FLUCLOXACILLIN 500MG CAPSULES

Active substance: FLUCLOXACILLIN SODIUM

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Package leaflet: Information for the patient

FLUCLOXACILLIN 250MG CAPSULES
FLUCLOXACILLIN 500MG CAPSULES
(flucloxacillin)
Read all of this leaflet carefully before
you start taking this medicine because it
contains important information for you.
•  eep this leaflet. You may need to read it
K
again.
•   f you have any further questions, ask your
I
doctor or pharmacist.
•   his medicine has been prescribed for you
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only. Do not pass it on to others. It may
harm them, even if their signs of illness are
the same as yours.
•   f you get any side effects, talk to your
I
doctor or pharmacist. This includes any
possible side effects not listed in this leaflet.
See section 4.

What is in this leaflet
1  hat your medicine is and what it is
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used for
2  hat you need to know before you
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take your medicine
3 How to take your medicine
4 Possible side effects
5 How to store your medicine
6  ontents of the pack and other
C
information
1  What your medicine is and what it is
used for

•  ou have other serious illnesses (apart from the
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infection this medicine is treating)
•  ou are taking this medicine for a long time as
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regular tests of liver and kidney function are
advised
• You are on a sodium-restricted diet.

Other medicines and Flucloxacillin
Capsules
Tell your doctor or pharmacist before taking this
medicine if you are taking any other medicines,
especially:
•  robenecid or sulfinpyrazone (used to treat
P
gout)
• Methotrexate (a chemotherapy drug)
•  he contraceptive pill as antibiotics can make
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these less effective (you will need to use extra
precautions such as condoms while taking
flucloxacillin and for a full 7 days after you finish
taking it)
•  ral typhoid vaccine (antibiotics can make this
O
less effective)
• Sugammadex (used with general anaesthetics)
• Piperacillin (an antibiotic taken by injection)
Some medicines may affect the way others
work. Tell your doctor or pharmacist if you are
taking, have recently taken or might take any
other medicines. This means medicines you
have bought yourself as well as medicines on
prescription from a doctor.

Pregnancy and breast-feeding

Flucloxacillin is an antibiotic used to treat
infections by killing the bacteria that can cause
them. It belongs to a group of antibiotics called
“penicillins”.

If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before
taking this medicine.

Flucloxacillin is used to treat:
• chest infections
• throat or nose infections
• ear infections
• skin and soft tissue infections
• heart infections
• bone and joint infections
• meningitis
• digestive system infections
• blood infections
•  idney, bladder or urethra (the tube which
k
carries urine from the bladder) infections.

Your medicine contains sodium

Flucloxacillin can also be used to prevent
infections during major surgery, particularly
heart or orthopaedic surgery.

2  What you need to know before you
take your medicine
Do not take this medicine if:
•  ou are allergic to flucloxacillin or any other
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penicillin antibiotics (see symptoms in section
4).
•  ou are allergic to any of the other ingredients
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of this medicine (listed in section 6).
•  ou have suffered previously from liver
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problems (e.g. jaundice) after taking
flucloxacillin.

Warnings and precautions
Talk to your doctor or pharmacist before taking
this medicine if:
•  ou suffer from kidney problems, as you may
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require a lower dose than normal
•  ou suffer from liver problems, as this medicine
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could cause them to worsen
• You are 50 years of age or older
Continued top of next column
AAAG0414

This medicine contains approximately 52.3mg
sodium per g. This should be taken into
consideration by patients on a sodium-restricted
diet.

3 How to take your medicine
Always take this medicine exactly as your doctor
or pharmacist has told you. Their directions may
differ from the information contained in this
leaflet. The pharmacist’s label should tell you
how much to take and how often. Check with
your doctor or pharmacist if you are not sure.
Take this medicine when your stomach is empty.
This means an hour before food or 2 hours after
food. It is important that you take your medicine
at the right times.
The dose will depend on the patient and will
be decided by your doctor. However, the usual
doses for each age group are:

Adults (including the elderly)
• The usual dose is 250mg four times a day.
•  one or heart infection: Up to 8g daily, in
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divided doses at six to eight hours apart.
•  urgical prophylaxis: 1 to 2g IV at induction of
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anaesthesia followed by 500mg every six hours
for up to 72 hours.

Use in children
Children (10-18 years of age): 250mg four times
daily
Children (2-10 years of age): 125mg four times
daily
Children under 2 years of age: 62.5mg four times
daily

Continued over page

colours/plates:

Flucloxacillin 250mg & 500mg PIL - UK

1. Black

item no: AAAG0414

dimensions: 148 x 335

print proof no: 5

pharmacode:

origination date: 08.10.13

min pt size: 8pts

3.
4.
5.
6.

originated by: SA
approved for print/date

2.

revision date: 30.10.13

Technical Approval

revised by: SA

date sent: 08.10.13

supplier: Athlone

technically app. date:

Non Printing Colours
1.
2.
3.

