FLUCLOXACILLIN 500MG CAPSULES

Active substance: FLUCLOXACILLIN SODIUM

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Patient Information Leaflet

FLUCLOXACILLIN 250MG CAPSULES
FLUCLOXACILLIN 500MG CAPSULES
Pharmacode
Position

Read all of this leaflet carefully before
you start taking your medicine.
•   eep this leaflet. You may need to read
K
it again.
•  f you have further questions, please
I
ask your doctor or pharmacist
(chemist).
•   his medicine has been prescribed for
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you personally and you should not
pass it on to others. It may harm them,
even if their symptoms are the same
as yours.
•  f any of the side effects gets serious,
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or if you notice any side effects not
listed in this leaflet, please tell your
doctor or pharmacist.

IN THIS LEAFLET
1  hat your medicine is and what
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it is used for
2 Before you take your medicine
3 How to take your medicine
4  ossible side effects of your
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medicine
5 How to store your medicine
6 Further information
1  HAT YOUR MEDICINE IS AND
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WHAT IT IS USED FOR

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”.
Flucloxacillin is used to treat:
•  hest infections
c
• throat or nose infections
•  ar infections
e
• skin and soft tissue infections
•  eart infections
h
• bone and joint infections
• meningitis
•  igestive system infections
d
• blood infections
•  idney, bladder or urethra (the tube which
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carries urine from the bladder) infections.
Flucloxacillin can also be used to
prevent infections during major surgery,
particularly heart or orthopaedic surgery.

2  EFORE YOU TAKE YOUR
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MEDICINE

Do not take this medicine if:

•  ou have ever had an allergic reaction
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to flucloxacillin or any other penicillin
antibiotics (see symptoms section 4).
•  ou have ever had an allergic reaction
Y
to any of the other ingredients of this
medicine – see list of ingredients in
section 6, Further information.
•  ou have suffered previously from liver
Y
problems (e.g. jaundice) after taking
flucloxacillin.

Take special care with your medicine
Check with your doctor or pharmacist
before taking this medicine if:
•  ou suffer from kidney problems, as you
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may require a lower dose than normal
•  ou suffer from liver problems, as this
Y
medicine could cause them to worsen
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• You are 50 years of age or older
•  ou have other serious illnesses (apart
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from the infection this medicine is
treating)
•  ou are taking this medicine for a long
Y
time as regular tests of liver and kidney
function is advised
• You are on a sodium restricted diet.

Taking other medicines

Check with your doctor or pharmacist
before taking this medicine if you are
taking any other medicines, especially:
•  robenecid or sulfinpyrazone (used to
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treat gout)
• Methotrexate (a chemotherapy drug)
•  he contraceptive pill as antibiotics can
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make 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
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make this less effective)
•  ugammadex (used with general
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anaesthetics)
•  iperacillin (an antibiotic taken by
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injection)
Some medicines may affect the way others
work. Always tell your doctor about all
the medicines you are taking. This means
medicines you have bought yourself as
well as medicines on prescription from a
doctor.

Pregnancy and breast-feeding

If you are pregnant, planning to become
pregnant or are breast-feeding, ask your
doctor or pharmacist for advice before
taking this medicine.

Important information about some
of the ingredients in your medicine
This medicine contains approximately
52.3mg sodium per g. Check with your
doctor before taking this medicine if you
are on a sodium restricted diet.

3 HOW TO TAKE YOUR MEDICINE
Follow all directions given to you by your
doctor or pharmacist. 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.
If it does not, or you are not sure, check
with your doctor or pharmacist.
Take this medicine when your stomach is
empty. This means an hour before food or
2 hours after food.
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
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induction of anaesthesia followed by
500mg every six hours for up to 72 hours.


Continued over page

Children

Children (10-18 years of age):
Same as adult dose
Children (2-10 years of age):
Half the adult dose
Children under 2 years of age:
Quarter the adult dose

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
the dose you have missed.

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.

4  OSSIBLE SIDE EFFECTS OF
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YOUR MEDICINE

Like all medicines, Flucloxacillin Capsules
may cause unwanted side effects. If they
occur, they are likely to be temporary, and
not serious. However, some may be serious
and need medical attention.

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

•  llergy or hypersensitivity including itchy
a
rash, 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
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whites of the eyes) (Can be delayed for up
to 2 months after finishing treatment.)
•  evere skin rash with flushing, fever,
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blisters or 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).

5 HOW TO STORE YOUR MEDICINE
Do not use this medicine after the expiry
date shown on the label.
KEEP OUT OF THE REACH AND SIGHT
OF CHILDREN
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. Medicines should not be
disposed of via wastewater or household
waste. Ask your pharmacist how to
dispose of medicines no longer required.
These measures will help protect the
environment.
6 FURTHER INFORMATION

What Flucloxacillin Capsules contain
Active ingredient: flucloxacillin as
flucloxacillin sodium
Other ingredients: sodium starch glycolate,
magnesium stearate, red iron oxide (E172),
yellow iron oxide (E172),black iron oxide
(E172), titanium dioxide (E171) and gelatin.
Please see further information on sodium
in section 2.

What Flucloxacillin Capsules look
like and contents of the pack

250mg Capsules are opaque caramel and
grey, printed with ‘FXN 250’ in black ink.
The capsules contain a granular off-white
powder.
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.


The licence holder and manufacturer
is:
Athlone Laboratories Limited, Ballymurray,
Co. Roscommon, Ireland.

Tell your doctor if you notice any of
the following effects:

Distributed by:

Common (occurs in less than 1 in 10 users
but more than 1 in 100 users):
•  iarrhoea, stomach upset and feeling sick
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-  hould be mild and wear off after a few
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days.

PL06453/0015
PL06453/0016

Actavis Barnstaple, EX32 8NS, UK

This leaflet was revised September 2012.

Very rare (occurs in less than 1 in 10,000
users):
•  ifficulty passing water or blood in the
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urine (may be a sign of inflammation of
the kidney)
•  nusual bleeding or bruising, anaemia
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(may be caused by changes in the
numbers of blood cells)
•  oint or muscle pains or fever (may
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develop 2 days after starting treatment).
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.
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Actavis, Barnstaple, EX32 8NS, UK

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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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