Krajina: Spojené kráľovstvo
Jazyk: angličtina
Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)
Flucloxacillin sodium
Kent Pharma (UK) Ltd
J01CF05
Flucloxacillin sodium
500mg
Oral capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05010102; GTIN: 5015201008521 5015201001126 5015201008514
CP.FLU.JNT.C.V12P1 P217/20 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 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. 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 reacti Prečítajte si celý dokument
OBJECT 1 Flucloxacillin 500mg Capsules Summary of Product Characteristics Updated 29-Oct-2021 | Kent Pharma UK Ltd • 1. Name of the medicinal product • 2. Qualitative and quantitative composition • 3. Pharmaceutical form • 4. Clinical particulars • 4.1 Therapeutic indications • 4.2 Posology and method of administration • 4.3 Contraindications • 4.4 Special warnings and precautions for use • 4.5 Interaction with other medicinal products and other forms of interaction • 4.6 Fertility, pregnancy and lactation • 4.7 Effects on ability to drive and use machines • 4.8 Undesirable effects • 4.9 Overdose • 5. Pharmacological properties • 5.1 Pharmacodynamic properties • 5.2 Pharmacokinetic properties • 5.3 Preclinical safety data • 6. Pharmaceutical particulars • 6.1 List of excipients • 6.2 Incompatibilities • 6.3 Shelf life • 6.4 Special precautions for storage • 6.5 Nature and contents of container • 6.6 Special precautions for disposal and other handling • 7. Marketing authorisation holder • 8. Marketing authorisation number(s) • 9. Date of first authorisation/renewal of the authorisation • 10. Date of revision of the text 1. Name of the medicinal product Flucloxacillin 500mg Capsules Flucloxin 500mg Capsules 2. Qualitative and quantitative composition Each capsule contains 500 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. Clinical particulars 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: Pneum Prečítajte si celý dokument