Страна: Великобритания
Език: английски
Източник: MHRA (Medicines & Healthcare Products Regulatory Agency)
Flucloxacillin sodium
IVAX Pharmaceuticals UK Ltd
J01CF05
Flucloxacillin sodium
250mg
Oral capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05010102
1 0016 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT FLUCLOXACILLIN 250MG CAPSULES FLUCLOXACILLIN 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 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 your medicine is and what it is used for 2. What you need to know before you take your medicine 3. How to take your medicine 4. Possible side effects 5. How to store your medicine 6. Contents of the pack and other information 1. WHAT YOUR MEDICINE IS AND WHAT IT IS 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”. Flucloxacillin is used to treat: - chest infections - throat or nose infections - ear infections - skin and soft tissue infections - heart infections - bone and joint infections - meningitis - digestive system infections - blood infections - kidney, bladder or 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 YOUR MEDICINE DO NOT TAKE THIS MEDICINE 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. penici Прочетете целия документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Flucloxacillin 250mg Capsules Flucloxin 250mg Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 250 mg of flucloxacillin as flucloxacillin sodium Ph. Eur. Excipients with known effect: Each capsule has a sodium content of 52.3 mg per gram. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsules 4.1 THERAPEUTIC INDICATIONS Treatment of infections due to sensitive Gram-positive organisms, including infections caused by β -lactamase-producing _Staphylococci _and_ Streptococci_. Typical indications include: _Skin and soft tissue infections:_ Boils Impetigo Abscesses Infected wounds Carbuncles Infected burns Furunculosis Protection for skin grafts Cellulitis Infected skin conditions e.g. ulcers, eczema and acne. _Respiratory tract infections:_ Pneumonia Pharyngitis Lung abscess Tonsillitis Empyema Quinsy Sinusitis Otitis media and externa _Other infections caused by flucloxacillin-sensitive organisms: _ Osteomyelitis Septicaemia Enteritis Meningitis Endocarditis Urinary tract infection Flucloxacillin is also indicated for use as a prophylactic during major surgical procedures such as 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 on the age, weight and renal function of the patient, as well as the severity of the infection. Adults (including the elderly) Oral: 250mg four times daily. In serious infections, the dosage may be doubled. Paediatric population 2 – 10 years: 125mg four times daily Under 2 years: 62.5mg four times daily _ _ _ _ _ _ _Premature infants, neonates, sucklings and i Прочетете целия документ