PROSTAPLANT

FOR MEDICINAL USE OF THE MEDICINAL PRODUCT PROSPLANТ PROSTAPLANTÒ

Composition:

Active substance: extract of saw palmetto fruits (Serenoa repens);

One capsule contains 320 mg of extract of saw palmetto fruits (Serenoa repens) (10–14.3:1), extracted with 90% ethanol (m/m);

Excipients: glycerol 85%, polysuccinate of gelatin, iron oxide yellow (E 172), iron oxide black (E 172), patent blue V (E 131).

Pharmaceutical form. Capsules.

Main physicochemical properties: oval, dark green, soft gelatin capsules with a seam.

Pharmacotherapeutic group.

Agents used in benign prostatic hyperplasia.

ATC code G04C X02.

Pharmacological Properties

Pharmacodynamics

Prostaplan suppresses the enzymes 5α-reductase and aromatase. 5α-reductase catalyzes the conversion of testosterone into dihydrotestosterone; aromatase promotes the conversion of testosterone into 17β-estradiol. Dihydrotestosterone and estrogens are considered to play a key role in the pathogenesis of prostate gland hyperplasia. The extract of saw palmetto fruits inhibits the growth of prostate tissue stimulated by dihydrotestosterone and estradiol, but this drug only relieves symptoms caused by prostate enlargement and does not eliminate the enlargement itself.

Animal experiments have also shown that the extract of saw palmetto fruits possesses anti-exudative and anti-edematous properties.

Pharmacokinetics

There is currently no data available on the pharmacokinetics of the drug.

Clinical characteristics.

Indications.

Urinary disorders associated with benign prostatic hyperplasia stages I and II according to Alken.

Contraindications.

Hypersensitivity to the extract of saw palmetto fruit or to any of the excipients of the medicinal product.

Interaction with other medicinal products and other forms of interaction.

Not established.

In isolated cases, interaction with warfarin has been reported. Increase in international normalized ratio (INR).

Special precautions for use

The drug is used as a symptomatic agent, not as a treatment for prostate hyperplasia. Therefore, it is recommended to consult a physician regarding the need for systematic monitoring, especially in the presence of blood in urine or acute urinary retention. Prostaplant should not be used in benign prostatic hyperplasia at the stage of decompensation (Stage III according to Alken).

Use during pregnancy or breastfeeding

The medicinal product is not to be used.

Ability to influence reaction speed when driving or operating machinery

Has no effect.

Method of administration and dosage.

For adults: 1 capsule once daily. Swallow the capsule whole without chewing, with a small amount of liquid. The maximum daily dose is 320 mg.

The duration of use is determined individually by a physician.

If symptoms do not improve or, conversely, worsen, consult a doctor.

Children.

The drug is not used.

Overdose.

No cases of overdose have been reported.

Adverse reactions.

Gastrointestinal disorders: in isolated cases abdominal pain, nausea, discomfort, diarrhea, vomiting may occur.

Immune system disorders: hypersensitivity reactions.

Nervous system disorders: headache may occur.

Reproductive system disorders: reversible gynecomastia in isolated cases.

If any adverse reactions occur, discontinue use of the medicinal product and consult a physician.

Reporting of adverse reactions following registration of the medicinal product is of great importance. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy via the Automated Information System for Pharmacovigilance at the following link: https://aisf.dec.gov.ua.

Shelf life: 5 years.

Do not use the medicinal product after the expiry date stated on the packaging.

Storage conditions.

Store at a temperature not exceeding 25 °C in a place inaccessible to children.

Packaging.

20 capsules in a blister; 2 blisters per cardboard box.

Supply category: Over-the-counter.

Manufacturer:

Dr. Willmar Schwabe GmbH & Co. KG.

Manufacturer's address and place of business:

Willmar-Schwabe-Strasse 4, 76227 Karlsruhe, Germany.