Finasteride

IMPORTANT SAFETY INFORMATION

Finasteride is for use by MEN ONLY and should NOT be used by women or children.

Read this patient information before you start taking Finasteride and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.

What is Finasteride?

Finasteride is a prescription medicine used for the treatment of male pattern hair loss (androgenetic alopecia).

It is not known if Finasteride works for a receding hairline on either side of and above your forehead (temporal area).

Finasteride is not for use by women and children, and should not be handled by women and children.

Who should not take Finasteride?

Do not take Finasteride if you:

• are pregnant or may become pregnant. Finasteride may harm your unborn baby.

  • Finasteride tablets are coated and will prevent contact with the medicine during handling, as long as the tablets are not broken or crushed. Females who are pregnant or who may become pregnant should not come in contact with broken or crushed Finasteride tablets.
  • If a pregnant woman comes in contact with crushed or broken Finasteride tablets, wash the contact area right away with soap and water. If a woman who is pregnant comes into contact with the active ingredient in Finasteride, a healthcare provider should be consulted. If a woman who is pregnant with a male baby swallows or comes in contact with the medicine in Finasteride, the male baby may be born with sex organs that are not normal.

• are allergic to any of the ingredients in Finasteride.

What should I tell my healthcare provider before taking Finasteride? Before taking Finasteride, tell your healthcare provider if you:

• have any other medical conditions, including problems with your prostate or liver.

Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Know the medications you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medication.

How should I take Finasteride?

• Take Finasteride exactly as your healthcare provider tells you to take it.
• You may take Finasteride with or without food.
• If you forget to take Finasteride, do not take an extra tablet. Just take the next tablet as usual.

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

What are the common side effects of this medication?

Common side effects include rash, breast tenderness or enlargement (reported in less than 1% of patients) which typically resolve after the medication is stopped, and sexual dysfunction (in clinical trials, 1.2%-1.4% of patients taking Finasteride experienced medication-related sexual dysfunction side effects including decreased libido, erectile dysfunction or a decrease in the volume of ejaculation vs. 1% of those taking placebo):

• Decreased libido 1.8%
• Erectile dysfunction 1.3%
• Decreased volume of ejaculate 1.2%

Several studies have documented the majority of these side effects are reversible. However, 1.4% of the patients who experience side effects may continue to have symptoms following discontinuation of Finasteride. Of particular note there has been an association of the sexual dysfunction symptoms and the use of NSAIDS (Motrin, Advil, Aleve type medications.) For this reason Finasteride should be stopped for the period of time when you take NSAIDS.

Does Finasteride cause depression?

A literature review shows there may be evidence of increased depressive symptoms in individuals younger than age 45 while using Finasteride for hair loss. Patients with new or worsening depression should stop Finasteride use and follow up with their health care provider or a mental health therapist. Source: MedPageToday.org

Does Finasteride cause prostate cancer or prostate enlargement (BPH)?

There have been reports of a slight increased risk (1.8% with 5mg Finasteride dosage versus 1.0% placebo) of high grade prostate cancer for men over age 55 years old. These reports are from men taking a higher dosage of Finasteride (5mg) than the dosage we prescribe for hair loss (1mg). There have been conflicting studies on the increased risk in the number of high grade prostate cancers; however, several recent studies have shown no increase in the number of deaths (with a recent study showing fewer deaths) in patients who use Finasteride at the 1mg dosage. Finasteride can be useful in the treatment of BPH and urinary retention because it can have an antiandrogenic effect (testosterone blocking) at a 5mg dosage. For hair loss, patients are given a 1mg dosage, which should not produce any antiandrogenic effect.

Does Finasteride change blood Prostate Specific Antigen (PSA) levels?

Finasteride 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 healthcare provider that you are taking Finasteride because Finasteride decreases PSA.

The following have been reported as less common side effects with Finasteride use:

• Allergic reactions including: rash, itching, hives and swelling of the lips, tongue, throat, and face
• Testicular pain
• Male infertility and/or poor quality of semen
• In rare cases, male breast cancer

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Finasteride. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

The following have been reported in general use with Finasteride:

• breast tenderness and enlargement. Tell your healthcare provider about any changes in your breasts such as lumps, pain or nipple discharge.
• decrease in sex drive that continued after stopping the medication.
• allergic reactions including rash, itching, hives and swelling of the lips, tongue, throat, 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.
• in rare cases, male breast cancer.

Depression: A literature review shows there may be evidence of increased depressive symptoms in users younger than age 45 while using finasteride for hair loss. Patients with new or worsening depression should stop finasteride use and follow up with their health care provider or a mental health therapist. Source: MedPageToday.org

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Finasteride. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA1088.

How should I store Finasteride?

• Store Finasteride at room temperature between 59˚F to 86˚F (15˚C to 30˚C).
• Keep Finasteride in a closed container and keep Finasteride tablets dry (protect from moisture).

Keep Finasteride and all medicines out of the reach of children.

General information about the safe and effective use of Finasteride.

Medicines are sometimes prescribed for purposes other than those listed in this Patient Information. Do not use Finasteride for a condition for which it was not prescribed. Do not give Finasteride to other people, even if they have the same symptoms you have. It may harm them.