Finasteride (Page 6 of 7)

14.3 Summary of Clinical Studies

The data from these studies, showing improvement in BPH-related symptoms, reduction in treatment failure (BPH-related urological events), increased maximum urinary flow rates, and decreasing prostate volume, suggest that finasteride arrests the disease process of BPH in men with an enlarged prostate.

16 HOW SUPPLIED/STORAGE AND HANDLING

Finasteride Tablets USP, 5 mg are available as blue, film-coated, capsule-shaped, unscored tablets, debossed “93” on one side and “7355” on the other side, in bottles of 30, 90, and 500 tablets.

NDC 0093-7355-56 bottle of 30.

NDC 0093-7355-98 bottle of 90.

NDC 0093-7355-05 bottle of 500.

Storage and Handling

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Protect from light. Keep container tightly closed.

Females should not handle crushed or broken finasteride tablets, USP when they are pregnant or may potentially be pregnant because of the possibility of absorption of finasteride, USP and the subsequent potential risk to a male fetus [see Warnings and Precautions (5.3), and Use in Specific Populations (8.1)].

Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

17.1 Increased Risk of High-Grade Prostate Cancer

Patients should be informed that there was an increase in high-grade prostate cancer in men treated with 5α-reductase inhibitors indicated for BPH treatment, including finasteride, compared to those treated with placebo in studies looking at the use of these drugs to prevent prostate cancer [see Indications and Usage (1.3), Warnings and Precautions (5.2), and Adverse Reactions (6.1)].

17.2 Exposure of Females – Risk to Male Fetus

Physicians should inform patients that females who are pregnant or may potentially be pregnant should not handle crushed or broken finasteride tablets because of the possibility of absorption of finasteride and the subsequent potential risk to the male fetus. Finasteride tablets are coated and will prevent contact with the active ingredient during normal handling, provided that the tablets have not been broken or crushed. If a female who is pregnant or may potentially be pregnant comes in contact with crushed or broken finasteride tablets, the contact area should be washed immediately with soap and water [see Contraindications (4), Warnings and Precautions (5.3), Use in Specific Populations (8.1) and How Supplied/Storage and Handling (16)].

17.3 Additional Instructions

Physicians should inform patients that the volume of ejaculate may be decreased in some patients during treatment with finasteride. This decrease does not appear to interfere with normal sexual function. However, impotence and decreased libido may occur in patients treated with finasteride [see Adverse Reactions (6.1)].

Physicians should instruct their patients to promptly report any changes in their breasts such as lumps, pain or nipple discharge. Breast changes including breast enlargement, tenderness and neoplasm have been reported [see Adverse Reactions (6.1)].

Physicians should instruct their patients to read the patient package insert before starting therapy with finasteride and to re-read it each time the prescription is renewed so that they are aware of current information for patients regarding finasteride.

Brands listed are the trademarks of their respective owners.

Manufactured In Croatia By:
Pliva Hrvatska d.o.o.
Zagreb, Croatia

Manufactured For:
Teva Pharmaceuticals USA, Inc.
North Wales, PA 19454

Rev. Q 1/2022

PATIENT INFORMATION

Finasteride (fin as’ ter ide) Tablets
Finasteride tablets are for use by men only.

Please read this leaflet before you start taking finasteride. Also, read it each time you renew your prescription, just in case anything has changed. Remember, this leaflet does not take the place of careful discussions with your doctor. You and your doctor should discuss finasteride when you start taking your medication and at regular checkups.

What is Finasteride?

Finasteride is a medication used to treat symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged prostate. Finasteride may also be used to reduce the risk of a sudden inability to pass urine and the need for surgery related to BPH in men with an enlarged prostate.

Finasteride may be prescribed along with another medicine, an alpha-blocker called doxazosin, to help you better manage your BPH symptoms.

Who should NOT take Finasteride?

Finasteride is for use by MEN only.

Do Not Take finasteride if you are:

• a woman who is pregnant or may potentially be pregnant. Finasteride may harm your unborn baby. Do not touch or handle crushed or broken finasteride tablets (see “A warning about finasteride and pregnancy ”).
• allergic to finasteride or any of the ingredients in finasteride tablets. See the end of this leaflet for a complete list of ingredients in finasteride tablets.

A warning about finasteride and pregnancy:

Women who are or may potentially be pregnant must not use finasteride. They should also not handle crushed or broken tablets of finasteride. Finasteride 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 who is pregnant with a male baby absorbs the active ingredient in finasteride after oral use or through the skin, it may cause the male baby to be born with abnormalities of the sex organs. If a woman who is pregnant comes into contact with the active ingredient in finasteride, a doctor should be consulted.

