Prosnorm® is indicated for the treatment and control of benign prostatic hyperplasia (BPH) in patients with an enlarged prostate to:
− cause regression of the enlarged prostate, improve urinary flow and improve the symptoms associated with BPH.

− reduce the incidence of acute urinary retention and the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy.

Dosage and Administration:
The recommended adult dose is one 5 mg tablet daily, with or without food.
Prosnorm® can be administered alone or in combination with the alpha- blocker doxazosin.  Although early improvement in symptoms may be seen, treatment for at least six months may be necessary to assess whether a beneficial response has been achieved. Thereafter, treatment should be continued long term.
No dosage adjustment is required in the elderly or in patients with varying degrees of renal insufficiency (creatinine clearances as low as 9 ml/min). There are no data available in patients with hepatic insufficiency.
Prosnorm® is contra-indicated in children.

Precautions and warning:
To avoid obstructive complications it is important that patients with large residual urine and/or heavily decreased urinary flow are carefully controlled. The possibility of surgery should be an option. Effects on PSA and prostate cancer detection. No clinical benefit has yet been demonstrated in patients with prostate cancer treated with Prosnorm®. 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, Prosnorm® 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 Prosnorm® or placebo.
Digital rectal examination, as well as other evaluations for prostate cancer, are recommended prior to initiating therapy with Prosnorm® and periodically thereafter. Serum PSA is also used for prostate cancer detection. Generally, a baseline PSA >10 ng/mL (Hybritech) prompts further evaluation and consideration of biopsy; for PSA levels between 4 and 10 ng/mL, further evaluation is advisable. There is considerable overlap in PSA levels among men with and without prostate cancer. Therefore, in men with BPH, PSA values within the normal reference range do not rule out prostate cancer, regardless of treatment with Prosnorm®. A baseline PSA <4 ng/mL does not exclude prostate cancer. Prosnorm® causes a decrease in serum PSA concentrations by approximately 50% in patients with BPH, even in the presence of prostate cancer. This decrease in serum PSA levels in patients with BPH treated with Prosnorm® should be considered when evaluating PSA data and does not rule out concomitant prostate cancer. This decrease is predictable over the entire range of PSA values, although it may vary in individual patients. In patients treated with Prosnorm® for six months or more, PSA values should be doubled for comparison with normal ranges in untreated men. This adjustment preserves the sensitivity and specificity of the PSA assay and maintains its ability to detect prostate cancer.
Any sustained increase in PSA levels of patients treated with finasteride 5mg should be carefully evaluated, including consideration of non-compliance to therapy with Prosnorm®. Drug/laboratory test interactions 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 Prosnorm®.

In most patients, a rapid decrease in PSA is seen within the first months of therapy, after which time PSA levels stabilize to a new baseline. The post-treatment baseline approximates half of the pre-treatment value. Therefore, in typical patients treated with Prosnorm® for six months or more, PSA values should be doubled for comparison to normal ranges in untreated men. For clinical interpretation, warnings and precautions for use, Effects on PSA and prostate cancer detection. Percent free PSA (free to total PSA ratio) is not significantly decreased by Prosnorm®. The ratio of free to total PSA remains constant even under the influence of Prosnorm®.When percent free PSA is used as an aid in the detection of prostate cancer, no adjustment to its value is necessary.

Breast cancer in men
Breast cancer has been reported in men taking finasteride 5 mg during clinical trials and the postmarketing period.
Physicians should instruct their patients to promptly report any changes in their breast tissue such as lumps, pain, gynaecomastia or nipple discharge.

Pediatric use: Prosnorm® is not indicated foruse in children.
Safety and effectiveness in children have not been established.

Incompatibilities
None reported.

Pregnancy and lactation
Pregnancy category X
Pregnancy: Prosnorm® is contra-indicated in women when they are or may potentially be pregnant. Because of the ability of Type II 5 α-reductase inhibitors to inhibit conversion of testosterone to dihydrotestosterone, these drugs, including finasteride, may cause abnormalities of the external genitalia of a male fetus when administered to a pregnant woman. In animal developmental studies, dose-dependent development of hypospadias were observed in the male offspring of pregnant rats given finasteride at doses ranging from 100 μg/kg/day to 100 mg/kg/day, at an incidence of 3.6% to 100%. Additionally, pregnant rats produced male offspring with decreased prostatic and seminal vesicular weights, delayed preputial separation, transient nipple development and decreased anogenital distance, when given finasteride at doses below the recommended human dose. The critical period during which these effects can be induced has been defined in rats as days 16-17 of gestation. The changes described above are expected pharmacological effects of Type II 5 α-reductase inhibitors. Many of the changes, such as hypospadias, observed in male rats exposed in utero to finasteride are similar to those reported in male infants with a genetic deficiency of Type II 5 α-reductase. It is for these reasons that ' Prosnorm®' is contra-indicated in women who are or may potentially be pregnant.
No effects were seen in female offspring exposed in utero to any dose of finasteride. Exposure to finasteride - risk to male fetus Women should not handle crushed or broken tablets of Prosnorm® when they are or may potentially be pregnant because of the possibility of absorption of finasteride and the subsequent potential risk to a male fetus. Prosnorm® tablets are coated and will prevent contact with the active ingredient during normal handling, provided that the tablets have not been broken or crushed. Small amounts of finasteride have been recovered from the semen in subjects receiving finasteride 5 mg/day. It is not known whether a male fetus may be adversely affected if his mother is exposed to the semen of a patient being treated with finasteride. When the patient's sexual partner is or may potentially be pregnant, the patient is recommended to minimize exposure of his partner to semen.

