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FLUCLOXACILLIN 125MG/5ML GRANULES FOR ORAL SOLUTION

Active substance(s): FLUCLOXACILLIN SODIUM

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93.5mm

PATIENT INFORMATION LEAFLET

Flucloxacillin 125mg/5ml
Granules for Oral Solution
Please read all of this leaflet carefully before you start
taking this medicine.
Keep the leaflet; you may need to read it again. If you
have any questions or are not sure about anything, ask
your doctor or pharmacist.
This medicine is for you. Only a doctor can prescribe it.
Never give the medicine to someone else. It may harm
them even if their symptoms are the same as yours.
If you get any side effects, talk to your doctor,

pharmacist or nurse. This includes
any possible side effects not listed
in this leaflet. See section 4.
IN THIS LEAFLET:
1. What this medicine is and what it is used for
2. Before you take this medicine
3. How to take this medicine
4. Possible side effects
5. How to store this medicine
6. Further information
1. WHAT THIS MEDICINE IS AND WHAT IT IS USED FOR
Each 5ml of oral solution contains 125mg of flucloxacillin (as flucloxacillin
sodium) as the active ingredient.

83mm

81.5mm

Peel here to open but do not remove

Flucloxacillin

BRAILLE

2

85mm

Granules for
Oral Solution

Code: XXXXXXX
M0246TB
Each 5ml contains Flucloxacillin 125mg (as
flucloxacillin sodium). Also contains sucrose,
aspartame (E951), E123, E217, E219 and sodium.
Please read the leaflet provided before use.
For oral use as directed by the doctor.
To the patient: Shake well before each use.
Store in a refrigerator and use within
7 days. Complete the prescribed course of
treatment.
To the pharmacist: Before reconstitution.
Do not store above 25ºC. Keep the bottle tightly
closed. To dispense, add 60ml of water and
shake well until all the powder is dissolved.

flucloxacillin
#abe 125mg/
mg_/#e ml
5ml
oral solution
KEEP OUT OF THE SIGHT AND REACH OF
CHILDREN

100ml

bleeding, bruising, pale skin, weakness, tiredness
joint or muscle pain or fever, which may develop 2 days or more
from the start of treatment
Ÿ effects on the skin such as rashes, red patches, peeling, swelling,
blistering
Ÿ very rare cases of blood and fluid abnormality (high anion gap
metabolic acidosis) which occurs when there is an increase in
plasma acidity, when flucloxacillin is used concomitantly with
paracetamol, generaly in the presence of risk factors (see section 2).
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.

6. FURTHER INFORMATION
Ingredients
Each 5ml of oral solution contains 125mg of flucloxacillin (as flucloxacillin
sodium) as the active ingredient.
It also contains the inactive ingredients: amaranth (E123), cherry flavour,
sodium methyl parahydroxybenzoate (E219), sodium propyl
parahydroxybenzoate (E217), sodium citrate, aspartame (E951), citric acid
anhydrous, sucrose and water (when dispensed by the pharmacist).

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82mm

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This medicine belongs to the penicillin group of antibiotics. It is used to
treat various bacterial infections by killing the bacteria or preventing
their growth. These include skin and soft tissue infections, throat and
chest infections, other infections such as urinary tract infection and
prevention of an infection occurring during surgery.
2. BEFORE YOU TAKE THIS MEDICINE
Do not take this medicine if:
Ÿ you are allergic to any penicillin or other kind of antibiotic or to any
of the other ingredients listed (see section 6)
Ÿ you have ever had any liver problems after taking flucloxacillin.
Check with your doctor before taking this medicine if:
Ÿ you have a history of allergy
Ÿ you have liver or kidney problems
Ÿ you have any serious illness

5. HOW TO STORE THIS MEDICINE
Store in a refrigerator. Use within 7 days of preparation.
KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN
Do not take this medicine if the expiry date on the pack has passed. If
you have any medicines that are out of date, return them to your
pharmacist for safe disposal.

