HERB OF HYPERICUM

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT ST. JOHN'S WORT HERB (HERBA HYPERICI)

Composition:

Active substance: St. John's wort herb (Herba Hyperici);

One pack contains St. John's wort herb (Herba Hyperici) – 50 g or 75 g; one filter bag contains St. John's wort herb (Herba Hyperici) – 1.5 g.

Pharmaceutical form. Herb.

Main physico-chemical properties:

Ground raw material: fragments of stems, leaves (greyish-green in color), flowers (yellow in color) of various shapes and immature fruits, passing through a sieve with hole diameter of 7 mm. Odor is weak, characteristic. Taste is bitter, slightly astringent;

Coarse powder: fragments of stems, leaves (greyish-green in color), flowers (yellow in color) of various shapes and immature fruits, passing through a sieve with hole diameter of 2 mm. Odor is weak, characteristic. Taste is bitter, slightly astringent.

Pharmacotherapeutic group.

Agents affecting the digestive system and metabolism. Agents used in dentistry. ATC code A01A D11.

Pharmacological Properties.

Pharmacodynamics.

Biologically active substances of the plant exert astringent, anti-inflammatory, and some antimicrobial effects, which promote tissue regeneration; they moderately affect bile secretion and stimulate gastric secretion.

Pharmacokinetics.

Pharmacokinetics has not been determined.

Clinical characteristics.

Indications.

As part of combination therapy for biliary tract diseases (biliary dyskinesia, cholecystitis); gastrointestinal tract disorders (acute and chronic colitis, diarrhea, meteorism, hypoacid gastritis).

In inflammatory conditions of the oral cavity (gingivitis, stomatitis).

Contraindications.

Individual hypersensitivity to the biologically active substances of the drug. Arterial hypertension.

Interaction with other medicinal products and other types of interactions.

Not recommended for use in patients taking anticoagulants, antibiotics, sulfonamides, contraceptives, antihypertensives (calcium channel blockers), female sex hormones, lipid-lowering agents (statins), or cardiac glycosides.

Usage peculiarities.

Use during pregnancy or breastfeeding.

The internal use of the drug is contraindicated.

Ability to affect reaction rate when driving or operating machinery.

The use of the drug may cause increased blood pressure in some patients; therefore, caution should be exercised when driving or operating complex machinery.

Method of Administration and Dosage.

Place 1.5 tablespoons of the herb into an enameled container, pour 200 mL of hot boiled water, cover with a lid, and heat in a boiling water bath for 30 minutes. Cool, strain, squeeze the residue, and add the expressed liquid to the strained decoction. Adjust the final volume of the decoction to 200 mL with boiled water.

Administer warm, 3 times daily, 30 minutes before meals:

• Adults and children aged 16 years and older: ⅓ cup
• Children aged 12–14 years: 1–2 tablespoons
• Children aged 15–16 years: ¼ cup

Place 2 filter bags into a glass or enameled container, pour 200 mL of boiling water, cover, and let stand for 15 minutes.
Administer warm, 3 times daily, 30 minutes before meals:

• Adults and children aged 16 years and older: ½–1 cup
• Children aged 12–14 years: ¼ cup
• Children aged 15–16 years: ½–⅓ cup

For external use: as a mouth rinse.

The duration of treatment is determined individually by a physician.

Children.

The drug is contraindicated in children under 12 years of age.

Overdose.

Overdose or prolonged use may cause a bitter taste in the mouth and discomfort in the liver area.

Side effects.

Increased blood pressure; allergic reactions (including hyperemia, rash, swelling and itching of the skin); photosensitization (during treatment, avoid UV exposure).

Shelf life. 3 years.

Storage conditions.

Store in the original packaging, out of reach of children, at a temperature not exceeding 25 °C. Prepared infusion should be stored in a cool place for no more than 2 days.

Packaging. 50 g or 75 g in cardboard boxes with an inner packet; 1.5 g in a tea bag; 20 tea bags per box.

Prescription status. Over-the-counter.

Manufacturer. JSC Pharmaceutical Factory "Viola".

Manufacturer's address and place of business.

69050, Zaporizhzhia, Skladska St., 4, Ukraine.

Marketing Authorization Holder. JSC Pharmaceutical Factory "Viola".

Address of the Marketing Authorization Holder.

69063, Zaporizhzhia, Amosova St., 75, Ukraine.