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

Active substance(s): FLUOROURACIL / SALICYLIC ACID

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PACKAGE LEAFLET: INFORMATION FOR THE USER

ACTIKERALL® 5MG/G + 100MG/G
CUTANEOUS SOLUTION
(fluorouracil / salicylic acid)
Your medicine is available using the name Actikerall 5mg/g +
100mg/g Cutaneous Solution but will be referred to as Actikerall
throughout this leaflet.

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.

What is in this leaflet:
1.
2.
3.
4.
5.
6.

What Actikerall is and what it is used for
What you need to know before you use Actikerall
How to use Actikerall
Possible side effects
How to store Actikerall
Content of the pack and other information

1. What Actikerall is and what it is used for
Actikerall contains two active ingredients, 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 hard skin softening substance.
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 might 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

in children and adolescents.
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 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.

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.

Actikerall should not be used on bleeding lesions.

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 currently no data available on Actikerall treatment
of other body areas apart from the face, forehead and bald
scalp.

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 taking or 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:




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.





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. Therefore your phenytoin
levels should be checked regularly.
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.
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Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant
or are planning to have a baby, ask your doctor or pharmacist for
advice before taking this medicine.
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.

Important information about some of the
ingredients of Actikerall

This medicine contains dimethyl sulfoxide which may irritate the
skin.

3. How to use Actikerall
Always use this medicine exactly as your doctor has told you. You
should 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 simply 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 on the
neck of the bottle.

Dab the solution on the actinic keratosis and a small area of
healthy skin surrounding it once daily. This rim of healthy
skin should be no more than 0.5cm wide.

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 25cm² (5cm x 5cm).

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.

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
6 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.
If you have the impression that the effect of Actikerall is too
strong or too weak, talk to your doctor or pharmacist.

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.

Reporting of side effects

Manufacturer

Manufactured by: Almirall Hermal GmbH, Scholtzstrasse 3,
21465 Reinbek, Germany.
Procured from within the EU and repackaged by: Doncaster
Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.

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.

Product Licence holder: Landmark Pharma Ltd., 7 Regents Drive,
Prudhoe, Northumberland, NE42 6PX.

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.

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

Leaflet revision and issue date: 23.02.15

If you forget to use Actikerall

5. How to store Actikerall

If you use more Actikerall than you should

Do not use a double dose to make up for a forgotten dose.
Continue the treatment as your 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.

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not use Actikerall 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 25ºC. Do not refrigerate or freeze.

4. POSSIBLE SIDE EFFECTS

Do not use Actikerall 3 months after first opening of the bottle.
Keep the bottle tightly closed. Do not use Actikerall if you notice
crystals.

Like all medicines, Actikerall can cause side effects, although not
everybody gets them.

Caution: flammable - keep away from fire or flames.

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

bleeding, loss of the top layer of skin (erosion), scab.

If your doctor decides to stop your treatment, take any leftover
medicine back to the pharmacy.
If your medicine appears to be discoloured or shows any other
signs of deterioration, take it back to your pharmacist who will
advise you.
Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.

6. Content of the pack and other information
What Actikerall contains

1g of cutaneous solution contains 5mg of fluorouracil and
100mg of salicylic acid.
The other ingredients are: dimethyl sulfoxide, ethanol,
ethyl acetate, pyroxyline and poly(butyl methacrylate-methyl
methacrylate).

What Actikerall looks like and contents of the pack
Actikerall is a clear, colourless solution contained in a clear glass
bottle with a brush applicator.
Actikerall is available in packs of 28ml (2 x 14ml bottles).

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PL No: 21828/0466

POM

Actikerall® is a registered trademark of Almirall S.A.

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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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