Prospan forte effervescent cough tablets 65 mg sachet strip No. 10

Instructions Prospan forte effervescent cough tablets 65 mg sachet strip No. 10

Composition

active ingredient: dry ivy leaf extract;

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

excipients: anhydrous citric acid, sodium bicarbonate, anhydrous sodium carbonate, mannitol (E 421), simethicone, sodium saccharin, sodium cyclamate, sodium citrate, sorbitol (E 420), medium chain triglycerides, macrogol glycerol hydroxystearate, flavoring.

Dosage form

Effervescent tablets.

Main physical and chemical properties: brownish with marbled inclusions, round tablets with a dividing line. Upon dissolution, a slightly opalescent solution of yellowish-green color with a sweet orange taste is formed.

Pharmacotherapeutic group

Medicines used for coughs and colds. Expectorants. ATX code R05C A.

Pharmacological properties

Pharmacodynamics

A herbal preparation that has an expectorant, mucolytic, and antispasmodic effect. Reduces the viscosity of sputum and promotes its discharge.

Indication

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

Contraindication

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

Interaction with other medicinal products and other types of interactions

Interaction studies have not been conducted.

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.

Each effervescent tablet contains 6.58 mmol (or 151.33 mg) sodium. Caution should be exercised when used in patients on a controlled sodium (low sodium/low salt) diet.

The flavouring included in the tablets contains lactose (29.7 mg per effervescent tablet). Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

In case of fructose intolerance, treatment should only be carried out after consulting a doctor.

1 effervescent tablet contains 382 mg of carbohydrates (corresponds to 0.03 bread units), which should be taken into account by diabetics.

Use during pregnancy or breastfeeding

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

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 effervescent tablet in the morning and ½ effervescent tablet in the evening (97.5 mg of dry ivy leaf extract per day), children aged 6 to 12 years - ½ effervescent tablet 2 times a day (65 mg of dry ivy leaf extract per day).

Effervescent tablets are taken in the morning (afternoon) and evening, having previously dissolved them in a glass of water (approximately 100–200 ml). Both hot and cold water can be used to dissolve the tablets.

The duration of treatment is determined by the doctor in each specific case, taking into account the nature and severity of the disease.

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

Allergic reactions (urticaria, skin rash, shortness of breath, angioedema) (frequency unknown), gastrointestinal disorders (nausea, vomiting, diarrhea, abdominal pain) (frequency unknown) are possible.

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 out of the reach of children.

Packaging

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

Vacation category

Without a prescription.

Producer

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

Address

Herzbergstrasse 3, 61138 Niederdorfelden, Germany.