BORIC OINTMENT 5 %

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT BORNA OINTMENT 5%

Composition:

Active substance: boric acid;

1 g of ointment contains 0.05 g of boric acid;

Excipient: white soft paraffin.

Pharmaceutical form. 5% ointment.

Main physicochemical properties: ointment of white or light yellow color, odorless. The ointment should be homogeneous in appearance.

Pharmacotherapeutic group.

Antiseptics and disinfectants. Boric acid preparations. ATC code D08AD.

Pharmacological properties.

Pharmacodynamics. Boric acid belongs to the group of antiseptic agents. It exerts antiseptic, fungistatic, as well as anti-pediculosis and astringent effects. It coagulates proteins (including enzymatic proteins) of microbial cells and disrupts the permeability of the cell membrane. It inhibits the growth and development of bacteria. It has a weak irritant effect on granulation tissues.

Pharmacokinetics. It is absorbed through damaged skin, wound surfaces, and the mucous membrane of the gastrointestinal tract (in case of accidental ingestion).

Boric acid may accumulate in the body's organs and tissues. It is slowly eliminated (repeated entry leads to accumulation).

Clinical characteristics.

Indications.

Pediculosis. As an antiseptic agent in diaper rash and skin fissures, dermatitis, pyoderma, eczema, acute and chronic external otitis.

Contraindications.

Chronic mesotympanitis with normal or minimally altered mucosa, traumatic perforations of the tympanic membrane.

Hypersensitivity to boric acid. Impaired renal function.

Interaction with other medicinal products and other forms of interaction.

When used simultaneously with topical medicinal products, new compounds with unpredictable effects may be formed.

Special precautions for use

Borax ointment 5 % should not be applied to hairy areas of skin in cases of acute inflammatory skin diseases. Care should be taken to avoid getting the ointment into the eyes (if contact occurs, rinse eyes with warm water). Do not apply to large areas of the body surface.

In case of individual hypersensitivity to boric acid or any other component of the medicinal product, use should be discontinued.

Use during pregnancy or breastfeeding

The use of this medicinal product is contraindicated during pregnancy and breastfeeding.

Ability to influence reaction rate when driving or operating machinery

The medicinal product does not affect the ability to drive or operate machinery.

Method of Administration and Dosage.

For pediculosis, apply boron ointment to the hairy part of the head depending on the degree of infestation, hair density, and length, using 10–15–25 g. After 20–30 minutes, wash off with warm running water using cleansing agents. Comb the hair thoroughly with a fine comb.

Use in inflammatory conditions of the external auditory canal is determined by a physician and depends on the nature of the pathological process.

For skin intertrigo and skin fissures, apply the ointment in a thin layer to affected areas.

Children.

Experience of use in children is lacking.

Overdose.

With prolonged use over large affected areas, symptoms of acute poisoning may occur: nausea, vomiting, diarrhea, circulatory disturbances, central nervous system depression, decreased body temperature, erythematous rash, shock, coma. With prolonged use, symptoms of chronic intoxication may develop: exhaustion, stomatitis, eczema, local tissue edema, menstrual cycle disturbances, anemia, convulsions, alopecia. Treatment is symptomatic. Blood transfusion, hemodialysis, and peritoneal dialysis are indicated. In case of accidental ingestion, perform gastric lavage via tube, administer saline laxatives and enterosorbents (activated charcoal) orally, as well as symptomatic therapy. In cases of severe poisoning, take measures to support vital functions of the body.

Side effects.

With prolonged use on large affected areas, nausea, headache, vomiting, confusion, diarrhea, skin rash, epithelial desquamation, oliguria may occur. The use of the product may cause allergic reactions (skin redness, itching, urticaria, swelling). In isolated cases – development of anaphylactic reactions, including shock. Seizures.

Shelf life. 3 years.

Storage conditions.

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

Keep out of reach of children.

Packaging.

25 g in tubes (in cardboard boxes or without boxes).

Supply category. Over-the-counter.

Manufacturer/Marketing Authorization Holder.

TOV "Ternopharm".

Address of manufacturer and location of its business activities / address of marketing authorization holder.

TOV "Ternopharm".

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

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