BOM-BENGE

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT BOM-BENGHE

Composition:

Active substances: levomenthol, methyl salicylate;

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

Excipients: yellow soft paraffin, paraffin.

Pharmaceutical form. Ointment.

Main physicochemical properties: ointment from white, yellowish-white to yellow in color, with the odor of menthol and methyl salicylate.

Pharmacotherapeutic group.

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

Pharmacological Properties

Pharmacodynamics. A combined medicinal product for topical use.

Methyl salicylate has anti-inflammatory, analgesic, irritant, and counterirritant effects, which are 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 results in a mild local analgesic effect.

Pharmacokinetics. The product is intended for topical application; therefore, absorption studies have not been conducted.

Clinical characteristics.

Indications.

Rheumatism (articular and muscular), sciatica, arthritis, neuralgia, exudative pleurisy.

Contraindications.

Hypersensitivity to the components of the medicinal product, skin diseases, skin injuries, wounds at the site of application. Hypersensitivity to acetylsalicylic acid, ibuprofen, or other nonsteroidal anti-inflammatory agents, particularly in patients with a history of bronchial asthma.

Interaction with other medicinal products and other forms of interaction. Although adequate controlled interaction studies have not been conducted, excessive use of topical salicylates may potentially enhance the effect of coumarin anticoagulants and antiplatelet medicinal agents. Therefore, caution should be exercised in patients receiving coumarin anticoagulants and antiplatelet medicinal agents, including aspirin.

Special precautions for use.

Avoid contact of the ointment with the eyes. If accidental contact occurs, rinse the eyes thoroughly with water and seek medical advice immediately.

Do not use in individuals with known hypersensitivity to any component of the medicinal product.

Apply the medicinal product only to intact skin areas.

Hands should be thoroughly washed after each application. If strong skin irritation occurs, discontinue rubbing in the ointment.

Do not use under occlusive dressings.

The medicinal product contains salicylates, which are aspirin-like substances; therefore, the warnings related to the use of aspirin should be observed.

Use during pregnancy or breastfeeding. Safety and efficacy of the medicinal product during pregnancy and breastfeeding have not been studied.

Ability to affect reaction speed when driving or operating machinery. No effect.

Method of administration and dosage.

The medicinal product is intended for topical use. It is rubbed into painful areas of the body 2–3 times a day, including the chest area (in pleuritis). After application of the ointment, it is recommended to apply a dry warming dressing. The duration of use is determined by the nature and severity of the disease, concomitant therapy, and the therapeutic effect achieved.

Children. Not recommended for children under 3 years of age due to the presence of menthol in the medicinal product.

Overdose.

Increased intensity of adverse reactions or sensation of strong warmth and burning at the site of ointment application.

Adverse reactions.

Sensation of cold, followed by warmth, mild burning, and tingling. Allergic reactions are possible, including skin redness, rash, urticaria, contact dermatitis, itching, which require discontinuation of the medicinal product. Skin burns, blisters, and transient skin reactions may occur.

Reporting of adverse reactions after medicinal product registration is highly important. It enables continuous monitoring of the benefit-risk balance of the medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy through the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua.

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. 30 g in tubes, 25 g in jars; 30 g in a tube, 1 tube per carton.

Availability category. Over-the-counter.

Manufacturer. JSC "FITOPHARM".

Manufacturer's address and location of business activity.

2 Sybirtseva Street, Bakhmut, Donetsk Oblast, 84500, Ukraine.

Marketing Authorization Holder. JSC "FITOPHARM".

Address of the Marketing Authorization Holder.

7, Verkhovnoi Rady Boulevard, Premises 18, 3rd Floor, Kyiv, 02100, Ukraine.

In case of adverse reactions or questions regarding safety, quality, and efficacy of the medicinal product, please contact the Pharmacovigilance Department of JSC "FITOPHARM" at the phone number: +38 (044) 390 52 96.

INSTRUCTIONS

for medical use of the medicinal product

BOM-BENGE

Composition:

Active ingredients: levomenthol, methyl salicylate;

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

Excipients: soft yellow paraffin, paraffin.

Pharmaceutical form. Ointment.

Main physicochemical properties: ointment of white, yellowish-white to yellow color with the odor of menthol and methyl salicylate.

Pharmacotherapeutic group.

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

Pharmacological properties.

Pharmacodynamics. A combined medicinal product for external use.

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. Stimulation of sensitive nerve endings by menthol leads to a mild local analgesic effect.

Pharmacokinetics. The medicinal product is intended for topical application; therefore, absorption studies have not been conducted.

Clinical characteristics.

Indications.

Rheumatism (articular and muscular), sciatica, arthritis, neuralgia, exudative pleurisy.

Contraindications.

Hypersensitivity to the components of the medicinal product, skin diseases, skin injuries, wounds at the site of application. Hypersensitivity to acetylsalicylic acid, ibuprofen, or other nonsteroidal anti-inflammatory agents, especially in patients with a history of bronchial asthma.

Interaction with other medicinal products and other forms of interaction. Although adequate controlled interaction studies have not been conducted, excessive use of topical salicylates may potentially enhance the effect of coumarin anticoagulants and antiplatelet medicinal agents. Therefore, caution should be exercised in patients receiving coumarin anticoagulants and antiplatelet agents, including aspirin.

Special precautions for use.

Avoid contact of the ointment with the eyes. If accidental contact occurs, rinse eyes thoroughly with water and seek immediate medical advice.

Do not use in individuals who are hypersensitive to any component of the medicinal product.

Apply the medicinal product only to intact skin areas.

Wash hands thoroughly after each application. If strong skin irritation occurs, discontinue rubbing in the ointment.

Do not use under occlusive dressings.

The medicinal product contains salicylates, which are aspirin-like substances; therefore, consider the warnings related to aspirin use.

Use during pregnancy or breastfeeding. The safety and efficacy of the medicinal product during pregnancy and breastfeeding have not been studied.

Ability to affect reaction speed when driving or operating machinery. No effect.

Method of Administration and Dosage

The medicinal product is intended for topical use. It should be rubbed into painful 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. The duration of treatment depends on the nature and severity of the disease, concomitant therapy, and the therapeutic effect achieved.

Children. Should not be used in children under 3 years of age due to the presence of menthol in the medicinal product.

Overdose.

Increased manifestations of adverse reactions or sensations of intense warmth and burning at the site of ointment application.

Adverse reactions.

Sensation of cold, followed by warmth, mild burning, and tingling. Allergic reactions are possible, including skin redness, rash, urticaria, contact dermatitis, itching, which may require discontinuation of the medicinal product. Skin burns, blisters, and transient skin reactions may occur.

Reporting of adverse reactions after medicinal product registration is of great importance. It enables continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy via the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua.

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. 30 g in tubes, 25 g in jars; 30 g in tube, 1 tube per carton.

Prescription status. Over-the-counter.

Manufacturer. JSC "FITOPHARM" (responsible for batch release, excluding batch control/testing).

Manufacturer's address and location of operations.

17, Chumatska Street, Boryspil, Kyiv Oblast, 08303, Ukraine.

Marketing Authorization Holder. JSC "FITOPHARM".

Address of the Marketing Authorization Holder.

18, 3rd floor, Building 7, Verkhovnoї Rady Boulevard, Kyiv, 02100, Ukraine.

In case of adverse reactions or questions regarding the safety, quality, and efficacy of the medicinal product, please contact the Pharmacovigilance Department of JSC "FITOPHARM" at the following phone number: +38 (044) 390 52 96.