Chelidonium herb

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT CHELIDONIUM HERB (CHELIDONII HERBA)

Composition:

Active substance: Chelidonium herb (Chelidonii herba);

One pack contains 50 g of Chelidonium herb (Chelidonii herba); one filter bag contains 1.5 g of Chelidonium herb (Chelidonii herba).

Pharmaceutical form. Herb.

Main physico-chemical properties:

Ground material: fragments of leaves, stems, flowers, and fruits of various shapes passing through a sieve with 7 mm diameter openings. Color is light green, green, grayish-green, or glaucous, with bright yellow, brownish, brown, or black specks. Odor is characteristic. Taste is not defined.

Coarse powder: fragments of leaves, stems, flowers, and fruits of various shapes passing through a sieve with 2 mm diameter openings. Color is light green, green, grayish-green, or glaucous, with bright yellow, brownish, brown, or black specks. Odor is characteristic. Taste is not defined.

Pharmacotherapeutic group. Agents affecting the digestive system and metabolism. ATC code A16A X.

Pharmacological properties.

Pharmacodynamics.

Biologically active substances of the herb exert choleretic, spasmolytic, analgesic, sedative, bactericidal, and diuretic effects.

Clinical characteristics.

Indications.

Used in the complex treatment of liver and gallbladder diseases (hepatitis, cholangitis, cholecystitis), skin diseases (impetigo, psoriasis, dermatitis, eczema).

Contraindications.

Individual hypersensitivity to the biologically active substances of the drug. Epilepsy, bronchial asthma, angina pectoris, organic liver or kidney disorders, neurological syndromes.

Safety precautions.

Administration of Chelidonium preparations is allowed only as prescribed and under the supervision of a physician.

The prepared infusion should be shaken before use.

Interaction with other medicinal products and other types of interactions.

Unknown.

Special precautions for use.

Use during pregnancy or breastfeeding.

Contraindicated.

Ability to affect reaction speed when driving or operating machinery.

May affect reaction speed when driving or operating machinery, considering the ability of Hypecoum preparations to suppress the central nervous system.

Method of Administration and Dosage

Place 1 teaspoon of the herb into an enameled container, pour 200 ml of hot boiled water, cover with a lid, and steep on a boiling water bath for 15 minutes. Cool at room temperature for 45 minutes, then strain, squeezing the residue into the strained infusion. Adjust the volume of the infusion to 200 ml with boiled water. Take warm, 1/4 cup twice daily, 15 minutes before meals. Treatment duration: 2–3 weeks.

Place 1 filter bag into a glass or enameled container, pour 200 ml of boiling water, cover and steep for 15–20 minutes. Take the infusion warm, 1/4 cup twice daily, 15 minutes before meals. Treatment duration: 2–3 weeks.

In skin diseases, internal administration of the infusion should be combined with external use in the form of compresses.

Store the prepared infusion at 8–15 °C for no more than 2 days.

Children.

Contraindicated.

Overdose.

Prolonged internal use of the drug or exceeding the recommended doses may cause dizziness, nausea and vomiting, stomach pain; in severe cases, respiratory center paralysis may develop. If such symptoms occur, discontinue the drug. Treatment is symptomatic.

Side effects.

In case of hypersensitivity, allergic reactions are possible (including hyperemia, itching, and skin rash), nausea, vomiting, and in severe cases — paralysis of the respiratory center.

Shelf life. 3 years.

Storage conditions.

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

Packaging.

50 g in a sachet, placed into a carton; 1.5 g in a filter bag, 20 filter bags in a carton.

Prescription status. By prescription only.

Manufacturer: JSC Pharmaceutical Factory "Viola".

Manufacturer's address and place of business.

4 Skladskaya Street, Zaporizhzhia, Ukraine, 69050.

Marketing authorization holder: JSC Pharmaceutical Factory "Viola".

Address of the marketing authorization holder:

75 Amosova Akademika Street, Zaporizhzhia, Ukraine, 69063.