Propsan® cough drops

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT PROSPAN® COUGH DROPS (PROSPAN® COUGHDROPS)

Composition:

Active ingredient: dried ivy leaf extract;

1 ml (30 drops) of the medicinal product contains 0.02 g of dried ivy leaf extract (Hedera helix L. folia) (5–7.5 : 1); extraction solvent: ethanol 30% (m/m);

Excipients: purified water, ethanol 96%, sodium saccharin, anise oil, peppermint oil, bitter fennel oil.

Pharmaceutical form. Drops.

Main physicochemical properties: dark brown liquid with an alcoholic and fennel odor. During storage, slight opalescence and sediment formation may occur.

Pharmacotherapeutic group. Agents used for cough and colds. ATC code R05C.

Pharmacological properties.

Pharmacodynamics.

A herbal cough medication. Exerts expectorant, mucolytic, and spasmolytic effects. Reduces sputum viscosity and facilitates its expulsion.

Clinical characteristics.

Indications.

For symptomatic treatment of chronic inflammatory diseases of the bronchi; acute inflammatory diseases of the respiratory tract accompanied by cough.

Contraindications.

Hypersensitivity to the active substance or to any other component of the medicinal product. The medicinal product is not recommended for patients to whom a physician has strictly prohibited alcohol intake, even in minimal amounts (e.g., after completion of alcoholism treatment). The medicinal product is not recommended for children under 2 years of age (due to the risk of exacerbation of respiratory symptoms).

Interaction with other medicinal products and other forms of interaction.

Interaction studies have not been conducted.

Special precautions for use.

If symptoms persist for a prolonged period, or if dyspnea, fever, or purulent or bloody sputum occur, consult a physician immediately.

Use in children aged 2–4 years should be under medical advice. Concomitant use with opioid antitussives such as codeine or dextromethorphan is not recommended without medical consultation.

Should be used with caution in patients with gastritis or peptic ulcer disease.

The medicinal product contains 47% (v/v) ethanol. The recommended daily dose should not be exceeded.

Use during pregnancy or breastfeeding.

Due to insufficient data, the use of the drug is not recommended during pregnancy or breastfeeding.

Ability to affect reaction speed when driving or operating machinery.

No effect.

Method of Administration and Dosage

For adults and children aged 10 years and older: 24 drops three times a day;

for children aged 4 to 10 years: 16 drops three times a day;

for children aged 2 to 4 years: 12 drops three times a day.

The drops should be taken before meals. It is recommended to administer the drops to children mixed with a small amount of fruit juice.

The duration of treatment is determined individually by a physician. Typically, the treatment course lasts 7 days. To achieve a sustained therapeutic effect, treatment is recommended to be continued for an additional 2–3 days after the symptoms have disappeared. If symptoms persist or worsen, medical advice should be sought.

Children.

The medicinal product is not recommended for children under 2 years of age (due to the risk of exacerbation of respiratory symptoms).

Overdose.

The recommended daily dose should not be exceeded. Ingestion of a large amount of the medicinal product (more than three daily doses) may cause nausea, vomiting, diarrhea, and anxious agitation.

Treatment is symptomatic.

Side effects.

Very rarely, allergic reactions (dyspnea, angioedema, skin rash, urticaria) (frequency unknown), gastrointestinal disorders (nausea, vomiting, diarrhea, abdominal pain) (frequency unknown) may occur.

If any adverse reactions occur, treatment should be discontinued and medical advice should be sought.

Shelf life. 4 years.

Shelf life after opening the bottle – 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.

Packaging.

20 ml, or 50 ml, or 100 ml in a bottle with a dropper cap; 1 bottle per cardboard box.

Supply category. Over-the-counter (without prescription).

Manufacturer.

Engelhard Arzneimittel GmbH & Co. KG.

Manufacturer's address and place of business.

Herzbergstrasse 3, 61138 Niederdorfelden, Germany.