Flucloxacillin 250mg capsules

מדינה: הממלכה המאוחדת

שפה: אנגלית

מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)

מרכיב פעיל:

Flucloxacillin sodium

זמין מ:

Noumed Life Sciences Ltd

קוד ATC:

J01CF05

INN (שם בינלאומי):

Flucloxacillin sodium

כמות:

250mg

טופס פרצבטיות:

Oral capsule

מסלול נתינה (של תרופות):

Oral

סיווג:

No Controlled Drug Status

סוג מרשם:

Valid as a prescribable product

leaflet_short:

BNF: 05010102; GTIN: 05060453460177 05060453460498

עלון מידע

Package leaflet: Information for the patient
Pharmacode
Pharmacode positions may change depending on machine requirements
FLUCLOXACILLIN
FLUCLOXACILLIN 250 MG AND 500 MG CAPSULES
1
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
Flucloxacillin is an antibiotic used to treat infections by killing
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 may also be used to prevent infections during major
surgery, particularly heart or orthopaedic surgery.
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
antibiotics (see symptoms in section 4).
•
You are allergic to flucloxacillin or 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 Flucloxacillin
Capsules if:
•
You are taking or will be taking paracetamol.
There is a risk of blood and fluid abnormality (high anion gap
metabolic acidosis) which occurs when there is an increase in
plasma acidity, when flucloxacillin is used concomitantly with
paracetamol, particularly in certain

מאפייני מוצר

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Flucloxacillin 250 mg Capsules
2. QUALITATIVE AND QUANTITATIVE COMPOSITIONS:
Each capsule contains 250 mg flucloxacillin as Flucloxacillin Sodium.
Excipients with known effect:
Each 250mg capsule contains 13mg of sodium.
For the full list of excipients see section 6.1.
3
PHARMACEUTICAL FORM
Capsules, hard
Gelatin capsules, size 2, with caramel body and black cap, printed
with FLU250 MIL,
containing white to almost white granular powder.
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
Abscesses
Carbuncles
Furunculosis
Cellulitis
Infected skin conditions e.g. ulcers, eczema and acne
Infected wounds
Infected burns
Protection for Skin grafts
Impetigo
_Respiratory tract infections_:_ _
Pneumonia
Pharyngitis
Tonsillitis
Quinsy
Empyema
Lung abscess
Sinusitis
Otitis media and externa
_Other infections caused by Flucloxacillin-sensitive organisms_:_ _
Osteomyelitis
Enteritis
Meningitis
Septicaemia
Urinary tract infections
Endocarditis
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 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 the age, weight and renal function of the
patient, as well as on
the severity of the infection.
ADULTS (including older people):
Oral - 250mg four times a day.
In serious infections, the dosage may be