Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Zinc undecylenate
Ricesteele Manufacturing Ltd
D01AE; D01AE04
Zinc undecylenate
100 milligram(s)/gram
Cream
Product not subject to medical prescription
Other antifungals for topical use; undecylenic acid
Marketed
1986-08-26
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. • Do not get Pedamed Cream in your eyes, nose or mouth. If you get this medicine in your eyes, nose or mouth, rinse immediately with cool tap water • Wash and dry your hands before and after using this medicine • Clean and dry the affected area • Apply a thin layer of Pedamed Cream over the affected area twice daily and rub the cream in gently. For athlete’s foot apply the cream in between the toes as well • Keep using Pedamed Cream for at least one week after all signs of infection have gone • For the best results, Pedamed Cream should be used together with an antifungal powder such as Pedamed 100mg/g Cutaneous Powder • To stop any reoccurrence of the infection, use regularly after showering and bathing. IF PEDAMED 100MG/G CREAM IS USED INCORRECTLY: If anyone accidently swallows this medicine contact your doctor or go to your hospital casualty department as soon as possible. Take your medicine and pack with you. IF YOU FORGET TO USE PEDAMED 100MG/G CREAM: If you forget to use Pedamed Cream don’t worry. Apply the cream as soon as possible and then continue the rest of your treatment as usual. Do not apply this cream more than twice daily. IF YOUR SYMPTOMS DO NOT GO AWAY OR YOU ARE NOT SURE HOW TO USE THIS MEDICINE AND WOULD LIKE FURTHER INFORMATION, THEN PLEASE CONTACT YOUR DOCTOR OR PHARMACIST. 4. POSSIBLE SIDE EFFECTS Like all medicines Pedamed Cream may sometimes cause side effects, although not everyone will get them. Skin irritation can occur occasionally when using this product. IN THIS LEAFLET: 1. What Pedamed Cream is and what it is used for 2. Before you use Read the complete document
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 INTERACTION None known. 4.6 FERTILITY, PREGNANCY AND LACTATION No information available. 4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES None known. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _0_ _7_ _/_ _0_ _6_ _/_ _2_ _0_ _1_ _7_ _C_ _R_ _N_ _ _ _2_ _1_ _9_ _2_ _3_ _1_ _2_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 4.8 UNDESI Read the complete document