Do not use Actikerall

• 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.

Warnings and precautions

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.

Children and adolescents

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

Other medicines and Actikerall

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.

Pregnancy, breast-feeding and fertility

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

Driving and using machines

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.