Αγαπητέ, η ιατρική προτείνει αλλά αναφέρει και warnings, precautions, side effects.
17 PATIENT COUNSELING INFORMATION “See FDA-approved patient labeling (Patient Information)”
17.1 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 PROPECIA tablets because of the possibility of absorption of finasteride and the subsequent potential risk to a male fetus. PROPECIA 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 PROPECIA tablets, the contact area should be washed immediately with soap and water [see Contraindications (4), Warnings and Precautions (5.1), Use in Specific Populations (8.1) and How Supplied/Storage and Handling (16)].
17.2 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 5αreductase inhibitors indicated for BPH treatment, compared to those treated with placebo in studies looking at the use of these drugs to prevent prostate cancer [see Warnings and Precautions (5.3) and Adverse Reactions (6.1)].
17.3 Additional Instructions
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 PROPECIA and to read it again each time the prescription is renewed so that they are aware of current information for patients regarding PROPECIA.
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