Serenoa Repens is native to and grows wild in North America, forming colonies in sandy soils of Texas and Louisiana, east to South Carolina and south to Florida. It is widely distributed in various islands in the Bahamas and Cuba. This species grows on acid or alkaline soils, on sand dune hammocks, pinelands or prairies. Its most extensive development occurs in the lower coastal plains of Georgia and Florida.

The plant is an evergreen shrub, usually 2 to 10 feet tall, with creeping or horizontal rhizomes. Occasionally, the species reaches the size of a small tree, upto 20 to 25 feet. The common name, Saw Palmetto, derives from the ascending fan-shaped leaves, erect, 1 to 2.5 feet broad, stiff and glabrous (non-hairy). In the northern hemisphere, blooming occurs from April to early June and the fruits ripen during September and October. Fruits are subspherical to ovoid drupes, green to yellow before ripening and bluish-black to dark brown when ripe.

The commercial Saw Palmetto products and the medically active constituents are derived from the ripe (fresh, partially dried or dried) fruits of Serenoa repens. A liposterolic oily extract (LESP), extracted either with hexane, 90% alcohol v/v or prepared by supercritical fluid extraction with CO and standardized to 70 to 95% 2 free fatty acids has been used and clinically studied for the treatment of Benign Prostatic Hyperplasia (BPH) stages I and II.

The German Commission has evaluated Saw Palmetto as safe and effective for urinary problems related to benign prostatic hyperplasia stages I and II. Countries, in which data from prescription and over-the-counter pharmacy sales are available, indicate that plant extracts like Saw Palmetto are used in patients with early and moderate outflow tract obstruction due to BPH. In Germany and Austria, herbal medicines are the first-Iine treatment for more than 90% of the time in patients with early and moderate outflow tract obstruction due to BPH. Over 50% of German urologists are reported to prefer herbal medicines to chemically derived agents in the treatment of mild to moderate BPH.

The U.S. Pharmacopeia (USP) released an extensive botanical monograph on Saw Palmetto. Following a review of the clinical trial data available in the literature, the USP's Advisory Panel on Nutritional Electrolytes, its adhoc Advisory Panel on Botanicals and its Urology Advisory Panel, concluded, that these studies provide evidence of the effectiveness of Saw Palmetto, in relieving lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH).

Each soft gelatin capsule contains:

Lipid extract of Serenoa Repens BP ..... 160 mg

Excipients ... q.s.

Approved colour used in capsule shell

In vitro pharmacodynamic studies indicate that S. repens may have multiple mechanisms of action in BPH. The mechanisms most likely involved include inhibition of type 1 and type 2 isoforms of 5a-reductase, inhibition of binding of dihydrotestosterone to cytosolic androgen receptors in prostate cells and alpha - adrenergic 1 blocking activity. Mechanisms also involved but less well-demonstrated are inhibition of prolactin and growth factor-induced prostatic cell proliferation, an anti-estrogenic activity and/or an anti-inflammatory effect.

Limited pharmacokinetic data are available for S. repens primarily because the drug is a complex mixture of several compounds. Tissue distribution studies in the rat indicate that the drug achieved higher concentrations in the prostate gland and skin than liver and other genito-urinary tissues.

In healthy young man, mean peak plasma drug concentration was 2.6mg/L and time to achieve peak concentration was 1.5 hours after oral administration of S. repens 320mg. Elimination half life was 1.9 hours and the mean value of area under the concentration versus time curve was 8.2mg/Lh.

The recommended dose of Saw Palmetto extract for BPH is 320mg/day (One capsule of Prostese twice daily). Administration of Saw Palmetto with food is recommended to minimize gastrointestinal disturbances.

Prostese is used for the treatment of Benign Prostatic Hyperplasia (BPH) and the management of Lower Urinary Tract Symptoms (LUTS). 

It has been reported in long-term studies that Saw Palmetto's efficacy is similar to Finasteride, Alfuzosin and Terazosin, and Tamsulosin in increasing the peak urinary flow rate.

No medical contraindications have been reported with the use of Saw Palmetto. There is no reliable clinical information about use of Saw Palmetto in patients suffering from hormonal-dependent diseases other than benign prostatic hyperplasia. However, the possible anti-androgenic and anti-estrogenic activity of the plant constituents should be taken into consideration when evaluating its use under these circumstances. Patients should have a medical and urological evaluation before beginning treatment with Saw Palmetto to rule out prostate cancer, nephritis, urinary tract infections and other nephrourologic disorders. Unlike finasteride, the extract does not lower serum PSA concentrations.

Prostese should not be used in patients with a history of hypersensitivity to any ingredient in the formulation and, for women and children also.

The possibility of endocrine or alpha-adrenergic blocking effects in combination with other drugs cannot be excluded, as scientific studies of interactions with other drugs have not been conducted. It has been recommended that patients taking hormonal therapies should avoid the use of Saw Palmetto.

No tests for monitoring are necessary specifically for patients taking Saw Palmetto. All patients with symptomatic benign prostatic hyperplasia should be followed medically because of the potential need for further intervention in progressive disease.

Data from clinical trials in men with BPH receiving S. repens indicate that the drug was well-tolerated by most patients. Overall 2% of patients reported adverse events in a large non comparative trial of 500 men receiving (21) the drug for 3 months . Complaints included minor gastro intestinal problem such as nausea which resolved when S. repens was taken with meals. No clinically significant changes from baseline values of laboratory parameters (i.e. routine blood chemistry analysis) were reported with S. repens in clinical trials.

A systematic review of Saw Palmetto found a withdrawal rate from clinical studies to be 9.1% S. repens, 7% (22) placebo, and 112% finasteride . The pooled tolerability data from 18 randomized trials indicate that S. repens is well tolerated. Gastrointestinal complaints (i.e. abdominal pain, diarrhea, constipation and nausea) were the most frequently reported adverse events. Other reported side effects in this study with an occurrence rate of 1% or more include abdominal pain, back pain, decreased libido, impotence, headache and urinary retention. Decreased libido and impotence were somewhat more common with finasteride than with (2,3) S. Repens .

3 Blister packs of 10 softgel each in a box

Store in a cool, dry & dark place. Storage above 25°C & above 40% RH may give undesirable results.

Keep out of reach of children