Eucabal^® (Syrup) Instructions for Use

Marketing Authorization Holder

Aristo Pharma, GmbH (Germany)

Manufactured By

Pharma Wernigerode, GmbH (Germany)

ATC Code

R05CA10 (Expectorants in combination)

Active Substances

Thyme (Ph.Eur. European Pharmacopoeia)

Plantago major (BP British Pharmacopoeia)

Dosage Form

Eucabal®

Syrup: bottle 100 ml or 250 ml

Dosage Form, Packaging, and Composition

Syrup as a transparent or slightly turbid dark brown liquid, with a characteristic odor; during storage, the formation of a small sediment or turbidity is possible.

* Extraction solvent ethanol 44.7% (V/V).
** Extraction solvent ammonia solution 10% (m/m) : glycerol 85% : ethanol 90% (V/V) : water (1:20:70:109).

Excipients : methylparahydroxybenzoate, propylparahydroxybenzoate, invert sugar solution (glucose, fructose, sucrose, purified water).

100 ml – dark glass bottles (1) with a dosing insert – cardboard boxes.
250 ml – dark glass bottles (1) with a dosing insert – cardboard boxes.

Clinical-Pharmacological Group

Herbal preparation with expectorant and anti-inflammatory effects

Pharmacotherapeutic Group

Herbal expectorant

Pharmacological Action

A medicinal product with expectorant and anti-inflammatory action.

Indications

As part of complex therapy for inflammatory diseases of the respiratory tract, accompanied by cough with difficult-to-discharge sputum, as well as spastic cough: tracheitis; bronchitis; tracheobronchitis.

ICD codes

Dosage Regimen

Administer orally after meals.

For children aged 6 months to 1 year, use 2.5 ml (one teaspoon) once daily.

For young children, use 2.5 ml (one teaspoon) twice daily.

For school-age children, use 5 ml (one tablespoon) twice daily.

For adults, use 5-10 ml (one to two tablespoons) three to five times daily.

Shake the bottle well before each use.

Use the provided dosing insert for accurate measurement.

The duration of treatment depends on the severity of symptoms and is determined by a physician.

Do not exceed the recommended daily dose.

If symptoms persist after one week of treatment, consult a physician.

Concomitant use with antitussive agents is not recommended.

Adverse Reactions

Allergic reactions.

Contraindications

Hypersensitivity to the components of the combination.

With caution

Liver diseases, chronic alcoholism, epilepsy, traumatic brain injury, childhood, diabetes mellitus, persons on a low-carbohydrate diet, pregnancy, lactation period.

Use in Pregnancy and Lactation

Medicinal products containing this combination may contain ethanol, therefore use during pregnancy and breastfeeding is not recommended.

Use in Hepatic Impairment

The drug should be prescribed with caution (due to the presence of ethanol) in liver diseases.

Pediatric Use

Use with caution in children.

Special Precautions

Concomitant use of antitussive medicinal products is not recommended.

Drug Interactions

Due to the ethanol content, it may enhance the effect of sedatives, hypnotics, and other agents that depress the central nervous system.

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.