Bom-benge ointment

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT BOM-BENGE OINTMENT

Composition:

Active substances: levomenthol, methyl salicylate;

1 g of ointment contains 39 mg of levomenthol and 202 mg of methyl salicylate;

Excipients: white soft paraffin, paraffin.

Pharmaceutical form. Ointment.

Main physicochemical properties: white or yellowish ointment with the odour of menthol and methyl salicylate.

Pharmacotherapeutic group.

Topical preparations for joint and muscular pain. ATC code M02A C.

Pharmacological properties.

Pharmacodynamics.

A combined topical preparation.

Methyl salicylate has anti-inflammatory, analgesic, irritant, and counterirritant effects, based on its influence on increased capillary permeability, microcirculation processes, and inhibition of inflammatory mediators' activity, including bradykinin, which has algogenic properties. Menthol-induced stimulation of sensitive nerve endings produces a mild local analgesic effect.

Pharmacokinetics.

Pharmacokinetics has not been determined.

Clinical characteristics.

Indications.

Rheumatism, sciatica, arthritis, neuralgia, exudative pleurisy.

Contraindications.

Hypersensitivity to the components of the drug. Skin diseases; skin injuries, wounds at the site of application.

Hypersensitivity to acetylsalicylic acid, ibuprofen, or other nonsteroidal anti-inflammatory drugs, especially in case of bronchial asthma in medical history.

Interaction with other medicinal products and other forms of interaction.

Although sufficient controlled interaction studies have not been conducted, excessive use of topical salicylates may potentially enhance the effect of coumarin anticoagulants and antiplatelet agents. Therefore, caution should be exercised in patients taking coumarin anticoagulants and antiplatelet agents, including aspirin.

Special precautions for use.

The product is intended for external use only.

Before applying the product, it should first be applied to a small area of skin to prevent the development of allergic reactions.

Some patients, especially those with sensitive skin, may experience discomfort when using the product in hot weather or after taking a bath.

Apply the product only to intact areas of skin.

Do not use with occlusive dressings.

Avoid contact with eyes and sensitive areas of skin. In case of accidental contact with eyes, rinse thoroughly with water and seek immediate medical advice.

Do not use in individuals prone to allergic reactions to the components of the product.

When rubbed into the skin, it may cause a sensation of coldness, followed by warmth, mild burning, and tingling.

Hands should be thoroughly washed after each application. If strong skin irritation occurs, application should be discontinued.

In case of accidental ingestion, seek medical advice or go to the nearest emergency unit immediately.

The product contains salicylates, which are aspirin-like substances; therefore, the precautions associated with aspirin use should be observed.

Use during pregnancy or breastfeeding.

The safety and clinical efficacy of the product during pregnancy and breastfeeding have not been studied.

Ability to affect reaction speed when driving or operating machinery.

No effect.

Dosage and Administration

Apply externally. Rub into affected areas of the body 2–3 times daily, including the chest area (in case of pleuritis). After application of the ointment, it is recommended to apply a dry warming dressing. Duration of treatment depends on the nature and severity of the disease, concomitant therapy, and the therapeutic effect achieved.

Children. Do not use in children under 3 years of age due to the presence of menthol in the preparation.

Overdose

Sensation of intense warmth and burning at the site of ointment application or exacerbation of adverse reactions.

Adverse Reactions

Allergic reactions to the components of the drug are possible. Skin burns, blisters, and temporary skin reactions including redness, burning sensation, and rash may occur.

Possible sensations of cold, followed by warmth, tingling; itching, urticaria; contact dermatitis.

If any adverse effects occur, discontinue use of the drug immediately and consult a physician without delay.

Shelf life. 3 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C; do not freeze. Keep out of reach of children.

Packaging. 25 g in plastic containers. 20 g in aluminum tubes, in a carton or without a carton. 20 g, 25 g, or 30 g in laminated tubes, in a carton or without a carton.

Supply category. Over-the-counter.

Manufacturer. JSC Pharmaceutical Factory "Viola".

Manufacturer's location and address of business activity.

75 Amosova Akademika Street, Zaporizhzhia, Ukraine, 69063.

Marketing Authorization Holder. JSC Pharmaceutical Factory "Viola".

Address of the Marketing Authorization Holder. 75 Amosova Akademika Street, Zaporizhzhia, Ukraine, 69063.