BORIC ACID ALCOHOLIC SOLUTION 3 %

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT BORIC ACID ALCOHOLIC SOLUTION 3%

Composition:

Active ingredient: boric acid;

100 ml of solution contain boric acid 3 g;

Excipients: ethanol 96%, purified water.

Pharmaceutical form.

Solution for external use.

Main physico-chemical properties: clear, colorless liquid with a characteristic odor of alcohol.

Pharmacotherapeutic group.

Antiseptics and disinfectants. ATC code D08AD.

Pharmacological properties.

Pharmacodynamics.

The drug exerts an antiseptic effect. It coagulates proteins (including enzymes) of microbial cells, disrupts the permeability of the cell membrane, thereby inhibiting the growth and development of bacteria.

Pharmacokinetics.

When applied externally, the drug is absorbed through damaged skin and wound surfaces; if accidentally ingested, it is absorbed through the mucous membrane of the gastrointestinal tract. Boric acid can accumulate in body tissues. It is slowly eliminated from the body.

Clinical characteristics.

Indications.

Pyoderma, weeping eczema, intertrigo, acute and chronic otitis media.

Contraindications.

Hypersensitivity to boric acid, impaired renal function, chronic mesotympanitis with normal or minimally altered mucosa, traumatic perforations of the tympanic membrane; pregnancy or breastfeeding periods, including application to mammary glands; in children (including newborns).

Special precautions.

Do not apply the drug to large skin areas; do not use for cavity irrigation. Avoid contact of the drug with eyes.

Do not violate the instructions for use of the medicinal product, as this may harm health.

Interaction with other medicinal products and other types of interactions.

Interaction is currently unknown.

When using any other medicinal products simultaneously, inform the physician.

Special precautions.

Use during pregnancy or breastfeeding.

The drug is contraindicated in women during pregnancy or breastfeeding.

Ability to affect reaction rate while driving or operating machinery. No effect.

Method of Administration and Dosage

For topical use only. In cases of pyoderma, intertrigo, and eczema, affected areas of the skin should be treated with a gauze pad previously moistened with the preparation, 2–3 times daily.

For otitis, insert into the external auditory canal pledgets moistened with the solution or instill 3–5 drops 2–3 times daily.

Children

The preparation is not intended for use in children.

Overdose

In case of accidental ingestion, perform gastric lavage via a tube, administer saline laxatives and enterosorbents (activated charcoal) orally, as well as symptomatic therapy.

Symptoms of acute poisoning: nausea, vomiting, diarrhea, circulatory disturbances, depression of the central nervous system, hypothermia, shock, coma, and erythematous rash. In cases of severe poisoning, measures should be taken to maintain vital functions; hemodialysis or peritoneal dialysis, or blood transfusion may be required.

With prolonged use of the preparation over large skin surface areas, symptoms of chronic intoxication may develop: tissue edema, exhaustion, stomatitis, eczema, menstrual cycle disturbances in women, anemia, seizures, and alopecia. In such cases, discontinue the drug and administer symptomatic treatment.

Side effects.

The use of the drug may cause allergic reactions (skin redness, itching, urticaria, rashes, swelling). In isolated cases, anaphylactic reactions including shock, and epithelial desquamation may develop.

With prolonged use and in patients with impaired renal function, nausea, vomiting, diarrhea, headache, confusion, oliguria, and seizures may occur.

If any adverse events occur, consult a physician immediately!

Shelf life. 3 years.

The drug must not be used 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.

20 ml or 25 ml in glass bottles stoppered with plugs or dropper inserts and caps, in a carton or without a carton. 20 ml or 25 ml in polymer bottles stoppered with dropper inserts and caps, in a carton or without a carton.

Dispensing category. Over-the-counter.

Manufacturer. JSC Pharmaceutical Factory "Viola".

Manufacturer's address and place of business.

75 Amosova Akademika Street, Zaporizhzhia, 69063, Ukraine.

Marketing Authorization Holder. JSC Pharmaceutical Factory "Viola".

Address of the Marketing Authorization Holder and place of business.

75 Amosova Akademika Street, Zaporizhzhia, 69063, Ukraine.