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PROSCAR (FINASTERIDE): PATIENT COUNSELING INFORMATION

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 5-alpha-reductase inhibitors indicated for BPH treatment, including Proscar (Finasteride), compared to those treated with placebo in studies looking at the use of these drugs to prevent prostate cancer.

Exposure of Women - Risk to Male Fetus

Physicians should inform patients that women who are pregnant or may potentially be pregnant should not handle crushed or broken Proscar (Finasteride) tablets because of the possibility of absorption of finasteride and the subsequent potential risk to the male fetus. Proscar 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 woman who is pregnant or may potentially be pregnant comes in contact with crushed or broken Finasteride (Proscar) tablets, the contact area should be washed immediately with soap and water.

Additional Instructions

Physicians should inform patients that the volume of ejaculate may be decreased in some patients during treatment with Finasteride (Proscar) 5 mg tablets. This decrease does not appear to interfere with normal sexual function. However, impotence and decreased libido may occur in patients treated with Proscar (Finasteride).

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.

Physicians should instruct their patients to read the patient package insert before starting therapy with Finasteride (Proscar) tablets and to reread it each time the prescription is renewed so that they are aware of current information for patients regarding Finasteride (Proscar).

Manufactured and distributed by Merck pharmaceutical company and its divisions.

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