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FLUOROURACIL INJECTION 25MG/ML SOLUTION FOR INJECTION

Active substance(s): FLUOROURACIL

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Fluorouracil Injection 25 mg/ml · 81300-VP1GB · CA · 08.14 · Pharma-Code: 411
Format: 444 x 150 mm · HKS 44 · Corrective action: KV01_osc_14.08.14 / KV02_osc_15.08.14

PACKAGE LEAFLET:
INFORMATION FOR THE USER

Fluorouracil Injection 25 mg/ml,
solution for injection
Fluorouracil

Read all of this leaflet carefully before you
start using this medicine.
• Keep this leaflet. You may need to read it
again.
• If you have any further questions, ask your
doctor or pharmacist.
• This medicine has been prescribed for you.
Do not pass it on to others. It may harm
them, even if their symptoms are the same
as yours.
• If any of the side effects gets serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor or
pharmacist.
In this leaflet:
1. What Fluorouracil Injection 25 mg/ml is and
what it is used for
2. Before you use Fluorouracil Injection
25 mg/ml
3. How to use Fluorouracil Injection 25 mg/ml
4. Possible side effects
5. How to store Fluorouracil Injection 25 mg/ml
6. Further information

1. WHAT FLUOROURACIL INJECTION
25 MG/ML IS AND WHAT IT IS USED FOR

• have had problems with your kidneys or liver,
• take phenytoin for epileptic fits.

Fluorouracil is an anti-cancer drug.

Your treatment will be first given to you in
hospital. Before you are given fluorouracil you
will have to have a blood test, and possibly
other tests, so that your doctor can be sure that
you can undergo fluorouracil treatment.

Fluorouracil Injection 25 mg/ml, solution for
injection, is used to treat the symptoms of
many common cancers, particularly cancers of
the large bowel and breast. It may be used in
combination with other anti-cancer drugs.
2. BEFORE YOU USE FLUOROURACIL
INJECTION 25 MG/ML
Do not use Fluorouracil Injection 25 mg/ml
• if you are allergic (hypersensitive) to
fluorouracil,
• if you are pregnant or breast-feeding,
• if you have been seriously weakened by
long illness or other treatments (including
radiotherapy) for your cancer,
• if you are receiving treatment for chickenpox
or shingles (Herpes zoster) with brivudine,
sorivudine or similar substances, or have
received such treatment in the last four
weeks.
Take special care with Fluorouracil Injection
25 mg/ml
Before you receive fluorouracil tell your doctor
if you
• have suffered from angina (heart condition
marked by sudden attacks of chest pain),
• have a history of heart disease,
• have ever experienced chest pain,

Tell your doctor if you experience any chest
pain during treatment.
Taking other medicines
Fluorouracil is known to interact with the
following medicines:
• allopurinol (used to treat high levels of uric
acid),
• leucovorin (also called folinic acid – used in
cancer therapy and treatment of folic acid
deficiency),
• cimetidine (used to treat heartburn and
gastrointestinal ulcers),
• clozapine (used to treat schizophrenia),
• methotrexate (used to treat cancer or
autoimmune diseases),
• metronidazole (used to treat infections),
• phenytoin (used to treat epilepsy),
• sorivudine (used to treat viral infections) or
chemically related analogues (e.g. brivudine),
• warfarin (used to prevent blood from clotting).
Tell your doctor if you are taking or have
recently taken any of these medicines.
Your doctor may decide that you can be
given fluorouracil at the same time as these
medicines.

Please also tell your doctor or pharmacist
if you are taking or have recently taken any
other medicines, including medicines obtained
without a prescription.
Pregnancy and breast-feeding
Do not use Fluorouracil Injection 25 mg/ml if
you are pregnant or breast-feeding.
Ask your doctor or pharmacist for advice before
taking any medicine.
Driving and using machines
Fluorouracil may induce side effects such as
nausea and vomiting. This may influence your
ability to drive or use machines.
3. HOW TO USE FLUOROURACIL INJECTION
25 MG/ML
If you are using Fluorouracil Injection 25 mg/ml,
solution for injection, at home, it is important
to follow the instructions given to you by your
doctor, nurse and pharmacist. If the container
is damaged, and fluorouracil is spilt, you should
contact your nurse or pharmacist. If fluorouracil
comes into contact with your skin, wash the
area with soap and water and contact your
doctor, nurse or pharmacist. Do not clean up
spilt fluorouracil without first contacting your
nurse or pharmacist.
Fluorouracil is given by intravenous injection or
infusion (drip or pump). If you are in hospital it
may be given by intra-arterial infusion.

