title: Observational study on the tolerability and safety of film-coated tablets containing ivy extract (Prospan® Cough Tablets) in the treatment of colds accompanied by coughing.
abstract: 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 tolerability and safety of film-coated tablets containing ivy leaves dry extract (extracting medium: ethanol 30%, DER 5-7.5:1 [Prospan® Cough Tablets]) under practice conditions. Adults and children aged 11-85 years of both genders were included. A total of 330 patients suffering from colds accompanied by coughing or from chronic, inflammatory bronchial diseases were scheduled to undergo treatment for a period of at least seven days. The tolerability of the tablets was rated by means of questionnaires. The results of this PMSS reflect the good to very good tolerability of the tablets in the global assessment by both, the practitioner (98.5%) and by the patient (96.4%). This is one of the reasons for the high acceptance and compliance (rated as 'good' in 98.8% of all cases). The safety not only regarding the administration form but also regarding the active substance is thus underlined once again.
authors.affiliation: Engelhard Arzneimittel GmbH & Co. KG, Herzbergstr. 3, 61138 Niederdorfelden, Germany. m.stauss-grabo@engelhard-am.de
authors.forename: M
authors.initials: M
authors.lastname: Stauss-Grabo
authors.forename: S
authors.initials: S
authors.lastname: Atiye
authors.forename: A
authors.initials: A
authors.lastname: Warnke
authors.forename: R S
authors.initials: RS
authors.lastname: Wedemeyer
authors.forename: F
authors.initials: F
authors.lastname: Donath
authors.forename: H H
authors.initials: HH
authors.lastname: Blume
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001991:Bronchitis / Q000188:drug therapy*; D002648:Child; D002908:Chronic Disease; D003139:Common Cold / Q000150:complications / Q000188:drug therapy*; D003371:Cough / Q000188:drug therapy* / Q000209:etiology; D005260:Female; D035981:Hedera; D006801:Humans; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance / Q000706:statistics & numerical data*; D008517:Phytotherapy; D010936:Plant Extracts / Q000008:administration & dosage / Q000009:adverse effects; D018515:Plant Leaves; D011358:Product Surveillance, Postmarketing; D011795:Surveys and Questionnaires; D013607:Tablets; D055815:Young Adult
chemical_list: D010936:Plant Extracts; D013607:Tablets; C012510:prospan