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FLUOROURACIL VIATRIS
Consumer Medicine Information (CMI) summary
The full CMI on the next page has more details. If you are worried about using this medicine, speak
to your doctor or pharmacist.
FLUOROURACIL VIATRIS contains the active ingredient fluorouracil. FLUOROURACIL VIATRIS
is used to treat solar keratoses, also known as actinic keratoses or sunspots and
Bowen’s disease (type of skin cancer)
For more information, see Section 1. Why am I using FLUOROURACIL VIATRIS? in the full CMI.
Do not use if you have ever had an allergic reaction to fluorouracil or any of the
ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use FLUOROURACIL VIATRIS? in the full CMI.
Some medicines may interfere with FLUOROURACIL VIATRIS and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.
Carefully follow all directions given by your doctor or other healthcare professionals.
Apply FLUOROURACIL VIATRIS once or twice daily as advised by your doctor.
More instructions can be found in Section 4. How do I use FLUOROURACIL VIATRIS? in the full CMI.
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using FLUOROURACIL
VIATRIS.
Limit your exposure to sun during and immediately following treatment with FLUOROURACIL
VIATRIS.
Apply a broad-spectrum sunscreen every day before going outdoors, and regularly reapply
during the day, except directly on the treatment area.
If you become pregnant while using FLUOROURACIL VIATRIS stop using it and tell your
doctor immediately.
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Things you should not do
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Do not let FLUOROURACIL VIATRIS come into contact with the eyes, eyelids, nostrils
or mouth. FLUOROURACIL VIATRIS is highly irritating to skin and the eyes.
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Looking after your medicine
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Keep FLUOROURACIL VIATRIS in a cool dry place where the temperature stays below 25°C
and protect from heat.
Keep out of reach of children.
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For more information, see Section 5. What should I know while using FLUOROURACIL VIATRIS? in the full CMI.
Common side effects include soreness and pain, itchiness or irritation, darkening
or reddening of the skin, burning, crusting, increased sensitivity of the skin to
the sun, rash, dermatitis, and scarring.
Serious side effects include stomach problems such as severe pain, cramps, bloody
diarrhoea and vomiting, swelling and soreness of the mouth and tongue, fever and chills,
or severe pain or ulceration at the site of application.
For more information, including what to do if you have any side effects, see Section
6. Are there any side effects? in the full CMI.
FLUOROURACIL VIATRIS
Active ingredient(s):
Fluorouracil
Consumer Medicine Information (CMI)
This leaflet provides important information about using FLUOROURACIL VIATRIS. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using FLUOROURACIL VIATRIS.
Where to find information in this leaflet:
FLUOROURACIL VIATRIS contains the active ingredient fluorouracil. FLUOROURACIL VIATRIS belongs to a group of anti-cancer medicines that are applied
to the skin. It works by destroying precancerous and cancerous cells, while having
little effect on normal cells.
FLUOROURACIL VIATRIS is used to treat the following skin conditions:
Solar keratoses, also known as actinic keratoses or sunspots.
Bowen's disease (type of skin cancer).
Solar keratoses are rough, red, scaly, or crusty spots on the skin that are caused
by too much exposure to sunlight. They are more common on sun-exposed areas, such
as the face, nose, ears, chest, forearms, and back of the hands.
Solar keratoses are usually harmless, but there is a small risk that they may eventually
turn into skin cancer.
Bowen's disease causes one or more small patches of scaly red skin. It occurs when
there is a growth of abnormal cells in the outer layer of skin. It is most commonly
found on the lower leg.
Do not use FLUOROURACIL VIATRIS 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.
You have a dihydropyrimidine dehydrogenase (DPD) enzyme deficiency.
Check with your doctor if you:
have any other medical conditions including inflammatory skin conditions such as darkening
of skin during pregnancy (chloasma) or a chronic rash (rosacea).
