Fluorouracil 50 mg / ml injection – patient leaflet, side effects, dosage

1. What Fluorouracil Injection is and what it is used for 2. What you need to know before you use Fluorouracil In 3. How to use Fluorouracil Injection

jection

1. 4. Possible side effects
2. 5. How to store Fluorouracil Injection
3. 6. Contents of the pack and other information
4. 1.

   What Fluorouracil Injection is and what it is use

   d for

   Fluorouracil Injection is an anti-cancer medicine. Treatme anti-cancer medicine is sometimes called cancer chemot Fluorouracil Injection is used to treat many common canc particularly cancers of the large bowel and breast. It may combination with other anti-cancer medicines or radiothe

   nt with an herapy.

   ers,

   be used in rapy.

2. What you need to know before you use Fluorou

racil

Injection

Do not use Fluorouracil Injection

• if you are allergic to Fluorouracil or any of the other of this medicine (listed in section 6)

  ingredients

• if you are in a seriously weakened (including nutritio due to long illness

  nal) state

• if your bone marrow has been damaged by other ca treatments (including radiotherapy)

  ncer

• if you know that you do not have any activity of the dihydropyrimidine dehydrogenase (DPD) (complete deficiency)

  enzyme

  DPD

• if you have a potentially serious infection • if your cancer is non-malignant
• if you are breast-feeding

• if you are taking or have taken in the past 4 weeks b sorivudine and similar drugs (antivirals) Tell your doctor if any of the above applies to you before medicine is used.

  rivudine,

  this

Warnings and precautions

Talk to your doctor or pharmacist before using Fluorourac

il Injection mally (your

• if your bone marrow is not producing blood cells nor doctor will do a blood test to check this)

  • if you have any problems with your kidney • if you have any problems with your liver in (yellowing of the skin)

    s

    cluding jaundice

  • if you have suffered from angina (chest pa of heart disease

    in) or have a history

  • if you have problems with your heart. Tell experience any chest pain during treatme • if you are in generally poor health and hav • if you have had surgery within the last 30

    your doctor if you nt

    e lost a lot of weight days

  • if you are elderly

  • if you know that you have a partial deficien the enzyme dihydropyrimidine dehydrogen

    cy in the activity of ase (DPD)

  • if you have a family member who has part deficiency of the enzyme dihydropyrimidin (DPD)

    ial or complete

    e dehydrogenase

  • if you require blood testing, because it can laboratory tests

    interfere with some

  • if you are monitoring your blood thyroxine DPD deficiency: DPD deficiency is a genetic co usually associated with health problems unless medicines. If you have DPD deficiency and tak injection, you are at an increased risk of severe

    levels

    ndition that is not you receive certain e Fluorouracil

    side effects (listed

under section 4 Possible side effects). It is reco for DPD deficiency before start of treatment. If of the enzyme you should not take Fluorouracil a reduced enzyme activity (partial deficiency) y prescribe a reduced dose. If you have negative deficiency, severe and life-threatening side effe Contact your doctor immediately if you are con the side effects or if you notice any additional si the leaflet (see section 4 Possible side effects). Contact your healthcare provider immediately, i following signs or symptoms: new onset of conf or otherwise altered mental status, difficulty wit coordination, visual disturbances. These could

mmended to test you you have no activity injection. If you have our doctor might test results for DPD cts may still occur. cerned about any of de effects not listed in

f you experience the usion, disorientation, h balance or

be signs of

encephalopathy which can lead to coma and d Some patients may experience a sensitivity to l administration of fluorouracil, it is recommended t exposure to sunlight (see section 4).

eath, if left untreated. ight following

o avoid prolonged

Patients undergoing radiotherapy are at an incr necrosis (death of tissue or skin) caused by rad If you have had leukaemia and are in remission vaccines before 3 months after your last chemo people in your direct contact such as family me a polio vaccine.

eased likelihood of iation.

do not take live

therapy. Also you and mbers should not take

The administration of fluorouracil has been ass occurrence of hand-foot syndrome. This syndro characterized as a tingling sensation of hands

ociated with the

me has been

and feet, which may

progress over the next few days to pain when h walking. The palms and soles become swollen Tell your doctor if any of the above applies to y medicine is used.

olding objects or and tender.

