TESTOGEL, 30 SACHETS

What are Testogel sachets?

Testogel sachets are a form of testosterone replacement to treat various health problems that are caused by a lack of testosterone (also known as Hypogonadism). This condition 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 is Hypogonadism?

Hypogonadism is a lack of the male sex hormone, testosterone and is thought to affect around 5 in every 1000 men. Testosterone is a hormone that is produced by the testes and is regulated by the pituitary gland and hypothalamus in the brain. It is require by all men for a healthy life, both physically and psychologically.

Common causes of Hypogonadism

Hypogonadism can be caused by a problem with the testes, the pituitary gland or hypothalamus. Common causes include:

• Disorders of the testes, such as Klinefelter’s syndrome (a genetic disorder)
• Inflammation of the testes (orchitis)
• Radiation or chemotherapy
• Alcohol abuse
• Removal of both testicles
• Injury of both testicles
• Undescended testicles
• Disease of the pituitary gland or hypothalamus

Hypogonadism Symptoms

The symptoms of Hypogonadism include:

• Fatigue (tiredness)
• Lethargy (lack of energy
• Depression, anxiety and irritability
• Decreased shaving frequency
• Reduced exercise tolerance and strength
• Excessive sweating and night sweats
• Poor concentration and/or memory

 

How does Testogel work?

Testogel is a clear gel that is rubbed onto the shoulders, chest or back once a day. Testogel contains the active ingredient testosterone, which replaces the testosterone produced in your body to maintain normal levels. Once applied, testosterone is absorbed through the skin and into the bloodstream.

Benefits of Testogel

• Easy application- Can apply without medical supervision
• Non-invasive – No need for needles as this medicine is applied topically
• Quick – Can be applied in minutes

 

How to apply this medicine

This medicine is for use by adult men only.

Always use this medicine exactly as described in the patient information leaflet or as advised by a doctor.

The recommended dose is 5mg of gel (equal to 50mg of testosterone) applied once daily at around the same time- preferably in the morning. Spread the gel, thinly, onto clean, dry and healthy skin 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 305 minutes before dressing. Wash your hands with soap and water after applying.

Do NOT apply to genital areas (penis or testes) as the high alcohol content may cause local irritation.

If you use more Testogel than you should seek advice from your doctor.

If you forget to use Testogel do NOT use a double dose to make up for a forgotten individual dose.

You should not stop using Testogel unless told to do so by your doctor.

Warnings

Before using Testogel, your testosterone deficiency must be clearly demonstrated by clinical signs such as:

• Regression of masculine characteristics
• Reduced lean body mass
• Weakness
• Fatigue
• Reduced sexual desire/drive
• Inability to gain or maintain an erection

These signs must be confirmed by laboratory tests and the following blood checks should be carried out by your doctor before and during the treatment:

• Testosterone blood level
• Full blood count

If you receive testosterone replacement treatment over long periods of time, you may develop an abnormal increase in the number of red blood cells, so you will need regular blood tests to check that this is not occurring.

During close and relatively long periods of skin contact, testosterone may be transferred to another person unless you cover the treated area. Transferral of testosterone can cause:

• More hair on the face and body
• Deepened voice
• Change in menstrual cycle of women

Following these precautions are recommended to prevent testosterone transfer:

• Wash our 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

If you believe testosterone has been transferred to another person (woman or child)

• Wash the area of skin which 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 the body or face to your doctor

You should wait at least 6 hours between applying the gel and taking a bath or shower.

 

Can you take Testogel with other medicines?

Inform your doctor or a pharmacist if you are taking, have recently taken or might take any other medicines, even those obtained without a prescription. In particular, ensure you notify your doctor if you are taking oral anticoagulants (used to thin the blood) insulin or corticosteroids, BEFORE using this medicine, as they may lead to your dose of Testogel being adjusted.

 

When NOT to take Testogel

Do NOT use Testogel if you are allergic to testosterone or to any of the ingredients used in this medicine (see ingredients tab for full list) or if you are

• Suffering from prostate cancer
• Suffering from breast cancer

Speak to your doctor BEFORE using Testogel if:

• You are suffering from epilepsy and/or from migraine, as these conditions may be made worse
• You have high blood pressure or if you are treated for high blood pressure, as testosterone may cause a rise in blood pressure
• You are suffering from severe heart, liver or kidney disease, treatment with Testogel may cause severe complications in the form of water retention in your body
• You have cancer that affects your bones, as you may develop increased levels of calcium in your blood or urine- Testogel may further affect these calcium levels
• Have or every had blood clotting problems

This medicine is not recommended for:

• The treatment of male sterility or impotence
• Children, as no clinicial information is available for boys under 18 yeaers
• By women because of possibly developing male characteristics

Pregnancy and breast-feeding

Testogel is NOT to be used by pregnant or breast-feeding women.

Pregnant women must avoid any contact with the Testogel application sites. This medicine 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 your partner becomes pregnant you must follow advice regarding avoiding transfer of the testosterone gel.

 

ALWAYS CHECK THE LABEL BEFORE USING ANY NEW MEDICINE.

Seek advice from your doctor or a pharmacist if you are unsure if this medicine is suitable for you.

 

Side Effects

Like all medicines, Testogel can cause side effects, although not everybody will experience them.

Because of the alcohol content this medicine contains, frequent applications to the skin may cause irritation or skin dryness. This medicine may also cause acne to occur.

Other common side effects include:

• Headaches
• Hair loss
• Development of painful, tender or enlarged breasts
• Changes to your prostate gland
• Diarrhoea
• Dizziness
• An increase in blood pressure
• Change to your mood
• Increase in red blood cell count, haematocrit and haemoglobin
• Changes in lipid levels
• Skin hypersensitivity
• Stinging
• Loss of memory

See patient information leaflet for full list of side effects.