Consumer medicine information

Flopen

Flucloxacillin

BRAND INFORMATION

Brand name

Flopen

Active ingredient

Flucloxacillin

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Flopen.

What is in this leaflet

This leaflet answers some common questions about FLOPEN. 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 and benefits. Your doctor has weighed the risks of you taking FLOPEN 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 need to read it again.

What FLOPEN is used for

This medicine contains the active ingredient flucloxacillin.

It is used to treat infections caused by bacteria in different parts of the body.

It is an antibiotic that belongs to a group of medicines called penicillins. These antibiotics work by killing the bacteria that are causing your infection.

FLOPEN 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 for another reason.

This medicine is not addictive.

It is available only with a doctor's prescription.

Before you take FLOPEN

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 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 if you have had a reaction affecting your liver while you were taking medicine containing flucloxacillin. Examples of liver reactions include hepatitis and jaundice (yellowing of the eyes or skin).

Do not use this medicine in your eyes.

Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return to your pharmacist for disposal.

If you are not sure whether you should start taking this medicine, talk to your doctor.

Before you start to take it

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor if you have or have had any of the following medical conditions:

  • liver problems
  • kidney problems
  • jaundice, yellowing of the skin or eyes
  • asthma, hayfever, eczema or other allergic conditions

Tell your doctor if you are pregnant or plan to become pregnant or are breast-feeding. Your doctor can discuss with you the risks and benefits involved.

The active ingredient in FLOPEN passes into breast milk and there is a possibility that your baby may be affected.

If you have not told your doctor about any of the above, tell them before you start taking FLOPEN.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.

Tell your doctor or pharmacist if you are taking this medicine in combination with paracetamol, particularly if you have impaired kidney function.

Some medicines and FLOPEN may interfere with each other. These include:

  • probenecid (e.g. Pro-Cid), a medicine commonly used to treat gout
  • oral contraceptive pills, medicines used for contraception

You should use other birth control methods while you are taking FLOPEN.

These medicines may be affected by FLOPEN or may affect how well it works. You may need different amounts of your medicine, or you may need to take different medicines.

Your doctor or pharmacist has more information on medicines to be careful with or avoid whilst taking this medicine.

How to take FLOPEN

Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.

If you do not understand the instructions on the box, ask your doctor or pharmacist for help.

How much to take

Usual Adult Dose
250 mg every 6 hours

Usual Child Dose
2 to 10 years: half of the adult dose

Under 2 years: quarter of the adult dose

How to take it

Swallow the capsules whole with a full glass of water.

When to take it

Take your medicine 30 minutes to 1 hour before food. Food can interfere with the absorption of FLOPEN.

How long to take it

Continue taking your medicine until you finish the pack or for as long as your doctor tells you. It is important to keep taking your medicine even if you feel well.

If you forget to take it

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Otherwise, take it as soon as you remember, and then go back to taking your medicine as you would normally.

Do not take a double dose to make up for the dose that you missed.

If you are not sure what to do, talk to your doctor or pharmacist.

If you have trouble remembering to take your medicine, ask your pharmacist for some hints.

If you take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much FLOPEN. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

Symptoms of an overdose may include diarrhoea and nausea.

While you are using FLOPEN

Things you must do

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking FLOPEN.

Tell any other doctors, dentists and pharmacists who treat you that you are taking this medicine.

If you become pregnant while taking this medicine, tell your doctor immediately.

Tell your doctor immediately if the symptoms of your infection do not improve within a few days or if they become worse.

If you develop yellow eyes or skin (jaundice) whilst or soon after taking FLOPEN tell your doctor immediately. Do this even if it occurs several weeks after you have stopped taking FLOPEN. Jaundice may mean that you have a serious condition affecting your liver. You may need urgent medical attention.

If you get severe diarrhoea, tell your doctor or pharmacist immediately. Do this even if it occurs several weeks after you have stopped taking FLOPEN. Diarrhoea may mean that you have a serious condition affecting your bowel. You may need urgent medical care. Do not take any diarrhoea medicine without checking with your doctor.

If you get a sore white mouth or tongue, or get vaginal itching or discharge, tell your doctor. This may mean you have a fungal infection called thrush. Sometimes the use of FLOPEN allows fungi to grow and the above symptoms to occur. FLOPEN does not work against fungi.

