Herba gentianae

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT POLYGONI AVICULARIS HERBA (POLYGONI AVICULARIS HERBA)

Composition:

Active substance: 1 packet contains Polygoni avicularis herba (Polygoni avicularis herba) – 50 g.

Pharmaceutical form. Herb.

Main physico-chemical properties: stem fragments from 0.5 mm to 2 mm in thickness, branched, with cylindrical or slightly angular and longitudinally furrowed internodes, covered with sessile or short-petiolate, glabrous upper leaves, varying in shape and size. Stipules fused into a sheath-like tube, which is lacerated and silvery. Small axillary flowers have 5 greenish-white perianth segments, the apex of which is often red. Fruits – trigonal nuts 2 mm to 4 mm in size, ranging from brown to black, usually spotted or striped.

Pharmacotherapeutic group. Agents used in urology. ATC code G04BC.

Pharmacological properties.

Pharmacodynamics. Biologically active substances of the herb prevent the formation and promote the elimination of urinary calculi in urolithiasis, enhance diuresis, increase excretion of excess sodium and chloride ions with urine, enhance glomerular filtration and reduce reabsorption in renal tubules, and decrease permeability of blood vessel walls.

Pharmacokinetics. Not studied.

Clinical characteristics.

Indications.

As part of complex therapy for initial stages of urolithiasis; uric acid diathesis; postoperative period after removal of urinary calculi; chronic renal failure; chronic glomerulonephritis, pyelonephritis, and bladder inflammation during remission.

Contraindications.

Hypersensitivity to biologically active substances contained in the medicinal product. Acute inflammatory diseases of kidneys and urinary bladder. Thrombophlebitis; changes in blood rheological properties; presence of urinary tract stones larger than 6 mm.

Interaction with other medicinal products and other types of interactions.

Should not be used concomitantly with anticoagulants. If simultaneous use of any other medicinal products is required, consult a physician.

Special precautions for use.

It is recommended to take the infusion through a straw to avoid contact with teeth (possible enamel erosion and dental damage).

Use during pregnancy or breastfeeding.

Contraindicated.

Ability to affect reaction speed when driving or operating machinery.

No effect.

Method of Administration and Dosage.

Place 15 g (3 tablespoons) of the herb into an enameled container, pour 200 ml (1 cup) of hot boiled water, cover with a lid and steep in a water bath for 15 minutes. Cool at room temperature for 45 minutes, strain, squeeze out the residue into the strained infusion. Adjust the volume of the infusion with boiled water to 200 ml. Adults should take warm, ⅓–½ cup 2–3 times daily, 15–20 minutes before meals. Children, upon physician's recommendation, should take 2–3 times daily, 15–20 minutes before meals: from 14 years of age – ¼ cup, children aged 12–14 years – 2 tablespoons, children aged 7–12 years – 1 tablespoon. Treatment duration – up to 20–25 days. Repeat courses (no more than 4 per year) should be conducted after a 10–12-day break (after consultation with a physician).

Shake the infusion before use.

Children.

The drug should be used in children aged 7 years and older.

Overdose.

No reports available.

Side effects.

Allergic reactions (including hyperemia, rash, itching, skin swelling), renal colic may occur. Prolonged use of the drug may lead to discoloration of dental enamel and disturbances in the structure of bone tissue (osteoporosis). If any adverse reactions occur, discontinue use of the drug and consult a physician.

Shelf life. 2 years.

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

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

The prepared infusion should be stored in a cool place (8–15 °C) for no more than 2 days.

Packaging.

50 g per package with an inner pouch.

Supply category. Over-the-counter (without prescription).

Manufacturer/Applicant.

LLC "Ternofarm".

Manufacturer's/ Applicant's address.

LLC "Ternofarm".

4 Fabrychna St., Ternopil, 46010, Ukraine.