Pajjiż: Irlanda
Lingwa: Ingliż
Sors: HPRA (Health Products Regulatory Authority)
Flucloxacillin
Athlone Laboratories Ltd
J01CF; J01CF05
Flucloxacillin
250 milligram(s)
Capsule, hard
Product subject to prescription which may not be renewed (A)
Beta-lactamase resistant penicillins; flucloxacillin
Not marketed
2011-10-14
0013 CCRF23100 PRAC 1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT FLUCLOXACILLIN 250MG 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 Capsules 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 is used 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: • are allergic to flucloxacillin or any other penicillin or cephalosporin antibiotics (such as amoxicillin or cefaclor - see section 4, Possible side effects). • are allergic 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 PRECAUTIONS Talk to your doctor or pharmacist before taking this medicine if you: • S Aqra d-dokument sħiħ
Health Products Regulatory Authority 23 June 2023 CRN00DMCY Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Flucloxacillin 250 mg Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains flucloxacillin 250 mg as flucloxacillin sodium. Excipient with known effect: Contains 13.2mg of sodium per capsule. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, hard. Size 2 hard gelatin capsule, with an opaque carmel body and opaque grey cap each printed FXN 250 in black ink. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Flucloxacillin capsules are indicated 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. 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. _Paediatric population under 10 years of age_ 25-50 mg/kg/24 hours in three to four equally divided doses. Example of posology: Weight Daily dose (mg/24 hours) Daily dosing regimen 22 kg 550 – 1,100 250 mg x 3-4 25 kg 625 – 1,250 250 mg x 3-4 27 kg 675 – 1,350 250 mg x 3-4 30 kg 750 – 1,500 250 mg x 4 or 500 mg x 3 35 kg 875 – 1,750 250 mg x 4 or 500 mg x 3 Health Products Regulatory Authority 23 June 2023 CRN00DMCY Page 2 of 8 _Renal impairment_: In common with other penicill Aqra d-dokument sħiħ