CALENDULA TINCTURE

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT CALENDULA TINCTURE

Composition:

Active substance: 1 bottle contains calendula flower tincture (Calendulae flores) (1 : 10)
(extractant – ethanol 70%) – 40 ml.

Pharmaceutical form. Tincture.

Main physico-chemical properties: yellowish-brown liquid.

Pharmacotherapeutic group.
Preparations promoting 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 cholagogue effects.

Pharmacokinetics.

Not studied.

Clinical characteristics.

Indications.

A local antiseptic agent 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.

Calendula tincture is contraindicated in individuals with hypersensitivity to any component of the preparation.

Interaction with other medicinal products and other forms of interactions.

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

Special precautions.

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

Use during pregnancy or breastfeeding.

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

Ability to affect reaction rate when driving or operating machinery.

Patients should refrain from driving or operating machinery during internal use of the preparation.

Method of Administration and Dosage

Apply 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 dosage is calculated as 1 drop of tincture per year of life, administered 3–4 times daily.

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

The method of using the preparation for local applications depends on the nature of skin lesions and is determined by a physician.

The duration of treatment depends on the therapeutic effect achieved and the patient's tolerance to the drug.

The patient should consult a physician if symptoms do not resolve during treatment or if adverse reactions not listed in the instructions occur.

Children

Do not use in children under 12 years of age due to the ethanol content.

Overdose

No reports available.

Adverse reactions.

Immune system. The drug is generally well tolerated; however, in some patients with individual hypersensitivity, allergic reactions may develop, including skin redness, rash, itching, angioedema.

Gastrointestinal tract. When taken orally, a bitter taste in the mouth, burning sensation in the epigastric area, abdominal pain may occur.

If any adverse reactions occur, discontinue use of the drug and consult a physician!

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.

40 ml in bottles.

Availability.

Over-the-counter.

Manufacturer.

JSC "FITOPHARM".

Manufacturer's address.

84500, Bakhmut, Sibirzeva St., 2, Donetsk region, Ukraine.

Marketing authorization holder.

JSC "FITOPHARM".

Address of the marketing authorization holder.

12 Almatinska St., Kyiv, 02092, Ukraine.