ou before this

Other medicines and Fluorouracil Inject

ion

Special care is needed if you are taking/using o some could interact with Fluorouracil Injection, • methotrexate, cisplatin, cytarabine, mitom (anti-cancer medicines)

ther medicines as for example:

ycin-C, tamoxifen

• metronidazole (an antibiotic)

• calcium leucovorin (also called c the harmful effects of anti-cance • allopurinol (used to treat gout) • cimetidine (used to treat stomac • warfarin (used to treat blood clot • interferon alpha 2a; brivudine, s (antivirals)

  alcium folinate - used to reduce r medicines)

  h ulcers)

  s)

  orivudine and similar drugs

• phenytoin (an anti-epilepsy med

  icine)

• vaccines

Tell your doctor or pharmacist if you a or might take any other medicines, in without a prescription.

re taking, have recently taken cluding medicines obtained

You may need to be monitored, and y Injection may be adjusted when given calcium folinate).

our dose of Fluorouracil with leucovorin (also called

Pregnancy, breast-feeding and

fertility

If you are pregnant or breast-feeding, are planning to have a baby, ask your this medicine.

think you may be pregnant or doctor for advice before taking

Women must avoid becoming pregna

nt and use a highly effective method of contraception during treatm least 6 months afterwards. Men treate not to father a child during and for up treatment.

ent with Fluorouracil and fo d with Fluorouracil are advi to 3 months following end o

r at sed f

Men and women should both seek ad such as conservation of eggs or sper the possibility of irreversible infertility Fluorouracil should be used during pr benefit justifies the potential risk to th If pregnancy occurs during your treat doctor and should seek genetic couns should be offered if you are planning treatment.

vice on fertility preservation m before treatment because due to therapy.

of egnancy only if the potential e foetus.

ment you mus

t inform your elling. Geneti to become pre

c counselling gnant after your

Since it is not known whether fluorour milk, breast-feeding must be discontin Fluorouracil Injection.

acil passes in

to breast ued before treatment with

Driving and using machines

Do not drive or use machines if you e Fluorouracil, such as nausea and vom produce adverse events on your nerv changes. If you experience any of the any tools or machines, as they may i

xperience any side effect from iting. Fluorouracil can also ous system and cause visual se effects, do not drive or use mpair your ability to do so.

Fluorouracil Injection contains s

odium

The 5 ml vial contains 40.1 mg of sod cooking/table salt) in each vial. This is

ium (main component of equivalent to 2% of the recommended maximum daily dietary The 10 ml vial contains 80.2 mg of so cooking/table salt) in each vial. This is recommended maximum daily dietary The 20 ml vial contains 160.4 mg of s of cooking/table salt) in each vial. Thi recommended maximum daily dietary

intake of sodium for an adult. dium (main component of equivalent to 4% of the intake of sodium for an adult. odium (main component s is equivalent to 8% of the intake of sodium for an adult.

The 50 ml vial contains 401 cooking/table salt) in each v recommended maximum da The 100 ml vial contains 80 cooking/table salt) in each v recommended maximum da

• increased ch healing due t • anaemia (red • difficulty brea • abnormality i mg of sodium (main component of ial. This is equivalent to 20% of the ily dietary intake of sodium for an adult. 2 mg of sodium (main component of ial. This is equivalent to 40% of the ily dietary intake of sodium for an adult.

If you experien soon as possibl Very common sid

ce any of the following tell your doctor as e:

e effects

• infections ance of picking up infections and/or delayed wound

  o low white blood cells uction in red blood cells)

3. How to use Fluorouraci

l Injection

thing

This medicine is given into

a vein or an artery. If it is given into a vein,

n the heart’s rhythm it can either be injected (usi is given into an artery, it will If it is to be given as an infus

ng a syringe) or infused (using a drip). If it be given as an infusion.

• diarrhoea • feeling or bei • anorexia (los • inflammation anus

  ng sick ion the medicine will be diluted before use.

  s of appetite)

Dose

of the lining of the mouth, throat, gut, rectum or

Your doctor will work out the you and how often it must b The dose of medicine given condition, your size, if you h your bone marrow, liver and Your doctor will tell how wel working using blood tests.

correct dose of Fluorouracil Injection for e given.

• hair loss (rev

  ersible especially in women)

• reddening, s soles of the f • tiredness

  welling or pain in the palms of the hands and/or the eet

to you will depend on your medical ave had recent surgery and how well kidneys are working.