If you get severe skin reactions with painful red areas, large blisters, peeling of skin layers; fever, chills, aching muscles, feeling unwell (signs of drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalised exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome or toxic epidermal necrolysis). Stop taking this medicine immediately and tell your doctor.

If you are taking FLOPEN for a long time, visit your doctor regularly so that they can check on your progress.

You may need to have tests to check your liver and kidney function.

Things you must not do

Do not take any medicine for diarrhoea without first checking with your doctor or a pharmacist.

Do not take FLOPEN to treat any other complaints unless your doctor tells you to.

Do not give your medicine to anyone else, even if they have the same condition as you.

Do not stop taking your medicine or lower the dosage without checking with your doctor. If you stop taking it suddenly, your condition may worsen.

Things to be careful of

Be careful driving or operating machinery until you know how FLOPEN affects you.

Things to be aware of

FLOPEN can cause jaundice (yellowing of skin and/or eyes) and severe liver disease. This is more frequent in older patients, particularly those over 55 years of age, and those who take the medicine for more than 14 days.

Immediately contact your doctor if you notice any yellowing of your eyes or skin.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking FLOPEN.

This medicine helps most people with a bacterial infection, but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor or pharmacist if you notice any of the following and they worry you:

  • nausea
  • vomiting or an upset stomach
  • diarrhoea
  • a mild rash
  • oral thrush - white, furry sore tongue and mouth
  • vaginal thrush - sore and itchy vagina and/or discharge

If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:

  • watery and severe diarrhoea, which may also be bloody
  • severe stomach cramps
  • tiredness, headaches, being short of breath when exercising, dizziness and looking pale
  • bleeding or bruising more easily than normal
  • frequent infections such as fever, chills, sore throat or mouth ulcers
  • yellowing of the eyes or skin (jaundice)
  • painful, swollen joints
  • aching muscles, muscle tenderness or weakness, not caused by exercise
  • irregular heart beat
  • dark or cloudy urine, blood in the urine

The above list includes very serious side effects. You may need urgent medical attention or hospitalisation.

If any of the following happen, stop taking FLOPEN and tell your doctor immediately, or go to Accident and Emergency at the nearest hospital:

  • any type of skin rash, itching or hives
  • swelling of the face, lips, tongue or other parts of the body
  • shortness of breath, wheezing or troubled breathing

Tell your doctor or pharmacist if you notice anything that is making you feel unwell.

Other side effects not listed above may also occur in some people.

After stopping FLOPEN

Tell your doctor if your skin and/or eyes have turned yellow (jaundice) whilst or soon after you finish taking FLOPEN.

Tell your doctor immediately if you notice any of the following side effects, even if they occur up to several weeks after finishing treatment with FLOPEN:

  • watery and severe diarrhoea, which may also be bloody
  • severe abdominal cramps or stomach cramps
  • fever, in combination with one or both of the above

These are rare but serious side effects. FLOPEN can change the bacteria (which are normally present in the bowel and are harmless) to multiply and therefore can cause the above symptoms. You may need urgent medical attention.

After using FLOPEN

Storage

Keep your capsules in the pack until it is time to take them. If you take capsules out of the pack they may not keep well.

Keep your capsules in a cool dry place where the temperature stays below 25°C.

Do not store FLOPEN or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car. Heat and dampness can destroy some medicines.

Keep it where children cannot reach it. A locked cupboard at least one-and-a-half metres above ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

Product description

What it looks like

FLOPEN 250 mg capsules are blue and marked "F250" in white.

FLOPEN 500 mg capsules are blue and marked "F500" in white.

Both strengths are available in packs of 24.

Ingredients

FLOPEN contains 250 mg or 500 mg of flucloxacillin as the active ingredient.

The capsules also contain the following inactive ingredients:

  • brilliant blue FCF
  • erythrosine
  • gelatin
  • magnesium stearate
  • sodium lauryl sulfate
  • titanium dioxide
  • Tekprint SW-0012 white ink

FLOPEN contains trace amounts of sulfites.

Distributor

FLOPEN is distributed in Australia by:

Alphapharm Pty Ltd
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
www.mylan.com.au

This leaflet was prepared in June 2020.

