USE

AndroGel® (testosterone gel) is a prescription medicine used to treat adult males who have low or no testosterone.

IMPORTANT SAFETY INFORMATION

Signs of puberty that are not expected have happened in young children who were accidentally exposed to testosterone through contact with men using AndroGel.

AndroGel can transfer from your body to others. This can happen if other people come into contact with the area where the AndroGel was applied to your skin.

• Women and children should avoid contact with the unwashed or unclothed application area where AndroGel has been applied.
• To lower the risk of transfer of AndroGel, you should apply AndroGel only to areas that will be covered by a short sleeve T-shirt. These areas include shoulders, upper arms, and stomach area. Do not apply AndroGel to your penis or scrotum. Wash your hands right away with soap and water after applying AndroGel. After the gel has dried, cover the application area with clothing. If you expect to have skin-to-skin contact with another person, first wash the application area well with soap and water. If a woman or child makes contact with the AndroGel application area, that area on the woman or child should be washed well with soap and water right away.

Stop using AndroGel and call your healthcare provider right away if you see any signs or symptoms of puberty in a child, or changes in body hair or increased acne in a woman, that may have occurred through accidental exposure to AndroGel.

Do not use AndroGel if you: have breast cancer; have or might have prostate cancer; or are allergic to any of the ingredients in AndroGel, including soy.

AndroGel is not meant for use in women and must not be used in women who are pregnant, may become pregnant, or are breast-feeding. AndroGel may harm the unborn or breast-feeding baby. Women who are pregnant or who may become pregnant should avoid contact with the skin area where AndroGel has been applied.

Other serious side effects include the following:

• If you already have enlargement of your prostate gland, your signs and symptoms can get worse while using AndroGel (including changes in urination)
• Possible increased risk of prostate cancer
• In large doses, AndroGel may lower your sperm count
• Swelling of your ankles, feet, or body, with or without heart failure. This may cause serious problems for people who have heart, kidney, or liver disease
• Enlarged or painful male breasts
• Having problems breathing while you sleep (sleep apnea)
• Blood clots in the legs. This can include pain, swelling, or redness of your legs

Tell your healthcare provider about all the medicines you take, especially if you take insulin, corticosteroids, or medicines that decrease blood clotting.

The most common side effects reported with use of AndroGel are acne, skin irritation where the gel is applied, increased cholesterol levels, increased prostate specific antigen, increased red blood cell count, and increased liver function tests.

For further information, talk with your healthcare provider.

Please see full Prescribing Information including the Medication Guide, for AndroGel.

If you have any questions about this information, be sure to discuss them with your doctor. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

If you cannot afford your medication, visit www.pparx.org or call the toll-free number (1-888-4PPA-NOW) for assistance.

This information is intended for residents of the United States.
For international product information please visit us at http://www.solvay.com.
© 2010 Solvay Pharmaceuticals, Inc.
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