Consumer medicine information

Fluorouracil Ebewe® Injection

Fluorouracil Ebewe® Injection

Active ingredient: fluorouracil


Consumer Medicine Information (CMI)

This leaflet provides important information about using Fluorouracil Ebewe Injection. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about being given Fluorouracil Ebewe Injection.

Where to find information in this leaflet:

1. Why am I using Fluorouracil Ebewe Injection?
2. What should I know before treatment with Fluorouracil Ebewe Injection?
3. What if I am taking other medicines?
4. How is Fluorouracil Ebewe Injection given?
5. What should I know while being treated with Fluorouracil Ebewe Injection?
6. Are there any side effects?
7. Product details

1. Why am I being treated with Fluorouracil Ebewe Injection?

Fluorouracil Ebewe Injection contains the active ingredient fluorouracil. Fluorouracil Ebewe Injection belongs to a group of medicines called antineoplastic or cytotoxic medicine. You may also hear of these being called chemotherapy medicines.

It works by killing cancer cells and stopping cancer cells from growing and multiplying. It may be used alone or in combination with other medicines to treat cancer.

This medicine is used to treat some types of cancer including breast, colon, rectum, stomach, liver, pancreatic, uterine (cervical particularly), ovarian and bladder cancer.

2. What should I know before treatment with Fluorouracil Ebewe Injection?

Warnings

Do not use Fluorouracil Ebewe Injection if you:

  • are allergic to fluorouracil, or any of the ingredients listed at the end of this leaflet. Always check the ingredients to make sure you can use this medicine.
  • have an infection or high temperature.
  • have any blood disorder with a reduced number of red blood cells, white blood cells or platelets.
  • have problems with blood clotting.
  • have a lowered immunity due to diseases including HIV / AIDS or cancer.
  • have a lowered immunity due to treatment with medicines such as corticosteroids, cyclosporin or other medicines used to treat cancer (including radiation therapy).
  • have a type of enzyme deficiency called complete dihydropyrimidine dehydrogenase (DPD) deficiency.

Check with your doctor if you:

  • have any other medical conditions have any other such as heart disease, kidney disease, liver disease or any known enzyme deficiencies
  • take any medicines for any other condition.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Females: tell your doctor immediately if you are pregnant or intend to become pregnant.

Like most cytotoxic medicines fluorouracil is not recommended for use during pregnancy. It is recommended that you use an appropriate method of birth control. Your doctor will discuss this with you. If there is any need to consider fluorouracil during your pregnancy, your doctor will discuss with you the benefits and risks of using it.

Talk to your doctor immediately if you are breastfeeding or intend to breastfeed.

Males: tell your doctor if your partner intends to become pregnant while you are being given fluorouracil or shortly after you have stopped treatment with fluorouracil.

Fluorouracil may cause birth defects if either the male or female is using it at the time of conception. It is recommended that you use an appropriate method of birth control. A barrier method of birth control, such as a condom, should be used. Your doctor will discuss this with you.

Previous radiation or other cancer treatment

Tell your doctor if you have had previous radiation treatment or other cancer treatment

Vaccinations

Tell your doctor if you are going to be vaccinated (have an injection to prevent a certain disease).

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with Fluorouracil Ebewe Injection and affect how it works.

  • allopurinol (used to treat gout)
  • cimetidine (used to treat stomach ulcers)
  • phenytoin (used to treat epilepsy)
  • warfarin (used to prevent blood clots)
  • brivudine and sorivudine (used to treat viral infections)
  • metronidazole (used to treat some types of infections)
  • leucovorin (folinic acid) (used together with some cancer therapy)
  • levamisole, methotrexate and other cytotoxic medicines (used to treat cancer).

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Fluorouracil Ebewe Injection.

4. How is Fluorouracil Ebewe Injection given?

How much will be given

  • Your doctor will decide what dose you will receive.
  • Fluorouracil Ebewe Injection may be given alone or in combination with other drugs to treat cancer.

How long will Fluorouracil Ebewe Injection need to be given

  • Several courses of fluorouracil therapy may be needed depending on your response to treatment.
  • Additional treatment may not be repeated until your blood cell numbers return to acceptable levels and any unwanted effects have been controlled.
  • Ask your doctor if you want to know more about the dose of fluorouracil you receive.

How Fluorouracil Ebewe Injection is given

Fluorouracil can be given in three ways:

  • as an injection into a vein
  • as a continuous slow injection via a ‘drip’ into a vein
  • as a slow injection via a ‘drip’ into an artery.

Fluorouracil must only be given by a doctor or nurse.

If too much Fluorouracil Ebewe injection is given

Fluorouracil Ebewe Injection will be given under medical supervision so an overdose is unlikely. However, if you experience severe side effects tell your doctor or nurse immediately.

Symptoms of an overdose may include the side effects listed in Section 6. Are there any side effects? but are usually of a more severe nature.

5. What should I know during treatment with Fluorouracil Ebewe Injection?

Things you should do

Keep all off your doctor’s appointments so your progress can be checked.

Your doctor may want to do blood and other tests from time to time to check on your progress and detect any unwanted side effects.

Keep follow up appointments with your doctor.

It is important to have your follow-up doses of fluorouracil at the appropriate times to get the best effects from your treatments.

