Flucloxacillin 500 mg capsules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

FLUCLOXACILLIN SODIUM

Available from:

Athlone Laboratories Ltd

ATC code:

J01CF; J01CF05

INN (International Name):

FLUCLOXACILLIN SODIUM

Dosage:

500 milligram(s)

Pharmaceutical form:

Capsule, hard

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Beta-lactamase resistant penicillins; flucloxacillin

Authorization status:

Marketed

Authorization date:

2011-10-14

Patient Information leaflet

FLUCLOXACILLIN 500MG CAPSULES
IE/H/0421/001
0022 PRAC CCRF23100
1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
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 Flucloxacillin Capsule
S
are and what they are 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 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 Capsules are used in adults and children over the age
of 10 years 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 CAPSULES
DO NOT TAKE FLUCLOXACILLIN CAPSULES IF YOU:
•
have ever had an allergic reaction to flucloxacillin or any other
penicillin antibiotics (see section 4,
Possible side effects)
•
have ever had an allergic reaction 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 PRECAU

Summary of Product characteristics

Health Products Regulatory Authority
22 June 2023
CRN00DMFP
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Flucloxacillin 500 mg capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains flucloxacillin 500 mg as flucloxacillin sodium.
Excipient with known effect:
Contains 26.4 mg of sodium per 500mg capsule.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard
Elongated hard gelatin capsule approximately 2 cm in length having an
opaque caramel body and opaque grey cap each
printed ‘FXN 500’ in black ink.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Flucloxacillin 500 mg capsules are 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,
_e.g._ enteritis, urinary tract infections.
Parenteral use is indicated where oral dosage is inappropriate.
Consideration should be given to official guidance on the appropriate
use of antibacterial substances.
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.
This medicinal product should not be administered to children under 10
years of age.
For doses not practicable with this product, other strengths and
pharmaceutical forms are available.
_Usual dosage (adults including elderly patients and children over 10
years of age)_
_Oral_ - 1-3 g daily in 3-4 equally divided doses.
_Renal impairment_
In common with other penicillins, flucloxacillin usage in patients
with renal impairment does not usually require dosage
reduction.
Health Products Regulatory Authority
22 June 2023
CRN00DMFP
Page 2 of 8
However, in the presence of severe renal failure (creatinine clearance
< 10