Fluourouracil Injection

Do not use Fluorouracil Injection

• if you have shown signs of hypersensitivity (severe allergy) to fluorouracil in the past
• if you are in a seriously weakened state due to long illness
• if your bone marrow has been damaged by other cancer treatments (including radiotherapy)
• if your cancer is non-malignant
• Tell your doctor if any of the above applies to you before this medicine is used.

Take special care with Fluorouracil Injection

• if your bone marrow is not producing blood cells normally (your doctor will do a blood test 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 (chest pain) or have a history of heart disease
• if you have reduced activity/deficiency of the enzyme DPD (dihydropyrimidine dehydrogenase)
• if you are in generally poor health and have lost a lot of weight
• if you have had surgery within the last 30 days

Special care is needed if you are taking/using other medicines as some could interact with Fluorouracil Injection, for example:

• 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)

Pregnancy and breast-feeding

• Tell your doctor if you are pregnant, trying to become pregnant or breast-feeding.
• This medicine must not be used during pregnancy and breast-feeding.
• Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

• Do not drive or use machines if you experience any side effect (e.g. visual disturbance) which may lessen your ability to do so.

How to use Fluorouracil Injection

This medicine is given into a vein or an artery.
If it is given into a vein, it can either be injected (using a syringe) or infused (using a drip).
If it is given into an artery, it will be given as an infusion.
If it is to be given as an infusion the medicine will be diluted before use.

Dose

Your doctor will work out the correct dose of Fluorouracil Injection for you and how often it must be given.
The dose of medicine given to you will depend on your medical condition, your size, if you have had recent surgery and how well your bone marrow, liver and kidneys are working.
Your doctor will tell how well your bone marrow, liver and kidneys are working using blood tests.
The total daily dose should not exceed 1 gram.
If you are given too much or too little Fluorouracil Injection
This medicine will be given to you by a doctor or nurse.
It is unlikely that you will be given too much or too little, however, tell your doctor or nurse if you have any concerns.

Possible side effects

Like all medicines, fluorouracil can cause side effects, although not everybody gets them.

If any of the following happen, tell your doctor immediately:

1. 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.
2. chest pains
3. your bowel motions are bloodstained or black
4. your mouth becomes sore or develops ulcers
5. symptoms of leucoencephalopathy (disease of brain):

— weakness
— coordination problems in arms and legs
— thinking/speech difficulties
— vision/memory problems
— seizures
— headaches

Serious side effects.
You may need urgent medical attention.
If you experience any of the following tell your doctor as soon as possible:

1. quickening of your heart rate and breathlessness
2. painful and/or watering eyes
3. changes in vision or sensitivity to light
4. numbness
5. tingling or tremor in the hands or feet
6. diarrhoea
7. feeling confused
8. feeling unsteady on your feet
9. fever
10. reddening of the palms of the hands and/or the soles of the feet
11. skin problems
12. changes in your nails
13. the vein where fluorouracil is administered may become painful or discoloured
14. hair loss (especially in women)
15. feeling or being sick
16. Fluorouracil may lead to changes in your blood cells.
17. Your doctor will take blood samples to check for these.

How to store Fluorouracil Injection

• Keep out of the reach and sight of children

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

• The product should be discarded if it appears brown or dark yellow in colour.

Disposal

• Medicines should not be disposed of via wastewater or household waste.
• Ask your pharmacist how to dispose of medicines no longer required.
• These measures will help to protect the environment.