Consumer medicine information

APOC-5FU 5% Cream

Fluorouracil

BRAND INFORMATION

Brand name

APOC-5FU Cream

Active ingredient

Fluorouracil

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using APOC-5FU 5% Cream.

1. Why am I using APOC-5FU?


APOC-5FU contains the active ingredient fluorouracil. APOC-5FU 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 APOC-5FU? in the full CMI.

2. What should I know before I use APOC-5FU?


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 APOC-5FU? in the full CMI.

3. What if I am taking other medicines?


Some medicines may interfere with APOC-5FU 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.

4. How do I use APOC-5FU?


Carefully follow all directions given by your doctor or other healthcare professionals.

  • Apply APOC-5FU once or twice daily as advised by your doctor.

More instructions can be found in Section 4. How do I use APOC-5FU? in the full CMI.

5. What should I know while using APOC-5FU?

Things you should do
  • Remind any doctor, dentist or pharmacist you visit that you are using APOC-5FU.
  • Limit your exposure to sun during and immediately following treatment with APOC-5FU.
  • 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 APOC-5FU stop using it and tell your doctor immediately.
Things you should not do
  • Do not let APOC-5FU come into contact with the eyes, eyelids, nostrils or mouth. APOC-5FU is highly irritating to skin and the eyes.
Looking after your medicine
  • Keep APOC-5FU in a cool dry place where the temperature stays below 25°C and protect from heat.
  • Keep out of reach of children and pets.

For more information, see Section 5. What should I know while using APOC-5FU? in the full CMI.

6. Are there any side effects?


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.

BRAND INFORMATION

Brand name

APOC-5FU Cream

Active ingredient

Fluorouracil

Schedule

S4

 

1 Name of Medicine

Fluorouracil.

2 Qualitative and Quantitative Composition

Cream containing fluorouracil 5% w/w.
Excipients with known effect. Methyl hydroxybenzoate, propyl hydroxybenzoate.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

APOC-5FU is a homogenous, white cream.

4 Clinical Particulars

4.9 Overdose

Symptoms. If fluorouracil is accidentally ingested, signs of fluorouracil overdosage may include nausea, vomiting and diarrhoea. Stomatitis and blood dyscrasias may occur in severe cases.
Treatment. Appropriate measures should be taken for the prevention of systemic infection and daily white cell counts should be performed.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. No data available.
Carcinogenicity. No data available.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSFLUORO.gif CAS number. 51-21-8.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/APOC5FST.gif