Prospan® cough syrup

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT PROSPAN® COUGH SYRUP (PROSPAN® COUGH SYRUP)

Composition:

Active substance: dry extract of ivy leaves;

1 ml of syrup contains 7 mg of dry extract of ivy leaves (Hedera helix L.) (5-7.5 : 1), extraction solvent: ethanol 30%;

Excipients: potassium sorbate; anhydrous citric acid; xanthan gum; cherry flavor; sorbitol solution, crystallizing (E 420); purified water;

2.5 ml of syrup contains 0.963 g of the sugar substitute sorbitol = 0.08 bread unit.

Pharmaceutical form. Syrup.

Main physicochemical characteristics: light brown, slightly cloudy syrup with a sweet fruity taste and cherry odor.

Pharmacotherapeutic group. Medicinal products used for cough and colds. Expectorants. ATC code R05CA.

Pharmacological properties.

Pharmacodynamics.

A plant-derived medicinal product containing glycosidic saponins, which provide antitussive, expectorant, spasmolytic, and antimicrobial effects. Reduces sputum viscosity and facilitates its elimination.

Clinical characteristics.

Indications.

Acute respiratory tract inflammatory diseases accompanied by cough; symptomatic treatment of chronic inflammatory bronchial diseases.

Contraindications.

Hypersensitivity to the active substance, to plants of the Araliaceae family, or to any other component of the medicinal product. Hereditary fructose intolerance. The medicinal product is not recommended for children under 2 years of age due to the risk of worsening respiratory symptoms.

Interaction with other medicinal products and other forms of interaction.

No interactions have been observed when Prospan® Cough Syrup is used concomitantly with other medicinal products. Therefore, the syrup may be used together with other medicinal products, such as antibiotics. Concurrent use of cough suppressants such as codeine or dextromethorphan is not recommended without medical consultation.

Special precautions for use

Prolonged or recurrent cough in children requires medical diagnosis prior to treatment. If disease symptoms persist or if dyspnea, fever, malaise, or purulent or bloody sputum appear upon coughing, immediate medical consultation is necessary. Use with caution in patients with gastritis or peptic ulcer disease.

The medicinal product contains sorbitol. When following the dosage instructions, the patient receives up to 1.9 g of sorbitol per dose. May have a mild laxative effect.

Use during pregnancy or breastfeeding
Due to lack of clinical data, this medication should not be used during pregnancy or breastfeeding.

Effect on the ability to drive vehicles or operate machinery
The drug does not affect the ability to drive vehicles or operate machinery.

Method of administration and dosage

For children aged 2 to 6 years, ProsPan® Cough Syrup should be administered orally at a dose of 2.5 mL twice daily. For children aged 6 to 12 years, the dose is 5 mL twice daily. For adults and adolescents aged 12 years and older, the dose is 5 mL three times daily, using the measuring cup provided.

The syrup should be taken in the morning, during the day, and in the evening.

The duration of treatment is determined individually by a physician, depending on the type and severity of symptoms. In uncomplicated cases, the treatment duration is 1 week.

If there is no improvement in the patient's condition after 1 week of treatment, consult a physician for further management.

The bottle must be shaken well before each use!

Children. The medicinal product is used in pediatric practice. The product is not recommended for children under 2 years of age due to the risk of worsening respiratory symptoms.

Overdose.

Do not exceed the recommended daily dose. Ingestion of doses higher than recommended may cause nausea, vomiting, diarrhea, or nervous excitement. Treatment is symptomatic.

Side effects

Allergic reactions such as dyspnea, angioedema, skin rash, urticaria, and pruritus may occur. Frequency is unknown.

Gastrointestinal disturbances including nausea, vomiting, diarrhea, and abdominal pain may occur in patients with hypersensitivity due to the presence of sorbitol.

Reporting of side effects

Reporting suspected adverse reactions after a medicinal product is authorized is important. It allows ongoing monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals and patients, or their legal representatives, should report any suspected adverse reactions and lack of efficacy to the automated pharmacovigilance information system via the following link: https://aisf.dec.gov.ua.

Shelf life. 3 years.

After opening the packaging, the product can be used for up to 6 months.

Do not use after the expiry date stated on the packaging.

Storage conditions.

Store at a temperature not exceeding 25 °C, in a place inaccessible to children.

During storage, slight opalescence and minor changes in the taste of the syrup may occur, which do not affect the therapeutic properties of the product.

Packaging.

100 mL or 200 mL of syrup in a bottle, 1 bottle with a measuring cup in a cardboard box.

Availability. Over-the-counter (without prescription).

Manufacturer.

Engelhard Arzneimittel GmbH & Co. KG.

Manufacturer's address and place of business.

Herzbergstrasse 3, 61138 Niederdorfelden, Germany.