Water pepper extract

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT WATER PEPPER EXTRACT

Composition:

Active substance: 1 vial contains 25 ml of liquid extract from water pepper herb (Herba Polygoni hydropiperis) (1:1), extraction solvent – ethanol 70%;

Excipients: apart from the extraction solvent, no excipients are present.

Pharmaceutical form. Alcoholic liquid extract for oral use.

Main physicochemical properties: greenish-brown liquid with a characteristic aromatic odor.

Pharmacotherapeutic group.

Haemostatic, haemostatic agent of plant origin.

ATC code B02B X.

Pharmacological Properties.

Pharmacodynamics.

Bioflavonoids contained in water pepper (rutin, quercetin, hyperoside, ramnetin, 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. Tannins exert anti-inflammatory and astringent effects and produce a synergistic effect with bioflavonoids regarding hemostatic action.

Pharmacokinetics.

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

Clinical characteristics.

Indications.

Use as an adjunct in obstetric and gynecological practice for postpartum uterine hemorrhage, uterine subinvolution, and hypermenorrhea. Additionally, use for bleeding from small vessels of the stomach and intestine, and for mild hemorrhoidal bleeding.

Contraindications.

Hypersensitivity to the components of the drug.

Interaction with other medicinal products and other forms of interaction.

At present, no interactions with other medicinal products have been identified.

Special precautions for use.

Sediment formation may occur during storage of the medicinal product. Do not use together with dairy products to prevent formation of non-absorbable complexes (chelates).

Use during pregnancy or breastfeeding.

The decision on prescribing the drug during pregnancy or breastfeeding is made individually, based on the benefit-risk ratio.

Ability to affect reaction rate when driving or operating machinery.

Since the preparation contains ethanol, it is not recommended to use "Extract of Capsicum tincture" when driving a vehicle or performing work requiring the use of potentially hazardous mechanical devices.

Method of Administration and Dosage.

Adults and children aged 12 years and older should take 30–40 drops of "Extract of Water Pepper" 3–4 times daily (30 minutes before meals). The duration of treatment depends on the course and severity of the disease, the therapeutic effect achieved, and the nature of concomitant therapy.

Children.

Do not use in children under 12 years of age due to the ethanol content.

Overdose.

In case of overdose, treat symptomatically.

Side effects.

Headache, nausea, vomiting, dizziness; in individual cases, allergic reactions are possible, 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 a dropper bottle, in a box or without a box.

Classification of supply.

Over-the-counter.

Manufacturer/Marketing Authorization Holder.

TOV "Ternopharm".

Manufacturer's address and location of its business activity / Address of the Marketing Authorization Holder.

TOV "Ternopharm".

46010, Ternopil, Fabrychna St., 4, Ukraine.

Tel./fax: (0352) 521-444, www.ternopharm.com.ua