Calendula tincture

Instructions for Medical Use of the Medicinal Product CALENDULA TINCTURE

Composition:

Active ingredient: 1 bottle contains tincture of calendula flowers (Calendulae flores) (1:10) (extractant – ethanol 70% v/v) 40 ml, 50 ml or 100 ml.

Pharmaceutical form. Tincture for external and internal use.

Main physicochemical properties: yellow-brown liquid.

Pharmacotherapeutic group.

Wound healing (scar formation) promoting agents. ATC code D03A X.

Pharmacological properties.

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, burns, skin cuts, and inflammation of mucous membranes of the oral cavity, gums (stomatitis, gingivitis), pharynx, and tonsils (tonsillitis, pharyngitis). Internally – 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 forms of interaction.

Tincture of Calendula enhances the effect of other anti-inflammatory and choleretic agents (particularly those based on chamomile and dandelion). When used simultaneously with any other medicinal products, a physician should be informed.

Instructions for use.

Since the formulation contains ethanol, the tincture is not recommended for long-term use.

Calendula tincture is a traditional herbal medicinal product used according to indications supported by long-standing use.

Use during pregnancy or breastfeeding.

Since the formulation contains ethanol, Calendula tincture is not recommended during pregnancy or breastfeeding.

Effect on the ability to drive or operate machinery.

When taking Calendula tincture orally, caution should be exercised when driving or operating 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 – 1 drop of tincture per year of life, 3–4 times daily.

If the medicinal product is sealed with a non-dropper stopper, a glass medical pipette should be used for administration; the dosage remains unchanged.

For mouth rinsing, 1 teaspoon of the tincture is diluted in a glass of warm boiled water.

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

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

Patients should consult a physician if symptoms persist during treatment or if adverse reactions not listed in the instructions occur.

Children.

The product may be used in children aged 12 years and older, as prescribed and under the supervision of a physician.

Overdose.

No cases reported.

Adverse Reactions.

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

If any adverse reactions occur, administration of the drug should be discontinued and medical advice must be sought immediately.

Reporting suspected adverse reactions.

Reporting of adverse reactions following drug registration is highly important. It enables continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare and pharmaceutical professionals, as well as patients or their legal representatives, are advised to report all suspected adverse reactions and lack of drug efficacy via the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua.

Shelf life. 4 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach and sight of children.

Packaging.

50 ml, 40 ml or 100 ml in glass bottles.

100 ml in a glass bottle; 1 bottle per cardboard pack.

Availability.

Over-the-counter (without prescription).

Manufacturer.

JSC "Lubnipharm".

Manufacturer's address and location of manufacturing operations.

16, Barvinkova St., Lubny, Poltava region, 37500, Ukraine.