sugammadex (used with general anaesthetics)
birth control pills
warfarin (used to prevent blood clotting)
if you are taking or will be taking paracetamol.
There is a risk of blood and fluid abnormality (high anion gap metabolic
acidosis) which occurs when there is an increase in plasma acidity, when
flucloxacillin is used concomitantly with paracetamol, particularly in
certain groups of patients at risk, e.g. patients with severe renal
impairment, sepsis or malnutrition, especially if the maximum daily doses
of paracetamol are used. High anion gap metabolic acidosis is a serious
disease that must have urgent treatment.
Tests:
Your doctor may want to carry out regular monitoring of your kidney or
liver function if you are taking this medicine long term. If you need to
have a liver function test, tell your doctor you are taking this medicine as

it may affect the results.
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.
Driving and using machinery:
This medicine should not affect your ability to drive or operate machinery.
However, if you think you are affected do not drive or operate machinery.
Important information about some of the ingredients of
this medicine:
- Each 5ml dose contains 3.0g sucrose; this should be taken into account
in patients with diabetes mellitus. Also if you have been told by your
doctor that you have an intolerance to some sugars, contact your doctor
before taking this medicine.

82mm

83mm

85mm

Flucloxacillin
Granules for
Oral Solution

125mg/
5ml

100ml

Ÿ
Ÿ
Ÿ
Ÿ

Code: XXXXXXX
M0246TB
Each 5ml contains Flucloxacillin 125mg
(as flucloxacillin sodium). Also contains
sucrose, aspartame (E951), E123, E217,
E219 and sodium.
Please read the leaflet provided before use.
For oral use as directed by the doctor.
To the patient: Shake well before each use.
Store in a refrigerator and use within
7 days. Complete the prescribed course of
treatment.
To the pharmacist: Before reconstitution.
Do not store above 25ºC. Keep the bottle
tightly closed. To dispense, add 60ml of
water and shake well until all the powder
is dissolved.
KEEP OUT OF THE SIGHT AND REACH OF
CHILDREN

Code

AW.CRC.165.03.V02

Although the bottle of your medicine appears to be only partially full, it
contains the correct amount of the solution. The extra space is to allow
you to shake the medicine.
What the medicine looks like:
Flucloxacillin Oral Solution is a clear, red solution. Each bottle contains
100ml.
Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder: Crescent Pharma Limited, Units 3 & 4,
Quidhampton Business Units, Polhampton Lane, Overton, Hampshire,
RG25 3ED, UK.
Manufacturer: Crescent Manufacturing Ltd, 2 Cunard Road, Park Royal,
London, NW10 6PN, UK.
This leaflet was last revised in December 2017
If you would like this leaflet in a different format please contact the
licence holder at the above address.

81.5mm

you are 50 years old or over
you are giving this medicine to a newborn child.
Taking other medicines
Check with your doctor or pharmacist before taking this medicine if you
are taking other medicines, including any that you can buy without a
prescription. This is important if you are taking other medicines,
especially:
Ÿ probenecid or sulfinpyrazone - used for treatment of gout
Ÿ oral anti-coagulants e.g. warfarin - used for thinning blood
Ÿ methotrexate - a cancer drug which can also be used to treat
psoriasis
Ÿ piperacillin (an antibiotic given by injection) or any other antibiotic
(used to treat infections)
Ÿ the oral typhoid vaccine
Ÿ
Ÿ

82mm

flucloxacillin Flucloxacillin
#abe mg_/#e ml 125mg /5ml
oral solution oral solution

