PROPECIA was developed to treat mild to moderate male pattern hair loss on the vertex (top of head) and anterior mid-scalp area (middle front of head) in MEN ONLY. There is not sufficient evidence that PROPECIA works for receding hairlines at the temples.

Important Risk Information About PROPECIA

PROPECIA is for the treatment of male pattern hair loss in MEN ONLY and should NOT be used by women or children.

You should not use PROPECIA if you are allergic to finasteride or any of the ingredients of PROPECIA.

Women who are or may potentially be pregnant must not use PROPECIA and should not handle crushed or broken PROPECIA tablets because the active ingredient may cause abnormalities of a male baby's sex organs. If a woman who is pregnant comes into contact with the active ingredient in PROPECIA, a doctor should be consulted. PROPECIA tablets are coated and will prevent contact with the active ingredient during normal handling, provided that the tablets are not broken or crushed.

In clinical studies for PROPECIA, a small number of men experienced certain sexual side effects, such as less desire for sex, difficulty in achieving an erection, or a decrease in the amount of semen. Each of these side effects occurred in less than 2% of men and went away in men who stopped taking PROPECIA because of them.

In general use, the following have been reported: breast tenderness and enlargement; depression; allergic reactions including rash, itching, hives, and swelling of the lips and face; problems with ejaculation; testicular pain; difficulty in achieving an erection that continued after stopping the medication; and, in rare cases, male breast cancer. You should promptly report to your doctor any changes in your breasts such as lumps, pain, or nipple discharge. Tell your doctor promptly about these or any other unusual side effects.

PROPECIA can affect a blood test called PSA (prostate-specific antigen) for the screening of prostate cancer. If you have a PSA test done, tell your doctor that you are taking PROPECIA because PROPECIA decreases PSA levels; also tell your doctor if you have not been taking PROPECIA as prescribed because this may affect PSA test results. Any changes in PSA test results while taking PROPECIA will need to be carefully evaluated by 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.

Please read the Patient Information and discuss it with your doctor. The physician Prescribing Information also is available.

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