Finasteride is used alone or with other medication to treat symptoms of benign prostatic hyperplasia (BPH) in men with enlarged prostate.

Finasteride is also used to treat male pattern hair loss in men.

finasteride is for use in men only.

Finasteride may also be used for purposes not listed in this medication guide.

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

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

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

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 finasteride 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 finasteride 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 Benign Prostatic Hyperplasia:

5 mg orally once a day

Comments:
-Dosing is the same both in monotherapy and in combination therapy.

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 finasteride if you are allergic to it.

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

Tell your doctor if you have ever had:

• prostate cancer; or

• liver disease or abnormal liver function tests.

finasteride 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 finasteride 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.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

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

Get emergency medical help if you have signs of an allergic reaction: 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 finasteride.

Common side effects of finasteride 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 affect finasteride, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to finasteride.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking finasteride.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.