CONSUMER MEDICINE INFORMATION
NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia. This page contains answers to some common questions about . It does not contain all the information that is known about . It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risk of you using this medicine against the benefits he/she expects it will have for you. If you have any concerns about using this medicine, ask your doctor or pharmacist. Bookmark or print this page, you may need to read it again.
What Fluorouracil Injection is used for
Fluorouracil belongs to a group of medicines known as antineoplastics and is classified as an antimetabolite. Fluorouracil works by preventing the growth of cancer cells and eventually destroying them. It is used for the cancer of the breast, colon, rectum, stomach or the pancreas.
Fluorouracil Injection may be used for the management of other conditions that are not mentioned above. Your doctor will be able to tell you about the specific condition for which you have been prescribed Fluorouracil Injection.
This medicine is available only with a doctor's prescription.
Before you are given Fluorouracil Injection
When you must not be given it
Do not use Fluorouracil Injection if:
you have an allergy to fluorouracil or any of the ingredients listed at the end of this leaflet
you have a poor diet
you have a low blood count
you have a serious infection
you are pregnant
If you are not sure whether any of these apply to you, check with your doctor.
Before you are given it
Tell your doctor if:
1. you have any allergies to:
any other medicine
any other substances, such as foods, preservatives or dyes
2. you are pregnant or intend to become pregnant
Fluorouracil Injection is not recommended for use during pregnancy. If it is necessary for you to be given it, your doctor or pharmacist will discuss the risks and benefits of taking/using it during pregnancy.
3. you are breast-feeding or plan to breast feed
Fluorouracil may pass into breast milk and therefore there is a possibility that the breast-fed baby may be affected.
4. you have received radiotherapy or any other treatment for cancer
5. you have or have had any medical conditions, especially the following:
any sort of infection e.g. sinusitis, tooth abscess etc
mouth ulcers
an ulcer or bleeding in the gut
vomiting, diarrhoea
any problems of the heart
kidney problems or disease
liver problems or disease
Taking other medicines
Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.
Some medicines and fluorouracil may interfere with each other. These include:
other anticancer drugs like methotrexate
allopurinol (used to treat gout)
metronidazole (used to treat infections)
cimetidine (used to reduce acid content in the stomach)
folinic acid or any vitamin preparation that contains folic or folinic acid
phenytoin (used to control epilepsy and treat certain cardiac arrhythmias)
Your doctor will advise you about continuing to take other medicines while you are receiving fluorouracil.
How Fluorouracil Injection is given
Fluorouracil is given by injection into a vein. It may also be given by an infusion (slow injection) into a vein or an artery.
Fluorouracil must only be given by a doctor or nurse.
Your doctor will decide what dose, how often and how long you will receive it. This depends on your condition and other factors, such as your weight, age, sex, blood tests, how well your kidneys and liver are working, and whether or not other medicines are being given at the same time.
If you are given too much (overdose)
This rarely happens as Fluorouracil Injection is administered under the care of a highly trained doctor.
However, if you are given too much fluorouracil, you may experience some of the effects listed under "Side effects" below.
Your doctor has information on how to recognise and treat an overdose. Ask your doctor if you have any concerns.
Side effects
Tell your doctor or nurse as soon as possible if you do not feel well while you are using Fluorouracil Injection.
Like other medicines, fluorouracil can cause some side effects. If they occur, most are likely to be minor or temporary. However, some may be serious and need medical attention.
Ask your doctor or pharmacist to answer any questions that you may have.
Do not be alarmed by this list of possible side effects. You may not experience any of them.
Tell your doctor immediately if you notice any of the following:
fever and chills, sore throat, sweats or generally feel unwell
chest pains fast or irregular heart beat
severe mouth ulcers, mouth soreness, redness of the inside of the mouth
difficulty in swallowing
severe diarrhoea or abdominal pain
a sore rectum or anus, blood in stools or urine
severe nausea or vomiting
bleeding, unusual bruising, bleeding gums or pinpoint red spots on the skin
rash or itching
dizziness, muscular weakness, unsteadiness when walking, slurred speech
rapid movement of the eye, excess tears, uncomfortable sensitivity to sunlight
darkening of the nailbed or any other body area
loss of fingernails or toenails
a feeling of tiredness, shortness of breath
tingling of hands and feet followed by pain, redness and swelling
confusion, euphoria, headache
memory loss, drowsiness or lack of energy
coma and seizures
These may be serious side effects. You may need urgent medical attention. Serious side effects are rare.
Tell your doctor immediately if you notice any of the following and if they worry you:
nausea
vomiting
diarrhoea
loss of appetite
weakness
hair loss
changes in skin or nail appearance
soreness or ulceration of the mouth
These are more common side effects.
Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor. Some side effects may only be seen by your doctor.
Storage
Fluorouracil Injection will be stored in the pharmacy or on the ward. The injection is kept in a cool dry place, protected from light, where the temperature stays between 15- 25 degrees C.
Product Description
What it looks like
Fluorouracil Injection is a clear, colourless solution in a plastic vial.
Fluorouracil Injection can be identified by an Australian Registration Number, which is found on the packaging: AUST R 11367, AUST R 49308 and AUST R 49309.
Ingredients
Fluorouracil Injection contains Fluorouracil BP 25mg/mL, Sodium Hydroxide BP and Water for Injections BP. It does not contain a preservative.
Manufacturer
Pfizer (Perth) Pty Limited
ABN 32 051 824 956
15 Brodie Hall Drive,
Bentley WA 6102 Australia
Distributed in Australia by:
Pfizer Australia Pty Ltd
ABN 50 008 422 348
38-42 Wharf Road
West Ryde NSW 2114 Australia
Sponsor in Australia
Pfizer (Perth) Pty Limited
ABN 32 051 824 956
15 Brodie Hall Drive
Bentley WA 6102 Australia
This Consumer Medicine Information was written in November 2000.
Date of most recent amendment: 03 August 2006