250 mg capsules: AUST R 209367

500 mg capsules: AUST R 209368

flopen_cmi\Jun20/00

Published by MIMS August 2020

BRAND INFORMATION

Brand name

Flopen

Active ingredient

Flucloxacillin

Schedule

S4

 

1 Name of Medicine

Flucloxacillin (as sodium).

2 Qualitative and Quantitative Composition

Each Flopen capsule contains 250 mg or 500 mg of flucloxacillin (as sodium) as the active ingredient.
Flopen capsules contain trace quantities of sulfites.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Flopen 250 mg capsules have a blue cap and blue body, both imprinted with "F250" in white ink.
Flopen 500 mg capsules have a blue cap and blue body, both imprinted with "F500" in white ink.

4 Clinical Particulars

4.1 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.

4.2 Dose and Method of Administration

Usual adult dose.

250 mg every 6 hours.

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.

Method of administration.

The oral dose should be administered ½ to 1 hour before meals.

Dosage in patients with 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).

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. Dosage recommendations for various plasma creatinine levels for patients with impaired renal function are not available. Flucloxacillin is not significantly removed by haemodialysis.

4.3 Contraindications

History of flucloxacillin associated jaundice or hepatic dysfunction.
History of a hypersensitivity reaction to beta-lactam antibiotics e.g. penicillins, cephalosporins.
Use in the eye.

4.4 Special Warnings and Precautions for Use

Hepatic toxicity.


High anion gap metabolic acidosis.

Caution is advised when flucloxacillin is administered concomitantly with paracetamol due to the increased risk of high anion gap metabolic acidosis (HAGMA). Patients at high risk for HAGMA are in particular those with severe renal impairment, sepsis or malnutrition especially if the maximum daily doses of paracetamol are used.
After co-administration of flucloxacillin and paracetamol, close monitoring is recommended in order to detect the appearance of acid-base disorders, namely HAGMA, including testing for urinary 5-oxoproline.
If flucloxacillin is continued after cessation of paracetamol, it is advisable to ensure that there are no signals of HAGMA, as there is a possibility of flucloxacillin maintaining the clinical picture of HAGMA (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions; Section 4.8 Adverse Effects (Undesirable Effects)).

Severe cutaneous adverse reactions.

Severe cutaneous adverse reactions (SCAR), such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalised exanthematous pustulosis (AGEP) have been reported in patient's taking beta-lactam antibiotics. When SCAR is suspected, flucloxacillin should be discontinued immediately and an alternative treatment should be considered.
The occurrence at treatment initiation of a feverish generalised erythema associated with pustula may be a symptom of acute generalised exanthematous pustulosis (AGEP). In case of AGEP diagnosis, flucloxacillin should be discontinued and any subsequent administration of flucloxacillin contra-indicated.

Hypersensitivity and anaphylaxis.

Serious, and occasionally fatal, hypersensitivity reactions (anaphylaxis) have been reported in patients receiving beta-lactam antibiotics e.g. penicillins. Although anaphylaxis is more frequent following parenteral therapy, it has occurred in patients on oral therapy. Before commencing therapy with any beta-lactam antibiotic, careful enquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins or other allergens. If a hypersensitivity reaction occurs, appropriate therapy should be instituted and Flopen therapy discontinued.
Serious anaphylactoid reactions require emergency treatment with adrenaline. Oxygen, intravenous steroids and airway management, including intubation, should also be administered as indicated.

Antibiotic associated pseudomembranous colitis.

Antibiotic associated pseudomembranous colitis has been reported with many antibiotics including flucloxacillin. A toxin produced by Clostridium difficile appears to be the primary cause. The severity of the colitis may range from mild to life threatening. It is important to consider this diagnosis in patients who develop diarrhoea or colitis in association with antibiotic use (this may occur up to several weeks after cessation of antibiotic therapy). Mild cases usually respond to drug discontinuation alone. However, in moderate to severe cases, appropriate therapy with a suitable oral antibacterial agent effective against Clostridium difficile should be considered. Fluids, electrolytes and protein replacement should be provided when indicated. Drugs which delay peristalsis, e.g. opiates and diphenoxylate with atropine may prolong and/or worsen the condition and should not be used.
Caution should be exercised in the treatment of patients with an allergic diathesis.

