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FLUCLOXACILLIN 125MG/5ML ORAL SUSPENSION

Active substance(s): FLUCLOXACILLIN / FLUCLOXACILLIN MAGNESIUM

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Floxapen

®

MOCK UP
125mg/5ml Oral suspension

(flucloxacillin)
Patient Information 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.
Your medicine is called Floxapen 125mg/5ml Oral Suspension but will be
called Floxapen Oral suspension throughout this leaflet.
Index
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

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.

Assessed against
the UK PIL dated
Feb 2016

Ref: LTT099/290616/1/F

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.

By Caroline McDermott at

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 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

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: 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.

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)

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

Ref: LTT0099/290616/1/B

®

Floxapen 125mg/5ml Oral Suspension
(flucloxacillin)
Patient Information Leaflet (continued)
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.

6

Further information

What Floxapen Oral Suspension contains
* The active substance (the ingredient that makes the Oral Suspension
work) is flucloxacillin. Each 5ml contains 125mg flucloxacillin as
flucloxacillin magnesium.
* The other ingredients are saccharin sodium, sucrose, xanthan gum
(E415), sodium citrate, citric acid anhydrous, sodium benzoate (E211),
blood orange, tutti frutti flavour and menthol flavours.

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).

What Floxapen Oral Suspension looks like and contents of the pack
100ml glass bottle containing white powder for the preperation of a white to
off white oral suspension. Reconstituted volume of 100ml.

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.

If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

Manufacturer and Licence Holder
This medicine is manufactured by MITIM s.r.l. Via Cacciamali, 34-36-38,
25125 Brescia, Italy and procured from within the EU. Product Licence
Holder: LTT Pharma Limited, Unit 18, Oxleasow Road East Moons Moat,
Redditch, Worcestershire B98 0RE. Repackaged by Lexon (UK) Limited,
B98 0RE.

POM

PL 33723/0099

Floxapen is a registered trademark of Actavis Group PTC ehf
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

If any medicine is left after two weeks (14 days), return it to your pharmacist.
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Store in a refrigerator.
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.
If your medicine becomes discoloured or shows any other signs of
deterioration consult your pharmacist who will tell you what to do.

Revision date: 29/06/16

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

Ref: LTT099/290616/2/F

Flucloxacillin 125mg/5ml Oral suspension
Patient Information 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.
Your medicine is called Flucloxacillin 125mg/5ml Oral Suspension but will be
called Flucloxacillin Oral suspension throughout this leaflet.
Index
1

What Flucloxacillin 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

1

What Flucloxacillin Oral Suspension is and what it is
used for

Flucloxacillin is an antibiotic used to treat infections by killing the bacteria
that can cause them. It belongs to a group of antibiotics called “penicillins”.
Flucloxacillin Oral Suspension is used to treat:
* chest infections
* throat or nose infections
* ear infections
* skin and soft tissue infections
* heart infections
* bones and joint infection
* meningitis
* digestive system infections
* blood infections
* kidney, bladder or the urethra (the tube which carries urine from the
bladder) infections.
Flucloxacillin Oral Suspension can also be used to prevent infections during
major surgery, particularly heart or orthopaedic surgery.

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 Flucloxacillin Oral Suspension.
Tell your doctor that you are taking Flucloxacillin Oral Suspension if you are
having liver function tests as Flucloxacillin may affect the results.
Important information about some of the ingredients in the Oral
Suspension
* 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

Always take Flucloxacillin 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: 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.

2

Before you take

Do not take Flucloxacillin 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 Flucloxacillin 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)

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

Ref: LTT0099/290616/2/B

Flucloxacillin 125mg/5ml Oral Suspension
Patient Information Leaflet (continued)
4

Possible side effects

Like all medicines, Flucloxacillin 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 Flucloxacillin 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 Flucloxacillin 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

If any medicine is left after two weeks (14 days), return it to your pharmacist.
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Store in a refrigerator.
Do not use Flucloxacillin 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.
If your medicine becomes discoloured or shows any other signs of
deterioration consult your pharmacist who will tell you what to do.

6

Further information

What Flucloxacillin Oral Suspension contains
* The active substance (the ingredient that makes the Oral Suspension
work) is flucloxacillin. Each 5ml contains 125mg flucloxacillin as
flucloxacillin magnesium.
* The other ingredients are saccharin sodium, sucrose, xanthan gum
(E415), sodium citrate, citric acid anhydrous, sodium benzoate (E211),
blood orange, tutti frutti flavour and menthol flavours.
What Flucloxacillin Oral Suspension looks like and contents of the
pack
100ml glass bottle containing white powder for the preperation of a white to
off white oral suspension. Reconstituted volume of 100ml.
Manufacturer and Licence Holder
This medicine is manufactured by MITIM s.r.l. Via Cacciamali, 34-36-38,
25125 Brescia, Italy and procured from within the EU. Product Licence
Holder: LTT Pharma Limited, Unit 18, Oxleasow Road, East Moons Moat,
Redditch, Worcestershire B98 0RE. Repackaged by Lexon (UK) Limited,
B98 0RE.
If you have any questions or are not sure about anything, ask your doctor
or pharmacist. They will have additional information about this medicine and
will be able to advise you.

POM

PL 33723/0099

Revision date: 29/06/16

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

Expand view ⇕

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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