Actikerall

Package leaflet:

Information for the patient
Actikerall 5 mg/g + 100 mg/g Cutaneous Solution
fluorouracil + salicylic acid
Read this leaflet carefully before using this medicine.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Never give it to others. It may be harmful to other people, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Actikerall is and what it is used for
2. What you need to know before using Actikerall
3. How to use Actikerall
4. Possible side effects
5. How to store Actikerall
6. Contents 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 cell growth (cytostatic agent). Salicylic acid is a substance that softens hardened skin.
Actikerall is a solution for the treatment of actinic keratosis (grade I/II) in adult patients with a healthy immune system.
Actinic keratoses are small, crusty, scaly, or flaky skin lesions. They may be red, light brown, or the same colour as your skin. They may feel dry or rough to the touch and sometimes are more easily felt than seen.
These skin lesions commonly occur in people who have had excessive sun exposure.

2. What you need to know before using Actikerall

Do not use Actikerall

• if you are allergic to fluorouracil, salicylic acid, or any of the ingredients of this medicine (listed in section 6)
• during breastfeeding
• during pregnancy or if there is a possibility that you may be pregnant
• if you have kidney problems
• if it may come into contact with the eyes, inside of the mouth, nose, or genital areas (mucous membranes)
  Some medicines may increase the side effects of Actikerall or cause new ones (see “Other medicines and Actikerall”).

Warnings and precautions
Talk to your doctor or pharmacist before using Actikerall

• if you know you have no activity of the enzyme dihydropyrimidine dehydrogenase (DPD) (complete absence of DPD activity). It is important that you do not apply more Actikerall than indicated in section 3 of this leaflet.
• if you suffer from reduced ability to sense touch, pain, or temperature (e.g., if you have diabetes). In such cases, treatment must be closely monitored by your doctor.
• Actikerall must not be used on bleeding lesions.
• The treated area must be protected as much as possible from direct sunlight during treatment with Actikerall, and you must not use sunlamps or sunbeds.
• There is no experience regarding treatment with Actikerall of skin tumours such as basal cell carcinoma (BCC) or Bowen’s disease; therefore, these conditions should not be treated with this product.
• When treating an area affected by actinic keratosis that is also affected by other skin diseases, it should be considered that the treatment outcome may be altered.
• There is no experience regarding repeated treatment cycles with Actikerall in patients with actinic keratosis or for the treatment of recurrent lesions.

Children and adolescents
Actikerall must not be used in children or adolescents under 18 years of age. Actinic keratosis generally does not affect children.

Other medicines and Actikerall
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. When several medicines are taken at the same time, the effect of each medicine may be increased or weakened.
In particular, inform your doctor if you are taking

• Medicines used to treat chickenpox or shingles (brivudine, sorivudine, or similar medicines). You must not use Actikerall if you are currently using or have used any of these medicines within the last 4 weeks, as this may cause an increase in side effects.
• A medicine for epilepsy (phenytoin). Use of Actikerall may lead to increased blood levels of phenytoin.
• A medicine used to treat cancer and autoimmune diseases (methotrexate). This medicine may interact with Actikerall, causing side effects.
• A medicine used to treat diabetes (sulfonylureas). This medicine may interact with Actikerall, causing side effects.

Pregnancy, breastfeeding and fertility
You must not use Actikerall during breastfeeding, if you are pregnant, or if there is any possibility that you may be pregnant.

Driving and using machines
No special instructions.

Actikerall contains dimethyl sulfoxide and ethanol.
Dimethyl sulfoxide may be irritating to the skin.
This medicine contains 160 mg of alcohol (ethanol) per gram. It may cause a burning sensation on damaged skin.

3. How to use Actikerall

Always use this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Dosage
Actikerall should be applied once daily, unless otherwise indicated by your doctor.
If you have actinic keratosis in an area with thin skin, such as around the eyes or temples, your doctor may advise you to apply Actikerall less frequently. If severe undesirable effects occur, reduce the frequency of application to three times a week until the adverse effects improve. Your doctor may also need to monitor your treatment more frequently.
Method of administration
Apply to the skin (cutaneous use).

