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Active substance(s): FLUOROURACIL

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Fluorouracil 50 mg/ml Injection
Read all of this leaflet carefully before you start taking this
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or
• This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their symptoms are the same
as yours.
• If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor or
In this leaflet:
1. What Fluorouracil Injection is and what it is used for
2. Before you use Fluorouracil Injection
3. How to use Fluorouracil Injection
4. Possible side effects
5. How to store Fluorouracil Injection
6. Further information

Fluorouracil Injection is an anti-cancer medicine. Treatment with an
anti-cancer medicine is sometimes called cancer chemotherapy.
Fluorouracil Injection is used to treat many common cancers, particularly
cancers of the large bowel and breast. It may be used in combination with
other anti-cancer medicines or radiotherapy.

Do not use Fluorouracil Injection
• if you have shown signs of hypersensitivity (severe allergy) to fluorouracil
in the past
• if you are in a seriously weakened state due to long illness
• if your bone marrow has been damaged by other cancer treatments
(including radiotherapy)
• if you have a potentially serious infection
• if your cancer is non-malignant
• if you are pregnant or you are breast-feeding
• if you are taking or have taken in the past 4 weeks brivudine, sorivudine
and similar drugs (antivirals)
Tell your doctor if any of the above applies to you before this medicine is used.

Take special care with Fluorouracil Injection
• if your bone marrow is not producing blood cells normally (your doctor
will do a blood test to check this)
• if you have any problems with your kidneys
• if you have any problems with your liver including jaundice (yellowing of
the skin)
• if you have suffered from angina (chest pain) or have a history of heart
• if you have reduced activity/deficiency of the enzyme DPD
(dihydropyrimidine dehydrogenase)
• if you are in generally poor health and have lost a lot of weight
• if you have had surgery within the last 30 days
• if you are elderly
Tell your doctor if any of the above applies to you before this medicine is used.

Taking/using other medicines
Special care is needed if you are taking/using other medicines as some
could interact with Fluorouracil Injection, for example:
• methotrexate, cisplatin, cytarabine, mitomycin-C, tamoxifen (anti-cancer
• metronidazole (an antibiotic)
• calcium leucovorin (also called calcium folinate - used to reduce the
harmful effects of anti-cancer medicines)
• allopurinol (used to treat gout)
• cimetidine (used to treat stomach ulcers)
• warfarin (used to treat blood clots)
• interferon alpha 2a; brivudine, sorivudine and similar drugs (antivirals)
• phenytoin (an anti-epilepsy medicine)
• vaccines
Please tell your doctor or pharmacist if you are taking or have recently taken
any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding
Tell your doctor if you are pregnant, trying to become pregnant or
This medicine must not be used during pregnancy and breast-feeding.
Both women of childbearing potential and men must use an effective method
of contraception while taking fluorouracil and for at least 6 months afterwards.
Men are advised to seek advice on the conservation of sperm due to the
possibility of irreversible infertility due to using fluorouracil.
If a pregnancy does occur during your treatment, you must inform your
doctor who will advise you of the potential hazards and may recommend
genetic counselling for you.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
Do not drive or use machines if you experience any side effect from
Fluorouracil, such as nausea and vomiting. Fluorouracil can also produce
adverse events on your nervous system and cause visual changes. If you
experience any of these effects, do not drive or use any tools or machines,
as they may impair your ability to do so.

Important information about one of the ingredients of Fluorouracil
This medicinal product contains 7 mmol (160 mg) sodium per 1 gram dose.
To be taken into consideration by patients on a controlled sodium diet.

This medicine is given into a vein or an artery. If it is given into a vein, it can
either be injected (using a syringe) or infused (using a drip). If it is given into
an artery, it will be given as an infusion.
If it is to be given as an infusion the medicine will be diluted before use.

Your doctor will work out the correct dose of Fluorouracil Injection for you
and how often it must be given.
The dose of medicine given to you will depend on your medical condition,
your size, if you have had recent surgery and how well your bone marrow,
liver and kidneys are working.Your doctor will tell how well your bone
marrow, liver and kidneys are working using blood tests.
The total daily dose should not exceed 1 gram.