How should I take finasteride?

Follow your doctor’s instruction.

• Take one tablet by mouth each day. To avoid forgetting to take finasteride, you can take it at the same time every day.
• If you forget to take finasteride, do not take an extra tablet. Just take the next tablet as usual.
• You may take finasteride with or without food.
• Do not share finasteride with anyone else; it was prescribed only for you.

What are the possible side effects of finasteride?

Finasteride may increase the chance of a more serious form of prostate cancer.

The most common side effects of finasteride include:

• trouble getting or keeping an erection (impotence)
• decrease in sex drive
• decreased volume of ejaculate
• ejaculation disorders
• enlarged or painful breast. You should promptly report to your doctor any changes in your breasts such as lumps, pain or nipple discharge.

The following have been reported in general use with finasteride tablets 5 mg and/or finasteride at lower doses:

• allergic reactions, including rash, itching, hives, and swelling of the lips, tongue, throat, and face
• rarely, some men may have testicular pain
• blood in semen
• trouble getting or keeping an erection that continued after stopping the medication
• problems with ejaculation that continued after stopping the medication
• male infertility and/or poor quality of semen. Improvement in the quality of semen has been reported after stopping the medication.
• depression
• decrease in sex drive that continued after stopping the medication
• in rare cases, male breast cancer has been reported.

You should discuss side effects with your doctor before taking finasteride and anytime you think you are having a side effect. These are not all the possible side effects with finasteride. For more information, ask your doctor or pharmacist.

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

What you need to know while taking finasteride:

• You should see your doctor regularly while taking finasteride. Follow your doctor’s advice about when to have these checkups.
• Checking for prostate cancer. Your doctor has prescribed finasteride for BPH and not for treatment of prostate cancer — but a man can have BPH and prostate cancer at the same time. Your doctor may continue checking for prostate cancer while you take finasteride.
• About Prostate-Specific Antigen (PSA). Your doctor may have done a blood test called PSA for the screening of prostate cancer. Because finasteride decreases PSA levels, you should tell your doctor(s) that you are taking finasteride. Changes in PSA levels will need to be evaluated by your doctor(s). Any increase in follow-up PSA levels from their lowest point may signal the presence of prostate cancer and should be evaluated, even if the test results are still within the normal range. You should also tell your doctor if you have not been taking finasteride as prescribed because this may affect the PSA test results. For more information, talk to your doctor.

How should I store finasteride?

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

Keep finasteride tablets and all medications out of the reach of children.

Do not give your finasteride tablets to anyone else. It has been prescribed only for you.

For more information call 1-888-838-2872.

What are the ingredients in finasteride?
Active ingredient: finasteride
Inactive ingredients: FD&C Blue No. 2 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized corn starch, sodium lauryl sulfate, sodium starch glycolate type A potato, and titanium dioxide.

What is BPH?

BPH is an enlargement of the prostate gland. The prostate is located below the bladder. As the prostate enlarges, it may slowly restrict the flow of urine. This can lead to symptoms such as:

• a weak or interrupted urinary stream
• a feeling that you cannot empty your bladder completely
• a feeling of delay or hesitation when you start to urinate
• a need to urinate often, especially at night
• a feeling that you must urinate right away.

In some men, BPH can lead to serious problems, including urinary tract infections, a sudden inability to pass urine (acute urinary retention), as well as the need for surgery.

What finasteride does:

Finasteride lowers levels of a hormone called DHT (dihydrotestosterone), which is a cause of prostate growth. Lowering DHT leads to shrinkage of the enlarged prostate gland in most men. This can lead to gradual improvement in urine flow and symptoms over the next several months. Finasteride will help reduce the risk of developing a sudden inability to pass urine and the need for surgery related to an enlarged prostate. However, since each case of BPH is different, you should know that:

• Even though the prostate shrinks, you may NOT notice an improvement in urine flow or symptoms.
• You may need to take finasteride for six (6) months or more to see whether it improves your symptoms.
• Therapy with finasteride may reduce your risk for a sudden inability to pass urine and the need for surgery for an enlarged prostate.

Manufactured In Croatia By:
Pliva Hrvatska d.o.o.
Zagreb, Croatia

Manufactured For:
Teva Pharmaceuticals USA, Inc.
North Wales, PA 19454

Rev. N 1/2022