Flucloxacillin 500mg capsules

Երկիր: Միացյալ Թագավորություն

Լեզու: անգլերեն

Աղբյուրը: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ակտիվ բաղադրիչ:

Flucloxacillin sodium

Հասանելի է:

Almus Pharmaceuticals Ltd

ATC կոդը:

J01CF05

INN (Միջազգային անվանումը):

Flucloxacillin sodium

Դոզան:

500mg

Դեղագործական ձեւ:

Oral capsule

Կառավարման երթուղին:

Oral

Դաս:

No Controlled Drug Status

Ռեկվիզորի տեսակը:

Valid as a prescribable product

Ապրանքի ամփոփագիր:

BNF: 05010102; GTIN: 05060057400258

Տեղեկատվական թերթիկ

0015
1
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
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. penici

Ապրանքի հատկությունները

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Flucloxacillin 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:_
Pneumonia
Pharyngitis
Lung abscess
Tonsillitis
Empyema
Quinsy
Sinusitis
Otitis media and externa
_Other infections caused by flucloxacillin-sensitive organisms: _
Osteomyelitis
Septicaemia
Enteritis
Meningitis
Endocarditis
Urinary-tract infection
Flucloxacillin is also indicated for use as a prophylactic during
major surgical
procedures such as 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 the severity of the infection.
Adults (including the elderly)
Oral: - 250mg four times daily.
In serious infections, the dosage may be doubled.
Paediatric population
2 - 10 years :
125mg four times daily.
Under 2 years:
62.5mg four times daily.
In cases of severe renal impairment (creatinine clearance