Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about taking this medicine,
speak to your doctor or pharmacist.
1. Why am I taking STAPHYLEX?
STAPHYLEX contains the active ingredient flucloxacillin (as sodium monohydrate). STAPHYLEX
is used to treat infections in different parts of the body caused by bacteria. For
more information, see Section
1. Why am I taking STAPHYLEX? in the full CMI.
2. What should I know before I take STAPHYLEX?
Do not take if you have ever had an allergic reaction to STAPHYLEX or any of the ingredients
listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding. For more information, see Section
2. What should I know before I take STAPHYLEX? in the full CMI.
3. What if I am taking other medicines?
4. How do I take STAPHYLEX?
Usual adult dose: 250 mg every 6 hours.
Usual child dose: 2 to 10 years: half of the adult dose.
Usual child dose: under 2 years: quarter of the adult dose.
Take STAPHYLEX 30 minutes to 1 hour before food.
5. What should I know while taking STAPHYLEX?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are taking STAPHYLEX.
If you get a sore, white mouth or tongue while taking or soon after stopping STAPHYLEX,
tell your doctor. Also tell your doctor if you get vaginal itching or discharge.
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Things you should not do
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Do not take any medicine for diarrhoea without first checking with your doctor or
pharmacist.
Do not stop taking your medicine or lower the dosage without checking with your doctor.
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Driving or using machines
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Be careful before you drive or use any machines or tools until you know how STAPHYLEX
affects you.
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Looking after your medicine
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Keep your capsules in a cool dry place where the temperature stays below 25°C.
Keep it where young children cannot reach it.
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6. Are there any side effects?
Tell your doctor or pharmacist if you have any of these: 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 vaginal
discharge).
Stop taking STAPHYLEX and tell your doctor immediately, or go to Accident and Emergency
at the nearest hospital if you notice any of these: 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 immediately, or go straight to the Emergency Department at your nearest
hospital if you notice any of these: 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.
For more information, including what to do if you have any side effects, see Section
6. Are there any side effects? in the full CMI.
Active ingredient(s):
flucloxacillin (as sodium monohydrate)
Full Consumer Medicine Information (CMI)
This leaflet provides important information about taking STAPHYLEX. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about taking STAPHYLEX.
Where to find information in this leaflet:
1. Why am I taking STAPHYLEX?
STAPHYLEX contains the active ingredient flucloxacillin (as sodium monohydrate).
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.
STAPHYLEX 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 STAPHYLEX for another reason.
This medicine is not addictive.
2. What should I know before I take STAPHYLEX?
Warnings
Flucloxacillin can cause severe liver damage, particularly in older patients and those
who take it for more than 14 days.
Do not take STAPHYLEX if:
you are allergic 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
Always check the ingredients to make sure you can take this medicine.
you have had a reaction affecting your liver while you were taking a 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.
Check with your doctor if you:
have allergies to any other medicines, foods, preservatives or dyes
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
take any medicines for any other conditions
are pregnant or plan to become pregnant or are breast-feeding.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Your doctor can discuss with you the risks and benefits involved.
The active ingredient in STAPHYLEX 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 STAPHYLEX.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy 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 STAPHYLEX may interfere with each other. These include:
probenecid, 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 STAPHYLEX.
methotrexate, a medicine used to treat inflammatory conditions, including severe psoriasis
and active rheumatoid arthritis
warfarin, a medicine used to prevent blood clotting.
These medicines may be affected by STAPHYLEX 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.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect STAPHYLEX.
4. How do I take STAPHYLEX?
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
Follow the instructions provided when STAPHYLEX was prescribed, including the number
of days it should be taken.
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.
When to take STAPHYLEX
STAPHYLEX should be taken 30 minutes to 1 hour before food.
Food can interfere with the absorption of STAPHYLEX.
How to take STAPHYLEX
Swallow the capsules whole with a full glass of water.
How long to take STAPHYLEX
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 STAPHYLEX
STAPHYLEX should be taken regularly at the same time each day.
If you miss your dose at the usual time and 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 the missed dose as soon as you remember, and then go back to taking
your tablets as you would normally.
