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FLUCLOXACILLIN 250 MG CAPSULES

Active substance(s): FLUCLOXACILLIN SODIUM / FLUCLOXACILLIN SODIUM

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24 mm

Package leaflet: Information for the user

FLUCLOXACILLIN 250MG CAPSULES
FLUCLOXACILLIN 500MG CAPSULES
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 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. What Flucloxacillin Capsules are and what are they
used for
2. What you need to know before you take
Flucloxacillin Capsules
3. How to take Flucloxacillin Capsules
4. Possible side effects
5. How to store Flucloxacillin Capsules
6. Contents of the pack and other information

1. What Flucloxacillin Capsules are and
what are they used for
The name of the medicine is Flucloxacillin 250mg or 500mg
Capsules which will be referred to as Flucloxacillin Capsules throughout
this leaflet. The active ingredient is flucloxacillin.
Flucloxacillin belongs to a group of medicines called Beta-lactamase
resistant penicillins. It is an antibiotic used to treat infections by killing the
bacteria that cause them.
Flucloxacillin is used to treat the following infections in adults, and children
aged 2-10 years. It can also be used in children less than 2 years of age.
Your doctor will adjust the dose depending on the age of the patient
• skin and soft tissue infections (including boils, abcesses, carbuncles,
ulcers, infected eczema and acne, wounds and burns.
• chest infections (including pneumonia and lung abcess)
• ear, nose and throat infections including tonsils (tonsillitis), sinuses
(sinusitis), pharynx (pharyngitis) and ear infections (otitis media
and otitis externa).








heart infections (endocarditis)
bones and joint infections (osteomyelitis)
infections of the membranes of the brain (meningitis)
digestive system infections
blood infections (septicaemia)
infections of kidney, bladder and urethra (the tube that
carries urine from the bladder)
• Flucloxacillin can also be used to prevent infections during
major surgical procedures, particularly in heart or orthopaedic
surgery.

2. What you need to know before you take
Flucloxacillin Capsules
Do not take Flucloxacillin Capsules if you:
• are allergic to flucloxacillin, any other antibiotics (especially penicillin)
or any of the other ingredients of this medicine (listed in section 6)
• have a previous history of jaundice (yellowing of the skin) or
liver problems related to flucloxacillin
Warnings and Precautions:
Talk to your doctor or pharmacist before taking Flucloxacillin Capsules
if you have or have had any medical conditions, and especially if you:
• have had a skin rash, swelling of the face or neck, or any
serious complaint when taking any antibiotic
• are 50 years of age or older
• are suffering from any serious illness
• have liver or kidney problems
• are on a low-sodium diet
• are being treated for kidney problems or gout
• are taking this medicine for a long time as regular tests of liver
and kidney function is advised.
New-borns receiving flucloxacillin treatment should be regularly
monitored by the doctor.
Tell your doctor that you are taking Flucloxacillin if you are having urine
tests or blood tests because Flucloxacillin may affect the results.
Other medicines and Flucloxacillin Capsules
Tell your doctor or pharmacist if you are taking or have recently
taken any other medicines, or might take any other medicines. This is
because Flucloxacillin Capsules can affect the way some medicines
work. Also some other medicines can affect the way Flucloxacillin Capsules
work.

Especially:
• probenecid or sulfinpyrazone (to treat gout)
• methotrexate (a chemotherapy drug)
• oral typhoid vaccine (antibiotics can make it less effective)
• sugammadex (used with general anaesthetics)
• piperacillin (an antibiotic taken by injection)
• warfarin (medicine to prevent blood clotting)
• other antibiotics (used to treat infections)
Pregnant, breast-feeding and fertility
• 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 advise before taking this medicine.
Driving and using machines
Adverse effects on the ability to drive or operate machinery have not
been observed.
Flucloxacillin capsules contain Sodium and Benzoates
Check with your doctor before taking this medicine if you are on a sodium
restricted diet. This medicine also contains methyl hydroxy benzoate
and propyl hydroxy benzoate which may cause allergic reactions.

