Fructus carvi

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT HELICHRYSUM FLOWERS (FLORES HELICHRYSI ARENARII)

Composition:

Active substance: Helichrysum flowers.

Pharmaceutical form. Flowers.

Main physicochemical properties:

Whole raw material: inflorescences are spherical, solitary or several together on short, hairy-pubescent peduncles up to 1 cm long, about 7 mm in diameter. The heads consist of numerous flowers arranged on a bare receptacle, surrounded by numerous loosely appressed bracts of the involucre. All flowers are tubular, five-toothed, bisexual, with a pappus. The bracts of the involucre are concave, dry, membranous, shiny; outer ones are ovate, middle ones are lobed and elongated, inner ones are narrow and linear.

Color of the involucre is lemon-yellow; flowers are lemon-yellow or orange. Odor is weak and pleasant. Taste is spicy-bitter.

Ground raw material and coarse powder: a mixture of fragments of flowers, peduncles, and involucral bracts of various shapes. Color of involucral remnants is lemon-yellow; flowers are lemon-yellow or orange. Odor is weak and pleasant. Taste is spicy-bitter.

Pharmacotherapeutic group. Agents used in diseases of the liver and biliary tract. ATC code A05A X.

Pharmacological Properties.

Pharmacodynamics.

Cumin preparations containing flavonoids, diterpenic alcohol, steroid compounds, phenolic dyes, fatty acids, inositol, and essential oil belong to choleretic agents. They increase bile secretion, reduce the concentration of bile acids and bilirubin content in bile, alter the cholesterol/bile acid ratio in favor of increased cholates, enhance gallbladder tone, stimulate gastric and pancreatic secretory function, and increase diuresis.

Clinical characteristics.

Indications.

To be used as a cholagogue agent in chronic liver and gallbladder disorders (chronic cholecystitis, cholecystoangiocholitis, cholelithiasis, chronic hepatitis, biliary tract dyskinesia).

Contraindications.

Hypersensitivity to the drug. Obstructive jaundice, cholelithiasis with stones larger than 10 mm in diameter. Acute inflammatory diseases of the liver, gallbladder, and pancreas. Children under 3 years of age.

Interaction with other medicinal products and other forms of interaction.

Not studied.

Instructions for use.

Use during pregnancy or breastfeeding.

There are no contraindications for the use of the drug during pregnancy or breastfeeding.

Ability to influence reaction rate while driving or operating machinery.

Does not affect.

Method of Administration and Dosage.

Place 3–4 g of flowers (1 tablespoon) into an enameled container, pour 200 mL (1 cup) of hot boiled water, cover with a lid, and heat in a water bath for 30 minutes. Allow to cool at room temperature and strain. Squeeze the remaining raw material, and adjust the volume of the resulting infusion to 200 mL with boiled water.

Place 2 filter bags into a glass or enameled container, pour 200 mL (1 cup) of boiling water, cover, and let steep for 15 minutes.

For adults, take warm, 1/2 cup 2–3 times daily, 15–20 minutes before meals. For children aged 3–7 years – 1 dessert spoon, aged 7–12 years – 1 tablespoon, aged 12–14 years – 2 tablespoons, over 14 years – 1/4 cup, 2–3 times daily, 15–20 minutes before meals.

The infusion should be shaken before use.

The duration of treatment is determined individually, taking into account the nature, severity, and characteristics of the disease course, stability of the achieved therapeutic effect, and the patient's tolerance to the drug.

Children.

For use in children aged 3 years and older only under medical supervision.

Overdose.

Not observed.

Side effects.

Possible allergic reactions (including rashes, urticaria, itching, hyperemia and swelling of the skin), increased blood pressure (with prolonged use in patients with arterial hypertension).

Shelf life. 4 years.

Storage conditions.

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

Packaging.

20 g, 40 g or 50 g in packets, with insertion into a carton; 1.5 g in tea-bags, with 20 tea-bags placed in cartons.

Supply category. Over-the-counter.

Manufacturer: JSC Pharmaceutical Factory "Viola".

Manufacturer's address and place of business.

4 Skladska Street, Zaporizhzhia, Ukraine, 69050.

Marketing authorization holder: JSC Pharmaceutical Factory "Viola".

Address of the marketing authorization holder:

75 Amosova Akademika Street, Zaporizhzhia, Ukraine, 69063.