Skip to Content

FLOXAPEN 125MG/5ML ORAL SUSPENSION

Active substance(s): FLUCLOXACILLIN / FLUCLOXACILLIN MAGNESIUM

PDF options:  View Fullscreen   Download PDF

PDF Transcript

Floxapen® 125mg/5ml Oral Suspension/Flucloxacillin 125mg/5ml Oral Suspension
(flucloxacillin magnesium)
Your medicine is known by the above names, but will be referred to as
Floxapen Oral Suspension throughout this:
Patient Information Leaflet
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 is in this leaflet
1) What Floxapen Oral Suspension is and what it is used for
2) What you need to know before you take Floxapen Oral Suspension
3) How to take Floxapen Oral Suspension
4) Possible side effects
5) How to store Floxapen Oral Suspension
6) Contents of the pack and other information

1) What Floxapen Oral Suspension is and what it is used for
Floxapen 125mg 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
benzoate
• 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.

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: 10ml 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 5ml spoonful four times a day.
• Children under 2 years: 2.5 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.
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 (may affect up to 1 in 10 people): minor stomach disturbances
e.g. stomach upset or diarrhoea.
• Very rare (may affect up to 1 in 10,000 people): 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 out of the sight and reach of children.
• If any medicine is left after two weeks (14 days), return it to your
pharmacist.
• Store in a refrigerator (between 2°C - 8°C).
• 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) Contents of the pack and information
What Floxapen Oral Suspension contains:
The active substance (the ingredient that makes the Oral Suspension
work) is flucloxacillin. Each 5 ml contains 125 mg of flucloxacillin as
flucloxacillin magnesium.
The other ingredients are saccharin sodium, sucrose, xanthan gum (E415),
anhydrous citric acid, sodium citrate, sodium benzoate (E211), blood
orange dry flavour, tutti frutti and menthol dry flavour.
What Floxapen Oral Suspension looks like and contents of the pack
Floxapen Oral Suspension comes in a bottle containing 100 ml of a white
to off-white liquid mixture, called a suspension
PL 10383/2028

Floxapen 125mg/5ml Oral Suspension/
Flucloxacillin 125mg/5ml Oral Suspension POM

Who makes and repackages your medicine?
Your medicine is manufactured by Mitim S.r.l Via Cacciamali, 34-38
Brescia Italy. Procured from within the EU and repackaged by Product
Licence Holder: Primecrown Ltd., 4/5 Northolt Trading Estate, Belvue
Road, Northolt, Middlesex, UB5 5QS.
Leaflet date: 25.08.2017
Floxapen is a registered trademark of Actavis UK Limited, United Kingdom.

Blind or partially sighted?
Is this leaflet hard to see or read?
Call 020 8839 3000 to obtain the
leaflet in a format suitable for you.

+ Expand Transcript

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Hide