Lactation: Prosnorm® is not indicated for use in women. It is not known whether finasteride is excreted in human milk.

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Side effects:
Which usually have been mild, generally have not required discontinuation of therapy. Finasteride for male pattern hair loss has been evaluated for safety in clinical studies involving more than 3.200 men. In three 12-month, placebo controlled, double- blind, multicenter studies of comparable design, the overall safety profile of 'Prohair®' and placebo were similar. Discontinuation of therapy due to clinical adverse experience occurred in 1.7% of 945 men treated with 'Prohair®' and 2.1% of 934 men treated with placebo. In these studies, the following drug –related adverse experiences were reported in ≥1% of men treated with 'Prohair®': decreased libido ('Prohair® 1.8% vs. placebo, 1.3%) and erectile dysfunction (1.3%, 0.7%). In addition, decreased volume of ejaculate was reported in 0.8% of men treated with 'Prohair®' and 0.4% of men treated with placebo. Resolution of these side effects occurred in men who discontinued therapy. The effect of 'Prohair®' on ejaculate volum was measured in separate study and was not different from that seen with placebo. By the fifth year of treatment with 'Prohair®', the proportion of paients reporting each of the above side effects decreased to <0.3%. Finisteride has also been studied for prostate cancer risk reduction at 5 times the dosage recommended for male pattern hair loss. In a 7-year placebo- controlled trial that enrolled 18,882 healthy men, of whom 9060 had prostate needle biopsy data available for analysis, prostate cancer was detected in 803 (18.4%) men receiving finasteride 5mg and 1147 (24.4%) men receiving placebo. In the finasteride 5mg group, 280 (6.4%) men had prostate cancer with Gleason scores of 7-10 detected on needle biopsy vs 237 (5.1%) men in the placebo group. Additional analyses suggest that the increase in the prevalence of high-grade prostate cancer observed in the finasteride 5 mg group may be explained by a detection bias due to the effect of finasteride 5 mg on prostate volume. Of the total cases of prostate cancer diagnosed in this study, approximately 98% were classified as intracapsular (stage T1 or T2). The relationship between long-term use o finasteride 5mg and tumours with Gleason scores of 7-10 is unknown.
The adverse reactions reported during clinical trials and/or post-marketing use are listed in the table below.

Frequency of adverse reactions is determined as follows:
Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000), not known (cannot be estimated from the available data).
The frequency of adverse reactions reported during post-marketing use cannot be determined as they are derived from spontaneous reports.
- Immune system disorders: Not known: hypersensitivity reactions including swelling of the lips and face.
- Cardiac disorder: Not Known: Palpitation.
- Psychiatric disorders: Common: decreased libido.
- Unknown: decreased libido that may continue after discontinuation of therapy, depression.
- Hepatobiliary disorders: Unknown: increased hepatic enzymes.
- Reproductive system and breast disorders: Common: impotence.
- Uncommon: ejaculation disorder, breast tenderness, breast enlargement.
- Unknown: testicular pain, sexual dysfunction (erectile dysfunction and ejaculation disorder) which may continue after discontinuation of treatment; male infertility and/or poor seminal quality. Normalization or improvement of seminal quality has been reported after discontinuation of finasteride.
- Skin and subcutaneous tissue disorders: Uncommon: rash, unknown: pruritus, urticaria.
- Investigations: Common: decreased volume of ejaculate.
- In addition, the following has been reported in clinical trials and post- marketing use:  male breast cancer.
- Medical Therapy of Prostatic Symptoms (MTOPS).
- The MTOPS study compared finasteride 5 mg/day (n=768), doxazosin 4 or 8 mg/day (n=756), combination therapy ofb finasteride 5 mg/day and doxazosin 4 or 8 mg/day (n=786), and placebo (n=737). In this study, the safety and tolerability profile of the combination therapy was generally consistent with the profiles of the individual components. 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.
Other Long-Term Data

In a 7 year placebo-controlled trial that enrolled 18,882 healthy men, of whom 9060 had prostate needle biopsy data available for analysis, prostate cancer was detected in 803 (18.4%) men receiving finasteride and 1147 (24.4%) men receiving placebo. In the finasteride group, 280 (6.4%) men had prostate cancer with Gleason scores of 7-10 detected on needle biopsy vs 237 (5.1%) men in the placebo group. 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 finasteride on prostate volume. Of the total cases of prostate cancer diagnosed in this study, approximately 98% were classified as intracapsular (stage T1 or T2). The relationship between long-term use of finasteride and tumours with Gleason Scores of 7-10 is unknown. Laboratory Test Findings.

When PSA laboratory determinations are evaluated, consideration should be given to the fact that PSA levels are decreased in patients treated with finasteride. 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 finasteride for six months or more, PSA values should be doubled for comparison to normal ranges in untreated men.

 No specific treatment of overdosage with finasteride is recommended. Patients have received single doses of 'Prosnorm' up to 400 mg and multiple doses of 'Prosnorm' up to 80 mg/day for up to three months without any adverse effects.

Prosnorm® belongs to a new class of specific inhibitors of 5-alpha reductase.
Mechanism of action:
Finasteride inhibits 5-alpha reductase, an intracellular enzyme that metabolizes testosterone into the more potent dihydrotestosterone. Finasteride has no affinity for androgen receptors.

not applicable

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Povidone, lactose monohydrate, sodium lauryl sulfate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, FD and C blue No.2, Opadry white.

None reported

Not applicable

Type of container closure system
The selected primary packaging for prosnorm® 5 mg tablets is PVDC and Aluminum foil blister which is commonly used for tablets.

Presentations:
Prosnorm® Tablets: Each tablet contains Finasteride 5 mg in packs of 30 tablets.

Not applicable