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FLOXAPEN 125 MG/5 ML ORAL SUSPENSION

Active substance(s): FLUCLOXACILLIN

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Floxapen® 125 mg/5 ml
Oral Suspension

2546
28.11.17[8]

(flucloxacillin magnesium)
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.
The name of your medicine is Floxapen 125 mg/5 ml Oral Suspension but
will be referred to as Floxapen Oral Suspension throughout this leaflet.
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 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 or pharmacist. This includes
any possible side effects not listed on this leaflet. You can also report side
effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the
Google Play or Apple App Store. 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.
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 pharmacist.
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.
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
- Each 5 ml contains 125 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.
Actavis B.V., Baarnse DIJK 1, 3741 LN Baarn, The Netherlands.
Actavis Group PTC ehf, Reykjavikurvegur 76-78, 220 Hafnarfjordur, Iceland.
Procured from within the EU by the Product Licence holder
Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex HA1 1XD.
Repackaged by Servipharm Ltd.
POM

PL 20636/2546

Leaflet revision and issue date (Ref.) 28.11.17[8]
Floxapen is a trademark of Actavis Group PTC ehf.

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