Coldrex^® Broncho (Syrup) Instructions for Use

Marketing Authorization Holder

GlaxoSmithKline Consumer Healthcare (United Kingdom)

Manufactured By

Wrafton Laboratories, Limited (United Kingdom)

ATC Code

R05CA03 (Guaifenesin)

Active Substance

Guaifenesin (Rec.INN registered by WHO)

Dosage Form

Coldrex® Broncho

Syrup 100 mg/5 ml: bottle 100 ml or 160 ml with measuring cup

Dosage Form, Packaging, and Composition

Syrup dark brown in color, viscous, with a licorice and anise odor.

Excipients: dextrose (solution), molasses, macrogol 300, color (simple sugar coloring), sodium cyclamate, glacial acetic acid, sodium benzoate, licorice-anise flavor 510877E, capsicum tincture, acesulfame K, sodium metabisulfite, xanthan gum (Keltrol TF), star anise seed oil, levomenthol, racemic camphor, deionized water.

100 ml – glass bottles (1) with a measuring cup – cardboard boxes.
160 ml – glass bottles (1) with a measuring cup – cardboard boxes.

Clinical-Pharmacological Group

Expectorant

Pharmacotherapeutic Group

Expectorant

Pharmacological Action

Expectorant. Reduces the surface tension and adhesive properties of sputum, which reduces its viscosity and facilitates evacuation from the respiratory tract.

Guaifenesin has an anxiolytic effect.

Pharmacokinetics

Rapidly absorbed from the gastrointestinal tract (within 25-30 minutes after oral administration). Penetrates into tissues containing acidic mucopolysaccharides. Metabolized in the liver. T_1/2 – 1 hour. Excreted with sputum through the lungs and by the kidneys as inactive metabolites.

Indications

Symptomatic treatment of diseases of the upper respiratory tract accompanied by productive cough.

As part of combination therapy: neurotic conditions, symptoms of neurocirculatory dystonia.

ICD codes

Dosage Regimen

Administer the dosage orally. Use the provided measuring cup for accurate dosing.

For adults and children 12 years and older: take 10 ml (two 5 ml teaspoonfuls) every four hours.

Do not exceed six doses (60 ml) within a 24-hour period.

For children 6 to under 12 years: take 5 ml (one teaspoonful) every four hours.

Do not exceed six doses (30 ml) within a 24-hour period.

For children 2 to under 6 years: take 2.5 ml (one-half teaspoonful) every four hours.

Do not exceed six doses (15 ml) within a 24-hour period.

This medication is contraindicated for children under 2 years of age.

Maintain a dosing interval of at least four hours between administrations.

Increase fluid intake during therapy to aid in sputum clearance.

The duration of treatment depends on symptom resolution; consult a physician if cough persists beyond 7 days.

Adverse Reactions

From the digestive system: nausea, vomiting, gastralgia, abdominal pain, diarrhea.

From the central nervous system: dizziness, headache, drowsiness.

Allergic reactions: skin rash, urticaria, hyperthermia.

Contraindications

Productive cough with copious sputum, gastric or duodenal ulcer, gastric bleeding (in history), children under 2 years of age (efficacy of use has not been studied), hypersensitivity to guaifenesin.

Use in Pregnancy and Lactation

During pregnancy and lactation, Guaifenesin should be used with caution, only in cases where the expected therapeutic benefit for the mother outweighs the potential risk to the fetus or infant.

Use in Hepatic Impairment

Should be used with caution in severe liver dysfunction.

Use in Renal Impairment

Should be used with caution in severe renal impairment.

Pediatric Use

Contraindicated in children under 2 years of age (efficacy of use has not been studied). Caution should be exercised when using in children aged 2 to 12 years with persistent or chronic cough against the background of bronchial asthma or with increased sputum production (careful medical supervision is required before prescribing guaifenesin).

Geriatric Use

There are no specific instructions for use limitation.

Special Precautions

Caution should be exercised when using in children aged 2 to 12 years with persistent or chronic cough against the background of bronchial asthma or with increased sputum production (careful medical supervision is required before prescribing guaifenesin).

During treatment, it is recommended to take a sufficient amount of fluid. It is advisable to combine with postural drainage or chest vibration massage.

Urine may turn pink.

Results of the determination of 5-hydroxyindoleacetic acid in urine (when using the nitrosynaphthol reagent) may be falsely elevated due to the influence of guaifenesin metabolites on color (guaifenesin should be discontinued 48 hours before urine collection for this test).

Guaifenesin and its metabolites may cause color changes in the determination of vanillylmandelic acid in urine and falsely elevate the results of the catecholamine test (guaifenesin should be discontinued 48 hours before urine collection for this test).

Drug Interactions

With simultaneous use, Guaifenesin enhances the effect of agents that have a depressant effect on the central nervous system, as well as ethanol.

Storage Conditions

Store at 2°C (36°F) to 30°C (86°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.