Šalis: Didžioji Britanija
kalba: anglų
Šaltinis: MHRA (Medicines & Healthcare Products Regulatory Agency)
Flucloxacillin sodium
Actavis UK Ltd
J01CF05
Flucloxacillin sodium
500mg
Oral capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05010102; GTIN: 5010004038638
FLOXAPEN 250MG AND 500MG CAPSULES (FLUCLOXACILLIN) 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, 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 1. WHAT FLOXAPEN CAPSULES ARE AND WHAT THEY ARE USED FOR 2. BEFORE YOU TAKE FLOXAPEN CAPSULES 3. HOW TO TAKE FLOXAPEN CAPSULES 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE FLOXAPEN CAPSULES 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1 1. WHAT FLOXAPEN CAPSULES ARE AND WHAT THEY ARE USED FOR 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”. Floxapen capsules are used to treat: chest infections throat or nose infections ear infections skin and soft tissue infections heart infections bones and joints infections meningitis digestive system infections blood infections kidney, bladder or urethra (the tube which carries urine from the bladder) infections. Floxapen capsules can also be used to prevent infections during major surgery, particularly heart or orthopaedic surgery. 2. BEFORE YOU TAKE FLOXAPEN CAPSULES DO NOT TAKE FLOXAPEN CAPSULES IF: you are allergic to flucloxacillin or any other penicillin antibiotics (see symptoms in section 4). • you are allergic to any of the other ingredients of this medicine (listed in section 6). • you have suffered previously from liver problems (e.g. jaundice) after taking flucloxacillin. • you have had an allergic reaction to β-lactam antibiotics (e.g. penicillins, cephalosporins). WAR Perskaitykite visą dokumentą
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Floxapen Capsules 500mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Floxapen Capsules (Flucloxacillin Capsules BP) containing 500 mg flucloxacillin as Flucloxacillin Sodium BP. 3 PHARMACEUTICAL FORM Capsule, hard Caramel coloured hard gelatin capsules printed with ‘ 500’, fitted with black caps 4 CLINICAL PARTICULARS Flucloxacillin is an isoxazolyl penicillin of the β -lactam group of antibiotics which exerts a bactericidal effect upon many Gram-positive organisms including β - lactamase-producing staphylococci and streptococci. 4.1 THERAPEUTIC INDICATIONS Floxapen 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 • Abscesses • Carbuncles • Furunculosis • Cellulitis • Infected skin conditions e.g. ulcer, eczema, and acne • Infected wounds • Infected burns • Protection for skin grafts • Impetigo _ _ _RESPIRATORY TRACT INFECTIONS: _ • Pneumonia_ _ • Sinusitis_ _ • Tonsillitis_ _ • Lung abscess_ _ • Pharyngitis_ _ • Quinsy_ _ • Empyema_ _ • Otitis media and externa_ _ _ _ _OTHER INFECTIONS CAUSED BY FLOXAPEN-SENSITIVE ORGANISMS: _ • Osteomyelitis_ _ • Enteritis_ _ • Endocarditis_ _ • Urinary tract infection_ _ • Meningitis_ _ • Septicaemia_ _ Floxapen is also indicated for use as a prophylactic agent during major surgical procedures when appropriate; for example cardiothoracic and orthopaedic surgery. Parenteral usage is indicated where oral dosage is inappropriate. 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 dosage depends Perskaitykite visą dokumentą