Flucloxacillin 250mg capsules

Krajina: Spojené kráľovstvo

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktívna zložka:

Flucloxacillin sodium

Dostupné z:

Milpharm Ltd

ATC kód:

J01CF05

INN (Medzinárodný Name):

Flucloxacillin sodium

Dávkovanie:

250mg

Forma lieku:

Oral capsule

Spôsob podávania:

Oral

Trieda:

No Controlled Drug Status

Typ predpisu:

Valid as a prescribable product

Prehľad produktov:

BNF: 05010102; GTIN: 5060035110223

Príbalový leták

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
1. 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.
2. 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 reaction to
β‑lactam antibiotics (e.g. penicillins,
cephalosporins).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before
taking this medicine if:
-
You suffer from kidney problems, as you
may require a lower dose than normal
(convulsions may occur very rarely in
patients with kidney problems who take
high doses)
-
You suffer from liver problems, as this
medicine could cause them to worsen
-
You are 50 years of age or older
-
You have other serious illnesses (apart
from the infection this medicine is treating)
-
You are taking this medicine for a long
time as regular tests of liver and kidney
function are advised
-
You are on a sodium-restricted diet
-
You have ever had swelling of the face
or skin ras

Súhrn charakteristických

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Flucloxacillin 250mg Capsules BP
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Flucloxacillin Sodium equivalent to 250mg Flucloxacillin per Capsule
For a full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Capsules
Hard gelatin size ‘2’ capsules with Caramel body and Black cap
printed with
‘FLU250 MIL’ and filled with white to almost white granular
powder.
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
Flucloxacillin Sodium 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, cellulitis, infected burns, abscesses, infected skin conditions
(e.g. ulcer,
eczema,
and
acne),
protection
for
skin
grafts,
carbuncles,
furunculosis,
infected wounds and impetigo
_RESPIRATORY TRACT INFECTIONS_:_ _
Pneumonia, lung abscess, empyema, sinusitis, pharyngitis, otitis media
and
externa, tonsillitis and quinsy
_OTHER INFECTIONS CAUSED BY FLUCLOXACILLIN-SENSITIVE ORGANISMS_:_ _
Osteomyelitis, urinary tract infection, enteritis, meningitis,
endocarditis and
septicaemia
Flucloxacillin Sodium 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 depends on