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The product code(s) for this leaflet is: PL 33016/0015 .
Actikerall 5mg/g + 100mg/g Cutaneous Solution
Actikerall 5 mg/g + 100 mg/g Cutaneous Solution
fluorouracil + salicylic acid
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
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 substance to soften hard skin.
Actikerall is a solution to treat actinic keratosis (grade I/II) in adult patients with a healthy immune system.
Actinic keratoses are small crusty, scaly or crumbly patches of skin. They may be red or light brown or have the same colour as your skin. They may be dry or rough to touch and they are sometimes easier to feel than see.
These skin changes commonly occur in people that have had a lot of sun exposure.
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
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:
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.
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist, if you are not sure.
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).
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 have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Mild to moderate irritation and inflammation at the site of application occur in the majority of patients treated with Actikerall. If these reactions get severe, please contact your treating doctor.
As this medicine has a very strong softening effect on the skin, whitish discolorations and scaling of the skin may occur.
The salicylic acid in Actikerall may cause slight irritation, such as skin inflammation (dermatitis) and contact allergic reactions, in patients with sensitive skin or allergy to salicylic acid. Symptoms of contact allergic reactions may include itching, reddening and small blisters even outside the area of application.
Side effects can occur with the following frequencies:
Very common, may affect more than 1 in 10 people
Common, may affect up to 1 in 10 people
Uncommon, may affect up to 1 in 100 people
Mild bleeding, loss of the top layer of skin (erosion), scab, swelling (oedema), ulcer and skin inflammation (dermatitis) frequencies were one category higher in one study when applying Actikerall on an affected area of 25 cm2
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.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and on the carton after EXP. The expiry date refers to the last day of that month.
Do not store above 25 °C. Do not refrigerate or freeze. Keep the bottle tightly closed to prevent drying up.
Caution flammable: keep away from fire and do not use near an open flame, lit cigarette or some devices (e.g. hairdryers).
Do not use Actikerall 3 months after first opening of the bottle.
Do not use Actikerall if you notice crystals.
Do not throw away any medicines via wastewater <or household waste>. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
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