Sodium content.

Each gram of flucloxacillin sodium contains 2.2 mmol of sodium.

Use in hepatic impairment.

Warning.

Hepatitis, predominantly of cholestatic jaundice, which may be protracted, has been reported with flucloxacillin therapy (see Section 4.8 Adverse Effects (Undesirable Effects)). Reports have been more frequent with increasing age (particularly over 55 years of age) or following prolonged treatment (beyond 14 days). Jaundice may appear several weeks after therapy; in several cases, the course of the reactions has been protracted and lasted for several months. Resolution has occurred with time in most cases. In rare cases, deaths have been reported, nearly always in patients with serious underlying disease or receiving concomitant medications.
During long-term treatment, regular monitoring of hepatic function is recommended.
Flopen should be used with caution in patients with evidence of hepatic dysfunction even though the latter is not a recognised predisposing factor to hepatic reactions to the drug.

Use in renal impairment.

During long-term treatment, regular monitoring of renal function is recommended. See Section 4.2 Dose and Method of Administration, Dosage in patients with impaired renal function.

Use in the elderly.

No data available.

Paediatric use.

Use in neonates.

Animal studies show that high doses of flucloxacillin reduce albumin-bound bilirubin to 50 to 70% of the base line concentration. The drug should therefore be used with extreme caution in jaundiced neonates or premature infants.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Caution should be taken when flucloxacillin is used concomitantly with paracetamol as concurrent intake has been associated with high anion gap metabolic acidosis (HAGMA), especially in patients with risk factors (see Section 4.4 Special Warnings and Precautions for Use; Section 4.8 Adverse Effects (Undesirable Effects)).
Probenecid decreases the renal tubular secretion of flucloxacillin. Concurrent use with Flopen may result in increased and prolonged blood levels of flucloxacillin.
In common with other antibiotics, patients should be warned that Flopen may reduce the effectiveness of oral contraceptives.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category B1)
The safety of flucloxacillin in the first trimester of pregnancy has not yet been established.
Animal studies with flucloxacillin have shown no teratogenic effects. The product has been in clinical use since 1970 and the limited number of reported cases of use in human pregnancy have shown no evidence of untoward effect. The use of flucloxacillin in pregnancy should be reserved for cases considered essential by the clinician.
 Flucloxacillin is excreted in breast milk in trace amounts. An alternative feeding method is recommended to avoid any possible sensitisation of the newborn.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

As with all penicillins, the possibility of hypersensitivity reactions should always be considered. Reactions are more likely to occur in those with an allergic diathesis. Anaphylactic shock is most likely to occur with injected penicillins (see Section 4.4 Special Warnings and Precautions for Use, Hypersensitivity and anaphylaxis).
The following adverse effects have been reported as associated with the use of flucloxacillin:

Metabolism and nutrition disorders.

Post-marketing experience: very rare cases of high anion gap metabolic acidosis (HAGMA) when flucloxacillin is used concomitantly with paracetamol, generally in the presence of risk factors (see Section 4.4 Special Warnings and Precautions for Use; Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).

Skin and other subcutaneous tissue disorders.

Severe cutaneous adverse reactions including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalised exanthematous pustulosis (red, scaly rash with bumps under the skin and blisters) (AGEP) have been reported in beta-lactam antibiotics.

Central nervous system.

Adverse effects have been reported rarely. They include dizziness and convulsions. Convulsions may occur in patients with impaired renal function or in those receiving high doses. As the blood brain barrier becomes more permeable in meningitis, toxic symptoms may be precipitated by lower levels of flucloxacillin in patients with meningitis.

Gastrointestinal.

Nausea, vomiting, diarrhoea, dyspepsia. As with other antibiotics, pseudomembranous colitis has been reported rarely (see Section 4.4 Special Warnings and Precautions for Use, Antibiotic associated pseudomembranous colitis).

Haematological.

Haemolytic anaemia has been reported during therapy with flucloxacillin. Reactions such as anaemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leucopoenia and agranulocytosis have been reported during therapy with penicillins. These reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena.

Hepatic.

