Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Actikerall 5mg/g + 100mg/g Cutaneous Solution
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Salicylic acid, Fluorouracil may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
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.
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What you need to know before you take it
e Actikerall
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.
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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.
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Actikerall should not be used on bleeding lesions.
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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.
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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.
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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.
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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.
3.
How to take it
Actikerall
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist, if you are not sure. Dosage 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
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to three times per week until the side effects improve. It may also be necessary for your doctor to monitor your treatment more often. Method of administration 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. Further instructions 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. Duration of 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 use more Actikerall than you should 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. If you forget to use Actikerall 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. If you stop using Actikerall 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.
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4.
Possible side effects
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.
Possible side effects
can occur with the following frequencies: Very common, may affect more than 1 in 10 people reactions at the application site
- skin redness (erythema), inflammation, irritation (including burning), pain, itch Common, may affect up to 1 in 10 people headache skin scaling (exfoliation) reactions at the application site
- mild bleeding, loss of the top layer of skin (erosion), scab Uncommon, may affect up to 1 in 100 people dry eye, itching eye, increased watery eyes (lacrimation) reactions at the application site
- skin inflammation (dermatitis), swelling (oedema), ulcer 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 Reporting of side effects 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.
5.
How to store it
Actikerall
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 oC. 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.
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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.
6.
Contents of the pack and other information
What Actikerall contains 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). What Actikerall looks like and contents of the pack 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. Marketing Authorisation Holder and Manufacturer
Almirall Hermal GmbH Schotzstrasse 3 21465 Reinbek Germany This medicinal product is authorised in the Member States of the EEA under the following names: Country Austria Czech Republic Germany Luxembourg Poland Slovak Republic United Kingdom
Trade names Actikerall 5 mg/g + 100 mg/g Lösung zur Anwendung auf der Haut Actikerall 5 mg/g + 100 mg/g Actikerall 5 mg/g + 100 mg/g Lösung zur Anwendung auf der Haut Actikerall 5 mg/g + 100 mg/g Lösung zur Anwendung auf der Haut Actikerall Actikerall 5 mg/g + 100 mg/g Actikerall 5 mg/g + 100 mg/g Cutaneous Solution
This leaflet was last revised in 08/2020
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Frequently asked questions about Actikerall 5mg/g + 100mg/g Cutaneous Solution
How do I take Actikerall 5mg/g + 100mg/g Cutaneous Solution?
Actikerall 5mg/g + 100mg/g Cutaneous Solution comes as solution containing 5mg / 100mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Actikerall 5mg/g + 100mg/g Cutaneous Solution?
The active substance in Actikerall 5mg/g + 100mg/g Cutaneous Solution is salicylic acid, fluorouracil.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Actikerall 5mg/g + 100mg/g Cutaneous Solution, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Actikerall 5mg/g + 100mg/g Cutaneous Solution without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: salicylic acid, fluorouracil
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Actikerall is indicated for the topical treatment of slightly palpable and/or moderately thick hyperkeratotic actinic keratosis (grade I/II) in immunocompetent adult patients.
Grade I/II intensity is based on the 4-point scale of Olsen et al. (1991), see section 5.1.
4.2. Posology and method of administration
Posology
Adults
Actikerall should be applied once daily to the affected area (up to 25 cm²) until the lesions have completely cleared or for up to a maximum of 12 weeks. If severe side effects occur, reduce the frequency of drug application to three times per week until the side effects improve. If areas of skin with a thin epidermis are treated, the solution should be applied less frequently and the course of the therapy monitored more often.
Response can be seen as early as in four weeks (see section 5.1). Response increases over time and data are available for treatment up to 12 weeks. Complete healing of the lesion(s) or optimal therapeutic effect may not be evident for up to eight weeks after treatment cessation. Treatment should be continued, although response is not apparent after the first four weeks.
When assessing options to treat recurrent lesions, the physician should consider that the efficacy of retreatment with Actikerall has not been formally measured in clinical trials.
Paediatric population
There is no relevant use of Actikerall in the paediatric population for the indication of actinic keratosis.
