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FLUCLOXIN 125MG/5ML ORAL SOLUTION

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

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Package leaflet: Information for the patient

FLUCLOXACILLIN 125MG/5ML ORAL SOLUTION
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 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 C
 ontents 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 • throat or nose infections
• ear infections
• skin and soft tissue infections
• heart infections • bone and joint infections
• meningitis
• digestive system infections
• blood infections
• kidney, bladder or urethra (the tube which carries urine
from the bladder) 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.
• You have had an allergic reaction to β‑lactam antibiotics
(e.g. penicillins, cephalosporins).

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 (convulsions may occur very
rarely in patients with kidney problems who take high
doses)
• 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 are advised

Other medicines and Flucloxacillin Oral
Solution

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)
• Oral typhoid vaccine (antibiotics can make this less
effective)
• Sugammadex (used with general anaesthetics)
• Piperacillin (an antibiotic taken by injection)
• Warfarin (medicine 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. This should be taken into account in
patients with diabetes mellitus. If you have been told
by your doctor that you have an intolerance to some
sugars, contact your doctor before taking this medicinal
product.
This medicine contains 18.05mg sodium per 5ml dose.
To be taken into consideration by patients on a
controlled sodium 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.

Continued over page

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S.Anson
10.01.17
13.01.17
S.Anson

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Date received:

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Supplier:
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Use in children and adolescents

Children (10-18 years of age): 2
 50mg four times
daily
Children (2-10 years of age): 1
 25mg four times
daily
Children under 2 years of age: 6
 2.5mg four times daily

Patients with kidney problems

If you suffer from severe kidney failure your doctor will
give you lower or fewer doses.

If you take more of your medicine than you
should
If you (or somebody else) takes 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 a forgotten dose.

If you stop taking your medicine

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 have any further questions on the use of this
medicine, ask your doctor or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor or
pharmacist. 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 out of the sight and reach of children.
Do not use this medicine after the expiry date which is
stated on the label. The expiry date refers to the last day
of that month.
Dry powder: Store below 25°C. 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 may be discarded.
Reconstituted mixture: Store for 7 days at 2°C-8°C in a
refrigerator.
Once reconstituted (mixed) by the pharmacist, this
medicine must be used within 7 days.
Return any left-over medicine to the pharmacist. Do not
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 Flucloxacillin Oral Solution contains

4 Possible side effects

Like all medicines, this medicine may 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 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).
• increase in the number of white blood cells in the blood
(eosinophilia).

The active substance is flucloxacillin as flucloxacillin
sodium.
The other ingredients are sodium benzoate (E211),
disodium edetate, saccharin sodium, monoammoniumglycyrrhizinate, sodium citrate, flavour pineapple, flavour
menthol, RED FD&C No. 3 (E127) and sucrose.
Please refer to information on sucrose in section 2.

What Flucloxacillin Oral Solution looks like
and contents of the pack

Unconstituted powder: a pink granular powder with a
characteristic odour of pineapple.
Reconstituted solution: a pink coloured solution with a
characteristic flavour and odour of pineapple.
Flucloxacillin Solution is available in a size of 100ml on
reconstitution.
Marketing Authorisation Holder
Athlone Pharmaceuticals Limited
Ballymurray
Co. Roscommon
Ireland
Manufacturer
Athlone Laboratories Limited, Ballymurray,
Co. Roscommon, Ireland.
Distributed by:
Actavis, Barnstaple, EX32 8NS, UK
PL30464/0167
This leaflet was last revised in January 2017.

Other side effects (frequency not known):
• 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.
Check with your doctor if you have any problems while
taking this medicine, even if you think the problems are
not connected with the medicine, or are not listed in this
leaflet.

Continued top of next column
BBBA0407

Actavis, Barnstaple, EX32 8NS, UK

Flucloxacillin 125mg/5ml 100ml Oral Solution PIL - UK
approved for print/date

Proof Round

3

UK-Eire-Artwork-Support@Actavis.com

Item no:

BBBA0407

Originator:
Origination Date:
Revision Date:
Revised By:

Technical
Approval

S.Anson
10.01.17
13.01.17
S.Anson

Date sent:
10.01.17
Date received:

Dimensions:
148 x 280
Min Body Text Size: 7pts
Supplier:
Athlone Labs

Colours

Non Printing Colours

1. Black

1.

2.

2.

3.

3.

4.
5.
6.

* Please note that only Artwork Studio is permitted to make changes to the above artwork.
No changes are permitted by any 3rd party other than added notes and mark ups for required changes.

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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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