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Active substance: FLUCLOXACILLIN

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Floxapen® 250 mg/5 ml Oral


(flucloxacillin magnesium)
The name of the product is Floxapen 250 mg/5 ml Oral Suspension but will
be referred to as Floxapen Oral Suspension throughout this leaflet.
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.
In this leaflet:
1. What Floxapen Oral Suspension is and what it is used for
2. Before you take
3. How to take
4. Possible side effects
5. How to store
6. Further information
Floxapen 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 Oral Suspension is used to treat:
- chest infections
- throat or nose infections
- ear infections
- skin and soft tissue infections
- heart infections
- bones and joints infection
- meningitis
- digestive system infections
- blood infections
- kidney, bladder or the urethra (the tube which carries urine from the
bladder) infections.
Floxapen Oral Suspension can also be used to prevent infections during
major surgery, particularly heart or orthopaedic surgery.
Do not take Floxapen Oral Suspension and tell your doctor if you or your
- 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 Oral
Suspension if you or your child:
- has liver or kidney problems
- have any serious illness, other than this infection
- are 50 years old or over
- are giving this medicine to a newborn child.
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)
- other antibiotics (used to treat infections)
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.
Regular monitoring of liver and kidney function should be performed whilst
taking Floxapen Oral Suspension.
Tell your doctor that you are taking Floxapen Oral Suspension if you are
having liver function tests as Floxapen may affect the results.
Important information about some of the ingredients in the Oral
- Each 5ml spoonful of Oral Suspension contains 10mg of sodium, this is
particularly important if you are on a reduced salt diet.
- If you, or your child have been told by your doctor that you have an
intolerance to some sugars, contact them before taking this medicine, as
it contains sucrose.

- This medicine also contains sodium benzoate which is a mild irritant to
the skin, eyes and mucous membrane. It may increase the risk of
jaundice in newborn babies.
Always take Floxapen Oral Suspension exactly as your doctor has told you.
If you are not sure, check with your doctor or pharmacist.
Swallow the Oral Suspension half to one hour before meals. Never take
more than the recommended dose each day.
- Adults and children over 10 years: 5ml four times a day.
- 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 2 to 10 years: one 2.5ml spoonful four times a day, your
pharmacist will explain how to give this to your child.
- Children under 2 years: 1.25 ml four times a day, your pharmacist will
explain how to give this to your child.
- Premature or babies less than 4 weeks old – Not recommended.
- Severe kidney disease: your doctor may reduce the dose, maximum
dose in adults is 1g every 8-12 hours.
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 Oral Suspension at the same time,
or you think another 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 Oral Suspension
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 Oral Suspension
Do not stop treatment early because some bacteria may survive and cause
the infection to come back.
Like all medicines, Floxapen Oral Suspension 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 Oral Suspension 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).
- blisters or ulcers (Stevens-Johnson syndrome) or a severe rash with
reddening, peeling and swelling of the skin that resembles burns (toxic
epidermal necrolysis).
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.
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. Joint or
muscle pain or fever, may develop after 2 days or more from the start of
treatment with Floxapen Oral Suspension.
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: By reporting side effects, you can help
provide more information on the safety of this medicine.

Keep out of the sight and reach of children.
Store the medicine in its original container.
Store in a refrigerator (2-8oC).
Do not freeze.
If any medicine is left after two weeks (14 days), return it to your
Do not use Floxapen Oral Suspension after the expiry date stated on the
label/carton/ bottle. The expiry date refers to the last day of that month.
If the suspension become discoloured or show any other signs of
deterioration, consult your pharmacist who will tell you what to do
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.
What Floxapen Oral Suspension contains
- The active substance (the ingredient that makes the Oral Suspension
work) is flucloxacillin.
- Each 5 ml contains 250 mg of flucloxacillin as flucloxacillin magnesium.
- The other ingredients are sucrose, xanthan gum E415, citric acid,
saccharin sodium, sodium citrate, sodium benzoate E211, orange
flavour, tutti frutti flavour and menthol flavour.
What Floxapen Oral Suspension looks like and contents of the pack
Floxapen Oral Suspension comes in a bottle containing 100ml of a white to
off-white liquid mixture, called a suspension. A dosing cup is included.
Manufacturer and Product Licence Holder
Manufactured by Mitim S.R.L., Via Cacciamali, 34-38, 25125 Brescia, Italy.
Procured from within the EU by the Product Licence holder
Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex HA1 1XD.
Repackaged by Servipharm Ltd.


Leaflet revision and issue date (Ref.) 06.10.14[3]
Floxapen is a trademark of Actavis Group PTC ehf.

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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.