Elderly population
No dose adjustment is necessary.
Method of administration
Actikerall is intended for cutaneous use only. There is experience in treating up to ten single lesions at the same time. Multiple actinic keratoses and surrounding skin can be treated simultaneously, when field treatment is preferred. The total area of skin being treated with Actikerall at any one time should not exceed 25 cm2 (5 cm x 5 cm).
Actikerall is applied by use of the brush applicator connected to the closure cap. To avoid overloading the brush with solution, the brush should be wiped off in the neck of the bottle before application, although allowing enough product for film formation upon drying.
The treated area should not be covered after application and the solution should be left to dry to form a film over the applied area. Each time Actikerall is reapplied the existing film should be removed beforehand by gently peeling it off. Warm water may help to remove the film. Actikerall should not be applied to hairy skin. Use on hairy skin can lead to conglutination of hair in the affected area. When applied to hairy skin a shave or other suitable methods of hair removal should be considered prior to any application of Actikerall.
4.3. Contraindications
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Actikerall is contraindicated in pregnancy and lactation (see section 4.6).
Actikerall must not be used to treat patients with renal insufficiency.
Actikerall must not be used in conjunction with brivudine, sorivudine and analogues. Brivudine, sorivudine and analogues are potent inhibitors of the fluorouracil-degrading enzyme dihydropyrimidine dehydrogenase (DPD) (see also section 4.5).
Actikerall must not be allowed to come into contact with the eyes or mucous membranes.
4.4. Special warnings and precautions for use
DPD enzyme
The enzyme dihydropyrimidine dehydrogenase (DPD) plays an important role in the breakdown of fluorouracil. Inhibition, deficiency or decreased activity of this enzyme can result in accumulation of fluorouracil. However, as percutaneous absorption of fluorouracil is negligible when Actikerall is administered as per the approved prescribing information, no differences in the safety profile of Actikerall are expected in this sub-population and no dose adjustments are considered necessary.
Sensory disturbances
In patients with sensory disturbances (e.g. those with diabetes mellitus) close medical monitoring of the treatment area is required.
Sun exposure
Actinic keratosis is due to chronic UV damage. Any local irritation where Actikerall has been applied may worsen with sun exposure. Patients should be counselled to protect the skin against further excessive or cumulative exposure, especially in the area being actively treated.
Other skin conditions
There is no experience in treating actinic keratoses in an area that is also affected by another skin disease and the clinician should take into account that the outcome of treatment may differ.
No experience exists for the treatment of basal cell carcinoma (BCC) and Bowen's disease, which should therefore not be treated with the product.
General
Actikerall contains the cytostatic agent fluorouracil.
Actikerall should not be used on bleeding lesions.
The bottle should be closed tightly after use or the solution will dry up quickly and can no longer be used correctly.
The solution should not be used if crystals occur.
Actikerall solution should not come into contact with textiles or acrylics (e.g. acrylic bathtubs) as the solution may cause permanent stains.
Caution flammable: keep away from fire and do not use near an open flame, lit cigarette or some devices (e.g. hairdryers).
This medicinal product contains dimethyl sulfoxide which may be irritant to the skin.
This medicine contains 160 mg of alcohol (ethanol) in each gram. It may cause burning sensation on damaged skin.
4.5. Interaction with other medicinal products and other forms of interaction
The enzyme dihydropyrimidine dehydrogenase (DPD) plays an important role in the breakdown of fluorouracil. Antiviral nucleoside analogues such as brivudine and sorivudine may lead to a drastic increase in plasma concentrations of fluorouracil or other fluoropyrimidines and thus an associated increase in toxicity. For this reason, an interval of at least 4 weeks between the use of fluorouracil and brivudine, sorivudine and analogues should be observed.
In case of accidental administration of nucleoside analogues such as brivudine and sorivudine to patients who are being treated with fluorouracil, effective measures for reducing fluorouracil toxicity should be taken. Admission to a hospital may be indicated. All necessary measures for protection from systemic infections and dehydration should be introduced.
