Calendula flowers

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT CALENDULA FLOWERS (CALENDULAE FLORES)

Composition:

Active substance: calendula flowers (Calendulae flores);

1 pack contains calendula flowers (Calendulae flores) – 30 g;

1 pack contains calendula flowers (Calendulae flores) – 50 g;

1 filter bag contains calendula flowers (Calendulae flores) – 1.5 g.

Pharmaceutical form. Flowers.

Main physico-chemical properties:
Whole raw material: flower heads whole or partially shed, without peduncles or with peduncle remnants. Color of ray florets reddish-orange, orange, bright or pale yellow; of disc florets – orange, yellowish-brown or yellow.

Powdered raw material: mixture of powdered receptacles, peduncles, whole or powdered tubular and pseudoligulate florets, involucral bracts. Color grayish-green, green, reddish-orange, orange, bright or pale yellow, yellowish-brown, yellow.

Coarse powder: fragments of various shapes of receptacles, peduncles, involucral bracts, tubular and pseudoligulate florets, whole tubular florets. Color grayish-green, green, reddish-orange, orange, bright or pale yellow, yellowish-brown, yellow.

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.

Clinical characteristics.

Indications. Orally indicated for gastritis, gastric and duodenal ulcers, 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 biologically active substances of the drug.

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

Special precautions for use.

Use during pregnancy or breastfeeding. Only under a doctor's prescription, when the benefit to the mother outweighs the potential risk to the fetus/child.

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

Method of Administration and Dosage.

Whole raw material: Place 1 tablespoon of whole flowers into an enameled container, pour

200 ml of hot boiled water, cover with a lid and infuse on a boiling water bath for

15 minutes. Cool at room temperature for 45 minutes, strain, squeeze the residue into the strained infusion. Adjust the infusion volume to 200 ml with boiled water. Use

warm, 3 times daily, 15–20 minutes before meals: for adults and children aged 14 years and older – ⅓ cup, for children aged 12–14 years – ¼ cup, aged 7–12 years – 2 tablespoons, aged 3–7 years – 1 dessert spoon. Shake the infusion before use.

For external use, apply for rinsing of the oral cavity and throat 3–4 times daily.

Powdered raw material: Place 1 dessert spoon of powdered flowers into an enameled container, pour 200 ml of hot boiled water, cover with a lid and infuse on a boiling water bath for 15 minutes. Cool at room temperature for 45 minutes, strain, squeeze the residue into the strained infusion. Adjust the infusion volume to 200 ml with boiled water.

Use warm, 3 times daily, 15–20 minutes before meals: for adults and children aged 14 years and older – ⅓ cup, for children aged 12–14 years – ¼ cup, aged 7–12 years – 2 tablespoons, aged 3–7 years – 1 dessert spoon. Shake the infusion before use.

For external use, apply for rinsing of the oral cavity and throat 3–4 times daily.

Coarse powder: Place 2 filter packets into a glass or enameled container, pour 200 ml of boiling water, cover and let stand for 15 minutes. Use warm, 3 times daily, 15–20 minutes before meals: for adults and children aged 14 years and older – ⅓ cup, for children aged 12–14 years – ¼ cup, aged 7–12 years – 2 tablespoons, aged 3–7 years – 1 dessert spoon. Shake the infusion before use. For external use, apply for rinsing of the oral cavity and throat 3–4 times daily.

Store the prepared infusion at 8–15 °C for no more than 2 days.

The duration of treatment is determined individually by a physician.

Children.

For children aged 3 years and older, the preparation may be used internally as prescribed by a physician.

Overdose. No reports available.

Side effects.

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

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 30 °C, in a place inaccessible to children.

Packaging. 30 g or 50 g in packs with an inner pouch;

1.5 g in filter sachets; 20 filter sachets per pack or in a pack with an inner pouch;

1.5 g in a filter sachet in an individual sachet; 20 filter sachets per pack.

Availability. Over-the-counter.

Manufacturer. JSC "Liktavy".

Manufacturer's address and place of business.

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