Patients with kidney problems
If you suffer from severe kidney failure your
doctor will give you lower or fewer doses.

If you take more of your medicine than
you should
If you (or somebody else) accidentally takes too
much of your medicine, speak to your doctor or
pharmacist immediately.

If you forget to take your medicine
If you forget to take a dose, take it as soon as you
remember, then carry on as before. Do not take a
double dose to make up for a forgotten dose.

If you stop taking your medicine
Keep taking your medicine until your doctor tells
you to stop. Do not stop taking it just because
you feel better. If you stop taking the medicine,
your infection may return or get worse. If you are
still unwell after taking all the medicine, go and
see your doctor.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.

4 Possible side effects

5 How to store your medicine
KEEP THIS MEDICINE OUT OF THE SIGHT AND
REACH OF CHILDREN
Do not use this medicine after the expiry date
shown on the label after EXP. The expiry date
refers to the last day of that month.
Securitainers: Store below 25oC. Store in the
original package. Keep the container tightly
closed to protect from light and moisture.
Blister packs: Store below 25oC. Do not open the
foil pouch until ready to use the product. Once
opened the foil pouch may be discarded. Store
the product in the outer carton to protect from
light and moisture.
Return any left-over medicine to the pharmacist.
Do not throw away any medicines via wastewater
or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These
measures will help protect the environment.

6  Contents of the pack and other
information
What Flucloxacillin Capsules contain

Like all medicines, this medicine can cause side
effects, although not everybody gets them. If
they occur, they are likely to be temporary, and
not serious. However, some may be serious and
need medical attention.

The active substance is flucloxacillin as
flucloxacillin sodium.
The other ingredients are sodium starch
glycolate, magnesium stearate, red iron oxide
(E172), yellow iron oxide (E172), black iron oxide
(E172), titanium dioxide (E171) and gelatin.

STOP taking Flucloxacillin Capsules and
contact your doctor immediately if you
experience:

Please see further information on sodium in
section 2.

•  llergy or hypersensitivity including itchy rash,
a
itching, sore mouth or eyes, swelling of the face,
lips, throat or tongue or breathing problems
• severe, possibly bloody, diarrhoea
•  aundice (yellow colour in the skin and whites of
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the eyes), hepatitis (liver inflammation)
-  ometimes these effects on the liver can be
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delayed for up to 2 months after finishing
treatment
•  evere skin rash with flushing, fever, blisters or
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ulcers (Stevens-Johnson syndrome)
•  evere rash with reddening, peeling and
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swelling of the skin that looks like a burn (toxic
epidermal necrolysis).

Tell your doctor if you notice any of the
following effects:
Common (may affect up to 1 in 10 people):
•  iarrhoea, stomach upset and feeling sick d
should be mild and wear off after a few days.
Very rare (may affect up to 1 in 10,000 people):
•  ifficulty passing water or blood in the urine
d
(may be a sign of inflammation of the kidney)
•  nusual bleeding or bruising, anaemia (may
u
be caused by changes in the numbers of blood
cells)
•  oint or muscle pains or fever (may develop 2
j
days after starting treatment).

What Flucloxacillin Capsules look like
and contents of the pack
The 250mg capsules are opaque caramel and
grey, printed with ‘FXN 250’ in black ink. The
capsules contain a granular off-white powder.
The 500mg capsules are opaque caramel and
grey, printed with ‘FXN 500’ in black ink. The
capsules contain a granular off-white powder.
Both strengths are available in the following pack
sizes:
Securitainers are available in pack sizes of 15, 18,
20, 21, 28, 30, 50, 100, 250 & 500 capsules.
Blister packs are available in pack sizes of 15, 18,
20, 21, 28, 30, 50, 100, 250 & 500 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and
Manufacturer
Athlone Laboratories Limited, Ballymurray, Co.
Roscommon, Ireland.
Distributed by: Actavis, Barnstaple, EX32 8NS,
UK

PL06453/0015
PL06453/0016
This leaflet was last revised in October 2013.

Check with your doctor if you have any problems
while taking this medicine, even if you think the
problems are not connected with the medicine,
or are not listed in this leaflet.

Reporting of side effects
If you get any side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet. You can also
report side effects directly via the yellow card
scheme at www.mhra.gov.uk/yellowcard. By
reporting side effects you can help provide more
information on the safety of this medicine.

Continued top of next column
AAAG0414

Actavis, Barnstaple, EX32 8NS, UK

colours/plates:

Flucloxacillin 250mg & 500mg PIL - UK

1. Black

item no: AAAG0414

dimensions: 148 x 335

print proof no: 5

pharmacode:

origination date: 08.10.13

min pt size: 8pts

3.
4.
5.
6.

originated by: SA
approved for print/date

2.

revision date: 30.10.13

Technical Approval

revised by: SA

date sent: 08.10.13

supplier: Athlone

technically app. date:

Non Printing Colours
1.
2.
3.

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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