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Package leaflet: Information for the patient

Fluorouracil 50 mg/ml
Solution for Injection/Infusion
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.
What is in this leaflet
1. What Fluorouracil is and what it is used for
2. What you need to know before you use Fluorouracil
3. How to use Fluorouracil
4. Possible side effects
5. How to store Fluorouracil
6. Contents of the pack and other information

1. What Fluorouracil is and what it is used for
Fluorouracil contains the active ingredient fluorouracil. It is an anti-cancer
Fluorouracil is used to treat many common cancers, particularly cancers of the
large bowel, oesophagus, pancreas, stomach, head and neck and breast. It may
be used in combination with other anti-cancer medicines and radiotherapy.

2. What you need to know before you use
Do not use Fluorouracil :
• if you are allergic to fluorouracil or any of the other ingredients of this medicine
(listed in section 6).
• if you have serious infections (e.g. Herpes zoster, chickenpox).
• 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
• if you are taking brivudin, sorivudin and analogues (an antiviral drug).
• if you are pregnant or breast feeding women.
• if you have serious impaired liver function.
• if you are homozygotic for dihydropyrimidine dehydrogenase (DPD) enzyme.
Warnings and precautions
Talk to your doctor or nurse before using Fluorouracil
Take special care with Fluorouracil :
• if the number of cells in your blood become too low (you will have blood tests to
check this).
• if you have oral ulceration, fever or haemorrhage at any site or weakness (these
symptoms may be the consequence of the very low number of cells in your
• if you have any problems with your kidneys.
• if you have any problems with your liver including jaundice (yellowing of the
• if you have problems 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
• if you have had high-dose pelvic radiation.
• if you have gastrointestinal side effects (stomatitis, diarrhoea, bleeding from the
G.I. tract) or haemorrhage at any site.
Other medicines and Fluorouracil
Tell your doctor if you are using, have recently taken or might take any other
The below medicines affect the effect of fluorouracil:
• 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)
Vinorelbine (an anti-cancer medicine)
Cyclophosphamide (an anti-cancer medicine)
Levamisol (medicine used to treat worm infection)
Tamoxifen (an anti-cancer medicine)

Pregnancy, breast-feeding and fertility
You must not take this drug if you are pregnant or planning to become pregnant.
If you are a women of childbearing potential you must use an effective method of
contraception while taking this drug and at least for 6 months afterwards. If
pregnancy occurs during your treatment you must inform your doctor and should
use genetic counselling.
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 . You are advice to sought
conservation of sperm prior to treatment because of the possibility of irreversible
infertility due to therapy with
Flurouracil .
Ask your doctor for advice before taking any medicine.
Driving and using machines
Do not drive or use machines because fluorouracil may produce side 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.
Fluorouracil contains sodium
This medicinal product contains less than 1 mmol sodium (23 mg) per millilitre,
i.e. essentially ‘sodium- free’.

3. How to use Fluorouracil
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. 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 or sodium chloride solution
before it is given to you. It will be given into a vein either as a normal injection or
a slow injection via a drip (infusion).
If you are given more Fluorouracil 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 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.

Like all medicines, this medicine 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,
• your bowel motions are bloodstained or black,
• your mouth becomes sore or develops ulcers,
• numbness, tingling or tremor in the hands or feet,
• quickening of your heart rate and breathlessness,
• feeling confused or feeling unsteady on your feet, coordination problems in
arms and legs, thinking/speech difficulties, vision/memory problems
These are serious side effects. You may need urgent medical attention.

The following information is intended for healthcare professionals only:

First Aid
Eye contact: irrigate immediately with water and seek medical advice.

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.

Skin contact: wash thoroughly with soap and water and remove contaminated

Preparation (guidelines):
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.

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.

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

a) Chemotherapeutic agents should be prepared for administration only by
professionals who have been trained in the safe use of the preparation.

Inhalation, Ingestion: seek medical advice.

Chemical inactivation can be achieved by 5% sodium hypochlorite over 24 hours.

b) Operations such as reconstitution of powder and transfer to syringes should be
carried out only in the designated area.

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
• 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
• 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 oesophagus
• 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 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
• 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
• 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
• 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
• 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
Not Known (Frequency cannot be estimated):
• Fever
• Numbness or weakness of the arms and legs
Reporting of side effects
If you get any side effects, talk to your doctor or nurse. This includes any possible
side effects not listed in this leaflet. You can also report side effects directly via:
Yellow Card Scheme at:
By reporting side effects, you can help provide more information on the safety of
this medicine.

5. HOW TO STORE Fluorouracil
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 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.
Do not use if the product appears brown or dark yellow in solution.
Do not use this medicine if you notice that the container is damaged or particles/
crystals are visible.
Do not throw away any medicines via wastewater. Ask your pharmacist how to
throw away medicines you no longer use. These measures will help protect the

6. Contents of the pack and other information
What Fluorouracil contains
• The active substance is fluorouracil.
• The other ingredients are trometamol, sodium hydroxide and water for injections.
What Fluorouracil looks like and contents of the pack
Fluorouracil 50 mg/ml, Solution for injection or Infusion is a clear, colourless to
almost colourless solution in a type I clear glass vial with rubber closure.
1 ml of solution contains 50 mg of fluorouracil (as sodium salt formed in situ).
Each 5 ml vial contains 250 mg of fluorouracil.
Each 10 ml vial contains 500 mg of fluorouracil.
Each 20 ml vial contains 1000 mg of fluorouracil.
Each 100 ml vial contains 5000 mg of fluorouracil.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Hikma Farmacêutica (Portugal), S.A., Estrada do Rio da Mó, 8, 8A e 8B
Fervença, 2705-906 Terrugem SNT, Portugal
Thymoorgan Pharmazie GmbH, Schiffgraben 23, 38690 Goslar, Germany
Distributed by:
Consilient Health (UK) Ltd., No. 1 Church Road, Richmond upon Thames, Surrey.
TW9 2QE.
This leaflet was last revised in January 2016

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.

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:
18 months

Instruction for Use
Fluorouracil can be given by intravenous injection, or intravenous or intra-arterial

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% solutions at concentration 0.6
mg/ml and 4.0 mg/ml of Fluorouracil .

Fluorouracil is incompatible with folinic acid, carboplatin, cisplatin, cytarabine,
diazepam, doxorubicin, droperidol, filgrastim, gallium nitrate, methotrexate,
metoclopramide, morphine, ondansetrone, parenteral nutrition, vinorelbin, and
other anthracyclines.

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

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