CHOLAGOGUE MIXTURE

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT BILIARY HERBAL MIXTURE

Composition:

Active substances: 110 g of the mixture contains: Helichrysum arenarium flowers (Helichrysi arenarii flos) – 40 g; Menyanthes trifoliata leaves (Menyanthidis trifoliatae folium) – 30 g; Mentha piperita leaves (Menthae piperitae folium) – 20 g; Coriander fruit (Coriandri fructus) – 20 g.

Pharmaceutical form. Herbal mixture.

Main physicochemical properties:

Powdered herbal material: a mixture of yellow, spherical flower heads of Helichrysum arenarium, green fragments of Menyanthes trifoliata and Mentha piperita leaves (all herbal materials crushed into particles of approximately 5 mm), and yellowish-brown coriander fruits. The mixture has a pleasant odour; the taste of the aqueous extract is bitter, spicy, and slightly cooling.

Coarse powder: a mixture of yellow flower heads of Helichrysum arenarium, green fragments of Menyanthes trifoliata and Mentha piperita leaves, and yellowish-brown coriander fruits (all herbal materials crushed into particles of approximately 2 mm). The mixture has a pleasant odour; the taste of the aqueous extract is bitter, spicy, and slightly cooling.

Pharmacotherapeutic group. Choleretic agent. ATC code A05AX.

Pharmacological properties.

Pharmacodynamics.

Aqueous extract of the herbal mixture has a choleretic effect. The drug promotes increased bile secretion, alters the chemical composition of bile (reduces the concentration of bile acids, increases the content of cholates and bilirubin in bile), enhances biliary excretion, exerts anti-inflammatory, antibacterial and spasmolytic actions, stimulates gastric and pancreatic secretory function, increases diuresis, and acts as a hemostatic agent.

Clinical characteristics.

Indications.

As part of combination therapy for chronic cholecystitis and cholangitis.

Contraindications.

Obstructive jaundice. Hypersensitivity to the components of the drug and to plants of the Asteraceae family (Compositae). Cholelithiasis; acute inflammatory diseases of the liver, gallbladder, and pancreas; bronchial asthma.

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

Special precautions.

Use during pregnancy or breastfeeding. Contraindicated.

Ability to affect reaction rate when driving or operating machinery. Not studied.

Method of Administration and Dosage.

To prepare the infusion: place 1 tablespoon of the herbal mixture into an enameled container, pour 200 mL (1 cup) of cold boiled water, cover with a lid, and heat in a boiling water bath for 15 minutes. Then allow to steep at room temperature for 45 minutes, strain. Squeeze the remaining plant material into the strained infusion. Adjust the final volume of the infusion to 200 mL with boiled water. Administer orally to adults and children aged 12 years and older, 30 minutes before meals, 1/2–1/3 cup three times daily.

Place 2 filter packets into a glass or enameled container, pour 200 mL (1 cup) of boiling water, cover, and let steep for 15 minutes. Take orally 30 minutes before meals, 1/2–1/3 cup three times daily. The maximum treatment course dose should be determined by a physician. The maximum daily dose is 1.5 cups of infusion.

Store the prepared infusion in a cool place for no more than 2 days.

Children.

Safety and efficacy of the drug in children have not been established. Do not use in children under 12 years of age.

Overdose.

Possible increase in arterial blood pressure, chest pain.

Side effects.

Allergic reactions are possible (including hyperemia, rash, itching, skin swelling, urticaria, contact dermatitis). If adverse reactions occur, discontinue use of the product and consult a physician.

Shelf life. 2 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 packs with an inner pouch; 1.5 g in filter bags, 20 bags per pack.

Availability. Over-the-counter (without prescription).

Manufacturer: JSC Pharmaceutical Factory "Viola".

Manufacturer's address.

4 Skladska Street, Zaporizhzhia, Ukraine, 69050.

Marketing Authorization Holder: JSC Pharmaceutical Factory "Viola".

Address of the Marketing Authorization Holder:

75 Amosova Akademyka Street, Zaporizhzhia, Ukraine, 69063.