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FLUCLOXACILLIN 125MG/5ML SUGAR FREE POWDER FOR ORAL SOLUTION

Active substance(s): FLUCLOXACILLIN SODIUM / FLUCLOXACILLIN SODIUM / 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
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.
- 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 Flucloxacillin Sugar-Free Oral
Solution is and what it is used for
2 What you need to know before you take
Flucloxacillin Sugar-Free Oral Solution

3 How to take Flucloxacillin Sugar-Free
Oral Solution
4 Possible side effects
5 How to store Flucloxacillin Sugar-Free
Oral Solution
6 Contents of the pack and other
information
1 What Flucloxacillin Sugar-Free Oral
Solution 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.

Other medicines and Flucloxacillin Sugar-Free
Oral Solution
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines. In
particular tell your doctor if you are taking any of the
following:
• 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.
Always tell your doctor about all the medicines you are
taking. This means medicines you have bought yourself
as well as medicines on prescription from a doctor.

Pregnancy, breastfeeding and fertility

If you are pregnant, planning to become pregnant or
are breastfeeding 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.

Flucloxacillin Sugar-Free Oral Solution
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.
This medicinal product contains sodium. 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 Flucloxacillin Sugar-Free
Oral Solution

Flucloxacillin can also be used to prevent infections
during major surgery, particularly heart or orthopaedic
surgery.

Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure. 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. If it does not, or you are not sure, check
with your doctor or pharmacist.

2 What you need to know before you take
Flucloxacillin Sugar-Free Oral Solution

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

Do not take Flucloxacillin Sugar-Free Oral Solution
if:
• You have ever had an allergic reaction to
flucloxacillin or any other penicillin antibiotics (see
symptoms section 4)
• You have ever had an allergic reaction to any of
the other ingredients of this medicine – see list of
ingredients in section 6, Contents of the pack and
other information
• You suffer from liver problems, as this medicine
could cause them to worsen.

Warnings and precautions

Talk to your doctor or pharmacist before taking
Flucloxacillin Sugar-Free Oral Solution 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).

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.

Flucloxacillin 125mg/5ml 250mg/5ml powder for oral solution PIL - UK
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Origination Date:
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Revised By:

Technical
Approval

C.Grant
25/04/17
01.06.17
S.Anson

Dimensions:
148x280
Min Body Text Size: 7pt
Supplier:
IL/Athlone Laboratories

Date sent:
25/04/17 + 26/05/17
Date received:

Colours

Non Printing Colours

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* 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.

Tell your doctor if you notice any of the
following effects:

INSTRUCTIONS FOR RECONSTITUTION OF THE
POWDER
1. R
 emove the cap and add the correct volume of
potable water (87mls if you have been given the
125mg/5ml strength of product and 79mls if
you have been given the 250mg/5ml strength of
product).
2. Replace the cap and shake well.
3. R
 emove 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.
INSTRUCTIONS FOR USE OF THE SYRINGE

1. R
 emove the cap and if necessary push the adaptor
into the neck of the bottle (Fig 1).
2. P
 ush the plunger of the syringe to remove
all the air.
Fig 1
3. I nsert 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.
Fig 2
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. R
 eplace the cap onto the bottle.
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.

• 
Common
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
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).
• Other side effects (frequency not known)
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 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.

Fig 3

When to take Flucloxacillin Sugar-Free Oral Solution:
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.
How long to take Flucloxacillin Sugar-Free Oral Solution
for:
Keep taking your medicine until your doctor tells you to
stop. Do not stop taking it just because you feel better.
If you take more Flucloxacillin Sugar-Free Oral Solution
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 Flucloxacillin Sugar-Free Oral
Solution:
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 stop taking Flucloxacillin Sugar-Free Oral
Solution:
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 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)
• 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).

5 How to store Flucloxacillin Sugar-Free
Oral Solution

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 stated on
the label. The expiry date refers to the last day of that
month.
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
Accord Healthcare Limited
Sage House
319 Pinner Road
North Harrow
Middlesex
HA1 4HF
United Kingdom
Manufacturer
Athlone Laboratories Limited
Ballymurray
Co. Roscommon
Ireland
This leaflet was last revised May 2017
Flucloxacillin 125mg/5ml Sugar Free Powder for Oral
Solution – PL 20075/0593
Flucloxacillin 250mg/5ml Sugar Free Powder for Oral
Solution –PL 20075/0594
Accord Healthcare Ltd, North Harrow, HA1 4HF, UK

BBBA0690

Flucloxacillin 125mg/5ml 250mg/5ml powder for oral solution PIL - UK
approved for print/date

Proof Round

04

UK-Eire-Artwork-Support@Actavis.com

Item no:

BBBA0690

Originator:
Origination Date:
Revision Date:
Revised By:

Technical
Approval

C.Grant
25/04/17
01.06.17
S.Anson

Dimensions:
148x280
Min Body Text Size: 7pt
Supplier:
IL/Athlone Laboratories

Date sent:
25/04/17 + 26/05/17
Date received:

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.

Expand Transcript

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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