Actikerall 5mg/g + 100mg/g Cutaneous Solution

• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any of the side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Actikerall is and what it is used for
2. What you need to know before you use Actikerall
3. How to use Actikerall
4. Possible side effects
5. How to store Actikerall
6. Content of the pack and other information

• if you are allergic to fluorouracil, salicylic acid or any of the other ingredients of this medicine (listed in section 6).
• while breast-feeding.
• during pregnancy, and if there is a possibility that you might be pregnant.
• if you have kidney problems.
• if it could come into contact with the eyes, the inside of the mouth or nose or the genitals (mucous membranes).

Certain other medicines can intensify the side effects of Actikerall or lead to other side effects. See ‘Other medicines and Actikerall’ below.

Talk to your doctor or pharmacist before using Actikerall

• if you kow that you do not have any activity of the enzyme dihydropryrimidine dehydrogenase (DPD) (complete DPD deficiency). It is important that you do not apply more Actikerall than indicated in section 3 of this package leaflet.
• if you suffer from a reduced ability to sense touch, pain and temperature (if you have diabetes, for example). In this case, your treatment areas must be closely monitored by your doctor.
• Actikerall should not be used on bleeding lesions.
• The area treated should be protected against direct sunlight as much as possible while using Actikerall and the patient must not use a sunlamp or sun bed.
• There is no experience with Actikerall for the treatment of skin cancers such as rodent ulcer (BCC) and Bowen's disease, which should therefore not be treated with the product.
• In treating an area with actinic keratosis that is also affected by another skin disease it should be taken into account that the outcome of treatment may differ.
• There is no experience with Actikerall for repeated treatment cycles in patients with actinic keratosis or for retreatment, if a lesion comes back.

Actikerall should not be used in children or adolescents under 18 years of age. Children usually do not get actinic keratosis.

Tell your doctor or pharmacist, if you are using, have recently taken or might take any other medicines. If several medicines are taken at the same time, the effect of individual medicines can be intensified or weakened.

In particular tell your doctor, if you take any of the following:

• medicines used to treat viruses such as chicken pox or shingles (brivudine, sorivudine or similar medicines). You must not use Actikerall, if you are using or have used any of these medicines in the past 4 weeks as it may result in increased side effects.
• epilepsy medicine (phenytoin). Using Actikerall may lead to elevated blood levels of phenytoin.
• medicine used to treat cancer and auto-immune diseases (methotrexate). This medicine may interact with Actikerall causing undesirable effects.
• medicine used to treat diabetes (sulfonylureas). This medicine may interact with Actikerall causing undesirable effects.

You must not use Actikerall while breast-feeding, during pregnancy and if there is a possibility that you might be pregnant.

No special precautions are required.

Actikerall contains dimethyl sulfoxide and ethanol. Dimethyl sulfoxide may be irritant to the skin. This medicine contains 160 mg alcohol (ethanol) in each gram. It may cause burning sensation on damaged skin.

Actikerall should be applied once daily unless your doctor has told you otherwise.

If you have an actinic keratosis in an area of thin skin e.g. around the eyes and temple, your doctor may tell you to apply Actikerall less frequently. If severe side effects occur, reduce the frequency of drug application to three times per week until the side effects improve. It may also be necessary for your doctor to monitor your treatment more often.

For application to the skin (cutaneous use).

• Remove the white film on your skin from the previous day’s application by gently peeling it off (unless this is the first time you have used this medicine). Warm water may help to remove the film.
• To open the bottle, press the lid down and turn.
• Remove excess solution from the brush by wiping it in the neck of the bottle. Although allowing enough product for film formation upon drying.
• Dab the solution on the actinic keratosis once daily.
• Multiple actinic keratoses (up to 10 lesions) can be treated simultaneously, but do not use on large areas of skin.
• The total area of skin being treated with Actikerall at any one time should not exceed 25 cm2 (5 cm x 5 cm).
• Let the solution dry and form a film.
• Do not cover with a dressing.
• Close the bottle tightly to prevent it drying out. If Actikerall dries out, it must not be used any longer. Do not use Actikerall if you notice any crystals.
• Do not apply to hairy skin due to sticking together of the hair in the skin area where Actikerall is applied, making it difficult to remove the film. When applied to hairy skin, a shave or other suitable methods of hair removal should be considered prior to any application.

Actikerall must not be allowed to come into contact with the eyes, the inside of the mouth or nose or the genitals (mucous membranes).

Actikerall solution may permanently stain clothing, fabric or acrylics (such as acrylic bathtubs), so avoid contact with them.

Caution flammable: keep away from fire and do not use near an open flame, lit cigarette or some devices (e.g. hairdryers).

Consult your doctor regularly during treatment.

Actikerall is applied to actinic keratoses once daily until the lesions have completely cleared or for up to a maximum of 12 weeks. Improvement of actinic keratoses can be seen as early as 4 weeks after starting treatment and the improvement increases over time up to 12 weeks. The clearance of actinic keratoses may continue for up to 8 weeks after stopping treatment. Treatment should be continued even in the absence of any effect after the first 4 weeks.

If you have the impression that the effect of Actikerall is too strong or too weak, talk to your doctor or pharmacist.

If you apply Actikerall more often than once daily, you will be more likely to experience skin reactions and they may be more severe. In this case, please contact your doctor.

Do not use a double dose to make up for a forgotten dose. Continue your treatment as the doctor has told you or as described in this leaflet.

Please contact your doctor, if you want to stop treatment.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

The active substances are fluorouracil and salicylic acid.

1 g (= 1.05 ml) of cutaneous solution contains 5 mg of fluorouracil and 100 mg of salicylic acid.

The other ingredients are: dimethyl sulfoxide; ethanol, anhydrous; ethyl acetate; pyroxyline; poly(butyl methacrylate, methyl methacrylate).

Actikerall is a clear, colourless to slightly orange-white cutaneous solution.

This medicinal product is packed in a brown glass bottle with a child resistant closure of white polypropylene in a cardboard carton. The closure of the bottle is connected to a brush with which to apply the solution. The brush applicator (CE mark) consists of plastic (polyethylene) with brush hairs of nylon secured in shaft with stainless steel (V2A).

Pack size: bottle containing 25 ml cutaneous solution.

This medicinal product is authorised in the Member States of the EEA under the following names:

Country Trade names

Austria Actikerall 5 mg/g + 100 mg/g Lösung zur Anwendung auf der Haut

Czech Republic Actikerall 5 mg/g + 100 mg/g

Germany Actikerall 5 mg/g + 100 mg/g Lösung zur Anwendung auf der Haut

Luxembourg Actikerall 5 mg/g + 100 mg/g Lösung zur Anwendung auf der Haut

Poland Actikerall

Slovak Republic Actikerall 5 mg/g + 100 mg/g

United Kingdom Actikerall 5 mg/g + 100 mg/g Cutaneous Solution

This leaflet was last revised in 08/2020