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FLUCLOXACILLIN 250MG/5ML SUGAR-FREE POWDER FOR ORAL SOLUTION

Active substance(s): FLUCLOXACILLIN SODIUM

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Package leaflet: Information for the patient

Flucloxacillin 125mg/5ml Sugar Free Powder for Oral Solution
Flucloxacillin 250mg/5ml Sugar Free Powder for 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 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 • 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),
• Are allergic to any of the other ingredients of this
medicine (listed in section 6),
• Have had liver problems after taking this medicine
(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,
• Suffer from liver problems,
• Are 50 years of age or older,
• Have other serious illnesses (apart from the
infection this medicine is treating).

Other medicines and Flucloxacillin Sugar
Free Powder for 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),
• Other antibiotics (used to treat infections),
• 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 sorbitol and
sodium.

This medicinal product contains sorbitol. If you
have been told by your doctor that you have an
intolerance to some sugars, contact your doctor
before taking this medicinal product.
The 125mg/5ml solution contains 17.08mg sodium
per 5ml dose, and the 250mg/5ml solution contains
49.41mg 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.

How much of your medicine to take and
when to take it

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): 250mg four times
a day
Children (2-10 years of age): 125mg four times
a day
Children under 2 years of age: 62.5mg four times
a day
Flucloxacillin Sugar Free Oral Solution is not
recommended for premature or babies less than 4
weeks old.
Severe kidney disease - your doctor may reduce
your dose, the maximum dose in adults is 1g every 8
to 12 hours.

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Flucloxacillin 125mg/5ml and 250mg/5ml Powder for Oral Suspension (100ml) PIL - UK

colours/plates:
1. Black

item no: AAAI2566

dimensions:

print proof no: 5

pharmacode:

origination date: 07.09.15

min pt size: 7pt

2.
3.
4.
5.
6.

originated by: DR
approved for print/date

148x280

revision date: 16.11.15

Technical Approval

revised by: DR

date sent: 07.09.15

supplier: Athlone Laboratories

technically app. date: 05.11.15

Non Printing Colours
1.
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Instructions for reconstitution of
the powder

1. Remove the cap and add the correct
volume of potable water (87ml if
you have been given the 125mg/5ml
strength of product and
79ml if you have been given the
250mg/5ml strength of product)
2. Replace the cap and shake well.
3. Remove the cap once more and place
the adaptor (Fig 1) into the bottle
opening. The adaptor should not be
removed at any stage.
4. Replace the cap, do not shake any
further.

Fig 1

Tell your doctor if you notice any of the
following effects

Instructions for use of the syringe
1. Remove the cap and if necessary push
the adaptor into the neck of the bottle
(Fig 1).
2. Push the plunger of the syringe to
remove all the air.
3. Insert the syringe into the adaptor
until it is firmly in place (Fig 2).
4. Whilst holding the bottle and syringe
shake the contents well.
5. While holding the bottle, turn the
entire assembly upside down.
6. Whilst supporting the syringe draw off
the required amount of medicine into
the syringe (Fig 3).
7. Turn the assembly back up the right
way and remove the syringe from the
bottle.
8. Replace the cap onto the bottle.

• Severe, bloody diarrhoea
• Jaundice (yellow colour in the skin and whites of
the eyes)
• 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).

Fig 2



Fig 3

Administer the dose by introducing the tip of the
syringe into the mouth of the infant/child, then
apply a light pressure on the plunger to slowly
release the solution. Keep it out of the reach of
children.
Note: For subsequent dosage follow steps 3 and 4
above, before shaking in order to prevent leakage.

When to take your medicine

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.

If you take more of your medicine than you
should
If you (or somebody else) takes too much of
your medicine, talk 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.

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
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• Common (may affect up to 1 in 10 people):
Diarrhoea, stomach upset and feeling sick, this
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):
Inflammation of the kidney or liver, changes in the
numbers of blood cells (might cause bleeding, easy
bruising or skin discolouration), anaemia, skin rash
with circular red patches (erythema multiforme).
Joint or muscle pains or fever (may develop 2 days
after starting treatment).
• Some of these reactions to flucloxacillin can be
delayed for up to 2 months after finishing the
treatment.
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.

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 store above 25°C.
Once reconstituted (mixed) by the pharmacist, store
the solution at 2°C to 8°C in a refrigerator and use
within 7 days.
Do not use this medicine after the expiry date which
is stated on the label.
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 Sugar Free Oral Solution
contains
The active substance is flucloxacillin as flucloxacillin
sodium.
The other ingredients are sodium citrate anhydrous,
disodium edetate, sodium benzoate, citric acid
monohydrate, colloidal anhydrous silica, xanthan
gum, saccharin sodium, menthol flavour, lemon
flavour, strawberry flavour and sorbitol.
Please see further information on sorbitol and
sodium in section 2.

What Flucloxacillin Sugar Free Oral Solution
looks like and contents of the pack
Unconstituted powder: a free-flowing white granular
powder with a slight lemon smell.
Reconstituted solution: an opaque off-white
coloured solution with a lemon smell and flavour.
The solution may become more yellow as time
progresses.
On reconstitution, each bottle contains 100ml of
Flucloxacillin Sugar Free Oral Solution.

Marketing Authorisation Holder

Actavis Group PTC ehf., Reykjavikurvegur 76-78
220 Hafnarfjordur, Iceland

Manufacturer

Athlone Laboratories Limited, Ballymurray
Co. Roscommon, Ireland
This leaflet was last revised in
November 2015.
Actavis, Barnstaple, EX32 8NS, UK

Flucloxacillin 125mg/5ml and 250mg/5ml Powder for Oral Suspension (100ml) PIL - UK

colours/plates:
1. Black

item no: AAAI2566

dimensions:

print proof no: 5

pharmacode:

origination date: 07.09.15

min pt size: 7pt

2.
3.
4.
5.
6.

originated by: DR
approved for print/date

148x280

revision date: 16.11.15

Technical Approval

revised by: DR

date sent: 07.09.15

supplier: Athlone Laboratories

technically app. date: 05.11.15

Non Printing Colours
1.
2.
3.

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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