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FLOXAPEN CAPSULES 500MG

Active substance: FLUCLOXACILLIN

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Floxapen® 250mg and 500mg capsules
(flucloxacillin)
Read all of this leaflet carefully before you
start taking this medicine.
• 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 symptoms are
the same as yours.

Index
1 What Floxapen capsules are and what
they are used for
2 Before you take
3 How to take
4 Possible side effects
5 How to store
6 Further information
1 What Floxapen capsules are and what


they are 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”.
Floxapen capsules are used to treat:
• chest infections
• throat or nose infections
• ear infections
• skin and soft tissue infections
• heart infections
• bones and joints infections
• meningitis
• digestive system infections
• blood infections
• kidney, bladder or urethra (the tube which carries
urine from the bladder) infections.
Floxapen capsules can also be used to prevent
infections during major surgery, particularly heart or
orthopaedic surgery.

2 Before you take

Do not take Floxapen capsules and tell your
doctor if you:
• are allergic (hypersensitive) to flucloxacillin,
penicillin, any other antibiotic or any of the other
ingredients (see section 6)
• have ever had liver problems after taking
flucloxacillin.

Check with your doctor or pharmacist before
taking Floxapen capsules if you:
• have liver or kidney problems
• have any serious illness, other than this infection
• are on a low sodium diet
• are 50 years old or over.

Taking other medicines

Please tell your doctor or pharmacist if you are
taking or have recently taken any other medicines,
including medicines obtained without a prescription.
Especially:
• probenecid (to treat gout)
• contraceptive pill (you will need to use extra
contraceptive precautions such as a condom)

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.

Tests

Regular monitoring of liver and kidney function
should be performed whilst taking Floxapen capsules.
Tell your doctor that you are taking Floxapen if
you are having urine tests or blood tests because
Floxapen may affect the results.

Sodium content

Each 250mg capsule contains 13mg of sodium and
each 500mg capsule contain 25mg of sodium.

3 How to take

Always take Floxapen capsules exactly as your doctor
has told you. If you are not sure, check with your
doctor or pharmacist.
Swallow the capsules whole with water, do not chew
them, half to one hour before meals. Never take
more than the recommended dose each day.
Continued over page

AAAE5292

Doses:
• Adults - one 250mg capsule four times a day, your
doctor may prescribe a different dose for severe
infections.
• Joint infections (osteomyelitis) or heart infections
(endocarditis) - up to 8g daily in divided doses, six to
eight hourly.
• To prevent infection due to surgery - 1 to 2g by
injection into a vein, at the same time as the
anaesthetic, followed by 500mg six hourly either by
mouth or injection into a vein or muscle for up to 72
hours.
• Children aged 2-10 years - half the adult dose.
• Children under 2 years - quarter the adult dose.
• Severe kidney disease - your doctor may reduce
your dose.
If you still feel unwell after finishing the treatment,
speak to your doctor.

If you take more than you should

If you (or someone else) swallow a lot of capsules
at the same time, or you think a child may have
swallowed any contact your nearest hospital
casualty department or tell your doctor immediately.
Symptoms of an overdose include feeling or being
sick and diarrhoea.

If you forget to take the capsules

Do not take a double dose to make up for a forgotten
dose. If you forget to take a dose take it as soon as you
remember it and carry on as before, try to wait about
four hours before taking the next dose.

If you stop taking the capsules

Do not stop treatment early because some bacteria
may survive and cause the infection to come back.

4 Possible side effects

Like all medicines, Floxapen capsules can cause side
effects, although not everybody gets them. Please
tell your doctor or pharmacist if you notice any of the
following effects or any effects not listed.
Stop taking Floxapen capsules and contact your
doctor at once if you experience any of the following:
• hypersensitivity or severe allergic reaction including
itchy rash, itching, sore mouth or eyes, swelling
of the face, lips, throat or tongue or breathing
problems.
• severe bloody diarrhoea (pseudomembranous
colitis).
Tell your doctor if you notice any of the following
side effects or notice any other effects not listed:
Common (occurs in less than 1 in 10 users): minor
stomach disturbances e.g. stomach upset or
diarrhoea.
Continued top of next column

Very rare (occurs in less than 1 in 10,000 users):
inflammation of the kidney or liver, jaundice (skin
or the white of your eyes turning yellow), changes
in numbers of blood cells (causing unexplained
bleeding, bruising or skin discolouration), anaemia,
skin rash with circular, red patches (Erythema
multiforme), severe skin rash with flushing, fever,
blisters or ulcers (Stevens-Johnson syndrome) or a
severe rash with reddening, peeling and swelling
of the skin that resembles burns (toxic epidermal
necrolysis). Joint or muscle pain or fever, may develop
after 2 days or more from the start of treatment with
Floxapen capsules.
Some of these reactions can be delayed for up to
two months after finishing the treatment.

5 How to store

Keep out of the reach and sight of children.
Store in a dry place in the original package.
Do not use Floxapen capsules after the expiry date
stated on the label/carton/bottle. The expiry date
refers to the last day of that month.
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 to protect the environment.

6 Further information
What Floxapen capsules contain

• The active substance (the ingredient that makes
the capsules work) is flucloxacillin. Each capsule
contains either 250mg or 500mg of the active
ingredient.
• The capsule also contains: magnesium stearate.
• The capsule shell contains: gelatin, titanium dioxide
(E171), black iron oxide (E172), yellow iron oxide
(E172), red iron oxide (E172).
• The printing ink contains: shellac (E904), propylene
glycol (E1520), sodium hydroxide (E524), povidone,
titanium dioxide (E171).

What Floxapen capsules look like and
contents of the pack

Floxapen are caramel hard gelatin capsules (body)
fitted with black caps.
is printed on the black
cap. The 250mg capsule has ‘250’ on the body and the
500mg capsule has ‘500’ on the body.
Pack sizes of 28
Marketing Authorisation Holder
Actavis Group PTC ehf, Reykjavíkurvegi 76-78,
220 Hafnarfjordur, Iceland
Manufacturer
Actavis B.V., Baarnse Dijk 1, 3741 LN BAARN, The Netherlands
Actavis Group PTC ehf, Reykjavíkurvegur 76-78,
220 Hafnarfjordur, Iceland
This leaflet was last revised in November 2012
Floxapen is a registered trademark of the
Actavis Group PTC ehf of Companies

AAAE5292

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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