Water pepper extract

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT WATER PEPPER EXTRACT

Composition:

Active substance: liquid extract of water pepper herb (Herba Polygoni hydropiperis) (1:1) (extraction solvent – 70% ethanol);

1 vial contains liquid extract of water pepper herb (Herba Polygoni hydropiperis) (1:1) (extraction solvent – 70% ethanol) 25 ml or 50 ml.

Pharmaceutical form. Liquid extract.

Main physicochemical properties: transparent greenish-brown liquid with a pleasant odor. Slight sediment formation may occur during storage.

Pharmacotherapeutic group. Hemostatic agents of plant origin.

ATC code B02B X.

Pharmacological properties.

Pharmacodynamics.

The extract of water pepper exerts hemostatic, analgesic, anti-inflammatory, and sedative effects.

Bioflavonoids present in water pepper (rutin, quercetin, hyperoside, ramnazin, kaempferol, myricetin, luteolin) exhibit P-vitamin activity, reduce capillary permeability, normalize vascular wall structure, and protect ascorbic acid present in water pepper from oxidation. Together with ascorbic acid, they participate in redox reactions and reduce hyaluronidase activity. The hemostatic effect of the drug is combined with the ability to stimulate uterine muscle contractions, similar to ergot, although this property is significantly weaker.

The glycoside polygopiperin accelerates blood coagulation.

Tannins exert anti-inflammatory and astringent effects. Together with bioflavonoids, they produce a synergistic hemostatic effect.

Pharmacokinetics.

The maximum pharmacological effect of water pepper bioflavonoids is achieved by extraction with 70% ethyl alcohol. At this concentration, flavonoids are dissolved in both free (aglycone) and bound (with glycosidic moiety) forms. This ensures maximum absorption of the main active substances. After absorption, flavonoids undergo hydrolysis into aglycone and glycoside. The former is excreted by the kidneys with urine and through the intestine with bile, while the latter (carbohydrate residue) is either oxidized in the Krebs cycle to carbon dioxide and water, or deposited in the body as glycogen.

Clinical characteristics.

Indications. As an adjunct in obstetric and gynecological practice for postpartum uterine hemorrhage, uterine subinvolution, and hypermenorrhagia. Additionally, indicated for bleeding from small vessels of the stomach and intestine, as well as for mild hemorrhoidal bleeding.

Contraindications. Hypersensitivity to the components of the drug, children under 12 years of age.

Special precautions. Do not take with dairy products to prevent formation of non-absorbable complexes (chelates).

Interaction with other medicinal products and other types of interactions. Not established.

Special precautions for use.

Use during pregnancy or breastfeeding.

Should be used only when the expected benefit to the mother outweighs the potential risk to the fetus or infant.

Ability to affect the speed of reactions when driving vehicles or operating machinery.

Since ethanol is an ingredient of the medicinal product, the use of Water Pepper extract is not recommended when driving vehicles or performing tasks involving potentially hazardous mechanical devices.

Dosage and Administration.

For adults: take 30–40 drops of water pepper extract 3–4 times daily (30 minutes before meals). The duration of treatment depends on the nature and severity of the disease, the therapeutic effect achieved, and the characteristics of combination therapy.

Children.

The efficacy and safety of the drug in children under 12 years of age have not been established; therefore, the drug is not recommended for this age group.

Overdose.

An overdose may enhance adverse reactions. In case of overdose, symptomatic treatment should be administered.

Side effects.

Headache, nausea, vomiting, dizziness; allergic reactions, including skin rash, redness, itching.

Shelf life. 3 years 6 months.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C. Keep out of reach of children.

Packaging.

25 ml in glass bottles stoppered with plugs or dropper caps and closures; 50 ml in glass bottles stoppered with dropper caps and closures; 25 ml or 50 ml in polymer bottles stoppered with dropper caps and closures; in a carton or without a carton.

Supply category. Over-the-counter.

Manufacturer. JSC Pharmaceutical Factory "Viola".

Manufacturer's location and address of business activity.

75 Amosova Akademyka Street, Zaporizhzhia, Ukraine, 69063.

Marketing authorization holder. JSC Pharmaceutical Factory "Viola".

Address of the marketing authorization holder. 75 Amosova Akademyka Street, Zaporizhzhia, Ukraine, 69063.