Hepatitis and cholestatic jaundice (occasionally severe) have been reported (see Section 4.4 Special Warnings and Precautions for Use). These may be delayed for up to two months post treatment. A frequency of about 1 in 15,000 exposures have been reported for cholestatic jaundice. Changes in liver function tests may occur but are reversible when treatment is discontinued.

Hypersensitivity reactions.

Erythematous maculopapular rashes, urticaria, purpura, eosinophilia, angioneurotic oedema. Anaphylaxis and erythema multiforme have been reported rarely. Certain reactions (fever, arthralgia and myalgia) sometimes develop more than 48 hours after the start of treatment. Whenever such reactions occur, the administration of Flopen should be discontinued.

Note.

Urticaria, other skin rashes and serum sickness-like reactions may be controlled with antihistamines and, if necessary, systemic corticosteroids.

Renal.

Isolated cases of nephritis, interstitial nephritis and haematuria have been reported.

Other.

Vaginal or oral moniliasis may occur following the use of antibiotics.
Amongst the adverse events reported spontaneously to ADRAC, 61% were dermatological effects, 17% were jaundice, 16% were gastrointestinal reactions and 2.5% were CNS related.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.9 Overdose

No information is available, but it could be anticipated that overdosage with oral Flopen would cause gastrointestinal and CNS symptoms (see Section 4.8 Adverse Effects (Undesirable Effects)). As the blood brain barrier becomes more permeable in meningitis, toxic symptoms may be precipitated by lower levels of flucloxacillin in patients with meningitis.
Flucloxacillin is not significantly removed from the circulation by haemodialysis. General supportive measures should be instituted and consideration given to the use of activated charcoal to minimise gastrointestinal absorption.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Microbiology.

Flucloxacillin is a narrow spectrum antibiotic with considerable activity against the following Gram-positive organisms: Beta-lactamase-producing Staphylococcus aureus; penicillin sensitive Staphylococcus aureus; β-haemolytic streptococci (Streptococcus pyogenes), Streptococcus pneumoniae.
It is less active than benzylpenicillin against organisms which are sensitive to benzylpenicillin.
It is not active against Gram-negative bacilli, methicillin resistant Staphylococcus aureus (MRSA), nor Streptococcus faecalis.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

Blood level studies in fasting subjects show that flucloxacillin is well absorbed following oral administration with peak levels being achieved within one hour. The presence of food in the gastrointestinal tract delays the absorption of flucloxacillin resulting in lower peak serum levels.

Distribution.

Flucloxacillin, in common with other isoxazolylpenicillins, is highly bound to serum proteins. However, the low minimum inhibitory concentrations of flucloxacillin against Gram-positive cocci and the free antibiotic levels achieved ensure that the preparation is fully active against susceptible pathogens.

Excretion.

The major route of excretion is renal (by both glomerular filtration and tubular secretion) and high levels of active antibiotic are produced in the urine. Following oral administration approximately 50% of the oral dose can be recovered unchanged in the urine in the first six hours. At least 10% of the dose is excreted as an active metabolite which can rise to as high as 50% in renal failure.
The concurrent administration of probenecid delays the excretion of flucloxacillin resulting in higher and more prolonged blood levels of the antibiotic.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

The capsules also contain the following inactive ingredients: brilliant blue FCF, erythrosine, gelatin, magnesium stearate, sodium lauryl sulfate, titanium dioxide and Tekprint SW-0012 white ink (proprietary ingredient number: 13175).

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 25°C.

6.5 Nature and Contents of Container

Container type: blister pack (Al/Al).
Pack sizes: 4, 24.
Some strengths, pack sizes and/or pack types may not be marketed.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking it to your local pharmacy.

6.7 Physicochemical Properties

Chemical structure.


Flucloxacillin sodium is a member of the beta-lactamase-stable group of penicillins derived from the penicillin nucleus, 6-amino-penicillanic acid.
Flucloxacillin sodium is the sodium salt of (2S,5R,6R)-6-[3-(2-chloro-6-fluorophenyl)-5-methylisoxazole-4-carboxamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo [3.2.0] heptane-2-carboxylic acid.
Molecular formula: C19H16ClFN3NaO5S,H2O.
Molecular weight: 493.9.

CAS number.

1847-24-1.

7 Medicine Schedule (Poisons Standard)

S4 (Prescription Only Medicine).

Summary Table of Changes