Flucloxacillin 250mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Flucloxacillin sodium

Available from:

Bristol Laboratories 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: 5060013942402

Patient Information leaflet

SAME SIZE ARTWORK
240 x 160 mm
Front
24 mm
240 mm
160 mm
IXXXXXX
PACKAGE LEAFLET: INFORMATION FOR THE USER
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 Flucloxacillin Capsules are and what are they 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 ARE THEY USED FOR
The name of the medicine is Flucloxacillin 250mg or 500mg Capsules
which will be referred to as Flucloxacillin Capsules throughout this
leaflet. The active ingredient is flucloxacillin.
Flucloxacillin belongs to a group of medicines called Beta-lactamase
resistant penicillins. It is an antibiotic used to treat infections by
killing
the bacteria that cause them.
Flucloxacillin is used to treat the following infections in adults,
and
children aged 2-10 years. It can also be used in children less than
2 years of age. Your doctor will adjust the dose depending on the age
of the patient
•
skin and soft tissue infections (including boils, abscess, carbuncles,
ulcers, infected eczema and acne, wounds and burns.
•
chest infections (including pneumonia and lung abscess)
•
ear, nose and throat infections including tonsils (tonsillitis),
sinuses
(sinusitis), pharynx (pharyngitis) and ear infections (otitis media
and otitis externa).
•

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Flucloxacillin 250mg Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 250 mg flucloxacillin as flucloxacillin sodium.
Excipient(s) with known effect: Each capsule contains 1.60 mg of
methyl
parahydroxybenzoate (E218) and 0.90 mg of propyl parahydroxybenzoate
(E216).
For the full list of excipients, see Section 6.1.
3
PHARMACEUTICAL FORM
Capsules
Blue cap/blue body capsule printed with “F 250” and containing a
white, free
flowing powder.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
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.
Flucloxacillin Capsules are indicated for the treatment of infections
due to
flucloxacillin sensitive gram-positive organisms, including
β
-lactamase-
producing staphyloccoci and streptococci. Typical indications include:
_Skin and soft tissue infections: _
Boils
Abscesses
Cellulitis
Infected skin conditions, e.g.
ulcer, eczema, and acne
Infected burns
Protection for skin
grafts
Carbuncles
Impetigo
Furunculosis
Infected wounds
_Respiratory tract infections: _
Pneumonia
Sinusitis
Tonsillitis
Lung abscess
Pharyngitis
Quinsy
Empyema
Otitis media and
externa
_Other infections caused by flucloxacillin-sensitive organisms: _
Osteomyelitis
Meningitis
Urinary tract infection
Endocarditis
Enteritis
Septicaemia
Flucloxacillin 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 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
PO