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FLUCLOXACILLIN 500 MG POWDER FOR SOLUTION FOR INJECTION OR INFUSION

Active substance(s): FLUCLOXACILLIN SODIUM

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832263/06 FLUCLOXACILLIN UK 250/500/1000mg.qxp_PIL-398UK_FLUX_v5 13/11/17 16:26 Pagina 2

PACKAGE LEAFLET: INFORMATION FOR THE USER

Flucloxacillin 250mg, 500mg or 1g, Powder for Solution for Injection or Infusion
Flucloxacillin as Flucloxacillin Sodium
Read all of this leaflet carefully before you start using 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 nurse.
• If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this
leaflet. See section 4.
In this leaflet:
1. What Flucloxacillin is and what it is used for
2. What you need to know before you are given Flucloxacillin Injection
3. How Flucloxacillin Injection is given
4. Possible side effects
5. How to store Flucloxacillin Injection
6. Contents of the pack and other information
The name of your medicine is “Flucloxacillin 250mg, 500mg,
1g Powder for Solution for Injection or Infusion” (referred
to as Flucloxacillin Injection throughout this leaflet).
1. WHAT FLUCLOXACILLIN IS AND WHAT IT IS
USED FOR
Your medicine contains the active substance flucloxacillin (as
flucloxacillin sodium), which is one of a group of medicines
called “penicillins”. These medicines are also known as
“antibiotics” and they work by killing the bacteria that cause
infections.
Flucloxacillin injection is used to treat a wide range of
bacterial infections which may include those affecting:
• The chest (pneumonia,
• Wounds and burns
emphysema and lung
• Heart (endocarditis)
abscess)
• Bones and joints
• Tonsils (tonsillitis, quinsy)
(osteomyelitis)
• Pharynx (pharyngitis)
• Membranes of the brain
• Sinuses (sinusitis)
(meningitis)
• Ears (otitis media and
• Gut (enteritis)
otitis externa)
• Blood (Septicaemia)
• Skin and soft tissue (boils, • Kidney, bladder or the
abscesses, carbuncles,
urethra (the tube which
impetigo, cellulites,
carries urine from the
furunculosis, ulcers and
bladder).
acne)
Flucloxacillin injection can also be used to prevent infections
following skin grafts or during major surgical procedures,
particularly in heart or orthopaedic surgery.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE
GIVEN FLUCLOXACILLIN INJECTION
You should not be given Flucloxacillin Injection if:
• You are allergic to flucloxacillin
• You are allergic to penicillin, cephalosporins or other
antibiotics
• You have had jaundice (your skin and the whites of your
eyes turn yellow) or you have had other liver problems
when you have been given flucloxacillin previously.
You must tell your doctor or nurse if any of these apply to you.
Flucloxacillin should not be given into the eye.

Warnings and precautions
Talk to your doctor or nurse before you are given
Flucloxacillin injection if any of the following apply to you:
• You have ever had a skin rash or swelling of the face or
neck when taking an antibiotic
• You are being treated for kidney problems or gout
• You are being treated for liver problems
• You are on a low sodium diet (See “Important information
about some of the ingredients of Flucloxacillin injection”)
• You are aged 50 or above
• 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
together with paracetamol, particularly in certain groups
of patients at risk e.g. patients with severe kidney
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.
Other medicines and Flucloxacillin
If you are taking another medicine when Flucloxacillin
injection is given, it can affect how Flucloxacillin or the other
medicine works.
Examples of other medicines that can affect Flucloxacillin
injection are:
• Probenecid (used for the treatment of gout)
• Oral contraceptives that contain oestrogen (the “pill”).
If you are using the pill, you should take extra precautions
(such as using a condom) while you are being treated with
this medicine, and for at least 7 days afterwards.
Please tell your doctor or nurse if you are taking, have recently
taken or might take any other medicines including medicines
obtained without a prescription.
Pregnancy and breast-feeding
Tell the doctor or nurse if you are pregnant, think you might be
pregnant or if you are breast feeding before you are given
this medicine.
Driving and using machines
This medicine has no known effects on the ability to drive or
use machines.

