Prospan, syrup 35mg/5ml, 100ml

Prospan, syrup 35mg/5ml, 100ml

Qualitative and quantitative composition:100 ml of syrup contains 0.7 g of dry extract of Hedera helix L., folium (ivy leaf) (5-7.5: 1), extraction solvent: ethanol 30 % (m/m).

Pharmaceutical form:Syrup

Indications for use:Prospan syrup is a herbal medicinal product used as an expectorant in productive cough (so-called wet cough).

Dosage and method of administration:

Dosage: Adults and adolescents over 12 years of age: take 5 ml of syrup 3 times a day (every

corresponds to 105 mg of dry ivy leaf extract per day).

Children aged 6 to 11 years: 5 ml of syrup 2 times a day (equivalent to 70 mg of dry ivy leaf extract daily).

Children aged 2 to 5 years: on average, 2.5 ml of syrup is administered twice a day (equivalent to 35 mg of dry ivy leaf extract per day).

Do not use in children under 2 years of age.

Method of administration: Oral administration.

The enclosed measuring cup is used to measure the medicine.

Shake the bottle before use!

Application time

Treatment with the preparation should last at least 7 days, even in cases of mild inflammation of the respiratory tract.

If symptoms persist for more than a week despite using the medicinal product, contact your doctor or pharmacist.

Contraindications:

Do not use in patients with hypersensitivity to the active substance or to other plants of the Araliaceae family or to any of the excipients listed in section 6.1. SPC.

Do not use in children under 2 years of age due to the risk of worsening respiratory symptoms.

Special warnings and precautions for use:

Persistent or recurrent cough in children between 2 and 4 years of age requires medical diagnosis before treatment.

If symptoms persist or symptoms such as shortness of breath, fever, purulent or bloody expectoration occur, consult a doctor immediately.

The simultaneous use of antitussive medications such as codeine or dextromethorphan is not recommended without consulting a doctor.

Caution is recommended when used in patients with gastritis or gastric ulcer.

The product contains sorbitol (E420). A single dose (5 ml) contains 1.9 g of sorbitol. The drug should not be used in patients with rare hereditary problems of fructose intolerance. In this case, treatment should only be carried out after consultation with a doctor.

2.5 ml of syrup contains 0.963 g of sorbitol = 0.08 bread units.

Adverse effects:

The frequency of adverse reactions is divided according to the MedDRA system organ class:

Very common (≥ 1/10). Common (≥1/100 and <1/10). Uncommon (≥ 1/1000 and <1/100). Rare (≥ 1/10,000 and <1/1000). Very rare (<1/10,000). Not known (frequency cannot be estimated from available data).

Immune system disorders: Very rarely, allergic reactions may occur after taking medicines containing ivy leaf extract, e.g. shortness of breath, Quincke's edema, rash, urticaria.

Gastrointestinal disorders: Sensitive people may rarely experience gastrointestinal symptoms, e.g. nausea, vomiting, diarrhea and a slight laxative effect related to the sorbitol content in the preparation.

There has not been enough research on the type and frequency of occurrence

side effects associated with the use of the drug in children under 10 years of age. Therefore, the drug should be used with careful observation of the patient.

Reporting suspected side effects: Once a medicinal product has been authorised, it is important to report suspected side effects. This enables continuous monitoring of the benefit-risk ratio of the medicinal product. Professional medical staff should report any suspected adverse reactions via the Department for Monitoring Adverse Reactions of Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. Adverse reactions may also be reported to the Marketing Authorization Holder or the Marketing Authorization Holder's representative.

Responsible entity: Engelhard Arzneimittel GmbH & Co KG, Herzbergstraße 3, 61138 Niederdorfelden,