Prospan® cough syrup
Ukraine
Table of Contents
INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT PROSPAN® COUGH SOLUTION (PROSPAN® COUGH SOLUTION)
Composition:
Active substance: dry extract of ivy leaves;
5 ml of solution (1 stick) contains 35 mg of dry extract of ivy leaves (Hedera helix L.) (5–7.5:1); extraction solvent: ethanol 30% (v/v);
Excipients: potassium sorbate; anhydrous citric acid; xanthan gum; sorbitol solution, crystallizing (E 420); Frescofort Permasil flavoring; natural orange flavoring; menthol; purified water.
Pharmaceutical form. Oral solution.
Main physicochemical properties: light brown, slightly cloudy solution with a fruity odor and a menthol taste.
Pharmacotherapeutic group. Medicinal products used in cough and colds. Expectorants. ATC code R05C A.
Pharmacological properties.
The bronchodilatory effect of the drug was observed in a clinical study. Experiments in animals demonstrated the spasmolytic effect of the drug.
The secretolytic effect is presumed to be caused by irritation of the gastric mucosa, leading to reflex stimulation of the mucous glands of the bronchi via sensory parasympathetic fibers.
Immunohistochemical and biophysical in vitro studies have shown inhibition of β2-receptor internalization by α-hederin—even under conditions of strong stimulation—in alveolar epithelial type II cells.
Clinical characteristics.
Indications.
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 of the excipients of the medicinal product.
Special precautions.
If disease symptoms persist or dyspnea, fever, or purulent or bloody sputum upon coughing occur, immediate medical advice should be sought.
Interaction with other medicinal products and other forms of interaction.
Interaction studies have not been conducted. Interactions are currently unknown.
Special precautions for use.
The product contains sorbitol. If used as directed, the patient will receive up to 1.9 g of sorbitol per dose. There is a risk for patients with hereditary fructose intolerance. In such cases, treatment should be administered only after consultation with a physician.
Do not exceed the recommended daily dose.
If symptoms persist for a prolonged period, or if dyspnea, fever, or purulent or bloody sputum occur, consult a physician immediately.
Concomitant use with opioid antitussive agents, such as codeine or dextromethorphan, is not recommended without medical consultation.
Use with caution in patients with gastritis or peptic ulcer disease.
Use during pregnancy or breastfeeding.
Since data on the safety of using the medicinal product during pregnancy or breastfeeding are lacking, it should not be used during these periods.
Ability to affect reaction speed when driving or operating machinery. No effect.
Method of Administration and Dosage
For adults and children aged 12 years and older: take 1 measure (5 ml) of the solution three times a day, corresponding to 105 mg of dry ivy leaf extract; for children aged 6–11 years: 1 measure (5 ml) twice daily, corresponding to 70 mg of dry ivy leaf extract.
Before use, the measure should be gently squeezed.
The solution should be taken undiluted in the morning (at noon) and in the evening.
The duration of treatment depends on the nature and severity of the disease symptoms and is generally one week, even in cases of mild respiratory tract inflammation.
To achieve a sustained therapeutic effect, it is recommended to continue treatment for an additional 2–3 days after the patient's condition improves.
Children. This medicinal product can be used in children aged 6 years and older.
Overdose. Ingestion of a large amount of the drug (three times higher than the daily dose) may cause nausea, vomiting, diarrhea, and anxious agitation. In such a case, immediate medical advice should be sought.
Side effects.
Allergic reactions are possible, including skin rash, itching, redness of the skin, urticaria, Quincke's edema, suffocation (frequency unknown).
Gastrointestinal disorders are possible, including nausea, vomiting, diarrhea, and abdominal pain (frequency unknown).
If any adverse reactions occur, treatment should be discontinued and medical advice 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. 5 ml of oral solution in a stick; 21 or 30 sticks in a cardboard box.
Prescription category. Over-the-counter.
Manufacturer.
Engelhard Arzneimittel GmbH & Co. KG.
Manufacturer's address and place of business.
Herzbergstrasse 3, 61138 Niederdorfelden, Germany.
