Држава: Ирска
Језик: Енглески
Извор: HPRA (Health Products Regulatory Authority)
FLUCLOXACILLIN SODIUM
Athlone Laboratories Ltd
J01CF; J01CF05
FLUCLOXACILLIN SODIUM
500 milligram(s)
Capsule, hard
Product subject to prescription which may not be renewed (A)
Beta-lactamase resistant penicillins; flucloxacillin
Marketed
2011-10-14
FLUCLOXACILLIN 500MG CAPSULES IE/H/0421/001 0022 PRAC CCRF23100 1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT 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 Flucloxacillin Capsule S are and what they are used for 2. What you need to know before you take Flucloxacillin Capsules 3. How to take Flucloxacillin Capsules 4. Possible side effects 5. How to store Flucloxacillin Capsules 6. Contents of the pack and other information 1. WHAT FLUCLOXACILLIN 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”. Flucloxacillin Capsules are used in adults and children over the age of 10 years to treat: • chest infections • throat or nose infections • ear infections • skin and soft tissue infections • digestive system infections • kidney, bladder or urethra (the tube which carries urine from the bladder) infections. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FLUCLOXACILLIN CAPSULES DO NOT TAKE FLUCLOXACILLIN CAPSULES IF YOU: • have ever had an allergic reaction to flucloxacillin or any other penicillin antibiotics (see section 4, Possible side effects) • have ever had an allergic reaction to any of the other ingredients of this medicine (listed in section 6, Contents of the pack and other information) • have ever suffered from jaundice or liver problems after taking flucloxacillin WARNINGS AND PRECAU Прочитајте комплетан документ
Health Products Regulatory Authority 22 June 2023 CRN00DMFP Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Flucloxacillin 500 mg capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains flucloxacillin 500 mg as flucloxacillin sodium. Excipient with known effect: Contains 26.4 mg of sodium per 500mg capsule. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, hard Elongated hard gelatin capsule approximately 2 cm in length having an opaque caramel body and opaque grey cap each printed ‘FXN 500’ in black ink. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Flucloxacillin 500 mg capsules are indicated in adults and children over the age of 10 years for the treatment of infections due to sensitive Gram-positive organisms, including β-lactamase-producing _staphylococci_ and _streptococci_ (see section 5.1) such as: Skin and soft tissue infections Respiratory tract infections Other infections caused by flucloxacillin-sensitive micro-organisms, _e.g._ enteritis, urinary tract infections. Parenteral use is indicated where oral dosage is inappropriate. Consideration should be given to official guidance on the appropriate use of antibacterial substances. 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. This medicinal product should not be administered to children under 10 years of age. For doses not practicable with this product, other strengths and pharmaceutical forms are available. _Usual dosage (adults including elderly patients and children over 10 years of age)_ _Oral_ - 1-3 g daily in 3-4 equally divided doses. _Renal impairment_ In common with other penicillins, flucloxacillin usage in patients with renal impairment does not usually require dosage reduction. Health Products Regulatory Authority 22 June 2023 CRN00DMFP Page 2 of 8 However, in the presence of severe renal failure (creatinine clearance < 10 Прочитајте комплетан документ