Prospan® forte effervescent tablets for cough

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT PROSPAN® FORTE EFFERVESCENT COUGH TABLETS

Composition:

Active substance: dry extract of ivy leaves;

1 effervescent tablet contains 65 mg of dry extract of ivy leaves (Hedera helix L.) (5–7.5:1); extraction solvent: ethanol 30% (m/m);

Excipients: anhydrous citric acid, sodium bicarbonate, anhydrous sodium carbonate, mannite (E 421), simethicone, sodium saccharin, sodium cyclamate, sodium citrate, sorbitol (E 420), medium-chain triglycerides, macrogol glycerol hydroxystearate, flavouring agent.

Pharmaceutical form. Effervescent tablets.

Main physico-chemical properties: brownish tablets with marbled inclusions, round, with a score line. When dissolved, a slightly opalescent yellowish-green solution with a sweet orange taste is formed.

Pharmacotherapeutic group. Medicinal products used in cough and common cold. Expectorants. ATC code R05C A.

Pharmacological Properties.

Pharmacodynamics.

A plant-derived preparation exerting expectorant, mucolytic, and spasmolytic 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 or to any component of the medicinal product.

Interaction with other medicinal products and other forms of interactions.

Studies on interactions 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, immediate medical advice should be sought.

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.

Each effervescent tablet contains 6.58 mmol (or 151.33 mg) of sodium. Caution is advised when administering to patients on a sodium-controlled (low-sodium/low-salt) diet.

The flavoring agent in the tablets contains lactose (29.7 mg per effervescent tablet). This medicinal product should not be administered to patients with rare hereditary galactose intolerance, lactase deficiency, or glucose-galactose malabsorption.

In patients with fructose intolerance, treatment should only be initiated after consultation with a physician.

One effervescent tablet contains 382 mg of carbohydrates (equivalent to 0.03 bread units), which should be taken into account in diabetic patients.

Use during pregnancy or breastfeeding.

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

Ability to influence reaction rate when driving or operating machinery.

No effect.

Dosage and method of administration.

For adults and children aged 12 years and older, the recommended dose is 1 effervescent tablet in the morning and ½ effervescent tablet in the evening (97.5 mg of dry ivy leaf extract per day). For children aged 6 to 12 years, the dose is ½ effervescent tablet twice daily (65 mg of dry ivy leaf extract per day).

Effervescent tablets should be taken in the morning (during the day) and in the evening, after dissolving them in a glass of water (approximately 100–200 ml). Both hot and cold water may be used to dissolve the tablets.

The duration of treatment is determined by the physician for each individual case, depending on the nature and severity of the disease.

Children.

The medicinal product is not recommended for children under 6 years of age.

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.

Allergic reactions (urticaria, skin rash, dyspnea, Quincke's edema) (frequency unknown), gastrointestinal disorders (nausea, vomiting, diarrhea, abdominal pain) (frequency unknown) are possible.

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

Shelf life.

3 years.

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.

1 tablet in a sachet; 2 sachets joined into a perforated strip; 5 or 10 strips in a cardboard box.

Prescription status.

Over-the-counter.

Manufacturer.

Engelhard Arzneimittel GmbH & Co. KG.

Engelhard Arzneimittel GmbH & Co. KG.

Manufacturer's address and place of business.

Herzbergstrasse 3, 61138 Niederdorfelden, Germany.