Work outside for long periods of time during the day. Exposure to UV radiation from
the sun or tanning salons may increase the intensity of skin reactions at the sites
where FLUOROURACIL VIATRIS is applied.
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
Do not use FLUOROURACIL VIATRIS if you are pregnant or intend to become pregnant.
FLUOROURACIL VIATRIS may affect your developing baby if you use it during pregnancy.
Talk to your doctor if you are breastfeeding or intend to breastfeed. Nursing mothers
should avoid using FLUOROURACIL VIATRIS as it is not known if the active ingredient
in FLUOROURACIL VIATRIS passes into breast milk, and if there is a possibility that
your baby may be affected.
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 VIATRIS and affect how it works.
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 VIATRIS.
How much to use
Apply FLUOROURACIL VIATRIS to the affected skin once or twice daily as advised by
your doctor.
Follow the instructions below and use FLUOROURACIL VIATRIS until your doctor tells
you to stop.
Wash the skin to be treated using lukewarm water. Avoid soap or other cleansing products
which may sting or irritate your skin, especially as treatment progresses.
Pat dry the affected area with a soft white paper towel.
Allow 15 minutes for your skin to completely dry.
Using a non-metal applicator, cotton bud or a rubber glove apply a thin film of FLUOROURACIL
VIATRIS, smoothing it gently onto your affected skin. Do not use too much cream.
Be very careful not to allow FLUOROURACIL VIATRIS to come into contact with mucous
membranes, such as eyes, eyelids, nostrils and lips.
Do not apply FLUOROURACIL VIATRIS to broken skin or open cuts as it is may be absorbed
into the bloodstream and may cause side effects.
Wash your hands carefully and thoroughly immediately after using FLUOROURACIL VIATRIS.
Do not cover the treated area unless your doctor tells you to.
If your doctor asks you to apply a dressing after using FLUOROURACIL VIATRIS, apply
a fresh dressing to the area(s) daily.
The total area of skin treated with FLUOROURACIL VIATRIS at any time should not exceed
500 sq cm (approx. 23 cm x 23 cm). Treat larger areas a section at a time.
When to use FLUOROURACIL VIATRIS
Apply in the morning and then again in the late afternoon or early evening.
Do not apply FLUOROURACIL VIATRIS immediately before going to bed.
Apply FLUOROURACIL VIATRIS at least 1.5 - 2 hours before bedtime to enable complete
absorption and prevent wiping off onto pillowcases and sheets. Contact with pillowcases
or sheets may result in undesirable spreading of FLUOROURACIL VIATRIS to normal skin
that does not need treatment.
How long to use FLUOROURACIL VIATRIS
Unless your doctor tells you to stop using FLUOROURACIL VIATRIS continue treatment
up until the ulceration stage, usually 3 to 4 weeks. The healing process is usually
complete 1 to 2 months after the end of treatment. The healthy skin surrounding the
treated area may occasionally become reddened but will soon resume its normal colour
once treatment is stopped.
If you forget to use FLUOROURACIL VIATRIS
FLUOROURACIL VIATRIS should be used regularly at the same time each day.
If you miss your dose at the usual time and it is almost time for your next dose,
skip the dose you missed and apply your next dose when you are meant to.
Do not try to make up the dose you missed by applying more the next time.
If you use too much FLUOROURACIL VIATRIS
If you think that you have used too much FLUOROURACIL VIATRIS, you may need urgent
medical attention.
You should immediately:
phone the Poisons Information Centre
(Australia telephone 13 11 26) for advice, or
(Australia telephone 13 11 26) for advice, or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
What you should expect
Expect your appearance to look worse and to feel uncomfortable while treatment is
in progress.
Sometimes it can take several weeks after treatment with FLUOROURACIL VIATRIS has
stopped before you see any improvement in your condition.
When FLUOROURACIL VIATRIS is applied to the skin, the following usually happens:
Redness of the affected area occurs (generally within 3 to 5 days).
