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FLUCLOXACILLIN ORAL SUSPENSION 250MG/5ML

Active substance(s): FLUCLOXACILLIN MAGNESIUM / FLUCLOXACILLIN MAGNESIUM / FLUCLOXACILLIN MAGNESIUM

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Package leaflet: Information for the patient

Floxapen 250mg in 5ml Oral Suspension
(flucloxacillin)
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 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. See section 4.
What
1.
2.
3.
4.
5.
6.

1.

is in this leaflet
What Floxapen Oral Suspension is and what it is used for
What you need to know before you take Floxapen Oral Suspension
How to take Floxapen Oral Suspension
Possible side effects
How to store Floxapen Oral Suspension
Contents of the pack and other information

What Floxapen Oral Suspension is and what it is used for

Floxapen 250mg in 5ml Oral Suspension contains the active substance
flucloxacillin. 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.

What you need to know before you take Floxapen Oral Suspension

Do not take Floxapen Oral Suspension and tell your doctor if you or your child:





are allergic to flucloxacillin, penicillin, any other antibiotic or any of the
other ingredients of this medicine (listed in section 6)
have ever had liver problems after taking flucloxacillin.

Warnings and precautions
Talk to 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.

Other medicines and Floxapen Oral Suspension

Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines. Especially:
 probenecid (to treat gout)
 other antibiotics (used to treat infections)
Pregnancy and breast-feeding

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
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.




Floxapen Oral Suspension contains sodium, sucrose and sodium benzoateEach
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 Floxapen Oral Suspension
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 Oral Suspension half to one hour before meals. Never take more
than the recommended dose each day.

The recommended dose is
 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.
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. 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.
 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.
5.

How to store Floxapen Oral Suspension

Keep this medicine out of the sight and reach 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 this medicine after the expiry date stated on the
label/carton/bottle. The expiry date refers to the last day of that month.
Do nto 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 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
Accord Healthcare Limited
Sage House
319 Pinner Road
North Harrow
Middlesex
HA1 4HF
United Kingdom
Manufacturer
Actavis Group PTC ehf, Reykjavíkurvegur 76-78,
220 Hafnarfjordur, Iceland
Balkanpharma – Dupnitsa AD
3 Samokovsko Shosse Str.
Dupnitsa 2600,
Bulgaria
This leaflet was last revised in June 2017
Floxapen® is a registered trademark of Accord Healthcare Limited
Accord Healthcare Ltd, North Harrow, HA1 4HF, UK

Expand Transcript

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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