Bronchinol^® (Syrup) Instructions for Use

Marketing Authorization Holder

VALEA NT, LLC (Russia)

Manufactured By

Natur Produkt Europe, B.V. (Netherlands)

ATC Code

R05CA10 (Expectorants in combination)

Dosage Form

Bronchinol®

Syrup: bottle 100 ml

Dosage Form, Packaging, and Composition

Syrup is a viscous brown liquid with a characteristic odor; slight turbidity is allowed.

Excipients: honey – 25 g, food coloring “caramel” – 0.5 g, sucrose (cane sugar) – 42.887 g, potassium sorbate – 0.15 g, purified water – up to 100 ml.

100 ml – dark glass bottles (1) – cardboard packs.

Clinical-Pharmacological Group

Herbal preparation with expectorant effect

Pharmacotherapeutic Group

Herbal expectorant

Pharmacological Action

A combined herbal preparation; it has an expectorant and anti-inflammatory effect.

Indications

• Use as part of complex therapy for inflammatory diseases of the respiratory tract.

• Employ for conditions such as tracheitis, tracheobronchitis, bronchitis, and bronchopneumonia.

• Applicable for both acute and chronic forms of these respiratory diseases.

ICD codes

Dosage Regimen

Administer orally with an individualized dosage based on the patient’s age.

Follow the standard treatment course of 2 to 3 weeks.

Extend the duration or initiate a repeat course of therapy only upon the explicit recommendation of a physician.

Adverse Reactions

Monitor for the potential development of allergic reactions.

Discontinue use immediately and seek medical advice if any signs of hypersensitivity, such as rash, itching, or swelling, occur.

Contraindications

• Avoid use in patients with a known hypersensitivity to any component of the formulation.

• Do not administer to individuals with hyperacid gastritis or a gastric ulcer with high acidity.

• This product is contraindicated during pregnancy and throughout the breastfeeding period.

• Do not use in children under 6 years of age.

Use in Pregnancy and Lactation

Contraindicated during pregnancy and breastfeeding.

Pediatric Use

Contraindicated for use in children under 6 years of age.

Special Precautions

Use with caution in patients with diabetes mellitus.

Drug Interactions

Do not use concurrently with antitussive medications, particularly those containing codeine.

Avoid this combination as it inhibits the cough reflex, which can impede the expulsion of liquefied sputum and increase the risk of respiratory complications.

Overdose

In case of suspected overdose, discontinue the medication immediately and initiate symptomatic and supportive care.

Seek immediate medical attention or contact a poison control center; treatment should be directed at managing potential symptoms such as nausea, vomiting, or severe gastrointestinal discomfort.

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.