This is followed by blistering, peeling, and cracking (within 11 to 14 days) with
occasional open sores and some discomfort.
The treated skin will then flake away.
Some redness of the skin will continue for some time after FLUOROURACIL VIATRIS is
stopped. Scarring is not expected.
Things you should do
Limit your exposure to sun during and immediately following treatment with FLUOROURACIL
VIATRIS.
This will help reduce the likelihood and severity of unwanted side effects.
Apply a broad-spectrum sunscreen (SPF 30 or higher) every day before going outdoors,
and regularly reapply during the day, except directly on the treatment area.
FLUOROURACIL VIATRIS can make you more sensitive to sunlight. In addition to sunscreen,
wear wide-brimmed hat, long sleeves, and trousers (or a long skirt) to protect your
skin.
Call your doctor straight away if you:
Become pregnant while using FLUOROURACIL VIATRIS.
Remind any doctor, dentist or pharmacist you visit that you are using FLUOROURACIL
VIATRIS.
Things you should not do
Do not let FLUOROURACIL VIATRIS come into contact with the eyes, eyelids, nostrils
or mouth. FLUOROURACIL VIATRIS is highly irritating to sensitive skin and the eyes.
Things to be careful of
While treatment is in progress follow these personal care tips:
Avoid using cosmetics or other topical medications, including sunscreens, directly
on the treatment area, unless directed by your doctor.
Your treated skin is expected to become irritated and uncomfortable whilst using FLUOROURACIL
VIATRIS. Applying other products directly on the treatment area may make your discomfort
worse.
You may continue to shave whilst using FLUOROURACIL VIATRIS but take care not to cut
your skin in the treatment area.
As facial skin becomes inflamed during FLUOROURACIL VIATRIS treatment shaving with
a conventional razor may become unpleasant. You may prefer instead to lightly shave
with an electric razor or clip the facial hair.
Looking after your medicine
Store below 25°C. Protect from heat.
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do
not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Keep it where young children cannot reach it.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not use FLUOROURACIL VIATRIS after the expiry date.
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.
During treatment with FLUOROURACIL VIATRIS expect to have a temporary unsightly appearance
and discomfort at the sites where you apply the cream.
Less serious side effects
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Less serious side effects
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What to do
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soreness and pain
itchiness and irritation
darkening or reddening of the skin
burning
crusting
increased sensitivity of the skin to the sun
rash
dermatitis
scarring.
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Speak to your doctor if you have any of these less serious side effects and they worry
you.
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Serious side effects
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Serious side effects
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What to do
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Stomach problems such as severe pain, cramps, bloody diarrhoea and vomiting
Swelling and soreness of the mouth and tongue
Fever and chills.
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Discontinue FLUOROURACIL VIATRIS immediately and 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.
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Tell your doctor 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.
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.
This medicine is only available with a doctor's prescription.
What FLUOROURACIL VIATRIS contains
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Active ingredient
(main ingredient)
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fluorouracil 5 %w/w
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Other ingredients
(inactive ingredients)
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methyl hydroxybenzoate
soft white paraffin
polysorbate 60
propyl hydroxybenzoate
propylene glycol
stearyl alcohol
purified water
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Potential allergens
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methyl hydroxybenzoate
propyl hydroxybenzoate
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Do not take this medicine if you are allergic to any of these ingredients.
What FLUOROURACIL VIATRIS looks like
FLUOROURACIL VIATRIS is a white cream that comes in a 20 g aluminium tube (AUST R
384710).
Who distributes FLUOROURACIL VIATRIS
Sponsor
Accord Healthcare
Level 24, 570 Bourke Street
Melbourne VIC 3000
Australia
Phone: 1800 134 988
Distributor
FLUOROURACIL VIATRIS is distributed in Australia by:
Viatris Pty Ltd
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Phone: 1800 274 276
This leaflet was prepared in February 2022.
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