Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Sodium fusidate
Leo Laboratories Limited
J01XC; J01XC01
Sodium fusidate
250 milligram(s)
Tablet
Product subject to prescription which may not be renewed (A)
Steroid antibacterials; fusidic acid
Marketed
1990-03-13
Page 1 of 4 PACKAGE LEAFLET: INFORMATION FOR THE USER FUCIDIN ® 250 MG TABLETS sodium fusidate READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 or pharmacist. 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. In this leaflet Fucidin ® 250 mg Tablets will be called Fucidin Tablets. WHAT IS IN THIS LEAFLET 1. What Fucidin ® Tablets are and what they are used for 2. What you need to know before you take Fucidin ® Tablets 3. How to take Fucidin ® Tablets 4. Possible side effects 5. How to store Fucidin ® Tablets 6. Contents of the pack and other information 1. WHAT FUCIDIN ® TABLETS ARE AND WHAT THEY ARE USED FOR Fucidin Tablets contain sodium fusidate. It is a type of antibiotic. Fucidin Tablets work by killing germs (bacteria) that cause infections. Fucidin Tablets are used to treat infections such as those caused by a bacteria called _Staphylococcus._ 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FUCIDIN ® TABLETS DO NOT TAKE FUCIDIN TABLETS: If you are allergic to sodium fusidate or any of the other ingredients of this medicine (listed in section 6). If you are taking statins, medicines to lower blood cholesterol. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Fucidin Tablets if: You are taking statins (medicines to lower blood cholesterol) You have problems with your liver or if you have recently been jaundiced (skin and whites of eyes appear yellow) You have a blockage or a problem with your bile duct, e.g. gallstones You are taking some medicines called HIV-Protease Inhibitors used to treat the HIV virus. When you are taking Read the complete document
Health Products Regulatory Authority 26 January 2021 CRN009ZFT Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Fucidin 250mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 250 mg of sodium fusidate. Excipient with known effect Lactose monohydrate 71.9 mg per tablet For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. White to off-white greyish marbled film-coated oval tablet without embossing. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In the treatment of infections due to micro-organisms sensitive to this anti-infective, such as Staphylococci. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Adults only: The usual total daily dose is 1500 mg in divided doses. In severe infections doses may be doubled or appropriate combined therapy may be used. Since fusidic acid is excreted in the bile, no dosage modifications are needed in renal impairment. The dosage in patients undergoing haemodialysis needs no adjustment as fusidic acid is not significantly dialysed. _Paediatric population_ Children: The usual total daily dose is 20 to 50 mg/kg in divided doses. Method of administration For oral administration. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients. Concomitant treatment with statins (HMG-CoA reductase inhibitors). (See section 4.4, 4.5). 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Statins (HMG-CoA reductase inhibitors) and systemic Fucidin must not be co-administered, (see section 4.3). There have been reports of rhabdomyolysis (including fatalities) in patients receiving this combination. Statin treatment should be discontinued throughout the duration of treatment with systemic Fucidin. The patient should be advised to seek medical advice immediately if they experience any symptoms of muscle weakness, pain or tenderness. Statin therapy may be re-introduced 7 days after the last dose of systemic Fucidin. Health Products Regulatory Authority 26 January 202 Read the complete document