PROPECIA

What is PROPECIA used for?
PROPECIA is used for the treatment of male pattern hair loss on the vertex and the anterior mid-scalp area.

PROPECIA is for use by MEN ONLY and should NOT be used by women or children.

What is male pattern hair loss?
Male pattern hair loss is a common condition in which men experience thinning of the hair on the scalp.

Often, this results in a receding hairline and/or balding on the top of the head. These changes typically begin gradually in men in their 20s.

Doctors believe male pattern hair loss is due to heredity and is dependent on hormonal effects. Doctors refer to this type of hair loss as androgenetic alopecia.

A 5-year clinical study demonstrated the effectiveness of PROPECIA.

• 9 of 10 men who took PROPECIA had visible results—either regrowth of hair (48% [134 of 279]) or no further hair loss (42% [117 of 279])—vs 25% [4 of 16] who took a placebo (sugar pill), according to an assessment of photographs by an independent panel of dermatologists.
• 2 of 3 men who took PROPECIA regrew hair, as measured by hair count. All of the men in the study who were not taking PROPECIA lost hair.
• A majority of men who took PROPECIA were rated as improved by doctors—77% (210 of 271) vs 15% (2 of 13) of men who took a placebo.
• A majority of men who took PROPECIA reported that their bald spot got smaller, their hair loss slowed down, and the appearance of their hair improved.

Who should NOT take PROPECIA?

• PROPECIA is for the treatment of male pattern hair loss in MEN ONLY and should not be taken by women (see A warning about PROPECIA and pregnancy).
• PROPECIA should not be taken by children.
• Anyone allergic to any of the ingredients.

A warning about PROPECIA and pregnancy.

• Women who are or may potentially be pregnant:
  - must not use PROPECIA
  - should not handle crushed or broken tablets of PROPECIA.
  

If a woman who is pregnant with a male baby absorbs the active ingredient in PROPECIA, either by swallowing or through the skin, it 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.

Like all prescription products, PROPECIA may cause side effects. In clinical studies, side effects from PROPECIA were uncommon and did not affect most men. A small number of men experienced certain sexual side effects. These men reported one or more of the following: less desire for sex; difficulty in achieving an erection; and, a decrease in the amount of semen. Each of these side effects occurred in less than 2% of men. These side effects went away in men who stopped taking PROPECIA. They also disappeared in most men who continued taking PROPECIA.

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, you should tell your doctor(s) that you are taking PROPECIA. Because PROPECIA decreases PSA levels, changes in PSA levels will need to be evaluated by your doctor(s). Any increase in follow-up PSA levels from their lowest point may signal the presence of prostate cancer and should be evaluated even if the test results are still within the normal range for men not taking PROPECIA. You should also tell your doctor if you have not been taking PROPECIA as prescribed because this may affect the PSA test results.