If you are given too much or too little Fluorouracil Injection
This medicine will be given to you by a doctor or nurse. It is unlikely that you
will be given too much or too little, however, tell your doctor or nurse if you
have any concerns. If you have taken too much, your doctor will monitor
you closely for at least 4 weeks.

Fluorouracil 50 mg/ml Injection
The following information is intended for medical or healthcare
professionals only
Further to the information included in section 3, practical information on the
preparation/handling of the medicinal product is provided here.

Fluorouracil Injection is incompatible with carboplatin, cisplatin, cytarabine,
diazepam, doxorubicin, epirubicin, levamisole, other anthracyclines and possibly
Formulated solutions are alkaline and it is recommended that admixture with
acidic drugs or preparations should be avoided.

Use and handling, and disposal
The pH of Fluorouracil Injection is 8.9 and the drug has maximal stability over
the pH range 8.6 to 9.0.
If a precipitate has formed as a result of exposure to low temperatures,
re-dissolve by heating to 60°C accompanied by vigorous shaking. Allow to cool
to body temperature prior to use.
The product should be discarded if it appears brown or dark yellow in colour.
Fluorouracil Injection may be diluted with Glucose 5% Injection or Sodium
Chloride 0.9% Injection or Water for Injections immediately before use.
Fluorouracil injection should not be mixed directly, in the same container, with
other chemotherapeutic agents or intravenous additives.
Chemical and physical in-use stability has been demonstrated for 5 days at
20-21°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 not normally be longer than
24 hours at 2-8°C, unless dilution has taken place in controlled and validated
aseptic conditions.

Cytotoxic Handling Guidelines
Should be administered only by, or under the direct supervision of, a qualified
physician who is experienced in the use of cancer chemotherapeutic agents.

Like all medicines, fluorouracil can cause side effects, although not
everybody gets them.

If any of the following happen, tell your doctor immediately:
• severe allergic reaction – you may experience a sudden itchy rash
(hives), swelling of the hands, feet, ankles, face, lips, mouth or throat
(which may cause difficulty in swallowing or breathing), and you may feel
you are going to faint
• chest pains (which may be due to heart problems, including having a
heart attack)
• your bowel motions are bloodstained or black
• your mouth becomes sore or develops ulcers
• symptoms of leucoencephalopathy (disease of brain) – extreme
weakness and fatigue, staggering while walking, thinking or speech
difficulties, seizures, coma.
These are very serious side effects. You may need urgent medical attention.
The frequency of possible side effects listed below is defined using the
following convention:
Very common (affects more than 1 user in 10)
Common (affects 1 to 10 users in 100)
Uncommon (affects 1 to 10 users in 1,000)
Rare (affects 1 to 10 users in 10,000)
Very rare (affects less than 1 user in 10,000)
Not known (frequency cannot be estimated from the available data)

If you experience any of the following tell your doctor as soon as
Very common side effects
• abnormality in the heart’s rhythm
• anaemia
• diarrhoea
• feeling or being sick
• anorexia
• tiredness or fatigue
• reddening of the palms of the hands and/or the soles of the feet
• hair loss (especially in women)
• increased chance of picking up infections and/or delayed wound healing
due to low white blood cells
• inflammation of the lining of the mouth, throat, gut, rectum or anus
Uncommon side effects
• low blood pressure (you may feel faint)
• watering eyes, changes in vision, sensitivity to light, side-to-side
movements of the eyes
• numbness, tingling or tremor in the hands or feet
• feeling euphoric
• symptoms of Parkinson’s disease (e.g. shaking hands)
• headache
• skin problems, (including dry skin, itchy weals, rash, redness, inflammation)
• skin may appear lighter or darker
• changes in your nails, such as changes in colour or thickening of the
Rare side effects
• feeling confused
• discolouration in your fingers and toes (Raynaud’s syndrome)
• reduced circulation to the brain, intestines and extremities (ischaemia)
• blood clots (pain, redness or swelling of the part affected)
Very rare side effects
• feeling unsteady on your feet
• muscle weakness
• sudden cardiac death
Frequency unknown
• quickening of your heart rate and breathlessness
• fever
• the vein where fluorouracil is administered may become painful or
discoloured, which may be the sign of a blood clot
Fluorouracil may lead to changes in your blood cells. Your doctor will take
blood samples to check for abnormalities (e.g. bone marrow depression which
may result in low white cells, low red cells, low platelets, low gamma globulins).
If any of the side effects gets serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.

