Flucloxacillin 500 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

FLUCLOXACILLIN SODIUM

Available from:

Azure Pharmaceuticals Ltd

ATC code:

J01CF05

INN (International Name):

FLUCLOXACILLIN SODIUM

Pharmaceutical form:

Film-coated tablet

Therapeutic area:

flucloxacillin

Authorization status:

Not marketed

Authorization date:

2023-03-24

Patient Information leaflet

SPACE FOR PC
SPACE FOR PC
150 MM
300 MM
150 MM
AZURE - FLUCLOXICILLIN TABLETS - PIL - CUTTERGUIDE
DIM: 150 X 300 MM (OPEN SIZE)
300 MM
FLUCLOXACILLIN 500 MG FILM-COATED TABLETS
FLUCLOXACILLIN 1000 MG FILM-COATED TABLETS
flucloxacillin
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
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 Tablets is and what it is used
for
2. What you need to know before you take
Flucloxacillin Tablets
3. How to take Flucloxacillin Tablets
4. Possible side effects
5. How to store Flucloxacillin Tablets
6. Contents of the pack and other information
1.WHAT FLUCLOXACILLIN TABLETS 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 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 TABLETS
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 li

Summary of Product characteristics

Health Products Regulatory Authority
18 July 2023
CRN00DLLZ
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Flucloxacillin 500 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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 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 <10ml/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 rem