PATIENT
INFORMATION LEAFLET
This
leaflet contains important information about your
medicine; read it carefully.
Keep
this leaflet; you may want to read it again.
If you
have any questions or are not sure about anything,
ask your doctor or pharmacist.
Fluorouracil 25 mg/ml Injection
- The
active substance is fluorouracil
- The
other ingredients are sodium hydroxide and Water for
Injections
1. What
Fluorouracil Injection is and what it is used for
Fluorouracil
Injection is an anti-cancer medicine, in the form of a
solution for injection. Treatment with an anti-cancer
medicine is sometimes called cancer chemotherapy.
The medicine
is presented in glass containers called vials. Each ml
(millilitre) of solution contains 25 mg (milligrams) of
fluorouracil. The 10ml vial contains 250 mg
fluorouracil, the 20 ml vial contains 500 mg
fluorouracil and the 100 ml vial contains 2.5 g
fluorouracil. It is available in packs containing 5 x 10
ml, 10 x 20 ml or 1 x 100 ml. Not all presentations may
be marketed.
Fluorouracil
Injection is used to treat many common cancers,
particularly cancers of the GI tract, pancreas, large
bowel, ovary, prostate and breast. It may be used in
combination with other anti-cancer medicines or
radiotherapy.
2.
Before Fluorouracil Injection is used
Fluorouracil Injection should not be used:
-
if you have shown signs of hypersensitivity
(severe allergy) to fluorouracil or any of the
ingredients of this medicine on previous
occasions
-
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 pregnant or trying for a baby
-
if you are breastfeeding
-
if your tumour is non-malignant
Special care will be taken:
-
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 have suffered from angina or have a
history of heart disease. 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 are taking certain other medicines, such
as:
-
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)
-
sorivudine (an antiviral)
Please
tell your doctor if you are taking, or have recently
taken, any other medicines, including ones that are
not prescribed for you.
Do
not drive or use machines:
-
if you experience any effect which may impair
your ability to drive or use machines.
3. How
Fluorouracil Injection is used
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 800 mg - 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.
As this
medicine will usually 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.
4.
Possible Side Effects
Like all
medicines, fluorouracil can have side effects.
If
any of the following happen, tell your doctor
immediately:
-
chest pains
-
your bowel motions are bloodstained or black
-
your mouth becomes sore or develops ulcers
-
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.
-
symptoms of leucoencephalopathy (disease of
brain) - weakness, coordination problems in arms
and legs; thinking/speech difficulties;
vision/memory problems; seizures; headaches.
These
are very serious side effects. You may need urgent
medical attention. All of these very serious side
effects are rare.
If
you experience any of the following tell your doctor
as soon as possible:
-
diarrhoea
-
feeling or being sick
-
hair loss (especially in women)
-
skin problems
-
changes in your nails
-
unsteady on your feet
-
fever
-
quickening of your heart rate and breathlessness
-
painful and/or watering eyes, changes in vision
or sensitivity to light
-
feeling confused
-
reddening of the palms of the hands and/or the
soles of the feet
-
the vein where fluorouracil is administered may
become painful or discoloured
If you
notice any side effects not mentioned in this leaflet,
please tell your doctor or pharmacist.
5.
Storing Fluorouracil Injection
Keep out of
the reach of children.
The vials
should not be stored above 25°C. They should not be put
in the fridge or frozen.
The vials
should be kept in the outer carton in order to protect
from light.
This
medicine should not be used after the expiry date
printed on the vial label.
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