CALENDULA OINTMENT

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT CALENDULA OINTMENT (UNGUENTUM CALENDULAE)

Composition:

Active substance: Calendula flower tincture (Calendulae flores);

1 g of ointment contains Calendula flower tincture (Calendulae flores) (1:10) (extractant – 70% ethanol) 0.1 g;

Excipients: yellow soft paraffin, emulsifier T-2, purified water.

Pharmaceutical form. Ointment.

Main physicochemical properties: yellowish ointment. It should be homogeneous in appearance.

Pharmacotherapeutic group. Medicinal products promoting wound healing. ATC code D03A X.

Pharmacological properties.

The drug exerts anti-inflammatory, reparative, and antiseptic effects. These effects are due to its rich content of substances (carotenoids, flavonoids, saponins, tannins, triterpenoid glycosides, organic acids, ascorbic acid) that promote granulation tissue growth, improve epithelialization, and enhance local defense mechanisms.

When applied topically, the drug does not enter the bloodstream.

Clinical characteristics.

Indications. Burns, cuts, cracks, and other skin injuries.

Contraindications. Hypersensitivity to the components of the drug.

Special precautions. Avoid contact of the ointment with eyes. In case of accidental contact with eyes, rinse thoroughly with water and seek medical advice immediately.

Interaction with other medicinal products and other forms of interaction. Not established.

Special precautions for use.

If there is individual intolerance to the ointment or its components, it is recommended to discontinue use of this medicinal product.

Use during pregnancy or breastfeeding.
Calendula ointment is not recommended during pregnancy and breastfeeding.

Ability to influence reaction rate when driving or operating machinery.
Has no effect.

Method of Administration and Dosage

The medication is intended for topical use. Apply the ointment as a thin layer to affected areas (can be used under occlusive dressing). The duration of treatment is determined individually by the physician and depends on the nature and severity of the pathological process, as well as the therapeutic response achieved.

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

Children. Safety and efficacy of the ointment in children under 12 years of age have not been established. Therefore, use in this patient population is permitted only after careful assessment of the risk-benefit ratio (under physician supervision).

Overdose. Overdose may result in an intensification of adverse reactions.

Side effects.

Allergic reactions, including redness, rash, itching, angioneurotic edema.

Shelf life. 2 years 6 months.

Do not use the drug after the expiry date stated on the packaging!

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

Keep out of reach of children.

Packaging. 30 g in tubes.

Supply category. Over-the-counter.

Manufacturer. JSC "FITOFARM".

Manufacturer's address.

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

Marketing Authorization Holder. JSC "FITOFARM".

Address of the Marketing Authorization Holder.

7, Verkhovnoyi Rady Ave., premises 18, 3rd floor, Kyiv, 02100, Ukraine.