Country: Malta
Language: English
Source: Medicines Authority
FLUCLOXACILLIN SODIUM
Novelgenix Therapeutics Limited 20, Oliver Business Park, Oliver Road, Park Royal, London, NW10 7JB, United Kingdom
J01CF05
FLUCLOXACILLIN SODIUM
POWDER FOR ORAL SOLUTION
FLUCLOXACILLIN SODIUM 250/5 milligram(s)
POM
ANTIBACTERIALS FOR SYSTEMIC USE
Authorised
2018-05-23
Page 1 of 6 PACKAGE LEAFLET: INFORMATION FOR THE USER FLUCLOXACILLIN 125MG/5ML & 250MG/5ML POWDER FOR ORAL SOLUTION, SUGAR FREE 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. Do not pass it onto others. It may harm them, even if their symptoms 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 Flucloxacillin is and what it is used for 2. What you need to know before you take Flucloxacillin 3. How to take Flucloxacillin 4. Possible side effects 5. How to store Flucloxacillin 6. Contents of the pack and other information 1. WHAT FLUCLOXACILLIN IS AND WHAT IT IS USED FOR Flucloxacillin 125mg/5ml & 250mg/5ml Powder for Oral Solution, Sugar Free contains the active substance flucloxacillin. Flucloxacillin is an antibiotic used to treat infections by killing the bacteria that can cause them. It belongs to a group of antibiotics called “penicillins”. Flucloxacillin is used to treat: • chest infections • throat or nose infections • ear infections • skin and soft tissue infections • heart infections • bones and joints infection • meningitis • digestive system infections • blood infections • kidney, bladder or the urethra (the tube which carries urine from the bladder) infections. Flucloxacillin can also be used to prevent infections during major surgery, particularly heart or orthopaedic surgery. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FLUCLOXACILLIN: DO NOT TAKE FLUCLOXACILLIN AND TELL YOUR DOCTOR IF YOU OR YOUR CHILD: • are ALLERGIC to flucloxacillin, penicillin, any other antibiotic or any of the other ingredients of this medicine (listed in section 6). • have ever had LIV Read the complete document
Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Flucloxacillin 250mg/5ml Powder for Oral Solution Sugar Free 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5ml reconstituted solution contains Flucloxacillin sodium equivalent to 250mg Flucloxacillin. Excipients with known effect: Each 5ml dose contains Sodium 30.56mg Mannitol 653mg Aspartame 10.00mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for oral solution White granular powder 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Flucloxacillin Sugar Free Powder for Oral Solution is indicated for the treatment of infections due to sensitive Gram-positive organisms, including β-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 and Impetigo _Respiratory tract infections: _ Pneumonia, Lung abscess, Empyema, Sinusitis, Pharyngitis, Otitis media and externa, Tonsillitis and Quinsy _Other infections caused by Flucloxacillin sensitive organisms:_ Osteomyelitis, Urinary tract infection, Enteritis, Meningitis, Endocarditis and Septicaemia Flucloxacillin is also indicated for use as a prophylactic during major surgical procedures when appropriate; for example cardiothoracic and orthopaedic surgery. Parenteral usage is indicated where oral dosage is inappropriate. Page 2 of 9 Consideration should be given to official local guidance (e.g. national recommendations) on the appropriate use of antibacterial agents. Susceptibility of the causative organism to the treatment should be tested (if possible), although therapy may be initiated before the results are available 4.2. POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY The depends on the age, weight and renal function of the patient, as well as the severity of the infection. Adults (including elderly patients) Oral - 250 Read the complete document