Althaeae sirupus (Syrup) Instructions for Use

Marketing Authorization Holder

Jadran-Galenski Laboratorij, D.D. (Croatia)

Contact Information

JADRAN-GALENSKI LABORATORIJ a.o. (Croatia)

ATC Code

R05CA05 (Althaea officinalis roots)

Active Substance

Althaeae radix (DAB German Pharmacopoeia)

Dosage Form

Althaeae sirupus

Syrup 35.9 g/100 g: 150 ml bottle

Dosage Form, Packaging, and Composition

Syrup is a viscous, light yellow liquid with a characteristic odor; slight opalescence may appear during storage.

Excipients: sucrose, potassium sorbate, citric acid monohydrate.

150 ml – brown plastic bottles (1) – cardboard packs.

Clinical-Pharmacological Group

Herbal preparation with expectorant effect

Pharmacotherapeutic Group

Herbal expectorant

Pharmacological Action

The preparation has an expectorant and local anti-inflammatory effect and helps to reduce the viscosity of bronchial secretions.

Pharmacokinetics

Pharmacokinetic data for the preparation are not available.

Indications

• Respiratory tract diseases accompanied by cough with difficult-to-expectorate sputum (tracheitis, bronchitis, tracheobronchitis).

ICD codes

Dosage Regimen

The preparation is taken orally, after meals.

Children under 12 years of age – 1 teaspoon of syrup, previously diluted in 1/4 glass of warm water, 3-4 times/day.

Children over 12 years of age and adults – 1 tablespoon of syrup, previously diluted in 1/2 glass of warm water, 4-5 times/day.

The duration of treatment is 10-15 days. Increasing the duration and conducting repeated courses of treatment is possible in consultation with a doctor.

Adverse Reactions

Possible allergic reactions.

If the patient notices any other side effects not listed in the instructions, they should inform their doctor.

Contraindications

• Sucrase/isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption.
• Increased individual sensitivity to the components of the preparation.

With caution in patients with diabetes mellitus and persons on a low-carbohydrate diet (consult a doctor before use).

Use in Pregnancy and Lactation

There are no data regarding the use of the preparation during pregnancy and breastfeeding.

Special Precautions

Patients with diabetes mellitus and persons on a low-carbohydrate diet should take into account that 1 teaspoon of syrup contains about 4.2 g of sucrose (0.35 XE), and 1 tablespoon contains about 16.8 g of sucrose (1.4 XE).

Effect on the ability to drive vehicles and mechanisms

The use of the preparation does not affect the ability to perform potentially hazardous activities that require increased concentration and speed of psychomotor reactions (driving vehicles, working with moving mechanisms, work of a dispatcher and operator).

Overdose

Symptoms nausea, vomiting.

Treatment discontinuation of the preparation, gastric lavage.

Drug Interactions

The preparation should not be used simultaneously with medicines containing codeine and other antitussives, as this makes it difficult to cough up liquefied sputum.

Storage Conditions

The preparation should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 2 years. Do not use after the expiration date.

Dispensing Status

The preparation is available without a prescription.

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.