3. How to take Flucloxacillin Capsules
Always take this medicine exactly as your doctor or pharmacist has told
you. Check with your doctor or pharmacist if you are not sure.
• The dosage and duration of treatment will depend on the type
and severity of the infection.
• Swallow the capsules whole with water, do not chew them, on an
empty stomach. This means an hour before food or two hours after
food. Never take more than the recommended dose each day.
The recommended dose is:
Adults:
• The usual dose is one 250 mg capsule four times a day.
• The dose may be doubled in case of severe infections.
• For infections of the joints (osteomyelitis) or heart (endocarditis), the
usual dose is up to 8 g daily in divided doses six to eight hourly.
• To prevent infection due to surgery, 1 to 2g is given intravenously at
induction of anaesthesia followed by 500mg every six hours either
by mouth or injection into a vein or muscle for upto 72 hours.
Use in children:
• The usual dose for children aged 2-10 years is half the adult dose.
• The dose for children under 2 years old is quarter of the adult dose.
• Premature or babies less than 4 weeks old – Not recommended.
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4. Possible side effects
Like all medicines, this medicine cause side effects, although not
everybody gets them.
STOP TAKING this medicine and tell your doctor immediately if you suffer
from any of the following:
• hypersensitivity or severe allergic reaction including swollen face or
breathing problems. An unexpected skin reaction,e.g. a rash and/or
a sore mouth or eyes
• severe skin rash with flushing, fever, blisters or ulcers (StevensJohnson syndrome)
• peeling and swelling of the skin that resembles burns (toxic epidermal
necrolysis)
• allergic skin reactions e.g. ‘hives’ or ‘nettle’ rash
• severe diarrhoea with bleeding
• notice your urine becoming darker or your faeces (otherwise known
as poo) becoming paler
• hepatitis (inflammation of the liver)

5. How to store Flucloxacillin Capsules
• Keep this medicine out of the sight and reach of children.
• Do not store above 250C. Store in the original package.
• Do not use this medicine after the expiry date stated on the carton
after EXP. The expiry date refers to the last day of that month.
• 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 enviroment.
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6. Contents of the pack and other information
What Flucloxacillin Capsules contain
• The active ingredient is flucloxacillin (as flucloxacillin sodium).
• Flucloxacillin Capsules come in two strengths, 250mg and 500mg.
Each capsule contains either 250mg or 500mg of the active ingredient.
• The other ingredients are magnesium stearate, gelatin, indigo carmine
(E132), titanium dioxide (E171), shellac, methyl hydroxybenzoate
and propyl hydroxybenzoate.
What Flucloxacillin Capsules look like and contents of the pack
• The 250 mg capsules are blue coloured printed with “F 250”.
• The 500 mg capsules are blue coloured printed with “F 500”.
• The capsules are supplied in packs containing 28 and 56 capsules.
• Not all the pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Name and address:
Bristol Laboratories Ltd,
Unit 3, Canalside, Northbridge Road,
Berkhamsted, Hertfordshire,
HP4 1EG, United Kingdom
Telephone:
0044 (0)1442 200922
Fax:
0044 (0)1442 873717
E-mail:
info@bristol-labs.co.uk
Flucloxacillin 250mg Capsules: PL 17907/0052
Flucloxacillin 500mg Capsules: PL 17907/0053
This leaflet was last revised in December 2016
To request a copy of this leaflet in Braille, large print or audio format,
please contact the licence holder at the address (or telephone, fax,
email) above.

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• cholestatic jaundice (skin or white of your eyes turning yellow)
• changes in numbers of blood cells (causing unexplained bleeding,
bruising or skin discolouration)
• Inflammation of kidney (interstitial nephritis) is usually reversible when
treatment is discontinued, but in rare situations can lead to kidney
failure, bowel and/or liver
• joint or muscle pain, this may develop after 2 days or more from the
start of treatment with Flucloxacillin
• fever, this may develop after two days or more from the start of treatment
with flucloxacillin
Other side 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 urine (may be a sign of inflammation
of kidney)
• an increase in certain type of white blood cells (eosinophilia).
Not Known: (frequency cannot be estimated from the available data)
• 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.
Some of these reactions can be delayed for up to two months
after finishing the treatment.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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.

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If you still feel unwell after finishing the treatment, speak to your doctor.
Patients with kidney problems
If you suffer from severe kidney failure your doctor will give you lower or
fewer doses.
If you take more Flucloxacillin Capsules than you should
It is important to stick to the dose on the label. Taking more than this can
make you ill.
If you accidently take too many capsules, tell your doctor immediately or
contact your nearest Hospital Casualty/Accident and Emergency
Department even if there are no signs of discomfort. Take your medicine
in its original packaging with you in order to enable the doctor to identify
your medication easily.
If you forget to take Flucloxacillin Capsules
If you forget to take a dose, take it as soon as you remember, however, if
it is almost time for your next dose then, skip the missed dose and then
take your next dose when it is due.
DO NOT TAKE A DOUBLE DOSE TO MAKE UP FOR THE FORGOTTEN
DOSE
If you stop taking Flucloxacillin Capsules
Take all the capsules that have been prescribed for you, even if you start
to feel better. Your symptoms may start to improve before the infection is
completely treated. If you stop taking the capsules too soon, your symptoms
may return.

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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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