• feel generally • weakness • liver cell dam

  unwell

l your bone marrow, liver and kidneys are age

The total d

aily dose should

not exceed 1 gram.

If you are

given too mu

ch or too little Fluorouracil Injection

This medic that you wi or nurse if doctor will

ine will be given ll be given too m you have any co monitor you clos

to you by a doctor or nurse. It is unlikely uch or too little, however, tell your doctor ncerns. If you have taken too much, your ely for at least 4 weeks.

Common side eff

ects

• low white blo • chest pain Uncommon side

  od cells accompanied by fever effects

• feeling of inte

  nse excitement and happiness

4. Possible

side effects

Like all medici

nes, fluoroura

cil can cause side effects, alt

hough not everybody get

s them.

• watering eye movements o • headache • dizziness

  s, changes in vision, sensitivity to light, side-to-side f the eyes

If any of the immediatel

following h y:

appen, tell your doctor

• severe al

  lergic reactio

  n – you may experience a sudden itchy rash (hiv

  es), swelling o

  f the hands, feet, ankles, face, lips, may cause difficulty in swallowing or ay feel you are going to faint

  mouth or throat (which breathing), and you m

• chest pains (which ma having a heart attack) • shortness of breath • your bowel motions ar • your mouth becomes s

  y be due to heart problems, including e bloodstained or black ore or develops ulcers

• symptoms of leucoenc weakness and fatigue, speech difficulties, seiz These are very serious side

  ephalopathy (disease of brain) – extreme staggering while walking, thinking or ures, coma.

  effects. You may need urgent medical attention.

The frequency of possible s the following convention: Very common: may affect m Common: may affect up to 1 Uncommon: may affect up t Rare: may affect up to 1 in 1 Very rare: may affect up to 1 Not known: frequency cann

ide effects listed below is defined using ore than 1 in 10 people in 10 people

o 1 in 100 people

,000 people in 10,000 people ot be estimated from the available data

• symptoms of • numbness, ti • sleepiness

  Parkinson’s disease (e.g. shaking hands) ngling or tremor in the hands or feet

• irregular hea • low blood pre • skin problem inflammation • skin may app • changes in y of the nails • sensitivity of Rare side effects

  rt beat, palpitations ssure (you may feel faint)

  s (including dry skin, itchy weals, rash, redness, )

  ear lighter or darker, may occur in patches our nails, such as changes in colour or thickening the skin to light

• serious allerg • feeling confu • reduced bloo

  ic reaction causing difficulty breathing or dizziness sed d supply to the brain, intestines and extremities

  (ischaemia) • discolouratio • blood clots (p Very rare side eff

  n in your fingers and toes (Raynaud’s syndrome) ain, redness or swelling of the part affected) ects

• disorientation • muscle weak

  ness

• brain disorde movements,

  rs have been reported causing uncontrollable difficulty speaking, fits and coma

  Fluorouracil 50 mg/ml Injection

  The followin professiona

  g information is intended for medical or healthcare ls only

  Further to th the preparati

  e information included in section 3, practical information on on/handling of the medicinal product is provided here.

  Incompat

  ibilities

  Formulated s with acidic dr is reported to

  olutions are alkaline and it is recommended that admixture ugs or preparations should be avoided. Fluorouracil Injection be incompatible with cytarabine, diazepam, methotrexate, platinum com that are unst

  pounds, doxorubicin (and presumably other anthracyclines able at alkaline pH), and calcium folinate (leucovorin).

  Use and h

  andling, and disposal

  The pH of Fl over the pH r If a precipitat re-dissolve b cool to body The product colour or if p Fluorouracil I Chloride 0.9 Fluorouracil i with other ch

  uorouracil Injection is 8.9 and the drug has maximal stability ange 8.6 to 9.0.

  e has formed as a result of exposure to low temperatures, y heating to 60°C accompanied by vigorous shaking. Allow to temperature prior to use.

  should be discarded if it appears brown or dark yellow in articles are visible.

  njection may be diluted with Glucose 5% Injection or Sodium % Injection or Water for Injections immediately before use. njection should not be mixed directly, in the same container, emotherapeutic agents or intravenous additives.

