FLUOROURACIL 50 MG/ML SOLUTION FOR INJECTION OR INFUSION

Active substance: FLUOROURACIL

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

Fluorouracil 50 mg/ml
Solution for Injection or
Infusion
Fluorouracil
Read all of this leaflet carefully before you start given this medicine.
• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask your doctor nurse
• 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 nurse.
In this leaflet:
1. What Fluorouracil Injection is and what it is used for
2. Before you use Fluorouracil Injection
3. How Fluorouracil Injection is given
4. Possible side effects
5. How to store Fluorouracil Injection
6. Further information

1. What Fluorouracil Injection is and what it
is used for
The name of your medicine is ‘Fluorouracil 50 mg/ml Solution for
Injection or Infusion’ but in the rest of the leaflet it will be called
‘Fluorouracil Injection’.
What Fluorouracil Injection is
Fluorouracil Injection contains the active ingredient Fluorouracil. It is
an anti-cancer medication.
What Fluorouracil Injection is used for
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 and radiotherapy.

2. Before you use Fluorouracil Injection
Do not use Fluorouracil Injection
• if you are allergic (hypersensitive) to Fluorouracil or any of the other
ingredients of Fluorouracil Injection.
• if you have serious infections (e.g. Herpes zoster, chickenpox)

The following information is intended for
medical or healthcare professionals only:
INSTRUCTIONS FOR USE/HANDLING, PREPARATION AND
DISPOSAL GUIDE FOR USE WITH FLUOROURACIL INJECTION
Cytotoxic Handling Guidelines
Fluorouracil should be administered only by or under the supervision of
a qualified physician who is experienced in the use of cancer
chemotherapeutic drugs.
Preparation guidelines:
Contamination
In the event of contact with the skin or eyes, the affected area should
be washed with copious amounts of water or normal saline.
Hydrocortisone cream 1% 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.

• if your tumour is non-malignant.
• if you have been very much weakened by long illness.
• if your bone marrow has been damaged by other treatments
(including radiotherapy).
• if you are taking brivudin, sorivudin and analogues (an antiviral drug)
• if you are pregnant or breast feeding women

effects like nausea and vomiting. It can also produce adverse event on
your nervous system and visual changes. If you experience any of this
effect, do not drive or use any tools or machines, it may impair your
ability to drive or use machines.

Take special care with Fluorouracil Injection:
• if the number of cells in your blood become too low
(you will have blood tests 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 problem with your heart. Tell your doctor if you experience
any chest pain during treatment.
• if you have reduced activity/deficiency of the enzyme DPD
(dihydropyrimidine dehydrogenase).
• If you have had high-dose pelvic radiation.

The dose of medicine given to you will depend on your medical
condition, your body weight, if you have had recent surgery and how
well your liver and kidneys are working. It will also depend on the
results of your blood tests. The dose should not be more than 1 g per
day. Your first course of treatment may be given daily or at weekly
intervals. Further courses may be given according to your response to
treatment. You may also receive treatment in combination with
radiotherapy.
The medicine may be diluted with glucose solution, sodium chloride
solution or Water for injections before it is given to you. It will be given
either into a vein or an artery. If it is given into a vein, it can either be
given as a normal injection or a slow injection via a drip (infusion). If it
is given into an artery, it will be given as an infusion.

Taking other medicines:
Please tell your doctor if you are taking any of the following medicines
or have recently taken any other medicines including medicines
obtained without a prescription
• Methotrexate (an anti-cancer medicine)
• 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; brivudin, sorivudin and analogues (an antiviral)
• Cisplatin (an anticancer medicine)
• Phenytoin (used to control epilepsy/fits and irregular heart rhythm)
• Vaccines
The above medicines affect the effect of Fluorouracil.
Pregnancy and breast-feeding:
If you are a woman of childbearing potential you must use an effective
method of contraception while taking this drug and atleast for 6 months
afterwards. If pregnancy occurs during your treatment you must inform
your doctor and should use genetic counsellation.
Since it is not known whether Fluorouracil passes into breast milk,
breast-feeding must be discontinued if the mother is treated with
Fluorouracil.
If you are a man you should avoid father a child during and for up to 6
months following cessation of treatment with Flurouracil Injection. You
are advice to sought conservation of sperm prior to treatment because
of the possibility of irreversible infertility due to therapy with Flurouracil
Injection.
Ask your doctor for advice before taking any medicine.
Driving and using machines:
Do not drive or use machines because Fluorouracil may produce side

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.
First Aid
Eye contact: Irrigate immediately with water and seek medical advice.
Skin contact: Wash thoroughly with soap and water and
remove-contaminated clothing.
Inhalation, Ingestion: Seek medical advice.
Disposal
Syringes, containers, absorbent materials, solution and any other
contaminated material should be placed in a thick plastic bag or other
impervious container, marked as cytotoxic waste and incinerated at a
minimum of 700°C.
Chemical inactivation can be achieved by 5% sodium Hypochlorite
over 24 hours.

