In clinical studies with ‘Propecia’ in men 18-41 years of age, the mean value of serum prostate-specific antigen (PSA) decreased from 0.7 ng/ml at baseline to 0.5 ng/ml at month 12. Doubling the PSA level in men taking ‘Propecia’ should be considered before evaluating this test result. This decrease in serum PSA concentrations needs to be considered, if treatment with 'Propecia', a patient requires a PSA assay. In this case the PSA value should be doubled before making comparison with the results from untreated men."
A new paragraph has been added regarding fertility.
" Long-term data on fertility in humans are lacking, and specific studies in sub fertile men have not been conducted. The male patients who were planning to father a child were initially excluded from clinical trials. Although, animal studies did not show relevant negative effects on fertility, spontaneous reports of infertility and /or poor seminal quality were received post-marketing. In some of these reports, patients had other risk factors that might have contributed to infertility. Normalisation or improvement of seminal quality has been reported after discontinuation of finasteride."
A statement on hepatic insufficiency has been added " The effect of hepatic insufficiency on the pharmacokinetics of finasteride has not been studied".
A new paragraph has been added regarding reports of breast cancer in men taking finasteride.
"Breast cancer has been reported in men taking finasteride 1 mg during the post-marketing period. Physicians should instruct their patients to promptly report any changes in their breast tissue such as lumps, pain, gynaecomastia or nipple discharge. "
Section 4.5 Interaction with other medicinal products and other forms of interaction -:
This section has been re-worded as follows:
"Finasteride is metabolized primarily via, but does not affect, the cytochrome P450 3A4 system. Although the risk for finasteride to affect the pharmacokinetics of other drugs is estimated to be small, it is probable that inhibitors and inducers of cytochrome P450 3A4 will affect the plasma concentration of finasteride. However, based on established safety margins, any increase due to concomitant use of such inhibitors is unlikely to be of clinical significance."
Section 4.8 Undesirable Effects -:
The section on post-marketing use has been revised. A table has been added listing adverse reactions during clinical trials and post-marketing use. In this table the following new side effects have been added:
" Cardiac disorder - not known: Palpitation"
"Hepatobiliary disorders - not known: increased hepatic enzymes"
"Reproductive system and breast disorders - …..not known:……..infertility"
Also in this section a new paragraph has been added to state that drug-related sexual undesirable effects were more common in the finasteride-treated men than the placebo-treated men:
"Drug-related sexual undesirable effects were more common in the finasteride-treated men than the placebo-treated men, with frequencies during the first 12 months of 3.8% vs 2.1%, respectively. The incidence of these effects decreased to 0.6% in finasteride-treated men over the following four years. Approximately 1% of men in each treatment group discontinued due to drug related sexual adverse experiences in the first 12 months, and the incidence declined thereafter
