Eucabal^® Balm S (Emulsion) Instructions for Use

Marketing Authorization Holder

Esparma, GmbH (Germany)

Manufactured By

Lichtenheldt, GmbH Pharmazeutische Fabrik (Germany)

Quality Control Release

ESPARMA, GmbH (Germany)

ATC Code

R05CA10 (Expectorants in combination)

Dosage Form

Eucabal® Balm S

Inhalation and topical emulsion: 40 ml or 100 ml tubes

Dosage Form, Packaging, and Composition

Emulsion for inhalation and external use light blue in color, with the odor of eucalyptus oil.

Excipients: cetearyl alcohol [cetyl alcohol 60%, stearyl alcohol 40%] – 4.5 g, glyceryl monostearate – 3 g, macrogol stearate 400 – 2 g, sodium cetearyl sulfate – 0.5 g, trometamol – 0.61 g, citric acid monohydrate – 0.39 g, guaiazulene – 0.05 g, purified water – 75.95 g.

40 ml – aluminum tubes (1) – cardboard boxes.
100 ml – aluminum tubes (1) – cardboard boxes.

Clinical-Pharmacological Group

Herbal preparation with expectorant and anti-inflammatory effects

Pharmacotherapeutic Group

Herbal expectorant

Pharmacological Action

Herbal expectorant for inhalations, baths, and external use. It also has an anti-inflammatory effect.

Indications

As part of complex therapy for diseases of the upper respiratory tract (including rhinitis, pharyngitis, bronchitis).

ICD codes

Dosage Regimen

For rubbing, it is recommended to apply to the skin of the chest and interscapular area 2-3 times/day and rub well.

For steam inhalations.

For baths (mainly in infants over 2 months of age and young children), an 8-10 cm long strip of emulsion is added to 20 liters of water at a temperature of 36-37°C (96.8-98.6°F) (for infants) or 2 strips 10 cm long per 40 liters (for young children), the bathing duration is 10 min.

Adverse Reactions

Possible allergic reactions, increased bronchospasm.

Contraindications

Bronchial asthma; whooping cough; children under 2 months of age (for use in the form of baths and rubbing); children under 5 years of age (for use in the form of inhalations); hypersensitivity to the components of the drug.

Should not be used for rubbing in case of impaired skin integrity, presence of skin diseases in the areas of intended application.

Should not be used for rubbing in the facial area (especially the nose) in infants and young children.

Use in the form of baths is contraindicated in diseases of the cardiovascular system (arterial hypertension, heart failure, arrhythmia, angina pectoris) in the stage of decompensation; increased body temperature (more than 38°C (100.4°F)) in infectious diseases.

Use in Pregnancy and Lactation

The question of the possibility of using the drug during pregnancy and lactation is decided by the doctor individually.

Pediatric Use

Contraindications

• Children under 2 months of age (for use in the form of baths and rubbing);
• Children under 5 years of age (for use in the form of inhalations).

Special Precautions

Use only for inhalations and externally.

After taking a bath, you should not take a shower or rub yourself with a towel.

Avoid getting the drug into the eyes.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°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.