Based on a photographic assessment by an expert panel of dermatologists following 5 years of clinical studies. Most men in the clinical studies saw results 3 to 12 months after starting PROPECIA. If PROPECIA has not worked for you in twelve months, further treatment is unlikely to be of benefit.
PROPECIA is a prescription medicine used for the treatment of male pattern hair loss (androgenetic alopecia). It is not known if PROPECIA works for a receding hairline on either side of and above your forehead (temporal area).

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.
Women who are or may 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.

HOW PROPECIA WORKS

PROPECIA blocks the formation of a key factor of certain types of male pattern hair loss (MPHL).
PROPECIA is the first pill that effectively treats MPHL on the vertex (at top of head) and anterior mid-scalp area.
PROPECIA blocks the formation of DHT in your scalp. Lowering the DHT appears to inhibit the further shrinking of affected hair follicles, (either regrowth of hair, 48% [134 out of 279], or no further hair loss, 42% [117 out of 279]) vs 25% (4 out of 16) on placebo (sugar pill), according to an assessment of photographs by an independent panel of dermatologists.

You should not use PROPECIA if you are allergic to finasteride or any of the ingredients of PROPECIA.
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 (tell your doctor about any changes in your breasts such as lumps, pain, or nipple discharge); depression; decrease in sex drive that continued after stopping the medication; allergic reactions including rash, itching, hives, and swelling of the lips and face; problems with ejaculation that continued after stopping medication; testicular pain; difficulty in achieving an erection that continued after stopping the medication; male infertility and/or poor quality of semen; and, in rare cases, male breast cancer. Tell your doctor if you have any side effect that bothers you or that does not go away.

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 health care provider that you are taking PROPECIA because PROPECIA decreases PSA levels. Changes in PSA levels will need to be evaluated by your health care provider. 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 health care provider if you have not been taking PROPECIA as prescribed because this may affect the PSA test results. For more information, talk to your health care provider. There may be an increased risk of a more serious form of prostate cancer in men taking finasteride at 5 times the dose of PROPECIA.

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.

CLINICAL STUDY

Clinical Study

• A study of men with mild to moderate hair loss taking PROPECIA after five years
• 90% of men who took PROPECIA had visible results: either regrowth of hair (48%) or no further hair loss (42%)
• Two out of three men who took PROPECIA regrew hair
• All the men not taking PROPECIA lost hair
• The majority of men who took PROPECIA were rated as improved by doctors 77% vs 15% of men who took a placebo
  Although results will vary, generally you will not be able to grow back all of the hair you have lost.

POSSIBLE SIDE EFFECTS

Possible Side Effects
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 (tell your doctor about any changes in your breasts such as lumps, pain, or nipple discharge); depression; decrease in sex drive that continued after stopping the medication; allergic reactions including rash, itching, hives, and swelling of the lips and face; problems with ejaculation that continued after stopping medication; testicular pain; difficulty in achieving an erection that continued after stopping the medication; male infertility and/or poor quality of semen; and, in rare cases, male breast cancer. Tell your doctor if you have any side effect that bothers you or that does not go away. 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. For more information, talk to your doctor.

ALREADY TAKING PROPECIA

Because hair loss may vary from one guy to the next, it makes sense that hair regrowth may vary, too. Some men notice a difference in as little as 3 months after starting treatment with PROPECIA, but most men have to use PROPECIA for at least 6 months before determining whether they have visible results. PROPECIA can only work over the long term if you continue taking it. If you stop, you will likely lose any hair you have gained within 12 months of stopping treatment. If PROPECIA has not worked for you within 12 months, further treatment is unlikely to be of benefit.