Do not take a double dose to make up for the dose you missed.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering to take your medicine, ask your pharmacist for some
hints.
If you take too much STAPHYLEX
If you think that you or anyone else may have taken too much STAPHYLEX, urgent medical
attention may be needed.
You should immediately:
phone the Poisons Information Centre
(Australia telephone 13 11 26) for advice, or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
Symptoms of an overdose may include diarrhoea and nausea.
5. What should I know while taking STAPHYLEX?
Things you should do
Before starting any new medicine, tell your doctor or pharmacist that you are taking
STAPHYLEX.
Remind any doctor, dentist or pharmacist you visit that you are taking STAPHYLEX.
If you get a sore, white mouth or tongue while taking or soon after stopping STAPHYLEX,
tell your doctor. Also tell your doctor if you get vaginal itching or discharge.
This may mean you have a fungal infection called thrush. Sometimes, the use of STAPHYLEX
allows fungi to grow and the above symptoms to occur. STAPHYLEX does not work against
fungi.
If you are taking STAPHYLEX 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.
Call your doctor straight away if you:
become pregnant while taking this medicine.
notice your symptoms do not improve within a few days, or if they become worse.
develop yellow eyes or skin (jaundice) whilst or soon after taking STAPHYLEX.
Do this even if it occurs several weeks after you have stopped taking STAPHYLEX.
Jaundice may mean that you have a serious condition affecting your liver. You may
need urgent medical care.
get severe diarrhoea.
Do this even if it occurs several weeks after you have stopped taking STAPHYLEX.
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.
get severe skin reactions with painful red areas, large blisters, peeling of skin
layers; fever, chills, aching muscles, feeling unwell. Stop taking this medicine immediately.
Things you should not do
Do not take any medicine for diarrhoea without first checking with your doctor or
pharmacist.
Do not take STAPHYLEX to treat any other conditions unless your doctor tells you to.
Do not give STAPHYLEX 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.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how STAPHYLEX
affects you.
Things to be aware of
STAPHYLEX can cause jaundice (yellowing of skin and/or eyes) and severe liver damage.
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.
Looking after your medicine
Keep your capsules in a cool dry place where the temperature stays below 25°C.
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do
not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Heat and dampness can destroy some medicines.
Keep it where young children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place
to store medicines.
Getting rid of any unwanted medicine
If you no longer need to take this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not take this medicine after the expiry date.
6. Are there any side effects?
Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are taking
STAPHYLEX.
STAPHYLEX treats infections in most people, but it may have unwanted side effects
in some people.
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
Do not be alarmed by this list of possible side effects. You may not experience any
of them.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
Very serious side effects
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
After stopping STAPHYLEX
Tell your doctor if your skin and/or eyes have turned yellow (jaundice) whilst or
soon after you finish taking STAPHYLEX.
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 STAPHYLEX:
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. STAPHYLEX can change the bacteria (which
are normally present in the bowel and are harmless) to multiply and therefore cause
the above symptoms. You may need urgent medical attention.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What STAPHYLEX contains
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Active ingredient
(main ingredient)
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flucloxacillin sodium monohydrate 250 mg or 500 mg per capsule
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Other ingredients
(inactive ingredients)
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povidone
purified talc
sodium starch glycollate
microcrystalline cellulose
magnesium stearate
iron oxide yellow
iron oxide red
brilliant blue FCF
titanium dioxide
gelatin
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Potential allergens
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trace amounts of sulfites
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Do not take this medicine if you are allergic to any of these ingredients.
What STAPHYLEX looks like
STAPHYLEX 250 mg is a Size 2 capsule with yellow body and black cap. (AUST R 17683).
STAPHYLEX 500 mg is a Size 0 capsule with yellow body and black cap. (AUST R 17684)
STAPHYLEX is available in blister packs of 24 capsules.
Who distributes STAPHYLEX
Alphapharm Pty Ltd trading as Viatris
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Phone: 1800 274 276
This leaflet was prepared in February 2024.
STAPHYLEX® is a Viatris company trade mark
STAPHYLEX_cmi\Feb24/01