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FLUCLOXACILLIN 125 MG/5 ML ORAL SOLUTION

Active substance(s): FLUCLOXACILLIN SODIUM

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Flucloxacillin 125 mg/5 ml Oral
Solution

2589
29.05.14[4]

(flucloxacillin sodium)
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, please ask your doctor or pharmacist
(chemist).
- 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 your medicine is and what it is used for
2. What you need to know before you take your medicine
3. How to take your medicine
4. Possible side effects
5. How to store your medicine
6. Contents of the pack and other information
1. WHAT YOUR MEDICINE 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 is used to treat:
- chest infections
- ear infections
- heart infections
- meningitis
- blood infections
- kidney, bladder or urethra (the tube which carries urine from the bladder)
infections.
- throat or nose infections
- skin and soft tissue infections
- bone and joint infections
- digestive system infections
Flucloxacillin can also be used to prevent infections during major surgery,
particularly heart or orthopaedic surgery.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE YOUR MEDICINE
Do not take this medicine if:
- You are allergic to flucloxacillin or any other penicillin antibiotics (see
symptoms in section 4).
- You are allergic to any of the other ingredients of this medicine (listed in
section 6).
- You have suffered previously from liver problems (e.g. jaundice) after
taking flucloxacillin.
Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine if:
- You suffer from kidney problems, as you may require a lower dose than
normal
- You suffer from liver problems, as this medicine could cause them to
worsen
- You are 50 years of age or older
- You have other serious illnesses (apart from the infection this medicine is
treating)
- You are taking this medicine for a long time as regular tests of liver and
kidney function is advised
Other medicines and Flucloxacillin 125mg/5ml Oral Solution BP
Check with your doctor or pharmacist before taking this medicine if you are
taking any other medicines, especially:
- Probenecid or sulfinpyrazone (used to treat gout)
- Methotrexate (a chemotherapy drug)
- The contraceptive pill as antibiotics can make these less effective (you
will need to use extra precautions such as condoms while taking
flucloxacillin and for a full 7 days after you finish taking it)
- Oral typhoid vaccine (antibiotics can make this less effective)
- Sugammadex (used with general anaesthetics)
- Piperacillin (an antibiotic taken by injection)
- Warfarin (medicine used to prevent blood clotting)
Some medicines may affect the way others work. Tell your doctor or
pharmacist if you are taking, have recently taken or might take any other
medicines. This means medicines you have bought yourself as well as
medicines on prescription from a doctor.

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 flucloxacillin for a long period of time. Tell your doctor that you are
taking Flucloxacillin if you are having urine tests or blood tests because it
may affect the results.
Your medicine contains sucrose and sodium
This medicine contains up to 3.09g of sucrose (sugar) per 5ml dose. Check
with your doctor before taking this medicine if you are a diabetic. Do not
use this medicine if you have been told by your doctor that you have an
intolerance to some sugars.
This medicine contains 18.05mg sodium per 5ml dose. To be taken into
consideration by patients on a sodium controlled diet.
3. HOW TO TAKE YOUR MEDICINE
Always take this medicine exactly as your doctor or pharmacist has told
you. Their directions may differ from the information contained in this
leaflet. The pharmacist’s label should tell you how much to take and how
often. Check with your doctor or pharmacist if you are not sure.
Take your medicine on an empty stomach, at least thirty minutes to one
hour before meals/food. It is important that you take your medicine at the
right times.
The dose will depend on the patient and will be decided by your doctor.
However, the usual doses for each age group are:
Adults (including the elderly)
- The usual dose is 250mg four times a day
- Bone or heart infection: Up to 8g daily, in divided doses at six to eight
hours apart.
- Surgical prophylaxis: 1 to 2g IV at induction of anaesthesia followed by
500mg every six hours for up to 72 hours.
Use in children
Children (10-18 years of age): 250mg four times daily
Children (2-10 years of age): 125mg four times daily
Children under 2 years of age: 62.5mg four times daily
Patients with kidney problems
If you suffer from severe kidney failure your doctor will give you lower or
fewer doses.
How long to take your medicine for:
Keep taking your medicine until your doctor tells you to stop. Do not stop
taking it just because you feel better. If you stop taking the medicine, your
infection may return or get worse. If you are still unwell after taking all the
medicine, go and see your doctor.
If you take more of your medicine than you should
If you (or somebody else) take too much of your medicine, speak to your
doctor or pharmacist immediately.
If you forget to take your medicine
If you forget to take a dose, take it as soon as you remember, then carry on
as before. Do not take a double dose to make up for the dose you have
missed.
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. If they occur, they are likely to be temporary, and not
serious. However, some may be serious and need medical attention.
STOP taking Flucloxacillin and contact your doctor if you experience:
- allergy or hypersensitivity including itchy rash, itching, sore mouth or
eyes, swelling of the face, lips, throat or tongue or breathing problems
- severe, bloody diarrhoea
- jaundice (yellow colour in the skin and whites of the eyes), hepatitis (liver
inflammation) – sometimes these effects on the liver can be delayed for
up to 2 months after finishing the treatment
- severe skin rash with flushing, fever, blisters or ulcers (Stevens Johnson
syndrome) or a severe rash with reddening, peeling and swelling of the
skin that looks like a burn (toxic epidermal necrolysis).

Tell your doctor if you notice any of the following effects:
Common (may affect up to 1 in 10 people):
- Diarrhoea, stomach upset and feeling sick - should be mild and wear off
after a few days. If severe or lasting longer, tell your doctor.
Very rare (may affect up to 1 in 10,000 people):
- difficulty passing water or blood in the urine (may be a sign of
inflammation of the kidney)
- unusual bleeding or bruising, anaemia (may be caused by changes in the
numbers of blood cells)
- skin rash with circular red patches (Erythema Multiforme).
- joint or muscle pains or fever (may develop 2 days after starting
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 YOUR MEDICINE
Keep this medicine in a safe place where children cannot see or reach
it.
Dry powder: Do not store above 25ºC.
Store in the original container in order to protect from light and moisture.
Do not open the foil pouch until ready to reconstitute the product.
Once opened the foil pouch may be discarded.
Store the solution at 2°C to 8°C in a refrigerator, and use within 7 days.
Do not freeze.
Store in the original container.
Do not use this medicine after the expiry date shown on the label.
Return any left-over medicine to the pharmacist.
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 Flucloxacillin 125mg/5ml Oral Solution contains
Active ingredient: flucloxacillin as flucloxacillin sodium
Other ingredients: sodium benzoate (E211), disodium edetate, saccharin
sodium, ammonium glycyrhizate, sodium citrate anhydrous, pineapple
flavour, menthol flavour, erythrosine (E127) and sucrose.
Please see further information on sucrose in section 2.
What Flucloxacillin 125mg/5ml Oral Solution looks like
Unconstituted powder: a pink granular powder with a characteristic odour of
pineapple.
Reconstituted solution: a pink coloured solution with a characteristic odour
of pineapple.
Flucloxacillin 125mg/5ml Oral Solution is available in size 100ml on
reconstitution.
5ml measuring spoon included in package.
Manufacturer and Product Licence Holder
Manufactured by Athlone Laboratories Limited, Ballymurray, Co.
Roscommon, Ireland. 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

20636/2589

Leaflet revision and issue date (Ref.) 29.05.14[4]

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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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