Ÿ

- Amaranth may cause allergic reactions.
- Aspartame contains a source of phenylalanine which may be harmful for
people with phenylketonuria.
- E217and E219 may cause allergic reactions (possibly delayed).
- Each 5ml dose contains approx 9mg of sodium. This may need to be
taken into consideration in patients on a controlled sodium diet,
particularly if you are prescribed more than the usual dose.
3. HOW TO TAKE THIS MEDICINE
For oral use. Shake the bottle well before use. Take the medicine half an
hour to an hour before meals.
Follow your doctor's instructions about taking your medicine. The label will
also tell you how much to take and how often. The dose for this medicine
may be different for different patients.
Adults (including the elderly): 250mg (two 5ml spoonfuls) 4 times a

93.5mm

Grasshopper Sistemas de Informação
geral@gsiportugal.com
www.gsiportugal.com

Customer

Date

2017-12-22

Description

FLUCLOXACILLIN 125mg/5ml
GRANULES FOR ORAL SOLUTION
(Leaflet Label EN)
Size

52x590 mm

Removable Glue

100ml

4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not
everybody gets them.
If you experience any of the following very rare effects (could happen to
less than 1 in 10,000 people) while you are taking this medicine, STOP
taking it and contact your doctor IMMEDIATELY:
Ÿ sudden wheeziness, difficulty breathing, swelling of the face, eyes,
lips, tongue or throat, itching or itchy skin rashes (may be signs of
allergy or a severe allergic reaction)
Ÿ severe bloody diarrhoea with fever and abdominal pain.

Other side effects
Frequency not known:
Ÿ 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.
Common effects (that could happen to less than 1 in 10 people):
Ÿ minor stomach upsets such as feeling sick or diarrhoea.
Very rare effects (that could happen to less than 1 in 10,000
people):
Ÿ inflammation of the kidney or liver and a type of jaundice
(symptoms include swollen ankles, yellowing of the skin or whites of
the eyes, loss of appetite, pale stools, dark urine). Some of these
effects may be delayed and may not occur until up to 2 months after
you have stopped taking this medicine
Ÿ changes in the numbers of blood cells which can cause unexplained

Permanent Glue

KEEP OUT OF THE SIGHT AND REACH OF
CHILDREN

If you forget to take a dose:
Take your dose as soon as you remember. However, if it is almost time for
your next dose, skip the missed dose and continue with your normal
dosing schedule. DO NOT DOUBLE THE DOSES.

Removable Glue

125mg/
5ml

day; your doctor may prescribe double this dose where necessary.
Children, over 10 years: The usual dose is the same as the
adult dose.
Children 2 to 10 years of age: Half the adult dose i.e.125mg
(one 5ml spoonful) 4 times a day.
Children under 2 years of age: A quarter of the adult dose
i.e. 62.5mg (2.5ml) 4 times a day.
The length of time for treatment varies depending on the severity
and type of infection. However, it is important to finish your
prescribed dose of this medicine. If you stop taking this medicine
too soon, your symptoms may return.
If you have taken too much medicine:
Contact your doctor straight away or go to the nearest hospital
casualty department. Take with you any remaining medicine and
the pack so that the medicine can be identified.

Product Licence holder: Crescent Pharma Ltd,
Polhampton Lane, Overton, Hampshire, RG25 3ED, UK
POM PL 20416/0076

Granules for
Oral Solution

Code: XXXXXXX
M0246TB
Each 5ml contains Flucloxacillin 125mg (as
flucloxacillin sodium). Also contains sucrose,
aspartame (E951), E123, E217, E219 and sodium.
Please read the leaflet provided before use.
For oral use as directed by the doctor.
To the patient: Shake well before each use.
Store in a refrigerator and use within
7 days. Complete the prescribed course of
treatment.
To the pharmacist: Before reconstitution.
Do not store above 25ºC. Keep the bottle tightly
closed. To dispense, add 60ml of water and
shake well until all the powder is dissolved.

Permanent Glue

1

Peel here to open but do not remove

Flucloxacillin

Pantone:
561 C
561 C (50%)
100 C

Notes

Colours

286 C
339 C
Braille

Keyline
Black

NO GOOD FOR COLOR PROOF
TEXT BODY: Font - Helvetica Neue
Min. size - 8 pt

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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