Flucloxacillin 1000 mg Film-coated Tablets

País: Irlanda

Idioma: anglès

Font: HPRA (Health Products Regulatory Authority)

ingredients actius:

FLUCLOXACILLIN SODIUM

Disponible des:

Azure Pharmaceuticals Ltd

Codi ATC:

J01CF05

Designació comuna internacional (DCI):

FLUCLOXACILLIN SODIUM

formulario farmacéutico:

Film-coated tablet

Área terapéutica:

flucloxacillin

Estat d'Autorització:

Not marketed

Data d'autorització:

2023-03-24

Informació per a l'usuari

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 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 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 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 liver problems after taking
flucloxacillin.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking this

Fitxa tècnica

Health Products Regulatory Authority
18 July 2023
CRN00DLLZ
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Flucloxacillin 1000 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains Flucloxacillin Sodium equivalent to
Flucloxacillin 1000mg.
Excipient with known effect
Flucloxacillin 1000mg film-coated Tablets contains 58.65 mg sodium,
equivalent to 3% of the WHO maximum 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 oval shaped film coated tablet, debossed with
'FL|1G' 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 removed by d