Prospan cough lozenges 26 mg blister No. 20

Instructions for Prospan cough lozenges 26 mg blister No. 20

Composition

1 lozenge contains 26 mg of dry extract of ivy leaves (Hedera helix L.) (5–7.5:1); extractant: ethanol 30% (m/m);

Excipients: acacia (gum arabic), non-crystallizing sorbitol solution (E 420), liquid maltitol, anhydrous citric acid, acesulfame K, natural orange flavor, menthol flavor, medium chain triglycerides, purified water.

Dosage form

Lozenges for resorption.

Main physicochemical properties: yellow-brown hexagonal lozenges with orange and menthol flavor. Lozenges may contain air bubbles.

Pharmacotherapeutic group

Remedies used for coughs and colds. Expectorants.

ATX code R05C A.

Pharmacological properties

Pharmacodynamics.

In a clinical study, the bronchodilator effect of the drug was noted. Animal experiments demonstrated the antispasmodic effect of the drug.

It is assumed that the expectorant action is caused by irritation of the gastric mucosa by reflex stimulation of the bronchial mucous glands through sensory parasympatholytic fibers.

In vitro immunohistochemical and biophysical studies have shown inhibition of b2 receptor uptake by a-hederin – even under conditions of strong stimulation – in alveolar epithelial type II cells.

Indication

Chronic inflammatory diseases of the bronchi; viral infections of the upper respiratory tract accompanied by cough.

Contraindication

Hypersensitivity to the active substance or to any other component of the medicinal product.

Interaction with other medicinal products and other types of interactions

Interaction studies have not been conducted. Interactions are unknown to date.

Application features

If symptoms of the disease persist for a long time, as well as if shortness of breath, fever, and purulent or bloody sputum appear, you should immediately consult a doctor.

Concomitant use with opiate antitussives such as codeine or dextromethorphan is not recommended without medical advice.

It should be used with caution in patients with gastritis or gastric ulcer.

Patients with rare hereditary problems of fructose intolerance should not take this medicine.

1 lozenge contains 0.53 g of maltitol and 0.53 g of sorbitol, which is equivalent to approximately 0.09 bread units, which should be taken into account by diabetics.

Use during pregnancy or breastfeeding

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

Ability to influence reaction speed when driving vehicles or other mechanisms

Does not affect.

Method of administration and doses

Adults and children over 12 years of age are prescribed 1 lozenge 4 times a day (104 mg of dry ivy leaf extract per day);

children aged 6 to 12 years – 1 lozenge 2 times a day (52 mg of dry ivy leaf extract per day).

The lozenges are dissolved in the mouth after meals. Do not dissolve while lying down.

The duration of treatment depends on the nature and severity of the symptoms of the disease and is usually one week, even in the case of mild inflammation of the respiratory tract.

To achieve a sustained therapeutic effect, it is recommended to continue treatment for another 2–3 days after the patient's condition improves.

Children

The medicine is not recommended for use in children under 6 years of age.

Overdose

Do not exceed the recommended daily dose. Swallowing large amounts of the drug (more than three daily doses) may cause nausea, vomiting, diarrhea, and anxiety.

Treatment is symptomatic.

Side effects

Very rarely (<1/10,000) allergic reactions may occur (shortness of breath, angioedema, skin rash, urticaria);

Infrequently (≥1/10,000 - 1,000) gastrointestinal disorders (nausea, vomiting, diarrhea and abdominal pain) are possible in sensitive patients.

If any adverse reactions occur, treatment should be discontinued and a doctor should be consulted.

Expiration date

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 protected from moisture.

Keep out of reach of children.

Packaging

10 pastilles in a blister; 2 blisters in a cardboard box.

Leave category. Without a prescription.

Vacation category

Without a prescription.

Producer

Engelhard Arzneimittel GmbH & Co. KG/Engelhard Arzneimittel GmbH & Co. KG.

Address

Herzbergstrasse 3, 61138 Niederdorfelden, Germany.