Floxapen 250mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Flucloxacillin sodium

Available from:

Actavis UK Ltd

ATC code:

J01CF05

INN (International Name):

Flucloxacillin sodium

Dosage:

250mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05010102; GTIN: 5010004038621

Patient Information leaflet

FLOXAPEN
 250MG AND 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, pharmacist or
nurse.

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, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1
1.
WHAT FLOXAPEN CAPSULES ARE AND WHAT THEY ARE USED FOR
2.
BEFORE YOU TAKE FLOXAPEN CAPSULES
3.
HOW TO TAKE FLOXAPEN CAPSULES
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE FLOXAPEN CAPSULES
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1
1.
WHAT FLOXAPEN 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”.
Floxapen capsules are used to treat:

chest infections

throat or nose infections

ear infections

skin and soft tissue infections

heart infections

bones and joints infections

meningitis

digestive system infections

blood infections

kidney, bladder or urethra (the tube which carries urine from the
bladder) infections.
Floxapen capsules can also be used to prevent infections during major
surgery, particularly
heart or orthopaedic surgery.
2.
BEFORE YOU TAKE FLOXAPEN CAPSULES
DO NOT TAKE FLOXAPEN CAPSULES 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. penicillins, cephalosporins).
WAR

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
FLOXAPEN® Capsules 250mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Floxapen Capsules _(Flucloxacillin Capsules BP) containing 250 mg
flucloxacillin as Flucloxacillin Sodium BP.
3
PHARMACEUTICAL FORM
Capsule, hard
Caramel coloured hard gelatin capsules printed with ‘
250’, fitted
with black caps
4
CLINICAL PARTICULARS
Flucloxacillin is an isoxazolyl penicillin of the
β
-lactam group of antibiotics which
exerts a bactericidal effect upon many Gram-positive organisms
including
β
-
lactamase-producing staphylococci and streptococci.
4.1
THERAPEUTIC INDICATIONS
Floxapen is indicated for the treatment of infections due to sensitive
Gram-
positive organisms, including
β
-lactamase-producing staphylococci and
streptococci. Typical indications include:
_SKIN AND SOFT TISSUE INFECTIONS: _
•
Boils
•
Abscesses
•
Carbuncles
•
Furunculosis
•
Cellulitis
•
Infected skin conditions e.g. ulcer, eczema, and acne
•
Infected wounds
•
Infected burns
•
Protection for skin grafts
•
Impetigo
_ _
_RESPIRATORY TRACT INFECTIONS: _
•
Pneumonia_ _
•
Sinusitis_ _
•
Tonsillitis_ _
•
Lung abscess_ _
•
Pharyngitis_ _
•
Quinsy_ _
•
Empyema_ _
•
Otitis media and externa_ _
_ _
_OTHER INFECTIONS CAUSED BY FLOXAPEN-SENSITIVE ORGANISMS: _
•
Osteomyelitis_ _
•
Enteritis_ _
•
Endocarditis_ _
•
Urinary tract infection_ _
•
Meningitis_ _
•
Septicaemia_ _
Floxapen is also indicated for use as a prophylactic agent during
major
surgical procedures when appropriate; for example 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 depe