3. How Fluorouracil Injection is given

If you are given more Fluorouracil Injection than you should:
As this medicine will be given to you whilst you are in hospital is
unlikely that you will be given too little or too much, however, tell your
doctor or pharmacist if you have any concerns.
You will need to have blood tests during and after treatment with
Fluorouracil Injection to check the levels of cells in your blood.
Treatment may have to be stopped if the level of white blood cells
drops too low.
Nausea, vomiting, diarrhoea, severe mucositis and gastrointestinal
ulceration and bleeding may occur if you have too much Fluorouracil. If
you have any further question on the use of this product ask your
doctor.

4. Possible side effects
Like all medicines, Fluorouracil can have side effects, although not
everybody gets them.
Very common side effects (more than 1 in 10 patients):
• Ischemic ECG abnormalities (an insufficient supply of blood to an
organ, usually due to a blocked artery)
• Neutropenia (an abnormally low level of neutrophils in the blood)
• Leucopenia (an abnormally low number of white blood cells in the
circulating blood)
• Anemia
(condition in which the circulating red cell mass is insufficient)
• Pancytopenia (a disorder in which the bone marrow greatly
decreases or stops production of blood cells)
• Decrease in the production of blood cells
• High fever and a sharp drop in circulating granular white blood cells
• The inflammation of the lining of the mouth and digestive tract
• Pharyngitis (inflammation of the mucous membranes lining the
pharynx)
• Inflammation of the rectum or anus

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 in the designated area.
c) The personnel carrying out these procedures should be adequately
protected with special clothing, two pairs of gloves one latex, one
PVC, (the latex being worn beneath the PVC), this covers
differences in permeabilities to the various antineoplastics, and eye
shields. Luerlock syringes and fittings should always be used both
in the preparation of cytotoxic products and for their administration.
d) Pregnant personnel are advised not to handle chemotherapeutic
agents.
(e) Refer to local guidelines before commencing.















Loss of appetite
Watery diarrhoea
Nausea
Vomiting
Hair loss
Hand-foot syndrome is a toxic skin reaction
Delayed wound healing
Bleeding from the nose
Fatigue
General weakness
Tiredness
Lack of energy
inflammation of the mucous lining of any of the structures in the
mouth
• inflammation of the esophagus.
• Increase in uric acid in the blood
Common side effects (less than 1 in 10 patients):
• Angina pectoris (Severe pain in the chest associated with an
insufficient supply of blood to the heart)

Uncommon side effects (less than 1 in 100 patients):
• Abnormality in the heart's rhythm
• Heart attack
• Myocardial ischemia (a loss of oxygen to the heart muscle)
• Myocarditis (inflammatory disease of the heart muscle)
• Heart insufficiency
• Dilative cardiomyopathy (a type of heart disease in which the heart
muscle is abnormally enlarged, thickened and/or stiffened)
• Cardiac shock
• Low blood pressure
• Sleepiness
• Dehydration
• Bacterial infection in the bloodstream or body tissues
• Gastrointestinal ulceration and bleeding, casting off the skin
• Rhythmic motions of the eyes
• Headache
• Sensations of imbalance and unsteadiness
• Symptoms of Parkinson's disease (a progressive movement
disorder marked by tremors, rigidity, slow movements)
• Pyramidal signs
• Feeling of being sick
• Inflammation of the skin
• Skin alterations e.g. dry skin, fissure erosion, Redness of the skin,
pruritic maculopapular rash (rash that had originated on the lower
extremities and had progressed to the arms, and then to the chest)
• A skin eruption accompanying certain infectious diseases
• Appearance of itchy weals on the skin
• Photosensitivity
• Hyperpigmentation of the skin
• Streaky hyperpigmentation or depigmentation near the veins.
• Changes in the nails (e.g. diffuse superficial blue pigmentation,
hyperpigmentation; nail dystrophy, pain and thickening of the nail
bed.
• Paronychia (Inflammation of the tissue surrounding a fingernail)
• An inflammation of the matrix of the nail with formation of pus and

