FAQ

What is Actinic Keratosis (AK)?

Actinic keratoses (AK) or Solar Keratoses (SK) 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 risk that they may turn into skin cancer.

ACTIKERALL Leisions

Picture courtesy of Almirall S.A.

Why do AK lesions occur?

Actinic keratosis lesions commonly occur in people over 40 after chronic sun exposure^6,7

Other risk factors include:

Age > 65
Regular outdoor activities
Place of residence (high UV)

Remember that sun damage adds up, so even a small amount of exposure counts.

What is ACTIKERALL?

ACTIKERALL is a clear, colourless to slightly orange–white solution. It is packed in a 25 mL brown glass bottle with a child-resistant closure. It is used to treat mild to moderate solar keratosis lesions, also known as actinic keratosis lesions or sunspots.¹

Ingredients

The active substances of ACTIKERALL are fluorouracil and salicylic acid.
One gram of solution contains:

5 mg of fluorouracil
100 mg of salicylic acid

It also contains the following inactive excipients:

dimethyl sulfoxide
ethanol absolute
ethyl acetate
pyroxylin
butyl methacrylate/methyl methacrylate copolymer (3:1)

This medicine does not contain lactose, sucrose, gluten, tartrazine, or any other azo dyes.

Ask your doctor if you have any questions about why this medicine has been prescribed for you.

Your doctor may have prescribed it for another reason.

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

How does ACTIKERALL work?

ACTIKERALL contains two active substances, fluorouracil and salicylic acid.

Fluorouracil belongs to a group of medicines known as antimetabolites which inhibit the growth of cells (cytostatic agent).

Salicylic acid is a hard skin softening substance.

How to use ACTIKERALL?

How to apply Actikerall

Things to remember

Close the bottle tightly to prevent it from drying out
After application, do not cover lesion(s) with a dressing until the solution is dry
ACTIKERALL should not be applied to hairy skin* as the hair becomes stuck together in the affected area.
When applied to hairy skin, a shave or other suitable hair removal methods should be considered before any application of ACTIKERALL
Using warm water, mineral oil or rubbing alcohol may help you to remove the film from the previous day’s application
⁵
If you forget one application, do not use a double dose to make it up

*Use only on the face, forehead or bald scalp (excluding eyelids, lips and mucosa).

When and where to apply ACTIKERALL?

ACTIKERALLshould beapplied once dailyto lesions forup to 12 weeksunless your doctor has told you otherwise, on the:

Face (excluding eyelids and lips)

Forehead or bald scalp

Ears

Temples

Nose
Your doctor will indicate if you should applyACTIKERALLto an area with several lesions(field) orto single lesions
Infield treatment,multiple lesionsas well as the surrounding skincanbe treated at the same time
ACTIKERALL should NOT be applied to hairy skin*as the hair becomes stuck in the affected area. When applied to hairy skin, a shave or other suitable hair removal methods should be considered before any application ofACTIKERALL
The total area of skin treated shouldnot exceed 25 cm²(eg. 5 cm x 5 cm). Examples of acceptable treatment areas are below:

It is important that you follow the instructions from your doctor

*Use only on the face, forehead or bald scalp (excluding eyelids and lips)

What if I forget to use ACTIKERALL?

Do not apply more than once daily.

You will be more likely to experience skin reactions and they will be more severe if used in higher doses than recommended.

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering to use your medicine, you could set a daily alarm or reminder, or integrate it into other daily routines like brushing your teeth. Just ask your pharmacist for some suggestions if you are having trouble remembering.

If you use too much (overdose) or swallow the solution

Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else has used too much ACTIKERALL or in the case of accidental swallowing. Do this even if there are no signs of discomfort or poisoning.

You may need urgent medical attention.

▼ This medicinal product is subject to additional monitoring in Australia. This will allow quick identification of new safety information. You can help by reporting any side effects you may get to your doctor, or directly at www.tga.gov.au/reporting-problems .

WARNING: Actikerall® is intended for use only on mild and moderate solar keratosis. Actikerall® should not be applied on a total area greater than 25 square centimetres (cm²) at any one time. Use Actikerall® only on the face, forehead, or bald scalp. Do not use Actikerall on eyelids, lips, or mucous membranes.

AK = Actinic Keratosis

References

1. ACTIKERALL Consumer Medicine Information 2023. 2. ACTIKERALL Product Information. 3. Stockfleth E, et al . Low-dose 5-fluorouracil in combination with salicylic acid as a new lesion-directed option to treat topically actinic keratoses: histological and clinical study results. Br J Dermatol . 2011;165(5):1101-8. 4. Simon JC, et al . A prospective randomized exploratory study comparing the efficacy of once-daily topical 0.5% 5-fluorouracil in combination with 10.0% salicylic acid (5-FU/SA) vs. cryosurgery for the treatment of hyperkeratotic actinic keratosis. J Eur Acad Dermatol Venereol . 2015;29(5):881-9. 5. Martínez N, et al . Alternative lacquer removal techniques to remove 0.5% 5-fluorouracil/10% salicylic acid topical solutions for actinic keratosis. Presented at 14th EADO Congress; 6-9 November; Barcelona, Spain. 2018. 6. https://www.cancervic.org.au/cancer-information/types-of-cancer/skin_cancers_non_melanoma/skin-cancer-overview.html [ accessed on 01 May 2023]. 7. British Association of Dermatologists, Patient Information Leaflet Actinic Keratosis 2020, accessed from https://www.skinhealthinfo.org.uk/wp-content/uploads/2018/11/Actinic-Keratoses-Update-Dec-2020-Lay-reviewed-Oct-2020.pdf [accessed on 01 May 2023].

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