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FLUCLOXACILLIN CAPSULES BP 500MG

Active substance(s): FLUCLOXACILLIN SODIUM / FLUCLOXACILLIN SODIUM MONOHYDRATE

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100 mm

flucloxacillin
capsules
BP #250 mg

flucloxacillin
capsules
BP #250 mg

250 Flucloxacillin
mg capsules BP
52 mm

28 capsules
Each capsule contains: Flucloxacillin sodium Ph Eur
equivalent to 250 mg Flucloxacillin.
Also contains: sodium.
Dosage: For oral use as directed by a doctor.
Read the attached leaflet.
Keep out of the sight and reach of children.
Store in a dry place below 25°C.
PL 04569/0039 POM 10004565
Mylan, Potters Bar, Herts, EN6 1TL, U.K.

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. 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.
What is in this leaflet:
1. What Flucloxacillin is and what it is
used for.
2. What you need to know before you
take Flucloxacillin.
3. How to take Flucloxacillin.

4. Possible side effects.
5. How to store Flucloxacillin.
6. Contents of the pack and other
information.
1. WHAT FLUCLOXACILLIN IS AND
WHAT IT IS USED FOR
Flucloxacillin is an antibiotic of the penicillin
group. It belongs to a group of medicines
called penicillinase-resistant antibiotics.
It is used:
• to treat infections in different parts of
your body caused by bacteria
• to prevent infections during surgery.

2. WHAT YOU NEED TO KNOW BEFORE
YOU TAKE FLUCLOXACILLIN
Do not take Flucloxacillin if you:
• are allergic to flucloxacillin (or other
penicillin antibiotics), or any of the other
ingredients of this medicine (listed in
section 6)
• have a history of liver problems from
taking Flucloxacillin.
Warnings and precautions
Talk to your doctor or pharmacist before
taking Flucloxacillin if you:
• have previously taken a penicillin antibiotic
and developed an allergic reaction

• have a history of allergy
• have kidney disease.
If you develop a rash during treatment you
should stop taking this medicine and tell
your doctor immediately (see section 4).
Your doctor will prescribe a different type
of antibiotic.
Tests
Your doctor may wish to monitor your liver and
kidney function during prolonged treatment.
Other medicines and Flucloxacillin
Tell your doctor or pharmacist if you are
taking, have recently taken or might take

any other medicines, including medicines
obtained without a prescription or
the following:
• methotrexate (used to treat cancer)
• probenecid (used to treat gout)
• other antibiotics (used to treat infection)
• anticoagulants e.g. warfarin (used to
thin blood)
• oral contraceptives. If you are taking an
oral contraceptive it may not work so well.
Your doctor will be able to advise you on
additional contraceptive precautions.
Pregnancy and breast‑feeding
Tell your doctor if you are pregnant or

breast-feeding. Very small amounts of
penicillin can be found in the breast milk
of a mother taking this medicine. This may
alter the normal bacteria in the gut of the
breast-fed child, sometimes causing a
stomach upset or allergic reaction.
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 any medicine.
Driving and using machines
Flucloxacillin is not known to affect your
ability to drive or use machines.

Flucloxacillin capsules contain Sodium
The 250 mg capsules contain
approximately 13 mg of sodium per
capsule. The 500 mg capsules contain
approximately 26 mg of sodium per
capsule. To be taken into consideration by
patients on a controlled sodium diet.
3. HOW TO TAKE FLUCLOXACILLIN
Always take this medicine exactly as your
doctor or pharmacist has told you. Check with
your doctor or pharmacist if you are not sure.
Swallow the capsules whole with a full glass
of water. The capsules should be taken

between 30 minutes to one hour before
food. Do not chew or crush the capsules.
The recommended dose is:
Adults (including the Elderly) and
Children over 10 years old:
250 mg four times a day. If your infection is
severe your doctor may double your dose
to 500 mg four times a day.
Osteomyelitis (bone infection) and
endocarditis (infection of the heart lining):
To treat these two conditions your doctor
may prescribe a total daily dose of up to
8 grams. This will be taken as divided doses

every six to eight hours.
Prevention of infection after surgery:
The usual dose is 500 mg four times a day
for three days.
If you have severe kidney disease:
Your doctor may prescribe a lower dose
than those stated above.
Use in Children under 10 years old:
Children aged 2 to 10 years old will
usually be given half of the adult dose.
Children under 2 years old will usually
be given a quarter of the adult dose.
Your doctor will tell you how much to take

and how often.
If you take more Flucloxacillin than
you should
Contact your doctor or nearest hospital
emergency department immediately.
Take the container and any remaining
capsules with you.
If you forget to take Flucloxacillin
Do not take a double dose to make up for
a forgotten dose. Take the next dose at the
usual time.
If you stop taking Flucloxacillin
Do not stop or change your treatment