INFORMATION FOR THE HEALTHCARE PROFESSIONAL
The following information is intended for medical or
healthcare professionals only.
Incompatibilities
• It is advisable not to combine flucloxacillin with other
drugs in solution for parenteral administration.
• Flucloxacillin should not be mixed with blood products or
other proteinaceous fluids (e.g. protein hydrolysates) or
with intravenous lipid emulsions.
• If flucloxacillin is prescribed concurrently with an
aminoglycoside, the two antibiotics should not be mixed
in the syringe, intravenous fluid container or giving set
as precipitation may occur.
Shelf life 36 months unopened. After opening: 24 hours.
Special precautions for storage Store below 25°C.
From a microbiological point of view, the product should be
used immediately. If not used immediately, in-use storage
times and conditions prior to use are the responsibility of
the user and would normally not be longer than 24 hours at
2 to 8°C unless reconstitution/ dilution has taken place in
controlled and validated aseptic conditions.

Administration
Intramuscular: Add 1.5 ml Water for Injections to 250 mg
vial contents. Add 2 ml Water for Injections to 500 mg vial
contents.
Intravenous: Dissolve 250-500 mg in 5-10 ml Water for
Injections. Dissolve 1 g in 15-20 ml Water for Injections.
Administer by slow intravenous injection (three to four
minutes). Flucloxacillin may also be added to infusion fluids
or injected, suitably diluted, into the drip tube over a period
of three to four minutes.
Intrapleural: Dissolve 250 mg in 5-10 ml Water for
Injections.
Intra-articular: Dissolve 250-500 mg in up to 5 ml Water
for Injections or 0.5% lidocaine hydrochloride solution.
Nebuliser solution: Dissolve 125-250 mg of the vial
contents in 3 ml sterile water.
The following displacement volumes have been determined:
Reconstitution
Displacement volume
Strength
volume
(approximate)
250 mg
1.5 - 10 ml
0.2 ml
500 mg
2 - 10 ml
0.35 ml
1g
15 - 20 ml
0.6 ml

832263/06 FLUCLOXACILLIN UK 250/500/1000mg.qxp_PIL-398UK_FLUX_v5 13/11/17 16:26 Pagina 3

Flucloxacillin injection contains sodium
The sodium content of each vial is 0.57mmol (250mg vial),
1.13mmol (500mg vial) and 2.26mmol (1g vial). This must be
taken into consideration for patients on a controlled sodium
diet.
Tell your doctor or nurse if this applies to you.
3. HOW FLUCLOXACILLIN INJECTION IS GIVEN
Your doctor or nurse will prepare your injection in the form of
a liquid. They will inject this into a muscle (intramuscular) or
into a vein (intravenous). It can also be given to you by
injection into a joint, or injection into the lining of the lung, or
by breathing in the medicine from a mask (nebuliser).
Your doctor will decide how much you need each day and
how often the injections should be given. The usual doses
are as follows.
Adults and children over 10 years old:
The usual dose for treating infections is:
• by intramuscular injection: 250mg four times a day.
• by intravenous injection is 250mg to 1g four times a day.
• by injection into the lining of the lung: 250mg once daily
• by breathing in the medicine from a mask (nebuliser):
125mg to 250mg four times a day
• by injection into a joint: 250mg to 500mg once daily
For infections of the bones and joints (osteomyelitis) or the
heart (endocarditis) – up to 8g daily can be given in divided
doses, every 6 to 8 hours.
To prevent infections after an operation, the usual dose is 1 to
2g before the operation when you are given your anaesthetic.
This is then followed by 500mg four times a day for up to
three days after your operation.
Children aged 10 years and below:
The usual dose for children aged two to ten is half the adult
dose.
The usual dose for children under two years old is a quarter
of the adult dose.
These doses can be increased in more serious infections.
If you are given more of this medicine than you should
This is unlikely to happen but if it does, the doctor will treat
any symptoms that follow.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Flucloxacillin Injection can cause side
effects, although not everybody gets them.
If you get any of the following side effects soon after
receiving this medicine, tell your doctor or nurse
immediately. If you get them, you may have had a
serious allergic reaction or other type of reaction to
this medicine. You may need urgent medical attention:
• Stomach pain or diarrhoea (possibly with bleeding)
• Your skin or the whites of your eyes turn yellow
• Your urine becomes darker or your faeces become paler
• Any unexplained bleeding or bruising or skin
discolouration
• Skin rash and itching
• Blistering of the skin, mouth, eyes or genitals
• Any sudden wheeziness, difficulty in breathing or
dizziness
• Any swelling of the face, neck or tongue.

