What is Androgel and what it is used for?

What Androgel is and what it is used for

Androgel contains testosterone, a male hormone that is normally produced in the body. It is a hormone replacement therapy to treat the symptoms caused by insufficient testosterone production as described in section 2. Before you start using ANDROGEL .

2. Before you start using Androgel

Do not take Androgel

• if you are allergic to testosterone or any other ingredient in the gel
• if you suffer from prostate cancer
• if you have breast cancer.

Be careful with Androgel

Before starting treatment with Androgel, testosterone deficiency must be clinically clearly evident (regression of male characteristics, reduction in muscle mass, weakness or fatigue, decreased sexual desire/drive, inability to achieve/maintain an erection, etc.) and confirmed by laboratory tests performed in the same laboratory.

Androgel is not recommended for the treatment of:

• male sterility or impotence,
• children, as clinical data are not available for boys under 18 years of age,
• women, due to the possible development of male characteristics.

Androgens may increase the risk of developing benign prostatic hyperplasia (enlarged prostate) or prostate cancer, so you should have a thorough prostate examination before starting treatment and during treatment, in accordance with your doctor’s recommendations.

If you have severe heart, liver or kidney disease, treatment with Androgel may cause serious complications characterised by water retention in the body (edema) which may sometimes be associated with congestive heart failure (fluid overload of the heart).

Testosterone can cause an increase in blood pressure and should be used with caution if you have high blood pressure.

There have been reports of worsening breathing problems during sleep in some people treated with testosterone, especially those who are very obese or who suffer from breathing difficulties.

If you have cancer that affects the bones, you may have high levels of calcium in your blood or urine. Androgel may also increase your calcium levels. Your doctor may want to check your calcium levels and perform blood tests during your treatment with Androgel.

If you receive long-term testosterone replacement therapy, an abnormal increase in the number of red blood cells in the blood (polycythemia) may occur. That is why regular blood tests are necessary for monitoring.

Androgel should be used with caution in patients with epilepsy and migraine as these diseases may be exacerbated.

In case of severe skin reactions, treatment should be considered and discontinued if necessary.

The following may indicate that you are taking too much medicine:

• irritability
• nervousness
• weight gain
• prolonged or frequent erections

Inform your doctor about this, who will adjust your daily dose of Androgel.

Before starting treatment, your doctor will perform the necessary examinations. For example, your testosterone levels will need to be determined during two visits before starting therapy. In addition, regular check-ups are required during therapy (at least once a year, and twice a year if you are an elderly person or a patient at risk).

Possible testosterone transfer

If the treated area is not covered, testosterone can be transmitted to another person through close and relatively prolonged skin-to-skin contact.

In your partner, this may manifest as signs of increased testosterone such as facial and body hair growth, deepening of the voice, and menstrual irregularities. Wearing clothing that covers the application site, or washing the area before contact, protects against such transmission.

The following precautions are recommended:

• Wash your hands with soap and water after applying the gel.
• After the gel has dried, cover the application site with clothing.
• take a shower before having sex

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

• Immediately wash any skin that may have been exposed to testosterone with soap and water.
• Tell your doctor about signs such as acne or increased body or facial hair.

To avoid putting anyone else at risk, you should wait a longer period of time between applying Androgel and having sex.

You should also wear a shirt that covers the Androgel application site during close contact, or take a bath or shower before contact.

Furthermore, you should wait at least six hours between applying the gel and bathing or showering. Taking a short bath or shower within one to six hours of applying the gel should not significantly affect the effects of the treatment.

Taking other medicines with Androgel

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, especially oral anticoagulants (for “blood thinning”), insulin and corticosteroids. In this case, the dose of Androgel may need to be adjusted.

Pregnancy and breastfeeding

Androgel should not be taken by pregnant or breastfeeding women.

Pregnant women should avoid any contact with the application site. The drug may have unwanted masculinizing effects on the fetus. In case of contact, as recommended above, wash the application site as soon as possible with soap and water.

If your partner becomes pregnant, you must follow the advice regarding avoiding testosterone transfer.

Vehicle and machinery management

Androgel does not affect the ability to drive or use machines.

Sportsmen and sportswomen

As the medicine contains the active substance testosterone, it should be kept in mind that it may cause a positive reaction during anti-doping testing.

3. How to use ANDROGEL

The medicine should only be taken by adult men.

Always use Androgel exactly as your doctor has told you.

The recommended dose is 5 g of gel (ie 50 mg of testosterone) once a day, around the same time, preferably in the morning.

The doctor may adjust the daily dose of the gel for each individual patient, but it should not exceed 10 g of gel per day. Gently spread the gel in a thin layer on clean, dry and healthy skin of the shoulders, arms or abdomen.

After opening, squeeze out the entire contents of the sachet and apply immediately to the skin. Allow to dry for at least 3 to 5 minutes before dressing. Wash hands with soap and water after application.

Do not apply in the genital area (penis and testicles) because the high alcohol content can cause local irritation.

If you take more Androgel than you should

Seek advice from your doctor.

If you forget to take Androgel

Do not apply a double dose to make up for a forgotten one.

If you stop taking Androgel

You should not stop treatment with Androgel unless your doctor tells you to.

If you have any questions or concerns about the use of Androgel, please contact your doctor or pharmacist.

4. Possible side effects

Like all medicines, Androgel can cause side effects.

Very common side effects (affecting more than 10 in 100 people treated): Due to the alcohol in the product, frequent application to the skin may cause irritation and dry skin. Acne may occur.

Common side effects (in 1 to 10 patients out of 100 treated):

Androgel can cause:

• headache, hair loss, painful, hard or enlarged breasts, prostate changes, diarrhea, dizziness, high blood pressure, mood swings, changes in laboratory findings (lipid changes, increased red blood cell count), skin hypersensitivity, tingling and memory loss.

Other side effects of oral forms or injections containing testosterone have also been registered :

• weight gain, changes in blood salts (electrolytes), muscle pain, nervousness, depression, hostile behavior, difficulty breathing during sleep, yellowing of the skin (jaundice), changes in liver function test results, seborrhea (increased secretion of the sebaceous glands), changes in sex drive, reduced sperm count, frequent or prolonged erections, blockage that makes it difficult to pass urine, water retention, hypersensitivity reactions.

If you notice any side effects, you should inform your doctor or pharmacist.

5. How to store Androgel

The medicine does not require any special storage conditions.

You must keep Androgel out of the reach and sight of children.

Androgel should not be used after the expiry date stated on the packaging.

6. Additional information

The active substance is testosterone. One sachet (5 g of gel) contains 50 mg of testosterone.

The excipients are carbomer 980, isopropyl myristate, ethanol (96 percent), sodium hydroxide, purified water.

What Androgel looks like and the contents of the package

Androgel 50 mg is a colorless gel packaged in a sachet (5 g of gel), in a box of 30 sachets.