CALENDULA TINCTURE

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT CALENDULA TINCTURE

Composition:

Active substance: Calendula tincture of flowers (Flores Calendulae);

One vial contains tincture of calendula flowers (Flores Calendulae) (1:10) (extractant –
ethanol 70%) 40 ml or 50 ml or 100 ml.

Pharmaceutical form.
Tincture.

Main physicochemical properties:
Clear yellowish-brown liquid with a specific odor. Sediment may occur during storage.

Pharmacotherapeutic group.
Medicinal products promoting wound healing. ATC code D03A X.

Pharmacological properties.

Pharmacodynamics.

Biologically active substances contained in the flowers and flower heads of calendula exert antimicrobial, anti-inflammatory, and mild cholagogue effects.

Clinical characteristics.

Indications.

For topical use as an antiseptic in infected (purulent) wounds, skin cuts, burns, and inflammation of mucous membranes of the oral cavity, gums (stomatitis, gingivitis), pharynx, and tonsils (pharyngitis, tonsillitis); for oral administration – as a choleretic agent in biliary dyskinesia, cholangitis, and cholecystitis (as part of complex therapy).

Contraindications.

Hypersensitivity to the components of the drug.

Interaction with other medicinal products and other types of interact ions.

Tincture of Calendula enhances the effect of other anti-inflammatory and choleretic agents (particularly drugs based on chamomile and yarrow). When used concurrently with any other medicinal products, inform your physician.

Special precautions for use.

Before starting treatment with the medicinal product, consult a physician.

Since the product contains ethanol, the tincture is not recommended for prolonged internal use.

Use during pregnancy or breastfeeding.

Since the product contains ethanol, the tincture is not recommended for internal use in women during pregnancy or breastfeeding.

Ability to influence reaction rate when driving or operating machinery.

When taking the tincture internally, avoid driving vehicles or operating potentially hazardous machinery.

Administration and Dosage

Take Calendula tincture orally 15–30 minutes before meals, diluted in a small amount of warm boiled water. The recommended dose for adults is 10–20 drops of the tincture 3–4 times daily for up to 1 month. For children aged 12 years and older, the dose is calculated as 1 drop per year of life, 3–4 times daily.

For mouth rinsing, dilute 1 teaspoon of Calendula tincture in a glass of warm boiled water.

For topical applications in cases of cuts, purulent wounds, and burns, dilute 1 teaspoon of the preparation in a glass of boiled water.

The duration and method of administration should be determined individually by a physician.

Children

Oral administration is not recommended for children under 12 years of age.

Overdose

No reports available.

Side effects.

Allergic reactions may occur (including skin redness, rash, itching, angioedema). When taken orally, bitter taste in the mouth, burning sensation in the epigastric area, abdominal pain are possible. If any adverse reactions occur, discontinue use of the product and consult a physician immediately.

Shelf life.

4 years.

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

Storage conditions.

Store at a temperature not exceeding 25 ºC in the original packaging, in a place inaccessible to children. Sediment formation may occur during storage.

Packaging.

40 ml, 50 ml or 100 ml in a bottle.

Availability.

Over-the-counter.

Manufacturer.

PP "Kilaff".

Manufacturer's location and address of business activity.

6 Kharkivska Street, Sumy, Sumy region, 40035, Ukraine.