Fructus carvi

I N S T R U C T I O N for medical use of the medicinal product SANDY CUMIN FLOWERS (HELICHRYSI ARENARII FLORES)

Composition:

Active substance: flowers of Helichrysum arenarium (L.) Moench.

Pharmaceutical form. Flowers.

Main physico-chemical characteristics:

Whole raw material: spherical heads, solitary or in clusters of several on short hairy-velvety stalks;

Powdered raw material: fragments of flower heads, receptacles, stems, stalks, involucres, flowers, bracts, and separate flowers or flower heads.

Color of fragments: pale yellow, lemon-yellow, orange, from light brown to dark brown. Color of flowers is yellow or orange-yellow; color of stalk and stem fragments is light gray or gray-green.

Pharmacotherapeutic group. Agents used in liver and biliary tract disorders. ATC code A05A X.

Pharmacological properties.

Pharmacodynamics.

Cumin preparations 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 cholates, enhance gallbladder tone, stimulate gastric and pancreatic secretory function, and increase diuresis.

Clinical characteristics.

Indications.

As a choleretic agent in liver and gallbladder diseases (chronic cholecystitis, cholecystoangiocholitis, cholelithiasis, chronic hepatitis, biliary tract dyskinesia).

Contraindications.

Hypersensitivity to the drug. 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 forms of interaction. Unknown.

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

Usage characteristics.

Use during pregnancy or breastfeeding. There are no contraindications for the use of the drug during pregnancy or breastfeeding (after consultation with a doctor).

Ability to affect reaction rate when driving or operating other machinery. Has no effect.

Method of Administration and Dosage

Place 2 tablespoons of uncrushed or crushed flowers into an enameled container, pour 200 mL of hot boiled water, cover with a lid, and heat on a boiling water bath for 15 minutes. Let stand at room temperature for 45 minutes, then strain and squeeze the residue into the strained infusion. Adjust the volume of the infusion to 200 mL with boiled water. Adults should take warm, ½ 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; aged 14 years and older – ¼ cup, 2–3 times daily, 15–20 minutes before meals. The infusion should be shaken before use.

The prepared aqueous extract should be stored in the refrigerator (at 2–8 °C) for no more than 2 days.

The duration of treatment course is determined individually by a physician.

Children. The drug may be used in children aged 3 years and older, as prescribed by a physician.

Overdose. No reports available.

Adverse reactions.

Allergic reactions are possible (including rash, urticaria, pruritus, hyperemia, and skin edema). With prolonged use, cholestatic phenomena are possible. Increased blood pressure (with prolonged use in patients with arterial hypertension).

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

Expiry date. 4 years.

Do not use after the expiry date stated on the packaging.

Storage conditions. Store at a temperature not exceeding 30 °C.

Packaging. 25 g and 50 g in carton packs with an inner pouch.

Supply classification. Over-the-counter (without prescription).

Manufacturer/Applicant. JSC "Liektravy".

Address of manufacturer and its business location / Address of applicant.

Ukraine, 10001, Zhytomyr Oblast, Zhytomyr, Kyivske Shose, 21.