Bom-benge ointment

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

Composition:

Active substances: 1 g of ointment contains: menthol 39 mg, methyl salicylate 202 mg;

Excipients: paraffin, white soft paraffin.

Pharmaceutical form. Ointment.

Main physicochemical properties: ointment of white or yellow color with a strong specific odor. The ointment should be homogeneous in appearance.

Pharmacotherapeutic group.

Preparations for local use in joint and muscle pain.

ATC code M02A C.

Pharmacological properties.

Pharmacodynamics. A combined topical preparation. Methyl salicylate exerts 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 algesic properties. Menthol-induced irritation of sensitive nerve endings produces a mild local analgesic effect.

Pharmacokinetics. Not studied.

Clinical characteristics.

Indications.

Rheumatism (articular and muscular), 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, 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 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 product.

Apply the preparation only to intact skin areas. Upon skin rubbing, a sensation of coldness followed by warmth, mild burning, and tingling may occur.

Do not use under occlusive dressings.

Hands should be washed thoroughly after each application. If significant skin irritation occurs, discontinue rubbing.

The product contains salicylates, which are aspirin-like substances; therefore, the warnings related to aspirin use should be taken into consideration.

Use during pregnancy or breastfeeding.

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

Ability to influence reaction rate when driving or operating machinery.

No effect.

Dosage and Administration.

The medication is intended for topical use. It should be rubbed into painful areas of the body 2–3 times a day, 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.

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

Overdose.

Sensation of intense warmth and burning at the site of ointment application, increased severity of adverse reactions.

Side effects.

Possible skin burns, blisters, and temporary skin reactions. Sensations of cold, followed by warmth, mild burning, and tingling; possible allergic reactions, including skin redness, rash, urticaria, contact dermatitis, and itching.

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 carton boxes or without carton boxes.

Supply category. 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