Propecia prevents the conversion of testosterone to dihydrotestosterone (DHT) in the body.

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

Propecia is for use by men only and should not be used by women or children.

Propecia should never be taken by a woman or a child.

Finasteride can be absorbed through the skin. Finasteride can cause birth defects if a woman is exposed to it during pregnancy. The tablets should not be handled by a woman who is pregnant or who may become pregnant.

Propecia tablets are coated and will prevent contact with the active ingredient during normal handling, provided that the tablets are not broken or crushed. If a woman accidentally comes into contact with this medication from a broken or crushed tablet, wash the area with soap and water right away.

Before taking Propecia, tell your doctor if you have ever had an allergic reaction to finasteride, or to a similar medicine called dutasteride (Avodart).

Using Propecia may increase your risk of developing prostate cancer. Your doctor will perform tests to make sure you do not have other conditions that would prevent you from safely using this medicine.

Call your doctor at once if you notice any breast lumps, pain, nipple discharge, or other breast changes. These may be signs of male breast cancer.

Before taking this medicine

You should not use Propecia if you are allergic to finasteride.

Using Propecia may increase your risk of developing a serious form of prostate cancer. Ask your doctor about this risk.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

• prostate cancer; or

• liver disease or abnormal liver function tests.

This medicine should never be taken by a woman or a child.

Finasteride can cause birth defects if a woman is exposed to it during pregnancy. A broken Propecia tablet should not be handled by a woman who is pregnant or may become pregnant. The medicine from a broken tablet could be absorbed through the skin.

If a woman accidentally comes into contact with a broken or crushed tablet, wash the area with soap and water right away.

Take Propecia exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Your doctor will perform tests to make sure Propecia is the right treatment for you.

Take with a full glass of water at the same time each day, with or without food.

You may not fully benefit from this medicine for up to 3 months or longer. Use Propecia regularly for the best results.

Your doctor will need to check your progress on a regular basis. You will need frequent prostate specific antigen (PSA) tests to check for prostate cancer.

Tell your doctor if you stop taking Propecia on a regular basis because this could affect your PSA test results.

Store this medicine at room temperature, away from moisture, heat, and light. Keep the tablets in the original container, tightly closed when not in use.

Usual Adult Dose for Androgenetic Alopecia:

1 mg orally once a day

For the treatment of male pattern hair loss (androgenetic alopecia) in men only. (Safety and efficacy have been demonstrated in men between 18 to 41 years of age with mild to moderate hair loss of the vertex and anterior mid scalp area):

Comments:
-Daily use for 3 months or more is necessary before benefit is observed. Continued use is recommended to sustain benefit.
-Withdrawal of treatment leads to reversal of effect within 12 months.

Use: For the treatment of male pattern hair loss (androgenetic alopecia) in men only. (Safety and efficacy have been demonstrated in men between 18 to 41 years of age with mild to moderate hair loss of the vertex and anterior mid scalp area).

You should not use Propecia if you are allergic to finasteride.

Using Propecia may increase your risk of developing a serious form of prostate cancer. Ask your doctor about this risk.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

• prostate cancer; or

• liver disease or abnormal liver function tests.

This medicine should never be taken by a woman or a child.

Finasteride can cause birth defects if a woman is exposed to it during pregnancy. A broken Propecia tablet should not be handled by a woman who is pregnant or may become pregnant. The medicine from a broken tablet could be absorbed through the skin.

If a woman accidentally comes into contact with a broken or crushed tablet, wash the area with soap and water right away.

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Do not share this medicine with another person, even if they have the same symptoms you have.

Get emergency medical help if you have signs of an allergic reaction to Propecia: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you notice any signs of male breast cancer, such as:

• breast pain or lumps;

• nipple discharge; or

• any other breast changes.

Tell your doctor right away if you have:

• blood in your semen;

• pain in your testicles; or

• depression.

It may be harder for you to get a woman pregnant while you are using Propecia.

Common Propecia side effects may include:

• decreased interest in sex;

• trouble getting or keeping an erection;

• trouble having an orgasm;

• abnormal ejaculation; or

• breast swelling or tenderness.

The sexual side effects of finasteride may continue after you stop taking this medicine. Talk to your doctor if you have concerns about these side effects.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may interact with finasteride, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.