Prostaplant capsules 320 mg No. 30

Instructions for Prostaplant capsules 320 mg No. 30

Composition

active ingredient: saw palmetto fruit extract (Serenoa repens);

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

excipients: glycerin 85%, gelatin polysuccinate, iron oxide yellow (E 172), iron oxide black (E 172), patent blue V (E 131).

Dosage form

Capsules.

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

Pharmacotherapeutic group

Drugs used for benign prostatic hypertrophy.

ATX code G04C X02.

Pharmacological properties

Pharmacodynamics.

Prostaplant inhibits the enzymes 5α-reductase and aromatase. 5α-reductase catalyzes the conversion of testosterone to dihydrotestosterone; aromatase promotes the conversion of testosterone to 17β-estradiol. In the pathogenesis of prostatic hyperplasia, the main role is attributed to dihydrotestosterone and estrogens. Saw palmetto fruit extract inhibits the growth of prostate tissue stimulated by dihydrotestosterone and estradiol, but this drug only relieves the discomfort caused by prostate enlargement, but does not eliminate this enlargement.

Animal experiments have also shown that saw palmetto fruit extract has anti-exudative and anti-edema properties.

Pharmacokinetics.

There is no data on the pharmacokinetics of the drug yet.

Indication

Urination disorders in benign prostatic hyperplasia stages I and II according to Alken.

Contraindication

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

Interaction with other medicinal products and other types of interactions

Not detected.

Interaction with warfarin has been reported in isolated cases. Increased international normalized ratio (INR).

Application features

The drug is used as a symptomatic agent, and not as a means for the treatment of prostatic hyperplasia. Therefore, it is recommended to consult a doctor about the need for a systematic control examination, especially in the presence of blood in the urine or in the case of acute urinary retention. Prostaplant should not be used in benign prostatic hyperplasia in the stage of decompensation (Alken stage III).

Use during pregnancy or breastfeeding

The medicine is not used.

Ability to influence reaction speed when driving vehicles or other mechanisms

Does not affect.

Method of administration and doses

Adults are prescribed 1 capsule once a day. The capsules are swallowed without chewing, with a small amount of liquid. The maximum daily dose is 320 mg.

The duration of use is determined by the doctor individually.

If the symptoms of the disease do not decrease or, on the contrary, increase, you should consult a doctor.

Children.

The drug is not used.

Overdose

No cases of overdose have been reported.

Side effects

On the part of the digestive tract: in rare cases, abdominal pain, nausea, discomfort, diarrhea, vomiting are possible.

Immune system disorders: hypersensitivity reactions.

From the nervous system: headache is possible.

On the part of the reproductive system: in isolated cases, reversible gynecomastia.

If any adverse reactions occur, you should stop taking the drug and consult a doctor.

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

Expiration date

5 years.

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

Storage conditions

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

Packaging

10 capsules in a blister; 3 blisters in a cardboard box.

Vacation category

Without a prescription.

Producer

Dr. Wilmar Schwabe GmbH & Co. KG.

Address

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