CALENDULA TINCTURE

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT CALENDULA TINCTURE

Composition:

Active substance: Calendula flower tincture (Flores Calendulae);

1 bottle contains Calendula flower tincture (Flores Calendulae) (1 : 10) (extractant —
ethanol 70%) 50 ml or 100 ml.

Pharmaceutical form.
Tincture.

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

Pharmacotherapeutic group.
Wound healing preparations. ATC code D03A X.

Pharmacological properties.

Pharmacodynamics.

Biologically active substances contained in the flowers and flower heads of calendula (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 cholagogue in biliary tract dyskinesia, cholangitis, cholecystitis (as part of complex therapy).

Contraindications.

Hypersensitivity to the components of the medicinal product.

Interaction with other medicinal products and other types of interactions.

Tincture of calendula enhances the effect of other anti-inflammatory and cholagogue agents (particularly preparations based on chamomile and tansy).

If simultaneous use of any medicinal products is necessary, consult a physician.

Special precautions for use.

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

Since ethanol is an ingredient of this medicinal product, prolonged oral administration is not recommended.

Tincture of Calendula is a traditional herbal medicinal product used according to indications supported by long-term use.

This medicinal product contains 69 vol.% ethanol (alcohol), i.e. 272 mg/dose. Harmful for patients suffering from alcoholism. Use with caution in patients with liver disorders and in patients with epilepsy.

Use during pregnancy or breastfeeding.

Since ethanol is an ingredient of this medicinal product, oral administration is not recommended for women during pregnancy or breastfeeding.

Ability to affect reaction speed when driving or operating machinery.

When taking the tincture orally, avoid driving or operating potentially dangerous machinery.

Method of Administration and Dosage

"Calendula Tincture" is taken 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 — calculated as 1 drop of tincture per year of life, 3–4 times daily.

For mouth rinsing, 1 teaspoon of "Calendula Tincture" should be diluted in a glass of warm boiled water.

The method of topical application depends on the nature of the skin lesion and is determined by the physician.

Duration of treatment depends on the achieved therapeutic effect 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 presence of ethanol in the medicinal product.

Overdose.

No reports available.

Adverse reactions.

Immune system side effects.
The medicinal product is generally well tolerated; however, allergic reactions such as skin redness, rash, itching, and angioedema may occur in some patients with individual hypersensitivity.

Gastrointestinal side effects.
When taken orally, a bitter taste in the mouth, epigastric burning sensation, and abdominal pain are possible.

If any adverse events occur, medical advice should be sought immediately.

Reporting of adverse reactions following registration of the medicinal product is of great importance, as it enables ongoing monitoring of the benefit-risk balance of this medicinal product. Healthcare and pharmaceutical professionals, as well as patients or their legal representatives, are encouraged to report all suspected adverse reactions and lack of efficacy via the Automated Information System for Pharmacovigilance at the following link: https://aisf.dec.gov.ua.

Shelf life.
4 years.

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

Storage conditions.
Store at a temperature not exceeding 25 °C in the original packaging, in a place inaccessible to children. Precipitation may occur during storage.

Packaging.
50 ml in glass bottles, 50 ml in polymer bottles, 100 ml in glass bottles, 100 ml in polymer bottles.

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

Manufacturer.
LLC "MEDLEV".

Manufacturer's address and place of business.
37 Shevchenka Street, Dnipro, 49000, Ukraine.