• Serious skin reactions
• A red, scaly rash with bumps under the skin and blisters
(exanthematous pustulosis)
Some of these reactions can be delayed for several
weeks after finishing treatment.
The following side effects may also occur. Tell your doctor
if any of these become troublesome.
Common side effects (may affect up to 1 in 10 people)
• Stomach upset.
Very rare side effects (may affect up to 1 in 10,000
people)
• Reduction in blood cell counts which makes infections
more likely
• Inflammation of the kidney which can cause swollen
ankles or high blood pressure
• Joint pain, muscle pain or fever. This may develop after 2
days or more from the start of treatment
• Convulsions (“fits”) in patients taking high doses
• Blood and fluid abnormality (high anion gap metabolic
acidosis) which occurs when there is an increase in
plasma acidity when flucloxacillin is used together with
paracetamol, particularly in the presence of risk factors
(see “Warnings and precautions” above).
Reporting of side effects
If you get any side effects, talk to your doctor, nurse, 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 FLUCLOXACILLIN INJECTION
Keep out of the reach and sight of children.
Store vials below 25°C. Your doctor, pharmacist or nurse
will know how to store Flucloxacillin Injection properly.
Do not use after the expiry date which is printed on the label
and carton, or if the powder shows signs of discoloration.
6. FURTHER INFORMATION
What Flucloxacillin injection contains
Each vial contains 250mg, 500mg or 1g of Flucloxacillin (as
flucloxacillin sodium). There are no other ingredients.
What Flucloxacillin injection looks like and contents
of the pack:
Flucloxacillin injection is a white powder in a glass vial.
Each carton contains 1, 5, 10, 20 or 50 glass vials. Not all
pack sizes may be marketed.
Marketing Authorisation Holder:
Ibigen Srl
Via Fossignano 2, 04011 Aprilia (LT)
Italy
Manufacturer:
Istituto Biochimico Italiano
Via Fossignano 2, 04011 Aprilia (LT)
Italy
This leaflet was last revised in November 2017.
832263/06

Instructions for use and handling
Flucloxacillin powder for solution may be added to most
intravenous fluids (e.g. Water for Injections, sodium
chloride 0.9%, glucose 5%, sodium chloride 0.18% with
glucose 4%).
N.B. FLUCLOXACILLIN VIALS ARE NOT SUITABLE FOR
MULTIDOSE USE.
Any residual flucloxacillin should be discarded.
Posology and method of administration
Depends on the age, weight and renal function of the
patient, as well as the severity of the infection.
Usual adult dosage (including elderly patients)
Intramuscular - 250 mg four times a day.
Intravenous - 250 mg to 1 g four times a day.
The above systemic dosages may be doubled where
necessary.
Osteomyelitis, endocarditis - Up to 8 g daily, in divided
doses six to eight hourly.
Surgical prophylaxis - 1 to 2 g IV at induction of
anaesthesia followed by 500 mg six hourly IV, IM or orally
for up to 72 hours.

Flucloxacillin may be administered by other routes in
conjunction with systemic therapy. (Proportionately lower
doses should be given in children.)
Intrapleural - 250 mg once daily.
By nebuliser - 125 to 250 mg four times a day.
Intra-articular - 250 to 500 mg once daily.
Usual children's dosage
2-10 years: half adult dose
Under 2 years: quarter adult dose.
Abnormal renal function:
In common with other penicillins, flucloxacillin usage in
patients with renal impairment does not usually require
dosage reduction. However, in the presence of severe renal
failure (creatinine clearance < 10 ml/min) a reduction in
dose or an extension of dose interval should be considered.
Flucloxacillin is not significantly removed by dialysis and
hence no supplementary dosages need to be administered
either during, or at the end of the dialysis period.

832263/06

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