Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Zinc undecylenate
Phoenix Healthcare Ltd
D01AE04
Zinc undecylenate
100 milligram(s)/gram
Cream
undecylenic acid
Marketed
1986-08-26
Package Leaflet: Information for the user PEDAMED 100MG/G CREAM Zinc undecylenate PLEASE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. • Keep this leaflet. You may need to read it again • If you need more information or advice, please ask your doctor or pharmacist • You must contact your doctor if your symptoms get worse or do not improve • If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Pedamed Cream is and what it is used for 2. Before you use Pedamed Cream 3. How to use Pedamed Cream 4. Possible side effects 5. How to store Pedamed Cream 6. Further information. 1. WHAT PEDAMED 100MG/G CREAM IS AND WHAT IT IS USED FOR Pedamed Cream contains the active ingredient zinc undecylenate. Zinc undecylenate is an antifungal which works by preventing fungal growth that can cause skin infections. Pedamed Cream is used for the treatment and prevention of athlete’s foot and other fungal skin infections. It is also used to remove foot odours and to stop feet from sweating. Pedamed Cream is for use on the skin only. 2. BEFORE YOU USE PEDAMED 100MG/G CREAM DO NOT USE PEDAMED CREAM if you are allergic to zinc undecylenate or to any of the other ingredients listed (see ingredients section). TAKE SPECIAL CARE WITH PEDAMED CREAM IF YOUR skin is damaged - do not use it on areas of broken skin. IF ANY OF THE ABOVE APPLIES TO YOU, PLEASE TALK TO A DOCTOR OR PHARMACIST BEFORE USING THIS MEDICINE. TAKING OTHER MEDICINES: Always tell your doctor or pharmacist about all the medicines you are taking. This means medicines you have bought yourself as well as those you have on prescription from your doctor. PREGNANCY AND BREAST-FEEDING: Please let your doctor or pharmacist know if you are pregnant or breast feeding or planning on getting pregnant. If you become pregnant whilst you are using Pedamed Cream, tell your doctor. DRIVING AND USING MACHINES: Pedamed Cream does not affect your abil Les hele dokumentet
Health Products Regulatory Authority 28 October 2021 CRN00CLFK Page 1 of 3 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Pedamed 100 mg/g Cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each gram of cream contains 100 mg zinc undecylenate equivalent to zinc undecylenate 10% w/w. Excipients: Bronopol 0.500 mg/g. Ethyl, Methyl and Propyl parahydroxybenzoates (E214, E218, E216) 1.5 mg/g. For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Cream Smooth, white cream. 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 Cream should be applied twice daily and rubbed in gently. For optimum effectiveness the cream should be used with an appropriate anti-fungal powder. 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 28 October 2021 CRN00CLFK 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: meds Les hele dokumentet