Prostamed

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT PROSTAMED (PROSTAMED®)

Composition:

Active substances: pumpkin seed powder (Cucurbitae semen), pumpkin globulin (cucurbitae globulin), dry extract of goldenrod (Solidago extractum), dry extract of aspen leaves (Populus tremula folia extractum).

Each tablet contains: pumpkin seed powder (Cucurbitae semen) 200 mg, pumpkin globulin (cucurbitae globulin) 100 mg, dry extract of goldenrod (Solidago extractum) (5-8:1), extraction solvent: ethanol 60 vol.% 2.6 mg, dry extract of aspen leaves (Populus tremula folia extractum) (5-8:1), extraction solvent: ethanol 60 vol.% 6.3 mg;
Excipients: cocoa powder, lactose monohydrate, sucrose, calcium hydrogen phosphate, colloidal anhydrous silicon dioxide, talc, gelatin, glycerin, sodium chloride, povidone.

Pharmaceutical form. Tablets.

Main physico-chemical properties: brown, round tablets with a convex surface.

Pharmacotherapeutic group. Agents used in benign prostatic hyperplasia. ATC code G04C X.

Pharmacological Properties.

Pharmacodynamics.

The preparation contains globulin derived from the seeds of Cucurbita pepo.

Of the 15 amino acids isolated from this globulin and identified to date, glutamic acid is of particular significance. Glutamic acid catalyzes the oxidative deamination of amino acids and reduces the pathologically elevated levels of free amino acids in the tissue of the hyperplastic prostate gland.

As a result, the amount of amino acids available for protein biosynthesis decreases, thereby slowing down the proliferation of prostate tissue.

Pumpkin seeds contain cucurbitin, phytosterols in both free and bound forms, tocopherols, and mineral substances, primarily selenium. Solidago (goldenrod) enhances the kidney's filtration capacity and thus helps prevent residual urine formation in stage II benign prostatic hyperplasia. Increased bladder muscle tone leads to a reduction in symptoms of micturition disorders, especially dysuria, and decreases the amount of residual urine. Solidago exerts anti-inflammatory, spasmolytic, and diuretic effects. Populus tremula (aspen) contains numerous phenolic glycosides (salicin, populin, and salipopulin). Salicin is oxidized in the human body and converted into salicylic acid, which exerts a disinfectant effect in ureterocystitis. Phenolic glycosides, possessing analgesic and anti-inflammatory properties, reduce pain in the prostate gland and bladder hypersensitivity.

Clinical characteristics.

Indications.

Urinary disorders in benign prostatic hyperplasia (adenoma) of the prostate gland, stages I-II: difficult urination, frequent urination, including nocturia, sensation of incomplete bladder emptying (presence of residual urine), uncontrollable urges to urinate.

Acute and chronic prostatitis (as part of complex therapy).

Contraindications.

Hypersensitivity to the components of the drug, salicylates, or plants of the Asteraceae (Compositae) family.

Conditions requiring restriction of fluid intake, for example, severe heart disease, severe kidney disease.

Special precautions.

The drug contains lactose and sucrose. The medication should not be used in patients with rare hereditary forms of galactose intolerance, sucrose intolerance, lactase deficiency, or glucose-galactose malabsorption, as well as in patients with sucrase-isomaltase deficiency.

If symptoms such as elevated temperature, dysuric symptoms, or spasms persist or recur, or if hematuria and/or acute urinary retention develops due to the underlying disease, medical consultation is required.

Do not store in the refrigerator.

Interaction with other medicinal products and other forms of interaction.

Not known so far.

Usage instructions.

Use during pregnancy or breastfeeding.

The drug is used for the treatment of men.

Ability to affect reaction rate when driving vehicles or operating machinery.

No effect.

Dosage and Administration.

For adults: take 2-4 tablets three times a day. The tablets should be crushed and swallowed with a small amount of liquid.

The duration of treatment is determined by a physician depending on the nature and course of the disease.

Children.

The drug is not intended for pediatric use.

Overdose.

In cases of overdose, the frequency of adverse reactions may increase.

Adverse Reactions.

Hypersensitivity reactions are possible, including allergic skin reactions; gastrointestinal disorders (such as heartburn, nausea, abdominal pain, diarrhea).

Tinnitus.

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

Shelf life. 3 years.

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

Note: Whitening or formation of a coating on the tablet surface does not indicate reduced quality of the medication. This is caused by lipid oxidation due to the presence of cocoa in Prostamed. Whitening and coating disappear upon slight heating of the tablets and affect only the appearance of the product.

Storage Conditions.

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

Packaging.

60, 120, or 200 tablets in a tube, with 1 tube per cardboard box.

Availability. Over-the-counter (without prescription).

Manufacturer.

Dr. Gustav Klein GmbH & Co. KG.

Manufacturer's Address and Place of Business.

Steinenfeld 3, 77736 Zell am Harmersbach, Germany.