Note: Women who are pregnant or may become pregnant should not use finasteride or handle the crushed or broken tablets. Finasteride can cause birth defects in male babies.

Finasteride is used to treat men with benign prostatic hyperplasia (BPH) and male pattern hair loss, also called androgenetic alopecia. BPH is caused by an enlarged prostate. Men with BPH usually have difficulty urinating, a decreased flow of urination, hesitation at the beginning of urination, and a need to get up at night to urinate. Finasteride will make these symptoms less severe and reduce the chance that prostate surgery will be needed. It may be used alone or in combination with other medicines such as an alpha-blocker (doxazosin, Cardura®) to treat BPH. For men with hair loss, finasteride will increase the number of scalp hairs but will not increase the amount of body hair.

Finasteride blocks the action of an enzyme called 5-alpha-reductase. This enzyme changes testosterone to another hormone that causes the prostate to grow or hair loss in males. It will increase testosterone levels in the body, which decreases prostate size and increases hair growth on the scalp. The effect of finasteride on the prostate and scalp will only last as long as the medicine is taken. When it is stopped, the prostate begins to grow again and the hair will be lost.

This medicine is available only with your doctor's prescription.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

You may take this medicine with or without food.

If you are taking this medicine for male pattern hair loss, it may take at least 3 months to see an effect. The medicine will not cure hair loss, but it will cause scalp hair to grow. The hair growth will only last as long as the medicine is used. The new hair will be lost within 1 year after the medicine is stopped.

If you are taking this medicine for benign prostatic hyperplasia (BPH), it may take up to 6 months to see the full effect. The medicine will not cure BPH, but it does help reduce the size of the prostate and improve symptoms. The effect on the prostate will only last as long as the medicine is used. When it is stopped, the prostate begins to grow again within a few months.

Take this medicine at the same time each day.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Chills

cold sweats

confusion

dizziness, faintness, or lightheadedness when getting up from a lying or sitting position

Less common

Bloating or swelling of the face, arms, hands, lower legs, or feet

breast enlargement and tenderness

hives or welts

itchy skin

rapid weight gain

redness of the skin

skin rash

swelling of the lips and face

tingling of the hands or feet

unusual weight gain or loss

Incidence not known

Clear or bloody discharge from the nipple

dimpling of the breast skin

inverted nipple

lump in the breast or under the arm

persistent crusting or scaling of the nipple

redness or swelling of the breast

sore on the skin of the breast that does not heal

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Decreased interest in sexual intercourse

inability to have or keep an erection

loss in sexual ability, desire, drive, or performance

Less common

Runny nose

sleepiness or unusual drowsiness

sneezing

stuffy nose

Less common or rare

Abdominal or stomach pain

back pain

decreased amount of semen

diarrhea

dizziness

headache

Incidence not known

Testicular pain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood tests may be needed to check for unwanted effects.

Women and children should not use this medicine. Women who are pregnant or may become pregnant should not handle crushed or broken tablets. Finasteride can be absorbed through the skin and cause birth defects in male babies. If a woman does come in contact with this medicine, the affected area should be washed right away with soap and water.

This medicine may cause changes to the breast tissue. Tell your doctor if you have any lumps, pain, tenderness, or an enlargement of the breasts while using this medicine.

This medicine will not prevent prostate cancer but may increase your risk of developing high-grade prostate cancer. Tell your doctor if you have concerns about this risk.

This medicine may affect the results of the prostate specific antigen (PSA) test, which may be used to detect prostate cancer. Make sure you tell all of your doctors that you are using this medicine.

This medicine may cause a decrease in the amount of semen you ejaculate during sex. This will not affect your sperm count or your ability to have children.