Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Calcium undecylenate
Clonmel Healthcare Ltd
D01AE; D01AE04
Calcium undecylenate
10 percent weight/weight
Cutaneous powder
Product not subject to medical prescription
Other antifungals for topical use; undecylenic acid
Marketed
2014-03-14
Health Products Regulatory Authority 22 May 2020 CRN008LTK Page 1 of 3 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Caldesene Adult 10% w/w Medicated Powder 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Calcium Undecylenate 10% w/w. Excipient(s) with known effect Contains benzyl benzoate, benzyl alcohol, eugenol, isoeugenol, linalool, cinnamyl alcohol and coumarin. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Cutaneous Powder. A white, perfumed, free flowing cutaneous powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Protects against skin irritation and chaffing especially in delicate skin folds. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ADULTS: Apply to affected area as required or as directed by a physician. There is no recommended dosing schedule. Method of administration: Topical. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE This medicine contains fragrance with: benzyl alcohol, benzyl benzoate, eugenol , isoeugenol, linalool, cinnamyl alcohol and coumarin. which may cause allergic reactions. Benzyl alcohol may cause mild local irritation. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTIONS No interaction studies have been performed. 4.6 FERTILITY, PREGNANCY AND LACTATION As this product is applied topically, its use is not contra-indicated during pregnancy and lactation. 4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES Not relevant. Health Products Regulatory Authority 22 May 2020 CRN008LTK Page 2 of 3 4.8 UNDESIRABLE EFFECTS None known. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971 ; Fa Read the complete document