is controlled by another set of hormones called gonadotrophins, which are released from the pituitary gland in the brain.

During adult life, testosterone is essential for the production of sperm, the maintenance of sex drive, erectile potency, and the functioning of the prostate gland and other reproductive structures. It also has functions in the skin, muscles, skeleton, kidney, liver, bone marrow and central nervous system.

Low levels of testosterone can cause decreased sex drive, impotence, infertility due to decreased sperm production, decreased mental and physical activity, fatigue and weakening of bones.

Testosterone is given as replacement therapy when natural testosterone levels fall too low, causing symptoms such as those above. Natural testosterone levels fall with age and following surgical removal of the testicles (castration). They may also fall due to decreased functioning of the testicles (hypogonadism or eunuchoidism) caused by testicular disease, or by decreased gonadotrophin production by the pituitary gland, as a result of pituitary disease.

Testosterone replacement allows natural testosterone levels to return to normal, thus relieving the symptoms of the deficiency.

Testim gel is applied in a thin layer to the skin. The testosterone is absorbed through the skin into the bloodstream.

What is it used for?

Replacement therapy of low testosterone levels in men.

Warning!

This medicine is not to be taken by mouth.

Testim gel should only be applied by the man being treated. No-one else should apply it for you. The gel should be applied at about the same time each day, preferably in the morning. Apply the gel as a thin layer onto clean, dry, healthy skin over the shoulders or upper arms. Do not apply to the genitals as this may cause irritation. Wash your hands after applying the gel. Allow the gel to dry for a few minutes before dressing.

Testosterone gel can be transferred to other people by close skin to skin contact. You should take precautions to avoid this, particularly to women, pregnant women and children, as the testosterone could have masculinising effects on them. This could cause symptoms such as growth of facial and/or body hair, deepening of the voice or irregularities of the menstrual cycle. To avoid transferring the gel to others, you should wash your hands with soap and water after applying the gel. Make sure you cover the application area with clothing, or take a shower before you have any close skin to skin contact with other people, including sex. Ideally you should leave six hours between applying the gel and showering.

You will need to have blood tests to measure your blood level of testosterone before starting and regularly throughout treatment with this medicine.

Tell your doctor if you experience symptoms such as frequent or persistent erections, irritability, nervousness or weight gain after starting treatment with this medicine, as these suggest your testosterone levels are too high and your dose may need adjusting.

You will also need to have regular blood tests to monitor your red blood cells, liver function and prostate specific antigen (PSA) levels.

Testosterone can increase the growth of prostate cancers and benign enlargement of the prostate. Your doctor will perform various examinations to make sure you don't have prostate cancer before you start treatment with this medicine. Your doctor will need to perform a digital rectal exam to check your prostate gland at least once a year while you are receiving testosterone replacement (more frequently than this if you are elderly or have risk factors for prostate cancer).

Use with caution in

Elderly people.

Decreased kidney function.

Decreased liver function.

Heart failure.

Heart disease caused by inadequate blood flow to the heart.

High blood pressure .

Epilepsy.

History of migraines.

Diabetes.

Cancer that has spread from its original site to the bones (skeletal metastases).

Sleep apnoea (temporarily stopping breathing during sleep).

Chronic disease affecting the lungs and airways.

Obesity.

Not to be used in

Women.

Children and adolescents under 18 years of age.

Men with breast cancer.

Prostate cancer.

A syndrome caused by kidney inflammation, characterised by a large amount of protein in the urine, swelling, weight gain and high blood pressure (nephrotic syndrome).

High level of calcium in the blood (hypercalcaemia).

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy. If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

This medicine is for men only and must not be used by women. Pregnant women should take particular care to avoid contact with any of the application sites on the man's skin, as the testosterone may be absorbed through the woman's skin and have adverse effects on a developing foetus. If a pregnant woman does come into contact with the application site or the gel, she should wash the area with soap and water as soon as possible.

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.

Skin reactions at application site.

Flushing of the skin due to widening of the small blood vessels (erythema).

Acne.

Dry skin.

Headache.

Diarrhoea.

Changes in mood.

Depression.

Abnormal enlargement of breasts in men (gynaecomastia).

Breast pain.

Pins and needles (paraesthesia).

Dizziness.

Loss of memory (amnesia).

Hair loss (alopecia).

High blood pressure (hypertension).

Salt and water retention.

Swelling caused by fluid retention (oedema).

Prostate disorders.

Persistent painful erection of the penis (priapism).

Decreased sperm count.

Increased levels of red blood cells and haemoglobin in the blood.

Jaundice.

The side effects listed above may not include all of the side effects reported by the drug's manufacturer. For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

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