INSTRUCTION FOR MEDICAL USE OF CALENDULA OINTMENT

Composition:

Active ingredient: 1 g of ointment contains calendula tincture (tinctura Calendulae) (1:10) – 100 mg;

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

Pharmaceutical form. Ointment.

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

Pharmacotherapeutic group.

Preparations promoting wound healing. ATC code D03A X.

Pharmacological properties.

Pharmacodynamics. The drug exerts anti-inflammatory, reparative, and antiseptic effects. These effects are due to its rich content of substances (carotenoids, flavonoids, saponins, tannins, triterpene glycosides, organic acids, ascorbic acid).

Pharmacokinetics. Not studied.

Clinical characteristics.

Indications.

Burns, cuts, cracks, wounds.

Contraindications.

Increased individual sensitivity to the components of the drug.

Interaction with other medicinal products and other forms of interactions.

Not established.

Special precautions for use.

Avoid getting the ointment into the eyes. If the ointment accidentally gets into the eyes, rinse them thoroughly with water and seek medical advice immediately.

Use during pregnancy or breastfeeding.

The use of Calendula ointment is not recommended during pregnancy or breastfeeding.

Ability to influence reaction rate when driving or operating machinery.

Has no effect.

Method of Administration and Dosage.

Apply the ointment in a thin layer to affected areas (it may be used under occlusive dressing). The duration of treatment depends on the nature, course, severity of the pathological process, and the therapeutic effect achieved.

Children.

The safety and efficacy of the oint manifestation in children under 12 years of age have not been established; therefore, the use of the drug in this patient category is allowed only after a careful assessment of the risk/benefit ratio (by prescription only).

Overdose.

Not reported. Overdose may lead to an intensification of adverse reactions.

Side effects.

Allergic reactions may occur in individuals with hypersensitivity, including skin redness, rash, itching, angioedema.

Shelf life. 2 years.

Storage conditions.

Store in a light-protected place at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

20 g in tubes, in a carton or without a carton.

Availability. Over-the-counter.

Manufacturer/Applicant.

LLC "Ternopharm".

Manufacturer's address and location of business activity / Applicant's address.

LLC "Ternopharm".

46010, Ternopil, Fabrychna St., 4, Ukraine.

Tel./fax: (0352) 521-444, www.ternopharm.com.ua