CALENDULA TINCTURE

APPROVED INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT CALENDULA TINCTURE (CALENDULAE TINCTURA)

Composition:

Active ingredient: 1 bottle contains tincture of marigold flowers and flower heads (Calendulae flos) (1:10) (extractant – 70% ethanol) – 50 ml;

Excipients: none, except the extractant.

Pharmaceutical form. Tincture.

Main physico-chemical properties: yellowish-brown liquid with a weak specific odor, bitter taste. Formation of a slight sediment during storage is permissible.

Pharmacotherapeutic group.

Medicinal products promoting wound healing. ATC Code D03A X.

Pharmacological properties.

Pharmacodynamics.

Biologically active substances contained in marigold flowers and flower heads (flavonoid and carotenoid glycosides, saponins, tannins, essential oil, organic acids) exert antimicrobial, anti-inflammatory, and mild choleretic effects.

Clinical characteristics.

Indications.

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

Contraindications.

The drug is contraindicated in individuals with hypersensitivity to biologically active substances contained in the herbal medicinal raw material.

Special precautions.

Consult a physician before starting treatment with this drug.

The preparation contains ethanol! Prolonged use of the drug is not recommended.

Interaction with other medicinal products and other types of interactions.

Calendula tincture enhances the effect of other anti-inflammatory and choleretic agents (particularly preparations based on chamomile and dandelion).

When using any other medicinal products simultaneously, inform your doctor.

Special precautions for use.

Shake well before use.

Use during pregnancy or breastfeeding.

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

Ability to affect reaction speed when driving or operating machinery.

Caution should be exercised when using the medicinal product orally, as the drug affects the ability to drive vehicles and operate machinery. The sedative effect develops gradually over a period of three weeks.

Dosage and Administration.

Calendula tincture should be taken internally 15–30 minutes before meals, diluted in a small amount of warm boiled water.

Adults are recommended to take 10–20 drops of the tincture 3–4 times daily for 1 month.

For children aged 12 years and older: 1 drop of tincture per year of life, 3–4 times daily.

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

The method of application for local use depends on the nature of the skin lesion and is determined by a physician.

The duration of treatment is determined individually for each patient, taking into account the nature, severity, and specific course of the disease, stability of the achieved therapeutic effect, and the drug's tolerability.

The patient should consult a physician if disease symptoms do not resolve during treatment or if adverse reactions occur that are not listed in the medicinal product's instructions for medical use.

Children.

Not recommended for children under 12 years of age.

Overdose.

No reports available.

Side effects.

The drug is generally well tolerated; however, allergic reactions (skin redness, rash, itching, angioedema) may occur in some patients with individual hypersensitivity. When taken orally, a bitter taste in the mouth, burning sensation in the epigastric area, and abdominal pain are possible.

If any adverse events occur, consult a physician immediately!

Shelf life.

4 years.

Do not use the drug after the expiry date stated on the package.

Storage conditions.

Store at a temperature not exceeding 25°C in a place inaccessible to children.

Packaging. 50 ml in bottles.

Availability. Over-the-counter.

Manufacturer. LLC "DKP "Pharmaceutical Factory".

Manufacturer's address.

4 Korolyov St., Stanishevska village, Zhytomyr district, Zhytomyr region, 12430, Ukraine.