  Chemical an at 20-21°C. F used immedi conditions pr normally be l place in cont Cytotoxic H

  d physical in-use stability has been demonstrated for 5 days rom a microbiological point of view, the product should be ately. If not used immediately, in-use storage times and ior to use are the responsibility of the user and would not onger than 24 hours at 2-8 °C, unless dilution has taken rolled and validated aseptic conditions.

  andling Guidelines

  Should be ad qualified phy agents.

  ministered only by, or under the direct supervision of, a sician who is experienced in the use of cancer chemotherapeutic

  Fluorouracil I professionals Preparation dedicated for

  njection should only be prepared for administration by who have been trained in the safe use of the preparation. should only be carried out in an aseptic cabinet or suite the assembly of cytotoxics.

  In the event protection an absorbent m be cleaned a spillage bag Contaminatio Fluorouracil i should be av In the event washed with may be used should be so ingested.

  of spillage, operators should put on gloves, face mask, eye d disposable apron and mop up the spilled material with an aterial kept in the area for that purpose. The area should then nd all contaminated material transferred to a cytotoxic or bin and sealed for incineration.

  n s an irritant, contact with skin and mucous membranes oided.

  of contact with the skin or eyes, the affected area should be copious amounts of water or normal saline. A bland cream to treat the transient stinging of the skin. Medical advice ught if the eyes are affected or if the preparation is inhaled or

  Please refer datasheets.

  to the marketing authorisation holder for COSHH hazard

  Preparation

  Guidelines

  1. a)

     Ch onl the

     emotherapeutic agents should be prepared for administration y by professionals who have been trained in the safe use of preparation.

  2. b)

     Op syr sui

     erations such as reconstitution of powder and transfer to inges should be carried out only under aseptic conditions in a te or cabinet dedicated for the assembly of cytotoxics. e personnel carrying out these procedures should be equately protected with clothing, gloves and eye shield.

  3. c) Th ad
• Pregnant personnel are advised not to handle chemotherapeutic agents.

Disposal

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 device.

23 Jun 2026

• kidney failure
• cardiac arrest
• sudden cardiac death

Frequency unknown

• a disorder of the nerves which can cause weakness, tingling or numbness
• hyperammonaemic encephalopathy (brain dysfunction caused by elevated ammonia)
• condition characterised by headache, confusion, seizures and changes in vision (posterior reversible encephalopathy syndrome [PRES])
• heart disease that presents with chest pain, shortness of breath, dizziness, fainting, irregular heartbeat (stress cardiomyopathy)
• faster heart beat
• inflammation of the outer lining of the heart
• breathlessness
• fever
• the vein where fluorouracil is administered may become painful or discoloured, which may be the sign of a blood clot
• inflammation of the skin causing red scaly patches and possibly occurring together with pain in the joints and fever (cutaneous lupus erythematosus [CLE])
• air in the intestinal wall
• serious condition that presents with difficulty breathing, vomiting and abdominal pain with muscle cramps (lactic acidosis)
• serious complication with rapid break down of cancer cells causing high levels of uric acid, potassium and phosphate (tumour lysis syndrome)
• high blood levels of triglycerides, a type of fat
• pain, redness or swelling at the infusion site during or shortly after the injection/infusion (may be due to the injection not going into the vein properly)
• vitamin B1 deficiency and Wernicke’s encephalopathy (brain damage caused by vitamin B1 deficiency)
• inflammation in the small and large bowel causing pain and diarrhoea, which can lead to death of bowel tissue (colitis, enterocolitis)
• Inflammation of the heart muscle
• Heart problems that can cause quickening of your heart rate and breathlessness

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).

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. 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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Fluorouracil Injection

Keep out of the sight and reach of children

12:55

Expiry

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.

Storage

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

Do not use this medicine if you notice it appears brown or dark yellow in colour, or if particles are visible.

Disposal

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 Fluorouracil Injection contains

The active substance is fluorouracil. Each millilitre (ml) of solution contains 50 mg of fluorouracil.

The other ingredients are sodium hydroxide (see section 2 “Fluorouracil Injection contains sodium”) and Water for Injections.

What Fluorouracil Injection looks like and contents of the pack

Fluorouracil Injection is clear, colourless or slightly yellow solution for injection without visible particles, 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(s)
• 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

Hospira UK Limited

Walton Oaks

Walton-On-The-Hill

Dorking Road

Tadworth

Surrey

KT20 7NS

UK

Manufacturer

Pfizer Service Company BV

Hermeslaan 11

1932 Zaventem

Belgium

This leaflet was last revised in 02/2026.

Ref: gxFU 22_0

Fluorouracil 50 mg/ml Injection

2026-1002385C