FLOPEN VIATRIS 250 FLUCLOXACILLIN 250mg (as sodium) capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

flucloxacillin sodium monohydrate, Quantity: 272.5 mg (Equivalent: flucloxacillin, Qty 250 mg)

Available from:

Alphapharm Pty Ltd

Pharmaceutical form:

Capsule, hard

Composition:

Excipient Ingredients: povidone; brilliant blue FCF; magnesium stearate; sodium starch glycollate; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; microcrystalline cellulose; Gelatin

Administration route:

Oral

Units in package:

24, 30

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

This product accepted for registration as 'currently supplied' at the time of commencement of the Act. Approval granted as specified in the letter of 1 May 1992 from Dr H. Arora. Indicated for the 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: Size 2 capsule with yellow body and black cap.; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2022-07-21

Patient Information leaflet

FLOPEN
® VIATRIS
_flucloxacillin (as sodium monohydrate)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about FLOPEN VIATRIS.
It does not contain all of the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking FLOPEN
VIATRIS against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT FLOPEN
VIATRIS IS USED FOR
FLOPEN VIATRIS contains the
active ingredient flucloxacillin.
It is used to treat infections in
different parts of the body caused by
bacteria.
It is an antibiotic that belongs to a
group of medicines called penicillins.
These medicines work by killing the
bacteria that are causing your
infection.
FLOPEN VIATRIS 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 VIATRIS for another
reason.
This medicine is not addictive.
It is available only with a doctor's
prescription.
BEFORE YOU TAKE
FLOPEN VIATRIS
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 VIATRIS 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 VIATRIS IF
YOU HAVE HAD A REACTION AFFECTING
YOUR LIVER WHILE Y

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
FLOPEN
® VIATRIS
_flucloxacillin (as sodium monohydrate) capsule _
1
NAME OF THE MEDICINE
Flucloxacillin sodium monohydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each FLOPEN VIATRIS 250 mg and 500 mg capsule contains 250 mg or 500
mg of flucloxacillin (as sodium
monohydrate) as the active ingredient.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
FLOPEN VIATRIS 250 mg: Size 0 capsule with yellow body and black cap.
FLOPEN VIATRIS 500 mg: Size 2 capsule with yellow body and black cap.
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
DOSAGE (DOSE AND INTERVAL)
Usual Adult Dose: 250 mg, 6 hourly.
Children: 2 to 10 years: half adult dose.
_NOTE: In severe infections the dosage may be increased. _
METHOD OF ADMINISTRATION
The oral dose should be administered half to one hour before meals.
DOSAGE ADJUSTMENT IN:
_RENAL IMPAIRMENT _
As flucloxacillin sodium monohydrate 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 sodium monohydrate is not significantly
removed by haemodialysis.
_HEPATIC IMPAIRMENT _
Adjustment of dosage may not be necessary as flucloxacillin sodium
monohydrate 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).
4.3
CONTRAINDICATIONS
FLOPEN VIATRIS is contraindicated for:
FLOPEN
®
VIATRIS – PRODUCT INFORMATION
2
•
Patients who are hypersensitive to beta-lactam an