Elevated plasma levels of phenytoin leading to symptoms of phenytoin intoxication have been reported with the concomitant administration of systemic fluorouracil and phenytoin.
There is no evidence for relevant systemic absorption of salicylic acid, however absorbed salicylic acid may interact with methotrexate and sulphonylureas.
4.6. Fertility, pregnancy and lactation
Pregnancy
There are no data from the use of topical fluorouracil in pregnant women. A teratogenic effect of systemically administered fluorouracil has been observed in animals (see section 5.3). Salicylic acid can adversely influence the outcome of pregnancy in rodents.
Actikerall is contraindicated during pregnancy (see section 4.3).
Breastfeeding
It is unknown whether fluorouracil or its metabolites are excreted in human milk after topical application. A risk to the suckling child cannot be excluded.
Actikerall is contraindicated during lactation (see section 4.3).
Fertility
Fertility studies with systemic fluorouracil resulted in transient male infertility and in reduction of pregnancy rates in female rodents. However, this is unlikely to be of relevance to human, due to the very limited absorption of active compounds after cutaneous administration of Actikerall.
4.7. Effects on ability to drive and use machines
Actikerall has no influence on the ability to drive and use machines.
4.8. Undesirable effects
Summary of the safety profile
Mild to moderate irritation and inflammation at the application site occurred in the majority of patients treated with the solution for actinic keratosis. In case of severe reactions frequency of treatment may be reduced.
As the medicinal product has a very strong softening effect on the stratum corneum, whitish discolorations and scaling of the skin may occur, particularly in the area surrounding the actinic keratosis.
Due to its salicylic acid content, use of this medicinal product may cause slight signs of irritation, such as dermatitis and contact allergic reactions, in predisposed patients. Such contact allergy reactions may be manifested in the form of itching, reddening and small blisters even outside the area of application.
Tabulated list of adverse reactions
Adverse reactions according to MedDRA system organ class and in decreasing frequency are listed below. Frequencies are defined as very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); and not known (cannot be estimated from the available data).
System organ class
Frequency
Adverse reaction
Nervous system disorders
Common
Headache
Eye disorders
Uncommon
Dry eye, eye pruritus, increased lacrimation.
Skin and subcutaneous tissue disorders
Common
Skin exfoliation
General disorders and administration site conditions
Very common
At application site: erythema, inflammation, irritation (including burning), pain, pruritus.
Common
At application site: bleeding, erosion, scab
Uncommon
At application site: oedema, ulcer, dermatitis
Description of selected adverse reactions
Application site reactions are frequently reported with Actikerall treatment and are expected to occur, because these are related to the pharmacological activity of the active substances fluorouracil and salicylic acid on the skin. Severe application site reactions can be managed by dose reduction (see section 4.2). In case of bleeding stop treatment until adverse reaction improves (see section 4.4). When surface of contiguous application increases (field up to 25cm2), administration site adverse reactions frequency may increase. In particular frequency of dermatitis, scab, erosion, bleeding, oedema may be Very common, while frequency of ulcer may be Common.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
4.9. Overdose
When applied on the skin as recommended, systemic intoxication with either active is unlikely. Significantly more applications than recommended result in an increase of frequency of reactions at the application site and their severity.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
⚠ Not the same combination. This medicine contains Salicylic acid, Fluorouracil. The products below do not contain exactly the same set of active substances — they are not direct substitutes.
⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.
- FLUOROURACIL ACCORD 50 mg/ml prescription partial — not the same combinationFLUOROURACILUM · injection / infusion
- 5 - Fluorouracil Ebewe 50Mg/Ml prescription partial — not the same combinationFLUOROURACILUM · injection / infusion
Some of these do not contain exactly the same active substances — check each one. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.
- VerrumalAcidum salicylicum + Fluorouracilum
- ActikerallFluorouracilum + Acidum salicylicum · taken by mouth
- VerrucutanFluorouracilum + Acidum salicylicum · taken by mouth
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Actikerall 5mg/g + 100mg/g Cutaneous Solution. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.