Investigation of the tolerability and safety of film-coated tablets containing ivy extracts (Prospan® Cough Tablets) in the treatment of colds accompanied by coughing

The only saponin drug currently prescribed in any significant amount in monotherapy medicines is ivy. This post-marketing surveillance study (PMSS) aimed at investigating the safety of film-coated tablets containing ivy extract (extracting medium: ethanol 30%, DER 5–7.5:1 [Prospan® Cough Tablets]) under practice conditions. The study included adults and children aged 12 and above suffering from colds accompanied by coughing or from chronic, inflammatory bronchial diseases but not taking any other preparations containing dried ivy leaf extracts. They were, however, allowed to take other medicines.

The patients were scheduled to undergo treatment for a period of at least seven days, take at least two film-coated tablets twice daily, and have a final medical examination seven days after starting the tablets at the earliest. The tolerability of the tablets was rated by means of questionnaires.

A total of 331 patients aged between 11 and 85 years (mean age: 42; median: 43) of both sexes were included in the PMSS. The patients took the tablets for nine to ten days on average. 310 patients were treated for at least seven days. No serious or unexpected adverse drug reactions occurred during the observation period.

The results of this recognised PMSS confirm once more the good to very good tolerability of the tablets in its global assessment of Prospan® Cough Tablets by both, the physician (98.48%) and the patient (96.36%) thus emphasizing the high acceptance and compliance (rated as “good“ in 98.8% of all cases) of this product.