Keep out of the reach and sight of children

This medicine must not be used after the expiry date which is stated on the
vial label and carton after ‘EXP’. Where only a month and year is stated, the
expiry date refers to the last day of that month.

Keep the vials in the outer carton, in order to protect from light and store at
or below 25°C. They should not be refrigerated or frozen.
Prepared infusions should be used immediately, however, if this is not
possible they can be stored for up to 5 days provided they have been
prepared in a way to exclude microbial contamination.

Visible signs of deterioration
The product should be discarded if it appears brown or dark yellow in colour.

Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required. These
measures will help to protect the environment.

What Fluorouracil Injection contains
The active substance is fluorouracil. Each millilitre (ml) of solution contains
50 mg of fluorouracil.
The other ingredients are sodium hydroxide and Water for Injections.

What Fluorouracil Injection looks like and contents of the pack
Fluorouracil Injection is a clear, colourless or slightly yellow solution for
injection which comes in glass containers called vials.
It may be supplied in packs containing:
• 5 x 250 mg/5 ml vials
• 5 x 500 mg/10 ml vials
• 5 x 1 g/20 ml vials
• 1 or 10 x 2.5 g/50 ml vial
• 1 x 5 g/100 ml vial
• 1 x 500 mg/10 ml ONCO-VIAL™
• 1 x 1 g/20 ml ONCO-VIAL™
• 1 x 2.5 g/50 ml ONCO-VIAL™
Not all packs may be marketed.

Marketing authorisation holder and manufacturer responsible for
batch release in Europe
Hospira UK Limited, Queensway, Royal Leamington Spa, Warwickshire,
CV31 3RW, UK

Hospira Australia Pty Ltd, Lexia Place, Mulgrave, Victoria 3170, Australia
This leaflet was last revised in 12/2013

Fluorouracil Injection should only be prepared for administration by
professionals who have been trained in the safe use of the preparation.
Preparation should only be carried out in an aseptic cabinet or suite dedicated
for the assembly of cytotoxics.
In the event of spillage, operators should put on gloves, face mask, eye
protection and disposable apron and mop up the spilled material with an
absorbent material kept in the area for that purpose. The area should then be
cleaned and all contaminated material transferred to a cytotoxic spillage bag or
bin and sealed for incineration.
Fluorouracil is an irritant, contact with skin and mucous membranes should be
In the event of contact with the skin or eyes, the affected area should be
washed with copious amounts of water or normal saline. A bland cream may be
used to treat the transient stinging of the skin. Medical advice should be sought
if the eyes are affected or if the preparation is inhaled or ingested.
Please refer to the marketing authorisation holder for COSHH hazard
Preparation Guidelines
a) Chemotherapeutic agents should be prepared for administration only by
professionals who have been trained in the safe use of the preparation.
b) Operations such as reconstitution of powder and transfer to syringes should
be carried out only under aseptic conditions in a suite or cabinet dedicated
for the assembly of cytotoxics.
c) The personnel carrying out these procedures should be adequately protected
with clothing, gloves and eye shield.
d) Pregnant personnel are advised not to handle chemotherapeutic agents.
Syringes, ONCO-VIAL™s and adaptors containing remaining solution, absorbent
materials, and any other contaminated material should be placed in a thick
plastic bag or other impervious container and incinerated at 700°C.

Directions for use of the ONCO-VIAL™
ONCO-VIAL™ should be used with an appropriate Hospira administration

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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.