before talking to your doctor. It is important
that you complete the course as directed
by your doctor. Do not stop taking your
capsules even though you may feel better.
If you stop taking your medicine your
infection may return or get worse.
If you have any further questions on the
use of this medicine, ask your doctor
or pharmacist.
4. POSSIBLE 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 mild. However, some may
be serious and need medical attention.
If the following side effects occur, stop
taking the capsules immediately and
contact your doctor:
• redness and swelling of the hands, feet,
ankles, face, lips, mouth or throat, (which
may cause difficulty in breathing)
• severe diarrhoea with or without bleeding
• skin rashes or severe allergic reactions
which may cause difficulty in breathing
or dizziness
• severe reduction in the number of white
blood cells which may cause fever, severe

chills, sore throat or mouth ulcers
• hepatitis (inflamed liver) and cholestatic
jaundice (jaundice occurring when bile
cannot flow from the liver properly).
This causes symptoms such as yellowing
of the eyes and skin. This may occur up
to two months after stopping treatment.
Very rarely this is fatal.
• severe skin rash with flushing, fever, blisters
or ulcers (Stevens-Johnson syndrome)
• severe rash with reddening, peeling and
swelling of the skin that resembles burns
(toxic epidermal necrolysis).

Common side effects (may affect up to
1 in 10 people):
• headache
• diarrhoea and feeling sick. These should
be mild and wear off after a few days.
If these are severe or last longer than a
few days you should see your doctor.
• skin rash (exanthema).
Uncommon side effects (may affect up to
1 in 100 people):
• fever
• muscle or joint pain
• increase in some white blood cells
(eosinophilia)

• a nettle like rash, hives.
Rare side effects (may affect up to
1 in 1,000 people):
• reduction in blood platelets which
increase the risk of bleeding or bruising
• inflammation of the kidney which may
affect the way your kidneys work.
If you get any side effects talk to your
doctor or pharmacist. This includes
any possible side effects not listed in
this leaflet.
Also you can help to make sure that
medicines remain as safe as possible by

reporting any unwanted side effects via the
internet at www.mhra.gov.uk/yellowcard.
Alternatively you can call Freephone
0808 100 3352 (available from 10 a.m. to
2 p.m. Mondays to Fridays) or fill in a paper
form available from your local pharmacy.
5. HOW TO STORE FLUCLOXACILLIN
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 bottle or carton
after 'EXP'. The expiry date refers to the last
day of that month.

Store your capsules in a dry place below 25°C.
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 contains
The active substance is flucloxacillin
sodium. Each capsule contains 250 mg or
500 mg flucloxacillin.
The other ingredients are magnesium
stearate, gelatin, titanium dioxide, black

iron oxide, yellow iron oxide, red iron oxide.
The printing ink contains shellac, iron oxide
black (E172), n-butyl alcohol, propylene
glycol, isopropyl alcohol and ammonium
hydroxide.
What Flucloxacillin looks like and
contents of the pack
Your medicine comes as a grey and brown
capsule, hard. The 250 mg capsules are
marked 'G' and 'FN 250'. The 500 mg
capsules are marked 'G' and 'FN 500'.
Flucloxacillin is available in containers, glass
bottles or blisters of 5, 7, 10, 14, 15, 20, 21,

25, 28, 30, 50, 56, 60, 84, 90, 100,
250 and 500 capsules. Not all pack
sizes may be marketed.
Marketing Authorisation Holder
Mylan, Potters Bar, Hertfordshire,
EN6 1TL, United Kingdom.
Manufacturer
Generics [UK] Ltd., Potters Bar,
Hertfordshire, EN6 1TL,
United Kingdom.
This leaflet was last revised in
06/2013.

PACKAGE LEAFLET: INFORMATION FOR THE USER

FLUCLOXACILLIN CAPSULES BP 250 mg
FLUCLOXACILLIN CAPSULES BP 500 mg
(flucloxacillin)

Job No.

37006565v4

15-DEC-2012

flucloxa250 Flucloxacillin
mg capsules BP
cillin
capsules
BP #250 mg
28 capsules

Each capsule contains: Flucloxacillin sodium Ph Eur equivalent
to 250 mg Flucloxacillin.
Also contains: sodium.
Dosage: For oral use as directed by a doctor.
Read the attached leaflet.
Keep out of the sight and reach of children.
Store in a dry place below 25°C.
PL 04569/0039 POM 10004565
Mylan, Potters Bar, Herts, EN6 1TL, U.K.

27-JUN-2013

FLUCLOXACILLIN
UK 2012

Black

PMS 306

PMS 203

PMS Reflex Blue

Lot/Expiry Area Braille

Dimensions Cutter

10004565

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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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