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FLUCLOXACILLIN 2G POWDER FOR SOLUTION FOR INJECTION OR INFUSION

Active substance(s): FLUCLOXACILLIN SODIUM

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Flucloxacillin 2 mg Powder for Solution for Injection or Infusion
Version 1 Created 12.08.16
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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Flucloxacillin 2g, 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 2g
Powder for Solution for Injection or Infusion”
(referred to as Flucloxacillin 2g 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 2g injection is used to treat:
• heart infections
• bones and joints infections
Flucloxacillin 2g injection can also be used to
prevent infections during major surgery, particularly
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 or
under the eye lids.
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 have any serious illness other than this
infection

• You are being treated for liver or kidney problems
• You are on a low sodium diet (See “Flucloxacillin
injection contains sodium”)
• You are being treated for an infection such as
syphilis or leptospirosis
• You are aged 50 or above
• You have porphyria
• You are a known carrier of the HLA-B* 5701 allele.
Special care is essential in the newborn because of
the risk of jaundice and high blood levels of
flucloxacillin.
Other medicines and Flucloxacillin
Tell your doctor or nurse if you are taking, have
recently taken or might take any other medicines,
especially:
• Probenecid (used for the treatment of gout)
• Methotrexate (used to treat some tumours)
• Chloramphenicol or tetracycline (anti-bacterial
medicines).
If you are being treated with Flucloxacillin, this can
affect some blood and urine test results.
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.
Flucloxacillin injection contains sodium
Each vial contains 4.52 mmol of sodium. This must
be taken into consideration by 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 vein
(intravenous).
Your doctor will decide how much you need each
day and how often the injections should be given.

INFORMATION FOR THE HEALTHCARE PROFESSIONAL
The following information is intended for healthcare professionals only
Incompatibilities
• This medicinal product must not be mixed with
other medicinal products except those mentioned
below (Instructions for use and handling ).
• 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.

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.

Shelf life 36 months unopened. After opening: 24
hours.

Instructions for use and handling
Flucloxacillin powder for solution may be added to
the following intravenous fluids: Water for Injections,
sodium chloride 0.9%, glucose 5%, sodium chloride
0.18% with glucose 4%, Compound Sodium Lactate
Intravenous Infusion (Ringer-Lactate solution;
Hartmaan's Solution).

Special precautions for storage Store below 25°C.
Reconstituted solution: From a microbiological point of
view, the product should be used immediately. If not
used immediately, in-use storage times and

Administration
Intravenous: Dissolve 2g in 40ml Water for injections
(final volume: 41.5 ml). Administer by slow intravenous
injection.
Flucloxacillin may also be added to infusion fluids or
injected, suitably diluted, into the drip tube.

The usual doses are as follows.
Adults and children over 10 years old
The recommended dose by intravenous injection is
250mg to 1g four times a day.
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.
Use in 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.

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.
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 this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date
which is stated on the carton and vial after EXP.
The expiry date refers to the last day of that month.
Store vials below 25°C. Your doctor, pharmacist or
nurse will know how to store Flucloxacillin Injection
properly.
Do not use this medicine if you notice signs of
deterioration.
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 injection contains
Each vial contains 2g 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

Common side effects
(may affect up to 1 in 10 people)
• Stomach upset.

This leaflet was last revised in February 2017.

N.B. FLUCLOXACILLIN VIALS ARE NOT SUITABLE FOR
MULTIDOSE USE.
Any residual flucloxacillin should be discarded.

Paediatric population:
2-10 years: half adult dose
Under 2 years: quarter adult dose.

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)
Intravenous - 250 mg to 1 g four times a day.
The above systemic dosages may be doubled where
necessary.

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.

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.

Hepatic impairment
No dose reduction is necessary in patients with
reduced hepatic function.

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