Calendula - vishfa

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT CALENDULA-VISHPHA (CALENDULA-VISHPHA)

Composition:

Active substance: calendula tincture (flowers and flower heads);

1 vial contains calendula tincture (flowers and flower heads) (Calendula officinalis L.) (1:10) (extractant — 70% ethanol) — 50 ml;

Excipients: none, except 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.

Preparations 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 cholagogue 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 dyskinesia, cholangitis, cholecystitis (as part of complex therapy).

Contraindications.

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

Interaction with other medicinal products and other types of interactions.

The medicinal product enhances the effect of other anti-inflammatory and choleretic agents (particularly preparations based on chamomile and yarrow).

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

Special precautions.

Shake well before use.

Consult a physician before starting treatment with this medicine.

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

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

Use during pregnancy or breastfeeding.

Since the medicinal product contains ethanol, it is not recommended for oral use in women during pregnancy or breastfeeding.

Ability to influence reaction speed when driving or operating machinery.

After taking the tincture orally, avoid driving vehicles or operating machinery.

Dosage and Administration.

Take the medicinal product orally, 15–30 minutes before meals, diluted in a small amount of warm boiled water.

For adults, it is recommended to take 10–20 drops of the tincture 3–4 times daily for one 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 tincture 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.

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 drug tolerability.

The patient should consult a physician if symptoms of the disease do not resolve during treatment or if any adverse reactions occur.

Children.

Not recommended for children under 12 years of age.

Overdose.

No reports available.

Side effects.

The medicinal product is generally well tolerated, but 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!

Reporting of adverse reactions after registration of the medicinal product is of great importance. It enables continuous monitoring of the benefit-risk balance of the medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy via the Automated Pharmacovigilance Information System 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 a place inaccessible to children.

Packaging. 50 ml in bottles.

Availability. Over-the-counter.

Manufacturer: LLC "DKP "Pharmaceutical Factory".

Manufacturer's address and place of business.

4 Korolyova St., Stanishivka village, Zhytomyr district, Zhytomyr region, 12430, Ukraine.