Country: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
FLUCLOXACILLIN SODIUM
Clonmel Healthcare Ltd
J01CF05
FLUCLOXACILLIN SODIUM
500 Milligram
Capsules Hard
Product subject to prescription which may not be renewed (A)
Beta-lactamase resistant penicillins
Authorised
1995-02-14
PACKAGE LEAFLET: INFORMATION FOR THE USER FLUCLON 250 MG HARD CAPSULES FLUCLON 500 MG HARD CAPSULES ACTIVE SUBSTANCE: FLUCLOXACILLIN (AS SODIUM) 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. WHAT IS IN THIS LEAFLET: 1. What Fluclon Capsules are and what they are used for 2. What you need to know before you take Fluclon Capsules 3. How to take Fluclon Capsules 4. Possible side effects 5. How to store Fluclon Capsules 6. Contents of the pack and other further information 1. WHAT FLUCLON CAPSULES ARE AND WHAT THEY ARE USED FOR ‘Fluclon’ is an antibiotic medicine and contains the active ingredient flucloxacillin. It is a penicillin antibiotic used to treat infections in different parts of your body caused by bacteria. It belongs to a group of medicines called penicillinase-resistant antibiotics. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FLUCLON CAPSULES DO NOT TAKE FLUCLON CAPSULES IF YOU: - have ever had an allergic reaction to flucloxacillin, any other penicillin antibiotics or cephalosporins (see possible side effects, section 4), or to any of the other ingredients of this medicine (listed in section 6) - have had liver problems in the past as a result of taking flucloxacillin. W Lestu allt skjalið
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Fluclon 500 mg Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains flucloxacillin sodium equivalent to 500 mg flucloxacillin. Excipients with known effect: contains up to 25 mg of sodium per capsule. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, hard Size 0 elongated, hard gelatin capsules with a blue cap and body printed with a twin triangle logo and the identifying code ‘FXN 500’. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Fluclon is indicated for the treatment of infections due to penicillinase-producing staphylococci and other gram- positive organisms susceptible to this anti-infective. Consideration should be given to official guidence on the appropriate use of antibiotic agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The dosage depends on severity and nature of the infection. The dosage may be increased if necessary. Usual Adult (and children over 10 years of age) dosage: 250 – 500 mg three times a day. Children under 10 years of age: Not recommended. Osteomyelitis, endocarditis: Up to 8 g daily in divided doses six to eight-hourly. Abnormal renal function: In common with other penicillins, flucloxacillin usage in patients with renal impairment does not usually require dosage reduction. In patients with severe renal failure (creatinine clearance < 10 ml/min) a reduction in dose or an extension of the dose interval should be considered. In high dose regimens the maximum recommended dose is 1 g every 8 to 12 hours. Since flucloxacillin is not removed by dialysis no supplementary dosages need be administered. Method of administration: Oral 4.3 CONTRAINDICATIONS Hypersensitivity to beta-lactam antibiotics (e.g. penicillins, cephalo Lestu allt skjalið