FLUCLOXACILLIN GH flucloxacillin (as sodium) 500 mg capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

flucloxacillin sodium monohydrate, Quantity: 563.78 mg

Available from:

Generic Health Pty Ltd

INN (International Name):

flucloxacillin sodium monohydrate

Pharmaceutical form:

Capsule

Composition:

Excipient Ingredients: indigo carmine; methyl hydroxybenzoate; propyl hydroxybenzoate; Gelatin; magnesium stearate; titanium dioxide; purified water; propylene glycol; butan-1-ol; isopropyl alcohol; Shellac; ethanol absolute; ammonia; potassium hydroxide

Administration route:

Oral

Units in package:

48, 24

Prescription type:

(S4) Prescription Only Medicine

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.

Product summary:

Visual Identification: Flucloxacillin capsules 500 mg are size 0 capsules with blue cap and blue body printed with 'F500'; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2015-06-10

Patient Information leaflet

CONSUMER MEDICINE INFORMATION
FLUCLOXACILLIN GH
(FLUCLOXACILLIN SODIUM MONOHYDRATE) CAPSULES
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY
BEFORE TAKING YOUR MEDICINE.
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.
The information in this leaflet
was last updated on the date
listed on the last page. More
recent information on this
medicine may be available.
ASK YOUR DOCTOR OR
PHARMACIST:
•
if there is anything you do
not understand in this
leaflet;
•
if you are worried about
taking your medicine; or
•
to obtain the most up-to-
date information.
You can also download the most
up to date leaflet from
www.generichealth.com.au.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you using
this medicine against the
benefits they expect it will have
for you.
Pharmaceutical companies
cannot give you medical advice
or an individual diagnosis.
Keep this leaflet with your
medicine. You may want to read
it again.
WHAT FLUCLOXACILLIN
GH IS USED FOR
The name of your medicine is
Flucloxacillin GH.
It is used to treat infections in
different parts of the body
caused by bacteria. It contains
the active ingredient
flucloxacillin (as sodium
monohydrate).
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.
_HOW IT WORKS _
Flucloxacillin is an antibiotic that
belongs to a group of medicines
called penicillins. These
medicines work by killing the
bacteria that are causing your
infection.
Flucloxacillin will not work
against infections caused by
viruses, such as colds or flu.
There is no evidence that this
medicine is addictive.
_USE IN CHILDREN _
Children 2 to 10 years can take
half the adult dose.
BEFORE YOU TAKE
FLUCLOXACILLIN GH
WARNING: FLUCLOXACILLIN CAN
CAUSE SEVERE LIVER DAMAGE,
PARTICULAR

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION – FLUCLOXACILLIN GH
(FLUCLOXACILLIN SODIUM MONOHYDRATE) CAPSULES
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.
Flucloxacillin is a narrow spectrum antibiotic belonging to the
isoxazolyl group of semi-synthetic
penicillins. It is acid stable and penicillinase resistant and is
closely related to cloxacillin. It is a white or
almost white powder and is hygroscopic. It is soluble in 1 part of
water, in 2 parts of methanol, in 8 parts
of ethanol (96%) and in 8 parts of acetone.
In addition, each capsule contains the following excipients with known
effects: methyl hydroxybenzoate,
propyl hydroxybenzoate and ethanol. For the full list of excipients,
see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
250 mg capsule:
Size 2 capsule with blue cap and blue body printed with “F250”.
500 mg capsule:
Size 0 capsule with blue cap and blue body printed with “F500”.
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
Flucloxacillin GH capsules are intended for oral 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.
Flucloxacillin GH v1.0
Page 2 of 8
(flucloxacillin sodium monohydrate) capsules
4.3 CONTRAINDICATIONS
Flucloxacillin should not be given to patients who are hypersensitive
to beta-lactam antibiotics (e.g.
penicillins,
cephalosporins)
or
to
patients
with
a
previous
history
of
flucloxacillin-associated
jaundice/hepatic dysfunction.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Serious, and occasionally fatal, hyper