Merck Sharp & Dohme Limited

Section 4.3 Contraindications -:
This section has been updated to state that the product is not indicated for use in women or children. The rest of the section has been editorially changed.

"‘Proscar’ is not indicated for use in women or children. 
‘Proscar’ is contraindicated in the following: 
Hypersensitivity to any component of this product
Pregnancy - Use in women when they are or may potentially be pregnant (see 4.6 Pregnancy and lactation, Exposure to finasteride - risk to male foetus)."

Section 4.4 Special warnings and precautions for use -:

The sub-section "General", has been editorially revised as follows:
To avoid obstructive complications it is important that P patients with large residual urine and/or heavily decreased urinary flow are carefully controlled. The possibility of surgery should be an option. volume and/or severely diminished urinary flow should be carefully monitored for obstructive uropathy.

The sub-section heading "Effects on PSA and prostate specific antigen (PSA) and prostate cancer detection" has been revised. A statement that Proscar did not appear to alter the rate of prostate cancer detection has been added as follows:

"No clinical benefit has yet been demonstrated in patients with prostate cancer treated with ‘Proscar’. Patients with BPH and elevated serum prostate specific antigen (PSA) were monitored in controlled clinical studies with serial PSAs and prostate biopsies. In these BPH studies, ‘Proscar’ did not appear to alter the rate of prostate cancer detection, and the overall incidence of prostate cancer was not significantly different in patients treated with ‘Proscar’ or placebo."

Also under the same sub-section as above, the paragraph beginning " Digital rectal examination…" has been editorially revised as follows:
"Digital rectal examination, as well as other evaluations for prostate cancer, are recommended prior to initiating therapy with Proscar and periodically thereafter. should be carried out on patients with BPH prior to initiating therapy with Proscar and periodically thereafter. Serum PSA is also used for prostate cancer detection. Generally, when PSA assays are performed a baseline PSA>10 ng/ml…."

A new sub-section has been created "Drug/laboratory test interactions". Under this with the heading "Effects on the levels of PSA", a paragraph has been added about PSA levels decreasing in patients treated with Proscar. Patients treated with Proscar for six months or more, PSA values should be doubled for comparison to normal ranges in untreated men.

"Effect on levels of PSA
Serum PSA concentration is correlated with patient age and prostatic volume, and prostatic volume is correlated with patient age. When PSA laboratory determinations are evaluated, consideration should be given to the fact that PSA levels decrease in patients treated with ‘Proscar’. In most patients, a rapid decrease in PSA is seen within the first months of therapy, after which time PSA levels stabilise to a new baseline. The post-treatment baseline approximates half of the pre-treatment value. Therefore, in typical patients treated with ‘Proscar’ for six months or more, PSA values should be doubled for comparison to normal ranges in untreated men. For clinical interpretation, see 4.4 Special warnings and precautions for use, Effects on PSA and prostate cancer detection."

A new sub-section on "Breast cancer in men" has been added:
"Breast cancer in men 
Breast cancer has been reported in men taking finasteride 5 mg during clinical trials and 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."

A new sub-section on "Paediatric use" has been added:

"Pediatric use 

'Proscar’ is not indicated for use in children.
Safety and effectiveness in children have not been established."

The sub-section on "Excipients" has been replaced with
"Lactose :The tablet contains lactose monohydrate. Patients with any of the following genetic deficiencies should not take this drug: galactose intolerance, total lactase deficiency or glucose-galactose malabsorption."

Section 4.5 Interaction with other medicinal products and other forms of interaction -
The first paragraph in this section has been editorially revised slightly and the paragraph "other concomitant therapy" has been deleted.

Section 4.6 Pregnancy and Lactation -:
Cross references to other sections of the SmPC have been added.

Section 4.8 Undesirable Effects -:
The first paragraph in this section has been deleted and replaced with the following statement:
"The most frequent adverse reactions are impotence and decreased libido. These adverse reactions occur early in the course of therapy and resolve with continued treatment in the majority of patients. " 
A table has been added listing adverse reactions reported during clinical trials and/or post-marketing use. The only new side effects included in this table are:

" Cardiac disorder - not known: Palpitation"
"Hepatobiliary disorders - not known: increased hepatic enzymes"

A new paragraph has been added regarding reports in post-marketing use:
"In addition, the following have been reported in post-marketing use: persistence of erectile dysfunction after discontinuation of treatment with ‘Propecia’; male breast cancer (see 4.4 Special warnings and precautions for use). "

Under the sub-section MTOPS, the last sentence in has been editorially revised as follows:
"….The incidence of ejaculation disorder in patients receiving combination therapy was comparable to the sum of incidences of this adverse experience for the two monotherapies. events without regard to drug relationship were: finasteride 8.3%, doxazosin 5.3%, combination 15.0%, placebo 3.9%."

In the sub-section "other long-term data", a statement has been added that "Additional analyses suggest that the increase in the prevalence of high-grade prostate cancer observed in the Proscar group may be explained by a detection bias due to the effect of prscar on prostate volume."

The sub-section on post-marketing experience has been deleted.

Under the sub-section "Laboratory test findings" the first sentence has now been deleted and a cross reference to section 4.4 added.