Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
FLUCLOXACILLIN SODIUM
Generics (UK) Limited
J01CF05
FLUCLOXACILLIN SODIUM
250 Milligram
Capsule
Product subject to prescription which may not be renewed (A)
Beta-lactamase resistant penicillins
Authorised
1988-07-25
Colours Non-Print Colours Date: Time: Equate CMYK with Dimensions Main Font Body Text Size Min Text Size used Page Count No. of colours Pharma Code SAP No. Vendor Job No. Trackwise Proof No. Glams Proof No. Client Market Keyline/Drawing No. Barcode Info Description Component Type Affiliate Item Code Superceded Affiliate Item Code TrackWise PR No. MA No. Packing Site/Printer Supplier Code Sign-offs v1/May 2015 Keyline Helvetica Neue LT Std 8 pt 4 pt Geriflox_500 mg_100 Label Leaflet 1098153 845584 1098153 PA0405/010/002 Medreich Ltd (Unit-I : Bangalore - IN) TBC TBC N/A 448962 4 N/A Ireland N/A 5099151000569 30 Jan 17 19:15 4 52 x 111 mm Black PMS 258 C PMS 186 C PMS 306 C 1 / 1 Varnish Free Braille Package leaflet: Information for the patient Geriflox 250 mg and 500 mg Capsules, Hard Flucloxacillin (as flucloxacillin 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 Geriflox is and what it is used for 2. What you need to know before you take Geriflox 3. How to take Geriflox 4. Possible side effects 5. How to store Geriflox 6. Contents of the pack and other information 1. What Geriflox is and what it is used for Geriflox Capsules, Hard contain the active substance flucloxacillin, an antibiotic of the penicillin group which can be used to treat a variety of bacterial infections. Geriflox is used to treat: • chest infections, including pneumonia, lung abscess or empyema • inflammation of sinuses or tonsils • throat or nose infections • ear infections • skin infections, incl Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Geriflox 250mg Capsules, Hard 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains flucloxacillin sodium equivalent to 250 mg of flucloxacillin. Excipient(s) with known effect: Each capsule contains approximately 13mg sodium. For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Capsule, hard Grey and brown, size 2, hard gelatin capsules marked with a ‘G’ and ‘FN 250’ in black, containing a white to off-white powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Geriflox is indicated for the treatment of infections due to sensitive Gram-positive organisms, including -lactamase- producing staphylococci and streptococci. Typical indications include: _Skin and soft tissue infections:_ Boils, cellulitis, infected burns, abscesses, infected skin conditions (e.g. ulcer, eczema and acne), protection for skin grafts, carbuncles, furunculosis, infected wounds, impetigo _Respiratory tract infections:_ Pneumonia, lung abscess, empyema, sinusitis, pharyngitis, otitis media and externa, tonsillitis, quinsy _Other infections caused by flucloxacillin-sensitive organisms:_ Urinary tract infection, enteritis, meningitis Consideration should be given to official guidance on the appropriate use of antibacterial agents. Parenteral usage is indicated where oral dosage is inappropriate. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The dosage depends on age, weight and renal function of the patient as well as the severity and nature of the infection. The dosage may be increased if necessary. ADULTS AND CHILDREN OVER 10 YEARS OF AGE Total daily dosage of 1 g to 3 g, administered in three to four equally divided doses. 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 ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _ Read the complete document