Take precautions to reduce your risk of bleeding or infection

This medicine can lower the number of white blood cells and platelets in your blood. This means that you have an increased chance of getting an infection or bleeding. The following precautions should be taken to reduce your risk of infection or bleeding:

  • Avoid people who have infections. Check with your doctor immediately if you think you may be getting an infection, or if you get a fever, chills, cough, hoarse throat, lower back or side pain or find it painful or difficult to urinate.
  • Be careful when using a toothbrush, toothpick or dental floss. Your doctor, dentist, nurse or pharmacist may recommend other ways to clean your teeth and gums. Check with your doctor before having any dental work.
  • Be careful not to cut yourself when you are using sharp objects such as a razor or nail cutters.
  • Avoid contact sports or other situations where you may bruise or get injured.

Take precautions to protecting other people while receiving treatment with Fluorouracil Ebewe Injection

Your body breaks down fluorouracil and uses it to fight cancer. The breakdown products may be excreted in body fluids and waste, including blood, urine, faeces, vomit and semen.

In general, precautions to protect other people should be taken while you are receiving chemotherapy and for one week after the treatment period by:

  • Flushing the toilet twice to dispose of any body fluids and waste
  • Wearing gloves to clean any spill of body fluid or waste. Use paper towels or old rags, a strong solution of non-bleaching detergent and large amounts of water to mop up the spill. Discard the towels or rags into a separate waste bag and dispose of fluids in the toilet
  • Washing linen or clothing that is heavily contaminated by body fluids or waste separately from other items. Use a strong solution of non-bleaching detergent and large amounts of water
  • Placing soiled disposable nappies and other pads in a plastic bag, seal and dispose into the garbage
  • For sexual intercourse, use a barrier method such as a condom.

Call your doctor immediately if you become pregnant while you are being given fluorouracil.

Remind any doctor, dentist, nurse or pharmacist you visit that you are using Fluorouracil Ebewe Injection.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how Fluorouracil Ebewe Injection affects you.

Fluorouracil Ebewe Injection may cause dizziness, tiredness or confusion in some people. If you have any of these symptoms, do not drive, operate machinery, or do anything else that could be dangerous.

Drinking alcohol

Tell your doctor if you drink alcohol.

Alcohol may make dizziness or confusion worse.

Looking after your medicine

Fluorouracil Ebewe Injection is stored in a hospital which is responsible for storing and disposing of any unused product correctly.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Side effects What to do
  • nausea, vomiting
  • diarrhoea
  • loss of appetite
  • hair loss
  • skin rash
  • changes in skin or nail appearance
  • euphoria
  • tiredness
  • headache
  • dizziness
  • fatigue
  • irritability
  • restlessness
Speak to your doctor if you have any of these side effects and they worry you.
Side effects What to do
  • sore mouth, mouth ulcers
  • a sore rectum or anus
  • loss of fingernails or toenails
  • unsteady walking, muscle weakness or muscle cramps
  • changes in vision, jerky eye movements, excess tears, or uncomfortable sensitivity to light
  • tingling of the hands and/or feet followed by pain, redness and swelling
  • slurred speech
  • memory loss, disorientation or confusion
  • an increased sensitivity of the skin to sunlight (such as redness, itching, swelling, blistering) which may occur more quickly than normal. You should avoid being in the sunlight for too long.
  • fever
  • pain, stiffness or swelling in joints
  • swelling, redness, or pain near the injection site.
Speak to your doctor as soon as possible if you notice any of these side effects.
Side effects What to do
  • chest pain
  • irregular and/or rapid heartbeat
  • loss of consciousness
  • signs of an infection (e.g. fever, chills, sore throat, cough, pain with urination, swollen or red skin)
  • unusual bleeding or bruising (including bloody or black stools, blood in urine)
  • severe diarrhoea
  • severe abdominal pain
  • severe mouth ulceration
  • difficulty swallowing
  • seizures, coma
  • any signs of an allergic reaction such as shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin.
Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

Tell your doctor, nurse or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people. Some of these side effects can only be found when your doctor does tests from time to time to check your progress.

The benefits and side effects of fluorouracil may take some time to occur. Therefore, even after you have finished receiving your fluorouracil treatment you should tell your doctor immediately if you notice any of the side effects listed in this section.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor’s prescription.

What Fluorouracil Ebewe Injection contains

Active ingredient
(main ingredient)
fluorouracil
Other ingredients
(inactive ingredients)
sodium hydroxide; water for injections

Fluorouracil Ebewe Injection does not contain gluten, lactose, sucrose, tartrazine or any other azo dyes.

Vial stopper is not made with natural rubber latex.

Do not take this medicine if you are allergic to any of these ingredients.

What Fluorouracil Ebewe Injection looks like

Fluorouracil Ebewe Injection is a clear colourless solution in a glass vial.

Fluorouracil Ebewe comes in the following strengths:

  • Fluorouracil Ebewe injection 500 mg of fluorouracil in a 10 mL vial (AUST R 98544)
  • Fluorouracil Ebewe injection 1000 mg of fluorouracil in a 20 mL vial (AUST R 98545)
  • Fluorouracil Ebewe injection 2500 mg of fluorouracil in a 50 mL vial (AUST R 166738)
  • Fluorouracil Ebewe injection 5000 mg of fluorouracil in a 100 mL vial (AUST R 166741)

*Not all presentations are marketed.

Who distributes Fluorouracil Ebewe Injection

Sandoz Pty Ltd
ABN 60 075 449 553
54 Waterloo Road
Macquarie Park, NSW 2113
Tel: 1800 726 369

This leaflet was revised in October 2022.