Geriflox 500mg Capsules, Hard

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Flucloxacillin

Available from:

McDermott Laboratories Ltd., T/A Gerard Laboratories

ATC code:

J01CF; J01CF05

INN (International Name):

Flucloxacillin

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:

Not marketed

Authorization date:

1988-07-25

Patient Information leaflet

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
GERIFLOX 500 MG CAPSULES, HARD
Flucloxacillin (as flucloxacillin sodium)
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 Geriflox is and what it is used for
2. What you need to know before you take Geriflox
3. How to take Geriflox
4. Possible side effects
5. How to store Geriflox
6. Contents of the pack and other information
1. WHAT GERIFLOX IS AND WHAT IT IS USED FOR
Geriflox Capsules, Hard contain the active substance flucloxacillin,
an antibiotic of the penicillin group
which can be used to treat a variety of bacterial infections.
GERIFLOX IS USED TO TREAT:

chest infections, including pneumonia, lung abscess or empyema

inflammation of sinuses or tonsils

throat or nose infections

ear infections

skin infections, including skin abscess, ulcer, eczema, acne,
carbuncles, impetigo

soft tissue infections, including infected burns or wounds, boils,
cellulitis

infection around the brain or spinal cord (meningitis)

digestive system infections (enteritis)

kidney, bladder or urethra (the tube that carries urine from the
bladder) infections
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE GERIFLOX
DO NOT TAKE GERIFLOX:

if you are allergic to flucloxacillin, beta-lactam antibiotics (e.g.
penicillins, cephalosporins) or any
other ingredients of this medicine (listed in section 6).

if you have ever had liver problems after taking flucloxacillin
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist bef

Summary of Product characteristics

Health Products Regulatory Authority
07 August 2020
CRN009T6X
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Geriflox 500mg Capsules, Hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains flucloxacillin sodium equivalent to 500 mg of
flucloxacillin.
Excipient(s) with known effect:
Each capsule contains approximately 26mg of sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard
Grey and brown, size 0E, hard gelatin capsules marked with a ‘G’
and ‘FN 500’ in black, containing a white to off-white powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Geriflox is indicated for the treatment of infections due to sensitive
Gram-positive organisms, including ß-lactamase-producing
staphylococci and streptococci.
Typical indications include:
_Skin and soft tissue infections:_
Boils, cellulitis, infected burns, abscesses, infected skin conditions
(e.g. ulcer, eczema and acne), protection for skin grafts,
carbuncles, furunculosis, infected wounds, impetigo
_Respiratory tract infections:_
Pneumonia, lung abscess, empyema, sinusitis, pharyngitis, otitis media
and externa, tonsillitis, quinsy
_Other infections caused by flucloxacillin-sensitive organisms:_
Urinary tract infection, enteritis, meningitis
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
Parenteral usage is indicated where oral dosage is inappropriate.
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.
PAEDIATRIC POPULATION
Health Products Regulatory Authority
07 August 2020
CRN009T6X
Page 2 of 8
Children up to 10 years of age: 25-50 mg/kg/24 hours in three to four
equally divided doses. If the posology cannot be
achieved using t