מדינה: אירלנד
שפה: אנגלית
מקור: HPRA (Health Products Regulatory Authority)
FLUCLOXACILLIN SODIUM
Actavis Group PTC ehf
J01CF05
FLUCLOXACILLIN SODIUM
250 Milligram
Capsules Hard
Product subject to prescription which may not be renewed (A)
flucloxacillin
Marketed
1979-01-18
Floxapen 250 mg & 500 mg Capsules PACKAGE LEAFLET: INFORMATION FOR THE USER FLOXAPEN 250 MG & 500 MG CAPSULES Flucloxacillin READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 Floxapen is and what it is used for 2. What you need to know before you use Floxapen 3. How to use Floxapen 4. Possible side effects 5. How to store Floxapen 6. Contents of the pack and other information 1. WHAT FLOXAPEN IS AND WHAT IT IS USED FOR Floxapen 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 a wide range of infections caused by bacteria, such as: chest infections throat or nose infections ear infections skin and soft tissue infections meningitis digestive system infections kidney, bladder or urethra (the tube which carries urine from the bladder) infections. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE FLOXAPEN DO NOT USE FLOXAPEN if you are ALLERGIC (hypersensitive) to flucloxacillin, penicillin, any other antibiotic or any of the other ingredients of this medicine (listed in section 6). if you have had an allergic reaction to β ‑ lactam antibiotics (e.g. penicillins, cephalosporins) if you have a previous history of flucloxacillin-associated jaundice/liver dysfunction. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before using Floxapen if you: have LIVER or KIDNEY problems. Floxapen 250 mg & 500 mg Capsules have קרא את המסמך השלם
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Floxapen 250mg Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 250 mg flucloxacillin (as flucloxacillin sodium) Excipients with known effect Each capsule has a sodium content of 13 mg. For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Capsules hard. Hard gelatine capsules with carmel body and black cap overprinted in white with the ‘250’containing a white powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Floxapen is indicated for the treatment of infections due to -lactamase-producing staphylococci and other sensitive Gram-positive organisms such as streptococci (see section 5.1 for details on sensitive strains). Typical indications include: _Skin and soft tissue infections:_ - Boils, abscesses, carbuncles, furunculosis, cellulites, infected burns, infected wounds, impetigo, protection for skin grafts, infected skin conditions e.g. ulcer, eczema, and acne _Respiratory tract infections:_ - Pneumonia, lung abscess, sinusitis, tonsillitis, quinsy, pharyngitis, empyema, otitis media and externa _Other infections caused by Floxapen-sensitive organisms:_ - Urinary tract infection, small intestine and colon infection, meningitis Consideration should be given to official guidance on the appropriate use of antibacterial agents. 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. _Children under 10 years of age:_ 25-50 mg/kg/24 hours 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 ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ קרא את המסמך השלם