Calendula tincture

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT CALENDULA TINCTURE

Composition:

Active substance: tincture of calendula flowers and flower heads (Calendulae flos) (1:10) (extractant – 70% ethanol);

1 vial contains tincture of calendula flowers and flower heads (Calendulae flos) (1:10) (extractant – 70% ethanol) – 20 ml, 25 ml, 40 ml or 50 ml.

Pharmaceutical form. Tincture.

Main physicochemical properties: yellowish-brown liquid. Sediment may form 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 moderately cholagogue effects.

Clinical characteristics.

Indications.

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

Contraindications.

Hypersensitivity to the components of the drug.

Interaction with other medicinal products and other forms of interaction.

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

Special precautions for use.

Before starting treatment with this medicinal product, it is necessary to consult a physician. Since ethanol is an ingredient of the preparation, the tincture is not recommended for prolonged internal use.

Use during pregnancy or breastfeeding.

Since ethanol is an ingredient of the preparation, the tincture is not recommended for internal use in women during pregnancy or breastfeeding.

Ability to affect reaction rate when driving or operating machinery.

When taking the tincture internally, caution should be exercised while driving or operating potentially hazardous machinery.

Dosage and Administration.

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 1 drop per year of age, administered 3–4 times daily.

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

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

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

Children.

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

Overdose.

No cases reported.

Side effects.

Allergic reactions may occur (including skin redness, rash, itching, angioedema). When taken orally, a bitter taste in the mouth, burning sensation in the epigastric area, and abdominal pain are possible. If any adverse reactions occur, discontinue use of the product immediately and consult a physician without delay.

Shelf life. 4 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C. Keep out of reach of children.

Packaging.

20 ml, 25 ml, 40 ml, or 50 ml in glass bottles sealed with a stopper and cap, or with a dropper stopper and cap; one 20 ml or 25 ml glass bottle sealed with a dropper stopper and cap in a carton; one 40 ml or 50 ml glass bottle sealed with a dropper stopper and cap or with a stopper and cap in a carton. 20 ml, 25 ml, 40 ml, or 50 ml in polymer bottles sealed with dropper stoppers and caps; one 20 ml, 25 ml, 40 ml, or 50 ml polymer bottle sealed with a dropper stopper and cap in a carton.

Availability. Over-the-counter (without prescription).

Manufacturer. JSC Pharmaceutical Factory "Viola".

Manufacturer's location and address of business activity.

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

Applicant. JSC Pharmaceutical Factory "Viola".

Applicant's address.

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