The dosage will depend on the condition being
treated and whether or not other drugs are
being administered. It will also depend on the
results of your blood tests and the state of your
health.
The usual fluorouracil dose is around
1 g (1000 mg) per day. Your treatment may be
given daily or at weekly intervals initially.
Further courses may be prescribed by your
doctor according to your response to treatment.
If you take more Fluorouracil Injection
25 mg/ml
If you are given more fluorouracil than intended,
consult your doctor immediately.
If you forget to take Fluorouracil Injection
25 mg/ml
If you miss a dose or if you are at home and
have any trouble with your pump, contact your
nurse or pharmacist as soon as possible.
If you stop using Fluorouracil Injection
25 mg/ml
When your course of fluorouracil is finished
you may feel tired and experience some of the
undesirable effects (see below) associated with
fluorouracil treatment.

doctor will inform you of the expected benefits
and potential risks of the use of Fluorouracil
Injection 25 mg/ml, solution for injection.
If your bowel motions are bloodstained or
if your mouth becomes very sore, tell your
doctor immediately.
Common side effects are:














an increased risk of infections,
changes in the components of the blood,
inflammation of the eyes,
unsteady on feet,
increase in heart rate,
chest pain,
breathlessness,
diarrhoea,
nausea,
vomiting,
sore mouth,
hair loss,
reddening of palms of hands and soles
of feet,
• tiredness,
• fever.
Diarrhoea and sickness are quite common, but
your doctor may be able to give you medicine(s)
to reduce this.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Fluorouracil Injection
25 mg/ml can cause side effects, although not
everybody gets them.
Prior to commencement of treatment, your

Hair loss is particularly common in women.
The hair usually grows again when fluorouracil
is stopped. Talk to your nurse if you are
unhappy about this.

Fluorouracil Injection 25 mg/ml · 81300-VP1GB · CA · 08.14 · Pharma-Code: 411
Format: 444 x 150 mm · HKS 44 · Corrective action: KV01_osc_14.08.14 / KV02_osc_15.08.14

You may become unsteady on your feet or
experience a quickening of your heart rate and
breathlessness. Tell your doctor or nurse if this
occurs.

Blood circulation disorders can lead to e.g.
numbness or paleness (extremities), pain
(digestive tract), paralysis or speech difficulties
(brain).

If you experience chest pain tell your doctor or
nurse.

You may experience one or several of these
symptoms during therapy or after your
fluorouracil treatment: be sure to inform your
doctor if you do.

Fluorouracil affects the components of blood
and you will need to have blood tests during
and after treatment with fluorouracil.
Less common side effects are:














severe infection,
increase in the level of uric acid in the blood,
allergic reaction,
headache,
seizure,
painful and/or watering eyes,
vision changes,
nose-bleeds,
wheezing,
stomach ulceration and bleeding,
liver problems,
skin and nail changes,
pain or discoloration of the vein where
Fluorouracil Injection 25 mg/ml is administered,
• confusion,
• abnormal movements,
• blood circulation disorders.
Fluorouracil treatment may cause you to
become confused; however this is reversible
when treatment is stopped. Tell your doctor
immediately if this occurs.

Reporting of side effects
If you get any side effects, talk to your doctor or
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.
By reporting side effects you can help provide
more information on the safety of this medicine.
5. HOW TO STORE FLUOROURACIL
INJECTION 25 MG/ML
Do not store above 25 °C.
Do not refrigerate or freeze.
Keep the container in the outer carton.
Do not use Fluorouracil Injection 25 mg/ml after
the expiry date which is stated on the carton.
Keep out of the reach and sight of children!
6. FURTHER INFORMATION
What Fluorouracil Injection 25 mg/ml contains
The active substance is fluorouracil. Each
septum vial contains 100 ml of solution
containing 2500 mg fluorouracil.

The other ingredients are: sodium hydroxide
and water for injections.
What Fluorouracil Injection 25 mg/ml looks
like and contents of the pack
Fluorouracil Injection 25 mg/ml, solution
for injection, is a clear, colourless or almost
colourless solution.
Fluorouracil Injection 25 mg/ml, solution for
injection, is an aqueous solution for injection
which is supplied in a colourless glass vial.
Fluorouracil Injection 25 mg/ml, solution for
injection vials are supplied in packs containing
one vial or ten vials.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
medac
Gesellschaft für klinische
Spezialpräparate mbH
Theaterstr. 6
22880 Wedel
Germany
Manufacturer
medac
Gesellschaft für klinische
Spezialpräparate mbH
Theaterstr. 6
22880 Wedel
Germany
This leaflet was last revised in 08/2014.

-----------------------------------------------------The following information is intended for
medical or healthcare professionals only:
Instructions on how to store, handle, and
dispose Fluorouracil Injection 50 mg/ml
Shelf life after preparing the solution for infusion
ready for use
Chemical and physical in-use stability of the
solution diluted with glucose 5 % or sodium
chloride 0.9 % injection has been demonstrated
for 24 hours at a temperature not exceeding
25 °C.

face mask and disposable apron should be
worn. Syringes and infusion sets should be
assembled carefully to avoid leakage (use of
Luer lock fittings is recommended).
All materials that have been utilised for dilution
and administration should be disposed of
according to standard procedures (incineration).
Any solution remaining after first use should be
discarded. Waste disposal procedures should
take into account the cytotoxic nature of this
substance.

From a microbiological point of view, the
product should be used immediately. If not
used immediately, in-use storage times and
conditions prior to use are the responsibility
of the user and would normally not be longer
than 24 hours at 2 to 8 °C, unless dilution has
taken place in controlled and validated aseptic
conditions.
If a precipitate has formed as a result of
exposure to low temperatures, redissolve by
heating to 40 °C accompanied by vigorous
shaking. Allow to cool to body temperature prior
to use.
Handling and disposal
Preparation of solution for administration should
be carried out in a designated handling area
and working over a washable tray or disposable
plastic-backed absorbent paper.
Suitable eye protection, disposable gloves,

81300-VP1GB
CA

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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