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PROPECIA®*

(finasteride) Tablets, 1 mg

Patient Information about

PROPECIA (Pro-pee-sha)

Generic name: finasteride

(fin-AS-tur-eyed)

PROPECIA** is for use by MEN ONLY.

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.

Results of clinical studies:

For 12 months, doctors studied over 1800 men aged 18 to 41 with mild to moderate amounts of ongoing hair loss. Of these men, approximately 1200 with hair loss at the top of the head participated in additional extension studies, resulting in a total study time of up to five years. In general, men who took PROPECIA maintained or increased the number of visible scalp hairs and noticed improvement in their hair in the first year. Improvement, compared to the start of the study, was maintained through the remaining years of treatment. Hair counts in men who did not take PROPECIA continued to decrease. In one study, patients were questioned on the growth of body hair. PROPECIA did not appear to affect hair in places other than the scalp.

Will PROPECIA work for me?

For most men, PROPECIA increases the number of scalp hairs in the first year of treatment, helping to fill in thin or balding areas of the scalp. In addition, men taking PROPECIA may note a slowing of hair loss. Although results will vary, generally you will not be able to grow back all of the hair you have lost. There is not sufficient evidence that PROPECIA works in the treatment of receding hairline in the temporal area on both sides of the head.

Male pattern hair loss occurs gradually over time. On average, healthy hair grows only about half an inch each month. Therefore, it will take time to see any effect. You may need to take PROPECIA daily for three months or more before you see a benefit from taking PROPECIA. PROPECIA can only work over the long term if you continue taking it. If the drug has not

worked for you in twelve months, further treatment is unlikely to be of benefit. If you stop taking PROPECIA, you will likely lose the hair you have gained within 12 months of stopping treatment. You should discuss this with your doctor.

PROPECIA is not effective in the treatment of hair loss due to androgenetic alopecia in postmenopausal women. PROPECIA should not be taken by women.

How should I take PROPECIA?

Follow your doctor’s instructions.

• Take one tablet by mouth each day.

• You may take PROPECIA with or without food.

• If you forget to take PROPECIA, do not take an extra tablet. Just take the next tablet as usual.

PROPECIA will not work faster or better if you take it more than once a day.

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.

What are the possible side effects of PROPECIA?

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 PROPECIA (finasteride) Tablets 96360013 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: allergic reactions including rash, itching, hives and swelling of the lips and face; problems with ejaculation; breast tenderness and enlargement; and testicular pain. 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.

Please note: 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 that you are taking PROPECIA.

Storage and handling.

Keep PROPECIA in the original container and keep the container closed. Store it in a dry place at room temperature. PROPECIA tablets are coated and will prevent contact with the active ingredient during normal handling, provided that the tablets are not broken or crushed.