Krajina: Írsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
Fusidic acid
PCO Manufacturing Ltd.
D06AX; D06AX01
Fusidic acid
20 milligram(s)/gram
Cream
Product subject to prescription which may not be renewed (A)
Other antibiotics for topical use; fusidic acid
Authorised
2007-04-13
_ _ PACKAGE LEAFLET: INFORMATION FOR THE USER FUCIDIN ® 20MG/G CREAM fusidic acid READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor, pharmacist or nurse. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Fucidin ® cream is and what it is used for 2. What you need to know before you use Fucidin ® cream 3. How to use Fucidin ® cream 4. Possible side effects 5. How to store Fucidin ® cream 6. Contents of the pack and other information 1. WHAT FUCIDIN ® CREAM IS AND WHAT IT IS USED FOR Fucidin ® cream belongs to a group of medicines called antibiotics. The antibiotic in this product is called fusidic acid. Fucidin ® cream works by killing germs (bacteria) that cause infections. It is used to treat skin infections such as those caused by bacteria called _Staphylococcus aureus_. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE FUCIDIN ® CREAM DO NOT USE FUCIDIN ® CREAM If you are allergic to fusidic acid or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS TALK TO YOUR DOCTOR, PHARMACIST OR NURSE BEFORE USING FUCIDIN ® CREAM Do not use Fucidin ® for a long time as the germs (bacteria) may no longer be killed by the antibiotic. Avoid getting the cream into your eyes (e.g. accidentally from your hands or by using it too close to your eyes) as it could irritate (sting) them. OTHER MEDICINES AND FUCIDIN ® CREAM Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. PREGNANCY AND BREAST-FEEDING If you are pregnant or breast-feeding, think you may be Prečítajte si celý dokument
Health Products Regulatory Authority 30 August 2022 CRN00D4NV Page 1 of 2 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Fucidin 20mg/g Cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each gram contains 20 mg fusidic acid. Excipients with known effect: contains cetyl alcohol, potassium sorbate, butylhydroxyanisole (E320). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Cream _Product imported from Greece:_ A white, homogeneous cream 4 CLINICAL PARTICULARS As per PA0046/004/012 5 PHARMACOLOGICAL PROPERTIES As per PA0046/004/012 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Butylhydroxyanisole (E320) Cetyl alcohol Glycerol Liquid paraffin Polysorbate 60 Potassium sorbate Purified water White soft paraffin all-rac-α-tocopherol and hydrochloric acid for pH adjustment 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf life expiry date of this product shall be the date shown on the container and outer package of the product on the market in the country of origin. After first opening: 28 days. Health Products Regulatory Authority 30 August 2022 CRN00D4NV Page 2 of 2 6.4 SPECIAL PRECAUTIONS FOR STORAGE Do not store above 25ºC. 6.5 NATURE AND CONTENTS OF CONTAINER Internally lacquered aluminium tube, sealed with an aluminium membrane and fitted with a white polyethylene screw cap. Contents: 15 g and 30 g. Not all pack sizes may be marketed. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL No special requirements. Any unused product or waste material should be disposed of in accordance with local requirements. 7 PARALLEL PRODUCT AUTHORISATION HOLDER PCO Manufacturing Ltd. Unit 10, Ashbourne Business Park Rath Ashbourne Co. Meath Ireland 8 PARALLEL PRODUCT AUTHORISATION NUMBER PPA0465/197/001 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 13April 2007 Date of last renewal: 13 April 2012 10 DATE OF REVISION OF THE TEXT August 2022 Prečítajte si celý dokument