FLUCIL flucloxacillin (as sodium) 125mg/5mL oral solution bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

flucloxacillin sodium monohydrate, Quantity: 27.2 mg/mL (Equivalent: flucloxacillin, Qty 25 mg/mL)

Available from:

Aspen Pharmacare Australia Pty Ltd

INN (International Name):

flucloxacillin sodium monohydrate

Pharmaceutical form:

Oral Liquid, powder for

Composition:

Excipient Ingredients: ammonium glycyrrhizinate; sodium benzoate; sucrose; saccharin sodium; disodium edetate; sodium citrate; erythrosine; Flavour

Administration route:

Oral

Units in package:

1s

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 skin structure and wound infections, infected burns and cellulitis.

Product summary:

Visual Identification: pink coloured dry granular powder which gives a pink coloured solution; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

2011-01-27

Patient Information leaflet

FLUCIL oral solution – CMI
Page 1 of 4
FLUCIL ORAL SOLUTION
_Flucloxacillin _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
FLUCIL.
It does not contain all the
available information.
It does not take the place of
talking to your doctor and
pharmacist.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you taking it
against the benefits this
medicine is expected to have for
you.
IF YOU HAVE ANY CONCERNS
ABOUT TAKING THIS MEDICINE,
ASK YOUR DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT FLUCIL IS USED
FOR
FLUCIL is an antibiotic used to
treat some infections in different
parts of the body caused by
bacteria.
FLUCIL will not work against
infections caused by viruses,
such as colds.
FLUCIL is an antibiotic that
belongs to a group of medicines
called penicillins. These
antibiotics work by killing the
bacteria that are causing your
infection.
ASK YOUR DOCTOR WHY FLUCIL
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have
prescribed it for another reason.
This medicine is available only
with a doctor
s prescription.
There is no evidence that
FLUCIL
®
is addictive.
BEFORE YOU TAKE IT
_ _
_WHEN YOU MUST NOT BE GIVEN IT _
DO NOT TAKE FLUCIL IF:
•
YOUR SKIN AND/OR EYES HAVE
TURNED YELLOW (JAUNDICE)
WHILE, OR SOON AFTER TAKING
FLUCLOXACILLIN (FLUCIL).
•
YOU HAVE AN ALLERGY TO
FLUCIL, OTHER PENICILLINS OR
ANY OF THE INGREDIENTS LISTED
AT THE END OF THIS LEAFLET.
Some of the symptoms of an
allergic reaction may include
skin rash, itching and difficult
breathing.
•
YOU HAVE HAD AN ALLERGIC
REACTION TO CEPHALOSPORINS.
You may have an increased
chance of being allergic to
FLUCIL if you are allergic to
cephalosporins.
IF YOU ARE NOT SURE WHETHER
YOU SHOULD START TAKING
FLUCIL, TALK TO YOUR DOCTOR.
_ _
_BEFORE YOU START TO TAKE IT_
FLUCLOXACILLIN (FLUCIL) CAN
CAUSE JAUNDICE (YELLOWING OF
SKIN AND/OR EYES) AND SEVERE
LIVER DISEASE WHICH MAY LAST
FOR A LONG TIME. THIS REACTION
IS MORE FREQUENT IN OLDER
PATIENTS

Summary of Product characteristics

Flucil-inj-pi-26nov19
1
AUSTRALIAN PRODUCT INFORMATION
FLUCIL
FLUCLOXACILLIN (AS FLUCLOXACILLIN SODIUM)
POWDER FOR ORAL LIQUID
1
NAME OF THE MEDICINE
Flucloxacillin (as flucloxacillin sodium)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
FLUCIL
powder for oral liquid
125 mg/5 mL - When dispensed, each 5 mL contains flucloxacillin sodium
equivalent to 125 mg
of flucloxacillin.
250 mg/5 mL - When dispensed, each 5 mL contains flucloxacillin sodium
equivalent to 250 mg
of flucloxacillin.
Each gram of flucloxacillin sodium contains 2.2 mmol of sodium.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
FLUCIL powder for oral liquid 125 mg/5 mL and 250 mg/5 mL are pink
coloured dry granular
powder which gives a pink coloured solution on reconstitution
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC 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
D
OSE AND METHOD OF ADMINISTRATION
The oral dose should be administered ½ to 1 hour before meals.
USUAL ADULT DOSE
250 mg 6-hourly
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.
Flucil-inj-pi-26nov19
2
DOSAGE IN PATIENTS WITH IMPAIRED LIVER 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 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. However dosage recommendations for various plasma
creatinine levels for patients
with impa