Bronchicum^® S (Pastilles) Instructions for Use

Marketing Authorization Holder

A. Nattermann and Cie., GmbH (Germany)

Manufactured By

Sanofi-Aventis, Sp. z o.o. (Poland)

Contact Information

SANOFI

ATC Code

R05CA10 (Expectorants in combination)

Active Substance

Thyme (Ph.Eur. European Pharmacopoeia)

Dosage Form

Bronchicum® S

Lozenges 100 mg: 20 pcs.

Dosage Form, Packaging, and Composition

Pastilles round, slightly biconvex, cream-colored with small inclusions.

Extraction solvent ammonia solution 10%, glycerol 85%, ethanol 90% (v/v), water (in a ratio of 1:20:70:109).

Excipients : sucrose, povidone, levomenthol, cineole, acacia gum, stearic acid, colloidal silicon dioxide, magnesium stearate.

10 pcs. – blisters (2) – cardboard packs.

Clinical-Pharmacological Group

Herbal preparation with expectorant effect

Pharmacotherapeutic Group

Herbal expectorant

Pharmacological Action

Expectorant preparation of herbal origin. It has expectorant and mucolytic action.

Pharmacokinetics

In accordance with the International Convention (EMEAHMPWG11/99), isolated studies of pharmacokinetic parameters are not required during clinical trials of herbal medicinal products.

Indications

• As a symptomatic agent in the complex therapy of inflammatory diseases of the upper respiratory tract, accompanied by cough with difficult-to-discharge sputum.

ICD codes

Dosage Regimen

Dissolve the pastilles slowly in the oral cavity. Do not chew or swallow whole.

For adults and adolescents over 12 years of age, take 1 to 2 pastilles. Repeat this dose up to 3 times daily.

For children aged 6 to 12 years, administer 1 pastille 3 times per day.

Adhere to a minimum interval of 3-4 hours between doses to maintain effect.

The maximum daily dose for adults is 6 pastilles. The maximum daily dose for children 6-12 years is 3 pastilles.

Limit the duration of self-treatment to 4-5 days. If symptoms persist or worsen after this period, discontinue use and consult a physician.

Adjust the frequency of administration based on the severity of cough and sputum production. Reduce frequency as symptoms improve.

For diabetic patients, note that one pastille contains sucrose and corresponds to approximately 0.07 Bread Units (XE).

Avoid concomitant use with antitussive medications, as this may counteract the expectorant effect and lead to sputum retention.

Adverse Reactions

Allergic reactions skin rash, urticaria, angioedema of the face and mucous membrane of the oral cavity and pharynx (Quincke’s edema) are possible. In this case, it is necessary to stop taking the drug and consult a doctor.

Contraindications

• Chronic heart failure (in the stage of decompensation);
• Severe impairment of liver and kidney function;
• Children under 6 years of age;
• Hypersensitivity to the components of the drug.

Use in Pregnancy and Lactation

The drug is not recommended during pregnancy and breastfeeding.

Pediatric Use

Contraindication: children under 6 years of age.

Special Precautions

If there is no improvement in the condition within 5 days, it is necessary to consult a doctor.

Information for patients with diabetes and patients on a hypocaloric diet: 1 pastille corresponds to 0.07 XE (Bread Units).

Overdose

Data on overdose of Bronchicum^® S have not been provided.

Drug Interactions

Concomitant use with antitussive drugs, as well as with drugs that reduce sputum formation, is not recommended, as this makes it difficult to cough up liquefied sputum.

Storage Conditions

The drug should be stored out of the reach of children at a temperature below 25°C (77°F).

Shelf Life

Shelf life – 3 years.

Dispensing Status

The drug is approved for use as an over-the-counter product.

RU.BRO.15.09.80

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.