APO-FLUCLOXACILLIN flucloxacillin (as sodium) 250 mg capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

flucloxacillin sodium monohydrate

Available from:

Apotex Pty Ltd

INN (International Name):

flucloxacillin sodium monohydrate

Authorization status:

Registered

Patient Information leaflet

APO-FLUCLOXACILLIN
_Flucloxacillin sodium_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about flucloxacillin. 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. Your
doctor has weighed the risks of you
using this medicine 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 want to read it again.
WHAT THIS MEDICINE IS
USED FOR
Flucloxacillin is used to treat
infections in different parts of the
body caused by bacteria. It belongs
to a group of medicines called
penicillins.
_HOW IT WORKS_
Flucloxacillin is an antibiotic that
works by killing the bacteria that are
causing your infection.
Flucloxacillin will not work against
infections caused by viruses, such as
colds or flu.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed this
medicine for another reason.
This medicine is available only with
a doctor's prescription.
This medicine is not addictive.
There is not enough information to
recommend the use of this medicine
for children under the age of 2 years
BEFORE YOU TAKE THIS
MEDICINE
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 THIS MEDICINE IF YOU
ARE ALLERGIC TO:
•
flucloxacillin
•
penicillin antibiotics
•
cephalosporin antibiotics
•
beta-lactam antibiotics including
imipenem and aztreonam
•
any of the ingredients listed at the
end of this leaflet.
Symptoms of an allergic reaction
may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue,
throat or other parts of the body
•
rash, itching or hives on the skin
DO NOT TAKE

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – APO-FLUCLOXACILLIN
(FLUCLOXACILLIN SODIUM MONOHYDRATE)
1
NAME OF THE MEDICINE
Flucloxacillin sodium monohydrate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 250 mg or 500 mg flucloxacillin (as sodium
monohydrate) as the
active ingredient.
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS
3 PHARMACEUTICAL FORM
500 MG CAPSULE:
Size 0 capsule with blue cap and blue body printed with “F500”.
250 MG CAPSULE:
Size 2 capsule with blue cap and blue body printed with “F250”.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of confirmed or suspected staphylococcal and other
Gram-positive coccal
infections including pneumonia, osteomyelitis, skin and soft tissue
and wound infections,
infected burns, cellulitis.
4.2
DOSE AND METHOD OF ADMINISTRATION
The oral dose should be administered half to one hour before meals.
_Usual Adult Dose:_
250 mg, 6 hourly.
_Children:_
2–10 years: half adult dose.
NOTE: In severe infections the dosage may be increased.
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).
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
these patients 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.
2
4.3
CONTRAINDICATIONS
Flucloxacillin is contraindicated for:
•
patients who are hypersensitive to beta-lactam antibiotics (e.g.
penicillins,
cephalosporins)
•
patients with a previous history of flucloxacillin-associated
jaundice/hepatic
dysfunction
•
use in the eye.
4.4
SPECIAL WARNINGS