FLUCLOXACILLIN 500MG CAPSULES

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.
• Keep this leaflet. You may need to read it
again.
• If you have any further questions, ask your
doctor or pharmacist.
• This medicine has been prescribed for you
only. Do not pass it on to others. It may
harm them, even if their signs of illness are
the same as yours.
• If you get any side effects, talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this leaflet.
See section 4.

What is in this leaflet
1 W
hat your medicine is and what it is
used for
2 W
hat you need to know before you
take your medicine
3 H
ow to take your medicine
4 P
ossible side effects
5 H
ow to store your medicine
6 C
ontents of the pack and other
information
1 W
hat your medicine is and 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”.

• You suffer from liver problems, as this medicine
could cause them to worsen

• You are 50 years of age or older
• You have other serious illnesses (apart from the
infection this medicine is treating)

• You are taking this medicine for a long time as
regular tests of liver and kidney function are
advised
• You are on a sodium-restricted diet
• You are taking or will be taking
paracetamol
There is a risk of blood and fluid abnormality
(high anion gap metabolic acidosis) which
occurs when there is an increase in plasma
acidity, when flucloxacillin is used
concomitantly with paracetamol, particularly
in certain groups of patients at risk, e.g.
patients with severe renal impairment, sepsis or
malnutrition, especially if the maximum daily
doses of paracetamol are used. High anion gap
metabolic acidosis is a serious disease that must
have urgent treatment.

Other medicines and Flucloxacillin
Capsules
Tell your doctor or pharmacist before taking this
medicine if you are taking any other medicines,
especially:
• Probenecid or sulfinpyrazone (used to treat
gout)
• Methotrexate (a chemotherapy drug)
• Oral typhoid vaccine (antibiotics can make this
less effective)
• Sugammadex (used with general anaesthetics)
• Piperacillin (an antibiotic taken by injection)
• Warfarin (medicine to prevent blood clotting)

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
• kidney, bladder or urethra (the tube which
carries urine from the bladder) infections.

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.

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

This medicinal product contains approximately
52.3mg sodium per g. To be taken into
consideration by patients on a controlled sodium
diet.

2 W
hat you need to know before you
take your medicine
Do not take this medicine if:
• You are allergic to flucloxacillin or any other
penicillin antibiotics (see symptoms in section
4).
• You are allergic to any of the other ingredients of
this medicine (listed in section 6).
• You have suffered previously from liver problems
(e.g. jaundice) after taking flucloxacillin.
•You have had an allergic reaction to β‑lactam
antibiotics (e.g. penicillins, cephalosporins).

Warnings and precautions
Talk to your doctor or pharmacist before taking
this medicine if:
• You suffer from kidney problems, as you may
require a lower dose than normal (convulsions
may occur very rarely in patients with kidney
problems who take high doses)

Pregnancy and breast-feeding
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.

Your medicine contains sodium

3 H
ow 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.
• Bone or heart infection: Up to 8g daily, in
divided doses at six to eight hours apart.

• Surgical prophylaxis: 1 to 2g IV at induction of
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anaesthesia followed by 500mg every six hours
Continued over page
for up to 72 hours.

Use in children and adolescents
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

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 P
ossible side effects
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.

STOP taking Flucloxacillin Capsules and
contact your doctor immediately if you
experience:
• allergy or hypersensitivity including itchy rash,
itching, sore mouth or eyes, swelling of the face,
lips, throat or tongue or breathing problems
• severe, possibly bloody, diarrhoea
• jaundice (yellow colour in the skin and whites
of the eyes), hepatitis (liver inflammation) sometimes these effects on the liver can be
delayed for up to 2 months after finishing
treatment
• severe skin rash with flushing, fever, blisters or
ulcers (Stevens-Johnson syndrome)
• severe rash with reddening, peeling and
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):
• diarrhoea, stomach upset and feeling sick should be mild and wear off after a few days.
Very rare (may affect up to 1 in 10,000 people):

• difficulty passing water or blood in the urine

(may be a sign of inflammation of the kidney)

• unusual bleeding or bruising, anaemia (may

be caused by changes in the numbers of blood
cells)
• joint or muscle pains or fever (may develop 2
days after starting treatment)
• increase in the number of white blood cells in
the blood (eosinophilia)
• cases of blood and fluid abnormality (high anion
gap metabolic acidosis) which occurs when
there is an increase in plasma acidity, when
flucloxacillin is used concomitantly with
paracetamol, generally in the presence of risk
factors (see section 2).

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.

5 H
ow to store your medicine
KEEP THIS MEDICINE OUT OF THE SIGHT AND
REACH OF CHILDREN
Do not use this medicine after the expiry date
which is stated 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 in order 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 in order 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 C
ontents of the pack and other
information
What Flucloxacillin Capsules contain
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.
Please see further information on sodium in
section 2.

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 December 2017.

Other side effects (frequency not known):

• Serious skin reactions

A red, scaly rash with bumps under the skin and
blisters (exanthematous pustulosis).
Contact a doctor immediately if you get any of
these symptoms.
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Actavis, Barnstaple, EX32 8NS, UK