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FLOXAPEN ORAL SUSPENSION 250MG/5ML

Active substance(s): FLUCLOXACILLIN MAGNESIUM

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Floxapen 250mg in 5ml Oral Suspension
(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.
2.
3.
4.
5.
6.

What Floxapen Oral Suspension is and what it is used for
Before you take
How to take
Possible side effects
How to store
Further information

1.

What Floxapen Oral Suspension is and what it is used for

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.
2.

Before you take
Do not take Floxapen Oral Suspension and tell your doctor if you or your child:
 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)
 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.
Tests

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 Suspension





Each 5ml 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.

3. How to take
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.
Doses:
 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: 2.5ml four times a day, your pharmacist will explain
how to give this to your child.
 Children under 2 years: 1.25ml 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.
4.

Possible side effects

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:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety
of this medicine.
5.

How to store

Keep out of the reach and sight of children.
If any medicine is left after two weeks (14 days), return it to your pharmacist.
Keep the medicine in its original bottle and store it in the fridge (5°C). Do not
freeze the medicine.
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.
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 Oral Suspension contains

 The active substance (the ingredient that makes the oral suspension work) is
flucloxacillin. 5ml contains 250mg of the active ingredient.
 The other ingredients are saccharin sodium, sucrose, xanthan gum (E415),
citric acid, sodium citrate, sodium benzoate (E211), orange, tutti frutti and
menthol flavours.

What Floxapen Oral Suspension looks like and contents of the pack

Floxapen Oral Suspension comes in a bottle containing 100ml of a white to offwhite liquid mixture, called a suspension.
Marketing Authorisation Holder
Actavis Group PTC ehf, Reykjavíkurvegi 76-78,
220 Hafnarfjordur, Iceland
Manufacturer
Actavis Group PTC ehf, Reykjavíkurvegur 76-78,
220 Hafnarfjordur, Iceland
Actavis B.V.
Baarnse Dijk 1, 3741 LN Baarn,The Netherlands
This leaflet was last revised in February 2016
Floxapen® is a registered trademark of the Actavis Group PTC ehf of Companies

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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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