INSTRUCTIONS
for medical use of the medicinal product
Prospan® Cough Solution
(PROSPAN® COUGH SOLUTION)
Composition:
Active substance: dried ivy leaf extract;
5 ml of solution (1 stick) contains 35 mg of dried ivy leaf extract (Hedera helix L.) (5–7.5:1); extraction solvent: ethanol 30% (v/v);
Excipients: potassium sorbate; anhydrous citric acid; xanthan gum; crystallizing sorbitol solution (E 420); Frescofort Permasil flavoring; natural orange flavoring; menthol; purified water.
Pharmaceutical form. Oral solution.
Main physicochemical properties: a slightly cloudy light brown solution with a fruity odor and a menthol taste.
Pharmacotherapeutic group. Medicinal products used for cough and colds. Expectorants. ATC code R05C A.
Pharmacological properties.
Broncholytic action of the drug was observed in clinical studies. Animal experiments demonstrated the spasmolytic effect of the drug.
The secretolytic effect is believed to be due to irritation of the gastric mucosa, resulting in reflex stimulation of bronchial mucous glands via sensory parasympathetic fibers.
Immunohistochemical and biophysical in vitro studies showed inhibition of β2-receptor uptake by α-hederin—even under conditions of strong stimulation—in alveolar epithelial cells of type II.
Clinical characteristics.
Indications.
Symptomatic treatment of chronic inflammatory bronchial diseases; acute inflammatory respiratory tract diseases accompanied by cough.
Contraindications. Hypersensitivity to the active substance or to any other component of the medicinal product.
Special precautions.
If symptoms persist, or if dyspnea, fever, or purulent or bloody sputum occur, immediate medical consultation is required.
Interaction with other medicinal products and other forms of interaction.
Interaction studies have not been conducted. No interactions are known to date.
Special instructions for use.
The product contains sorbitol. When used as directed, the patient receives 1.9 g of sorbitol per dose. There is a risk for patients with hereditary fructose intolerance. In such cases, treatment should only be initiated after consultation with a physician.
Do not exceed the recommended daily dose.
If symptoms persist for a prolonged period, or if dyspnea, fever, or purulent or bloody sputum occur, immediate medical consultation is required.
Concomitant use with opioid antitussives such as codeine or dextromethorphan is not recommended without medical advice.
Use with caution in patients with gastritis or peptic ulcer disease.
Use during pregnancy or breastfeeding.
As safety data on the use of the medicinal product during pregnancy or breastfeeding are lacking, it should not be used during these periods.
Ability to influence reaction speed when driving or operating machinery. No effect.
Method of administration and dosage. For adults and children aged 12 years and older: take 1 stick (5 ml) of solution three times daily, corresponding to 105 mg of dried ivy leaf extract; for children aged 6–11 years: 1 stick (5 ml) twice daily, corresponding to 70 mg of dried ivy leaf extract.
Before use, gently squeeze the stick to open.
The solution should be taken undiluted in the morning (or at noon) and in the evening.
The duration of treatment depends on the nature and severity of disease symptoms and is generally one week, even in cases of mild respiratory inflammation.
To achieve a sustained therapeutic effect, treatment should be continued for an additional 2–3 days after symptom improvement.
Children. This pharmaceutical form may be used in children aged 6 years and older.
Overdose. Ingestion of a large amount of the drug (three times the daily dose) may lead to nausea, vomiting, diarrhea, and anxious agitation. In such cases, immediate medical consultation is required.
Side effects.
Allergic reactions are possible, including skin rash, itching, redness of the skin, urticaria, Quincke's edema, suffocation (frequency unknown).
Gastrointestinal disorders are possible, including nausea, vomiting, diarrhea, and abdominal pain (frequency unknown).
If any adverse reactions occur, treatment should be discontinued and medical advice 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. 5 ml of oral solution per stick; 21 or 30 sticks in a cardboard box.
Prescription category. Over-the-counter.
Manufacturer.
Engelhard Arzneimittel GmbH & Co. KG.
Manufacturer's address and place of business.
Herzbergstrasse 3, 61138 Niederdorfelden, Germany.