FLOPEN flucloxacillin 250 mg (as sodium) capsule blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
30-06-2021
Summary of Product characteristics
(SPC)
30-06-2021
Public Assessment Report
(PAR)
20-10-2017
Active ingredient:
flucloxacillin, Quantity: 250 mg
Available from:
Viatris Pty Ltd
INN (International Name):
Flucloxacillin
Pharmaceutical form:
Capsule, hard
Composition:
Excipient Ingredients: titanium dioxide; erythrosine; brilliant blue FCF; Gelatin; magnesium stearate; sodium lauryl sulfate; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; Shellac; ethanol absolute; ammonia; potassium hydroxide
Administration route:
Oral
Units in package:
24, 4
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
For the treatment of confirmed or suspected staphylococcal and other Gram-positive coccal infections. Indications include pneumonia, osteomyelitis, skin and soft tissue and wound infections, infected burns, cellulitis. Changes made as described in the letter of 30/4/1998 from Jason Borg
Product summary:
Visual Identification: Hard gelatin size 2 capsule - blue cap and body, both imprinted with F250 in white ink; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius
Authorization status:
Licence status A
Authorization date:
2013-06-14
Patient Information leaflet
FLOPEN
_flucloxacillin (as sodium)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about FLOPEN. It does not
contain all the available information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking FLOPEN
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT FLOPEN IS USED
FOR
This medicine contains the active
ingredient flucloxacillin.
It is used to treat infections caused by
bacteria in different parts of the
body.
It is an antibiotic that belongs to a
group of medicines called penicillins.
These antibiotics work by killing the
bacteria that are causing your
infection.
FLOPEN will not work against
infections caused by viruses, such as
colds.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed
FLOPEN for another reason.
This medicine is not addictive.
It is available only with a doctor's
prescription.
BEFORE YOU TAKE
FLOPEN
WARNING: FLUCLOXACILLIN CAN
CAUSE SEVERE LIVER DAMAGE,
PARTICULARLY IN OLDER PATIENTS AND
THOSE WHO TAKE IT FOR MORE THAN 14
DAYS.
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE FLOPEN IF YOU HAVE
AN ALLERGY TO:
•
any medicine containing
flucloxacillin
•
any other penicillin medicines or
cephalosporins
•
beta-lactam antibiotics including
imipenem and aztreonam
•
any of the ingredients listed at the
end of this leaflet
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty in
breathing
•
swelling of the face, lips, tongue
or any other parts of the body
•
rash, itching or hives on the skin
DO NOT TAKE FLOPEN IF YOU HAVE
HAD A REACTION AFFECTING YOUR LIVER
WHILE YOU WERE TAKING MEDICINE
CONTAINING FLUCLOXACILLIN.
Examples of liver reactions include
hepatiti
Read the complete document
Summary of Product characteristics
AUSTRALIAN PRODUCT INFORMATION
FLOPEN
_flucloxacillin (as sodium) capsule _
1
NAME OF THE MEDICINE
Flucloxacillin (as sodium)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each FLOPEN capsule contains 250 mg or 500 mg of flucloxacillin (as
sodium) as the active ingredient.
FLOPEN capsules contain trace quantities of sulfites.
For the full list of excipients, see section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
FLOPEN 250 mg capsules have a blue cap and blue body, both imprinted
with “F250” in white ink.
FLOPEN 500 mg capsules have a blue cap and blue body, both imprinted
with “F500” in white ink.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of confirmed or suspected Staphylococcal and other
Gram-positive coccal infections.
Indications include pneumonia, osteomyelitis, skin and skin structure
and wound infections, infected burns
and cellulitis.
4.2
DOSE AND METHOD OF ADMINISTRATION
USUAL ADULT DOSE
250 mg every 6 hours
USUAL CHILDREN'S DOSE
2 to 10 years
half of the adult dose
under 2 years
quarter of the adult dose
Note: in severe infections the dosage may be increased.
METHOD OF ADMINISTRATION
The oral dose should be administered ½ to 1 hour before meals.
DOSAGE IN PATIENTS WITH IMPAIRED HEPATIC FUNCTION
Adjustment of dosage may not be necessary as flucloxacillin is not
metabolised in the liver to any appreciable
extent. However, during prolonged treatment, it is advisable to check
periodically for hepatic dysfunction (see
section 4.4 Special Warnings and Precautions for Use).
DOSAGE IN PATIENTS WITH IMPAIRED RENAL FUNCTION
As flucloxacillin is excreted to a large extent by the kidney, the
dose or dose interval may need modification
in
patients
with
renal
failure,
as
the
half-life
in
patients
with
renal
failure
is
increased.
Dosage
recommendations for various plasma creatinine levels for patients with
impaired renal function are not
available. Flucloxacillin is not significantly removed by
haemodialysis.
FLOPEN – PRODUCT INFORMATION
2
4.3
CONTRAINDICATIONS
•
History of fluc
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