Ülke: İrlanda
Dil: İngilizce
Kaynak: HPRA (Health Products Regulatory Authority)
Zinc undecylenate
Ricesteele Manufacturing Ltd
D01AE; D01AE04
Zinc undecylenate
100 milligram(s)/gram
Cutaneous powder
Product not subject to medical prescription
Other antifungals for topical use; undecylenic acid
Marketed
1986-08-26
Leaflet revision date: April 2017 18006/P/02 REPORTING OF SIDE EFFECTS If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971 Fax: +353 1 6762517 Website: www.hpra.ie E-mail: medsafety@hpra.ie By reporting side effects you can help provide more information on the safety of this medicine. Leaflet revision date: April 2017 18006/P/02 REPORTING OF SIDE EFFECTS If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971 Fax: +353 1 6762517 Website: www.hpra.ie E-mail: medsafety@hpra.ie By reporting side effects you can help provide more information on the safety of this medicine. Belgenin tamamını okuyun
Health Products Regulatory Authority 16 November 2020 CRN009Y3R Page 1 of 3 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Pedamed 100 mg/g Cutaneous Powder 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each gram of powder contains 100 mg zinc undecylenate equivalent to zinc undecylenate 10% w/w. For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Cutaneous powder Fine, white powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the prevention of athlete's foot and other fungal skin infections. For the elimination of foot odours and antiperspirant effect. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION After cleansing and drying the affected area, Pedamed Powder should be applied twice daily and rubbed in gently. For optimum effectiveness the powder should be used with an appropriate anti-fungal cream. Treatment should be continued for one week after all signs of infection have disappeared. 4.3 CONTRAINDICATIONS Known hypersensitivity to any of the ingredients. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Do not use on broken skin. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTIONS None known. 4.6 FERTILITY, PREGNANCY AND LACTATION No information available. 4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES None known. 4.8 UNDESIRABLE EFFECTS Skin irritation can occur occasionally to some of the ingredients. If this occurs, use of the product should be discontinued. Health Products Regulatory Authority 16 November 2020 CRN009Y3R Page 2 of 3 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; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie. 4.9 OVERDOSE Not applicable. 5 PHARMACOLOGICAL PROPERTIES 5.1 PHARMA Belgenin tamamını okuyun