Bronchomed balm

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT BRONCHOMED BALSAM (BRONCHOMED BALSAM)

Composition:

Active substances: menthol (levomenthol), anise oil, tincture of pepper.

Each 5 ml of solution contains: menthol (levomenthol) 1.0 mg; anise oil 0.0035 ml; tincture of pepper 0.025 ml;

Excipients: ginger oil, clove oil, peppermint oil, glycerol, glucose solution, sucrose, tragacanth, benzoic acid (E 210), caramel (E 150), tincture of benzoic, tolu balsam, ethanol 90%, purified water.

Pharmaceutical form. Oral solution.

Main physicochemical properties: dark brown syrup with the odor of ethanol and menthol.

Pharmacotherapeutic group. Medicinal products used in cough and colds.

ATC code R05X.

Pharmacological properties.

A combined herbal preparation used for respiratory tract infections associated with colds. The preparation exhibits mucolytic, bronchodilatory, expectorant, anti-inflammatory, sedative, and diaphoretic effects.

Menthol produces spasmolytic, antiseptic, and local anesthetic actions, promoting the clearance of mucus from the respiratory tract. Anise oil has expectorant, spasmolytic, and antibacterial properties. Pepper tincture exerts a counterirritant effect.

Clinical characteristics.

Indications.

Symptomatic treatment of infectious-inflammatory diseases of the respiratory tract accompanied by sore throat, cough, rhinitis, and inflammation of mucous membranes.

Contraindications.

Hypersensitivity to the components of the drug.

Special precautions.

Use with caution in patients with diabetes mellitus, because the drug contains sucrose and glucose. Do not use in patients with fructose intolerance, glucose-sucrose malabsorption, or sucrose-isomaltase deficiency.

Interaction with other medicinal products and other forms of interaction.

Interaction not described.

Special precautions for use.

Use during pregnancy or breastfeeding.

The drug may be used during pregnancy or breastfeeding after a physician has evaluated the benefit-risk ratio.

Ability to influence reaction rate when driving or operating machinery.

The drug does not have a sedative effect and does not affect the ability to drive or operate machinery.

Method of Administration and Dosage

For oral use.

Adults and children aged 12 years and older – 2 teaspoons (10 ml) every hour or 3 teaspoons (15 ml) every 2–3 hours.

Children aged 6–12 years – 1 teaspoon (5 ml) every hour or 2 teaspoons (10 ml) every 2–3 hours.

Children aged 3–6 years – 1 teaspoon (5 ml) every 2 hours.

Shake the bottle before use.

Do not exceed 6 doses within 24 hours. The treatment course lasts 14 days.

Elderly patients should be given the same doses as adults.

Children.

Contraindicated in children under 3 years of age.

Overdose.

Cases of overdose have not been reported.

Side effects.

Gastrointestinal disorders and hypersensitivity reactions, including skin rash and itching, may occur in individuals with individual intolerance to any component of the drug.

Shelf life. 3 years.

Storage conditions.

Keep out of reach of children at a temperature not exceeding 25 °C.

Packaging.

100 ml or 200 ml in a bottle; 1 bottle in a cardboard box.

Prescription status.

Over-the-counter (without prescription).

Manufacturer.

Bell Sons & Company (Druggists) Limited.

Bell Sons & Company (Druggists) Limited.

Manufacturer's address.

Gifford House, Slaidburn Crescent, Southport, PR9 9AL, United Kingdom.

Gifford House, Slaidburn Crescent, Southport, PR9 9AL, United Kingdom.