Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
flucloxacillin sodium monohydrate, Quantity: 272.5 mg (Equivalent: flucloxacillin, Qty 250 mg)
Alphapharm Pty Ltd
Capsule, hard
Excipient Ingredients: povidone; brilliant blue FCF; magnesium stearate; sodium starch glycollate; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; microcrystalline cellulose; Gelatin
Oral
24, 30
(S4) Prescription Only Medicine
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.
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
Registered
2022-07-21
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 Read the complete document
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 Read the complete document