Flucloxacillin 500 mg Film-coated Tablets

देश: माल्टा

भाषा: अंग्रेज़ी

स्रोत: Medicines Authority

थमां उपलब्ध:

Azure Pharmaceuticals Ltd 12 Hamilton Drive, The Rock Road, Blackrock, Co. Louth A91 T997, Ireland

ए.टी.सी कोड:

J01CF05

INN (इंटरनेशनल नाम):

FLUCLOXACILLIN 500 mg

फार्मास्यूटिकल फॉर्म:

FILM-COATED TABLET

रचना:

FLUCLOXACILLIN 500 mg

प्रिस्क्रिप्शन प्रकार:

POM

चिकित्सीय क्षेत्र:

ANTIBACTERIALS FOR SYSTEMIC USE

उत्पाद समीक्षा:

Licence number in the source country: NOT APPLICAPABLE

प्राधिकरण का दर्जा:

Authorised

प्राधिकरण की तारीख:

2023-02-07

सूचना पत्रक

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FLUCLOXACILLIN 500 MG FILM-COATED TABLETS
FLUCLOXACILLIN 1000 MG FILM-COATED TABLETS
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 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 Tablets is and what it is used for
2.
What you need to know before you take Flucloxacillin Tablet
3.
How to take Flucloxacillin Tablet
4.
Possible side effects
_5._
_ _
How to store Flucloxacillin Tablet
_ _
6.
Contents of the pack and other information
1.
WHAT FLUCLOXACILLIN TABLETS 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”.
Flucloxacillin can be used to treat:
•
chest infections
•
throat or nose infections
•
ear infections
•
skin and soft tissue infections
•
digestive system infections
•
kidney, bladder or urethra (the tube which carries urine from the
bladder) infections.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE FLUCLOXACILLIN TABLET
DO NOT TAKE THIS MEDICINE IF YOU:
•
are
allergic to
flucloxacillin
or
any
other penicillin
or
cephalosporin
antibiotics
(such
as
amoxicillin or cefaclor - see section 4, Possible side effects).
•
are allergic to any of the other ingredients of this medicine (listed
in section 6, Contents of the
pack and other information).
•
have ever suffered from jaundice or liver problems after taking
flucloxacillin.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking this medicine

उत्पाद विशेषताएं

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Flucloxacillin 500 mg Film-coated Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITIONS
Each film-coated tablet contains flucloxacillin sodium equivalent to
flucloxacillin 500 mg.
Excipient with known effect
Flucloxacillin
500 mg Film-coated Tablets contains 29.33 mg of sodium, equivalent to
1.5% of the
WHO's highest recommended daily intake (2 grams of sodium for adults).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
White to off-white capsule-shaped film-coated tablet debossed with
‘FL|500’ on one side and break line
on other side.
The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Flucloxacillin is indicated in adults and children over the age of 10
years for the treatment of infections
due
to
sensitive
Gram-positive
organisms,
including
β-lactamase-producing
staphylococci
and
streptococci (see section 5.1) such as:
•
Skin and soft tissue infections
•
Respiratory tract infections
•
Other infections caused by flucloxacillin-sensitive micro-organisms.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dosage depends on age, weight and renal function of the patient,
as well as the severity and nature of
the infection. The dosage may be increased if necessary.
Adults and children over 10 years of age: Total daily dosage of 1 g to
3 g, administered in three to four
equally divided doses.
Abnormal renal function: In common with other penicillins,
Flucloxacillin usage in patients with renal
impairment does not usually require dosage reduction. However, in the
presence of severe renal failure
(creatinine clearance <10 ml/min) a reduction in dose or an extension
of dose interval should be
considered. In high dose regimens the maximum recommended dose is 1 g
every 8 to 12 hours.
Flucloxacillin is not significantly removed by dialysis and hence no
suppl