NAGIDOK FLOWERS

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT NAGIDOK KVITY (CALENDULAE FLOS)

Composition:

Active substance: Calendulae flos (Calendula flowers).

Pharmaceutical form. Flowers.

Main physico-chemical characteristics:

Whole raw material: Whole or partially disintegrated flower heads up to 5 cm in diameter, without peduncles or with peduncle remnants no longer than 3 cm. Involucre gray-green, single- or double-rowed, composed of linear, acute, densely pubescent bracts. Receptacle slightly convex, glabrous. Ray florets ligulate, reddish-orange, orange, bright or pale yellow, 15–28 mm long, 3–5 mm wide, arranged in 2–3 rows in single-flowered forms and in 10–15 rows in double-flowered forms. Corolla of ligulate florets has a bent, short, pubescent tube and a tridentate lamina with 4–5 veins, twice as long as the involucre. Pistil of these florets with bent inferior unilocular ovary, thin style, and bifid stigma. Disk florets tubular, with a five-toothed corolla, orange, yellowish-brown or yellow in color.

Powdered raw material, coarse powder: A mixture of fragments of flowers, peduncles, and involucral bracts of various shapes. Color of ray florets – reddish-orange, orange, bright or pale yellow; of disk florets – orange, yellowish-brown or yellow. Odor weak. Taste slightly salty and bitter.

Pharmacotherapeutic group.

Antiseptics. ATC code R02A A20.

Pharmacological properties.

Pharmacodynamics.

The complex of biologically active substances exerts anti-inflammatory, wound-healing, bactericidal, spasmolytic, and choleretic effects, accelerates tissue regeneration processes, and promotes healing of ulcers and erosions.

Pharmacokinetics. Not studied.

Clinical characteristics.

Indications.

Orally indicated for gastritis, peptic ulcer of the stomach and duodenum, colitis, enterocolitis, inflammatory diseases of the liver, biliary tract and spleen; externally – for oral cavity diseases (oral candidiasis in children, gingivitis, pyorrhea, inflammatory-dystrophic form of periodontosis), tonsillitis, angina – as part of complex therapy.

Contraindications.

Hypersensitivity to the biologically active substances of the drug.

Interaction with other medicinal products and other forms of interaction. Unknown.

Usage Notes.

Use during pregnancy or breastfeeding. Use only as directed by a physician if the benefit to the woman outweighs the potential risk to the fetus/child.

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

Method of Administration and Dosage

Crude material: Place 1 tablespoon of flowers into an enameled container, pour 200 mL of hot boiled water, cover with a lid, and steep in a water bath for 15 minutes. Cool 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. Administer warm, 3 times daily, 15–20 minutes before meals: for adults and children aged 14 years and older – 1/3 cup; for children aged 12–14 years – 1/4 cup; aged 7–12 years – 2 tablespoons; aged 3–7 years – 1 dessertspoon.

Powdered material: Place 1 dessertspoon of flowers into an enameled container, pour 200 mL of hot boiled water, cover with a lid, and steep in a water bath for 15 minutes. Cool 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. Administer warm, 3 times daily, 15–20 minutes before meals: for adults and children aged 14 years and older – 1/3 cup; for children aged 12–14 years – 1/4 cup; aged 7–12 years – 2 tablespoons; aged 3–7 years – 1 dessertspoon.

Coarse powder: Place 2 filter packets into a glass or enameled container, pour 200 mL of boiling water, cover, and steep for 15 minutes. Administer warm, 3 times daily, 15–20 minutes before meals: for adults and children aged 14 years and older – 1/3 cup; for children aged 12–14 years – 1/4 cup; aged 7–12 years – 2 tablespoons; aged 3–7 years – 1 dessertspoon.

Shake the infusion before use.

The duration of treatment is determined individually by a physician.

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

Children.

The medication may be administered orally to children aged 3 years and older as prescribed by a physician.

Overdose.

No cases of overdose have been reported.

Adverse reactions.

Allergic reactions are possible, including hyperemia, rash, itching, and skin swelling.

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

Shelf life. 2 years.

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

Storage conditions.

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

Packaging.

25 g or 50 g per package with inner pouch; 1.5 g in a filter bag No. 20 per package.

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

Manufacturer: JSC Pharmaceutical Factory "Viola".

Manufacturer's address and place of business.

69050, Ukraine, Zaporizhzhia, Skladska St., 4.

Marketing authorization holder: JSC Pharmaceutical Factory "Viola".

Address of the marketing authorization holder:

69063, Ukraine, Zaporizhzhia, Amosova Akademika St., 75.