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ACTIKERALL 5 MG/G + 100 MG/G CUTANEOUS SOLUTION

Active substance(s): FLUOROURACIL / SALICYLIC ACID / FLUOROURACIL / SALICYLIC ACID / FLUOROURACIL / SALICYLIC ACID

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Actikerall 5 mg/g + 100 mg/g Cutaneous Solution
Fluorouracil + Salicylic acid

Read all of this leaflet carefully before you start using this medicine because it
contains important information for you.
- 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.
What is in this leaflet:
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
1. What Actikerall is and what it is used 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.
2. What you need to know before you use 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 ‘Using other medicines’ below.
Warnings and precautions
Talk to your doctor or pharmacist before using Actikerall
- if you have reduced levels or reduced activity of an enzyme in your body called
dihydropyrimidine dehydrogenase (DPD). This enzyme plays an important role in the
breakdown of an active ingredient of this medicine (fluorouracil) and as a result this active
ingredient might accumulate in your body. It may be necessary to have your DPD levels or
activity checked before starting treatment with Actikerall.
- 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,
if you have reduced activity of an enzyme called DPD, which breaks down an active ingredient
of this medicine (fluorouracil). In this case, your phenytoin levels should be checked.
- 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 which may be irritant to the skin.
3. How to use 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 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.
Section 3 continued overleaf

- 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 or flames.
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.
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.
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 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.
Do not use Actikerall 3 months after first opening of the bottle.
Do not use Actikerall if you notice crystals.
Keep the bottle tightly closed.
Caution flammable: keep away from fire or flames.
Do not throw away any medicines via wastewater . 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
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 01/2017
brush applicator

00000000 / GB / 0117

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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