Fructus carvi

INSTRUCTION FOR MEDICAL USE OF HELICHRYSUM FLOS

Composition:

Active substance:

1 packet contains 50 g of Helichrysi arenarii flores (Helichrysi arenarii flores).

Pharmaceutical form. Flowers.

Main physicochemical characteristics:
Heads are spherical, solitary or several together, on short, hairy, tomentose peduncles up to 1 cm long, up to 7 mm in diameter. The heads consist of numerous flowers arranged on a naked receptacle and surrounded by numerous loosely appressed bracts of the involucre. All flowers are tubular, pentadentate, bisexual, with a pappus. Involucral bracts are concave, dry, membranous, and shiny; outer ones are ovate, middle ones are lanceolate and elongated, inner ones are narrow and linear. The color of the involucre is greenish-yellow; flowers are greenish-yellow or orange. Odor is weak, pleasant.

Pharmacotherapeutic group.
Agents used in liver and biliary tract disorders.

ATC Code: A05AX.

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 towards an increase in bile salts, enhance gallbladder tone, stimulate gastric and pancreatic secretory function, and increase diuresis.

Pharmacokinetics. Not studied.

Clinical characteristics.

Indications.

Liver, gallbladder, and biliary tract diseases (cholecystitis, cholecystoangiocholitis, cholelithiasis, hepatitis, biliary tract dyskinesia).

Contraindications.

Hypersensitivity to biologically active substances of the medicinal product.

Obstructive jaundice, cholelithiasis with presence of stones larger than 10 mm in diameter.

Acute inflammatory diseases of the liver, gallbladder, and pancreas.

Interaction with other medicinal products and other types of interactions.

Not known.

If simultaneous use of any other medicinal products is required, inform your physician.

Special precautions.

Use during pregnancy or breastfeeding.

There are no contraindications regarding the use of the medicinal product during pregnancy or breastfeeding. It should be used during these periods only after consulting a physician, when the expected benefit for the mother outweighs the potential risk to the fetus or infant.

Ability to affect reaction rate while driving or operating machinery.

Does not affect.

Method of administration and dosage.

Place 3–4 g (1 tablespoon) of flowers into an enameled container, pour 200 ml (1 cup) of hot boiled water, cover with a lid, and keep on a boiling water bath for 30 minutes. Cool at room temperature and filter. Squeeze the residue into the filtered decoction. Adjust the decoction volume to 200 ml with boiled water.

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

The decoction should be shaken before use.

The duration of treatment is determined individually, depending on the course of the disease, stability of the achieved therapeutic effect, and drug tolerance.

Children.

For children aged 3 years and older, use only as directed by a physician.

Overdose.

No reports available.

Side effects.

Allergic reactions are possible (including rash, urticaria, itching, hyperemia and skin swelling). With prolonged use, cholestasis may occur. Increase in blood pressure (with prolonged use by patients with arterial hypertension).

If any adverse reactions occur, discontinue use of the product and consult a physician.

Shelf life. 4 years.

Storage conditions.

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

The prepared decoction should be stored in a cool place for no more than 2 days.

Keep out of reach of children.

Packaging.

50 g per package with an inner pouch.

Supply category. Over-the-counter.

Manufacturer/Applicant.

TOV "Ternopharm".

Manufacturer's address and location of business activity/Applicant's address.

4 Hryhorovycha St., Ternopil, 46010, Ukraine.

Tel./Fax: (0352) 521-444, www.ternopharm.com.ua