Instructions for use
Fluorouracil Injection can be given by intravenous injection, or
intravenous or intra-arterial infusion.
Incompatibilities
Fluorouracil is incompatible with calcium folinate, Carboplatin,
Cisplatin, Cytarabine, Diazepam, Doxorubicin, Droperidol, Filgrastim,
Gallium nitrate, Methotrexate, Metoclopramide, Morphine,
Ondansetrone, parenteral nutrition, Vinorelbin, other Anthracyclines.
Formulated solutions are alkaline and it is recommended that
admixture with acidic drugs or preparations should be avoided.
In the absence of compatibility studies, this medicinal product must not
be mixed with other medicinal products.
Shelf Life and storage
Shelf-life of unopened vial
2 years. Single use only. Discard any unused portion.
Store below 25°C. Do not refrigerate or freeze. Keep container in the
















shedding of the nail
Sperm or ovum production disorder
Secretion of tears
Blurred vision,
Inflammation or redness of the lining of the white part of the eye
and the underside of the eyelid.
Eye movement disturbance
Optic neuritis (a vision disorder characterized by inflammation of
the optic nerve)
double vision
decrease in visual sharpness
excessive sensitivity to light and the aversion to sunlight or well-lit
places
ocular disease characterized by chronic inflammation of the eyelid
margins
lower eyelid turns outwards
Blocked tear ducts
A layer or mass of dead tissue separated from surrounding living
tissue, as in a wound, a sore, or an inflammation.
liver cell damage

Rare side effects (more than 1 in 10,000 but less than 1 in 1,000
patients):
• Generalized allergic reaction
• Insufficient blood flow in brain, intestine and peripheral organs
• discoloration of the fingers, toes, and occasionally other areas
• Development of a clot within blood vessels, can occur in arteries or
veins
• swelling (inflammation) of a vein caused by a blood clot
• severe, whole-body allergic reaction (anaphylaxis)
• systemic vasodilation (widening of blood vessels) which results in
low blood pressure
• confusion
• Increase of T4 (total thyroxin), increase of T3 (total trijodthyronin)
Very rare side effects (less than 1 in 10,000 patients):
• Cardiac arrest (sudden cessation of heartbeat and cardiac function)
• Sudden cardiac death (unexpected death due to heart problems)
• Symptoms of leucoencephalopathy (diseases affecting the white
substance of the brain) including ataxia (loss of the ability to
coordinate muscular movement)
• Difficulty in articulating words
• Confusion
• Mental confusion or impaired awareness especially regarding to
time, place or identity
• Abnormal muscular weakness or fatigue
• Acute cerebellar syndrome
• Partial or total loss of the ability to communicate verbally or using
written words.
• Convulsion or coma in patients receiving high doses of 5-fluorouracil
and in patients with dihydropyrimidine dehydrogenase deficiency
• kidney failure
• Damage of liver cells (cases with fatal outcome)
• inflammation of the gall bladder
• slow progressive destruction of the small bile ducts
If any of the side effects get serious, or if you notice any side effects not

outer carton in order to protect from light.
If a precipitate has formed as a result of exposure to low temperature,
redissolve 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 solution.
Shelf Life after dilution
In use: Chemical and physical in-use stability has been demonstrated
for 24 hours at 25°C with Glucose 5% or Sodium Chloride 0.9%
Injection B.P or Water for Injections B.P at concentration 0.98 mg/ml of
Fluorouracil.
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 2-8°C, unless dilution has
taken place in controlled and validated aseptic conditions.

listed in this leaflet, please tell your doctor or pharmacist

5. How to store Fluorouracil Injection
• Keep out of the reach and sight of children.
• Do not use Fluorouracil Injection after the expiry date, which is
stated on the Label and carton after EXP.
• Store below 25°C. Do not refrigerate or freeze.
• Keep container in the outer carton in order to protect from light.
Single use only. Discard any unused portion.
Shelf Life after dilution
Chemical and physical in-use stability has been demonstrated for 24
hours at 25°C with Glucose 5% or Sodium Chloride 0.9% Injection B.P
or Water for Injections B.P at concentration 0.98 mg/ml of Fluorouracil.
However 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 2-8°C, unless dilution has
taken place in controlled and validated aseptic conditions.
• Do not use if the product appears brown or dark yellow in solution.
• Do not use if you notice that the container is damaged or particles/
crystals are visible.
• 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.

6. Further information
What Fluorouracil Injection contains:
The active substance in Fluorouracil Injection is Fluorouracil.
The other ingredients are water for injections, sodium hydroxide and
hydrochloric acid.
What Fluorouracil Injection looks like and content of the pack:
1ml of solution contains 50 mg of Fluorouracil (as sodium salt formed
in situ).
Fluorouracil solution for Injection or Infusion is a clear, almost
colourless solution in a Ph.Eur Type I clear glass vial with rubber
closure.
Each 5 ml vial contains 250 mg of Fluorouracil
Each 10 ml vial contains 500 mg of Fluorouracil
Each 20 ml vial contains 1 g of Fluorouracil
Each 50 ml vial contains 2.5 g of Fluorouracil
Each 100 ml vial contains 5 g of Fluorouracil
Not all pack sizes may be marketed
Marketing Authorization Holder and Manufacturer:
Accord Healthcare Limited
Sage House, 319, Pinner Road,
North Harrow, Middlesex, HA1 4HF,
United Kingdom
The leaflet was last approved in 01/2011.

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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.

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