Prostamol Uno, 320 mg capsules 90 pcs

Pharmacotherapeutic group

The treatment of benign prostatic hyperplasia of plant origin.

TAC code: G04CX02

Pharmacological properties
Extract of fruits of the creeping palm (Serenoa repens) has antiproliferative anti-androgenic, anti-inflammatory, and anti-edema effects that are selectively expressed at the prostate level. Thus the preparation does not influence the level of sex hormones in blood plasma, does not influence potency and libido and does not change the level of prostate-specific antigen in blood plasma. Local antiproliferative action of the drug is manifested by a decrease in the activity of growth factors (primarily epidermal and fibroblastic), inhibition of binding of prolactin receptors with subsequent disruption of signal transmission to prostate cells and acceleration of apoptosis of prostate cells, which is reflected in inhibition of growth of prostate volume. The mechanism of local anti-androgenic action is conditioned by inhibition of dihydrotestosterone synthesis from testosterone (due to inhibition of 5-alpha reductase type I and II enzyme) and its fixation to cytosolic receptors of prostate cells which prevents hormone penetration into the nucleus. As a result, protein synthesis is reduced. The mechanism of local anti-inflammatory action is due to the fact that the extract of fruits of creeping palm (Serenoa repens) inhibits the activity of phospholipase A2, 5-lipoxygenase and release of arachidonic acid, thereby reducing the synthesis of prostaglandins and leukotrienes, which are mediators of inflammation. Prostamol® Uno reduces capillary permeability and vascular stasis, reduces swelling and inflammation in the prostate, eliminates compression of the bladder neck and urinary tract, improving urodynamic indicators. Thus, Prostamol® Uno, on the one hand, helps to reduce the severity of pathological symptoms of benign prostatic hyperplasia (dysuria, pollakiuria, nycturia, painful sensations and feelings of tension during urination, incomplete emptying of the bladder), increasing the volume and strength of urination. On the other hand, against the background of using the drug, further growth and increase of prostate volume slows down.

Pharmacokinetics
Extract of fruits of the creeping palm (Serenoa repens) is quickly absorbed. After oral administration maximum concentration in plasma is reached after approximately 1.5 hours.

Indications

Benign prostatic hyperplasia (stages I and II). Elimination of dysuric symptoms (urinary disorder, nocturnal pollakiuria, pain syndrome, etc.) in chronic prostatitis.

Pharmacological effect

Pharmacotherapeutic group

Herbal remedy for benign prostate hyperplasia.

ATX code: G04CX02

Pharmacological properties
The extract of the fruits of the creeping palm (Serenoa repens) has antiproliferative, antiandrogenic, anti-inflammatory, and decongestant effects that selectively manifest themselves at the level of the prostate gland. At the same time, the drug does not affect the level of sex hormones in the blood plasma, does not affect potency and libido, and does not change the level of prostate-specific antigen in the blood plasma. The local antiproliferative effect of the drug is manifested by a decrease in the activity of growth factors (primarily epidermal and fibroblastic), inhibition of the binding of prolactin receptors with subsequent disruption of signal transmission processes in prostate cells and acceleration of the processes of apoptosis of prostate cells, which is reflected in the inhibition of prostate volume growth. The mechanism of local antiandrogenic action is due to inhibition of the synthesis of dihydrotestosterone from testosterone (due to inhibition of the enzyme 5-alpha reductase types I and II) and its fixation to the cytosolic receptors of prostate cells, which prevents the penetration of the hormone into the nucleus. As a result, protein synthesis decreases. The mechanism of local anti-inflammatory action is due to the fact that the extract of the fruits of the creeping palm tree (Serenoa repens) inhibits the activity of phospholipase A2, 5-lipoxygenase and the release of arachidonic acid, thereby reducing the synthesis of prostaglandins and leukotrienes, which are mediators of inflammation. Prostamol® Uno reduces capillary permeability and vascular stasis, reduces swelling and inflammation in the prostate, eliminates compression of the bladder neck and urinary canal, improving urodynamics. Thus, the drug Prostamol® Uno helps, on the one hand, to reduce the severity of pathological symptoms of benign prostatic hyperplasia (dysuria, pollakiuria, nocturia, pain and a feeling of tension when urinating, incomplete emptying of the bladder), increasing the volume and force of urination. On the other hand, the use of the drug slows down further growth and increase in the volume of the prostate gland.

Pharmacokinetics
Palm tree (Serenoa repens) fruit extract is quickly absorbed. After oral administration, maximum plasma concentrations are achieved after approximately 1.5 hours.

Special instructions

Prostamol® Uno reduces the severity of symptoms of an enlarged prostate gland, without eliminating its enlarged size. Prevents further growth of prostate tissue. Prostamol® Uno does not affect sexual function.

The effect of the drug on the ability to drive vehicles and operate machinery

Prostamol® Uno does not affect the ability to drive vehicles or work requiring increased concentration.

Active ingredient

Creeping palm fruit extract

Composition

Active ingredient:
Alcoholic extract of the fruits of the creeping palm (9−11:1) – 320 mg
Excipients:
Capsule shell: succinylated gelatin – 120.20-141.11 mg, glycerol – 45.20 – 53.07 mg, purified water – 7.98 – 9.36 mg, titanium dioxide – 0.65-0.77 mg, black iron oxide dye – 0.78 – 0.92 mg, crimson dye [Ponceau 4R] – 1.05 – 1.23 mg.

Contraindications

Individual intolerance to the components of the drug.

Side Effects

Allergic reactions to the components of the drug are possible. In rare cases, discomfort from the gastrointestinal tract: nausea, heartburn (when taken on an empty stomach).

Interaction

No interactions with other medicinal substances have been identified.

Overdose

There have been no cases of overdose of Prostamol® Uno.

Storage conditions

Store at a temperature not exceeding 25°C.
Keep the medicine out of the reach of children!

Shelf life

3 years. Do not use the drug after the expiration date indicated on the package.

Organization receiving complaints from consumers:

LLC “Berlin-Chemie/A. Menarini”, Russia

123112, Moscow, Presnenskaya embankment, building 10, Business Center “Tower on the Embankment”, Block B, tel. (495) 785-01-00, fax (495) 785-01-01.

Manufacturer

Berlin-Chemie AG/Katalent Germany Eberbach GmbH, Germany