• Remove the white film left on the skin from the previous day's application by gently peeling it off (unless this is the first time you are using the medicine). Warm water may be used to facilitate removal.
• To open the bottle, press the cap downwards and rotate it.
• Remove excess solution from the brush by wiping it against the neck of the bottle, while ensuring sufficient product remains on the brush to form a film once dry.
• Dab the solution onto the actinic keratoses once daily.
• Multiple actinic keratoses (up to 10 lesions) may be treated simultaneously, but do not use the product on large areas of skin. The total area of skin treated with Actikerall must not exceed 25 cm² (5 cm x 5 cm).
• Allow the solution to dry completely to form a film.
• Do not cover with bandages.
• Close the bottle tightly to prevent drying. If Actikerall dries out, it must not be used. Do not use Actikerall if you see crystals.
• Do not apply to areas with hair, as the hair may adhere to the area where Actikerall has been applied, making removal of the film difficult. To treat such areas, remove hair appropriately before applying the product.

Additional instructions
Actikerall must not come into contact with the eyes, inside of the mouth or nose, or genital areas (mucous membranes). Avoid contact of Actikerall with clothing, fabrics, or acrylic materials (e.g., acrylic bathtubs), as it may leave permanent stains.
Flammable: keep away from fire, flames, and open flames, lit cigarettes, or certain devices (e.g., hair dryers).
Consult your doctor regularly during treatment.
Duration of treatment
Actikerall should be applied to actinic keratoses once daily until the lesions have completely disappeared, up to a maximum of 12 weeks. Effects on actinic keratoses may become noticeable after 4 weeks of treatment, with continued improvement over time up to 12 weeks. Actinic keratoses may continue to improve for up to eight weeks after the end of treatment. Treatment should continue even if no improvement is seen during the first 4 weeks.
If you feel that the effect of Actikerall is too strong or too weak, consult your doctor or pharmacist.
If you use more Actikerall than you should
If you apply Actikerall more than once a day, you are more likely to experience skin reactions, even severe ones. In this case, consult your doctor.
If you forget to use Actikerall
Do not use a double dose to make up for a forgotten dose. Continue treatment according to your doctor's recommendations or the instructions in this leaflet.
If you stop using Actikerall
Consult your doctor if you intend to stop treatment.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
In most patients treated with Actikerall, mild to moderate irritation and inflammation occur at the application site. If these reactions worsen, consult your doctor.
Since this medicine has a strong keratolytic effect on the skin, whitish discoloration and desquamation of the skin may occur.
The salicylic acid contained in Actikerall may cause mild signs of irritation, such as skin inflammation (dermatitis) and contact allergic reactions in patients with sensitive skin or allergy to salicylic acid. Contact allergic reactions may manifest as itching, redness, and small blisters, even in areas where the product was not applied.
Side effects may occur with the following frequencies:
Very common: may affect more than 1 in 10 people

• Reactions at the application site
• Redness of the skin (erythema), inflammation, irritation (including burning), pain, itching

Common: may affect up to 1 in 10 people

• Headache
• Skin desquamation (exfoliation)
• Reactions at the application site
• Mild bleeding, loss of the superficial layer of skin (superficial ulcers), crusts

Uncommon: may affect up to 1 in 100 people

• Dry eye, eye itching, increased lacrimation
• Reactions at the application site
• Skin inflammation (dermatitis), swelling (edema), ulcer

The frequencies for mild bleeding, loss of the superficial layer of skin (superficial ulcers), crusts, swelling (edema), ulcer, and skin inflammation (dermatitis) were found to be in a higher category in one study where Actikerall was applied to a 25 cm² affected area.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa . 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 stated on the label and carton after "Exp.".
The expiry date refers to the last day of the stated month.
Do not store above 25°C. Do not store in the refrigerator or freeze.
Keep the bottle tightly closed to prevent drying out.
Do not use Actikerall more than 3 months after first opening the bottle.
Do not use Actikerall if you notice crystals.
Flammable: keep away from fire, flames, and open flames, such as lighted cigarettes or certain appliances (e.g. hair dryers).
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Actikerall contains
The active substances are fluorouracil and salicylic acid.
Each 1 g (=1.05 ml) of cutaneous solution contains 5 mg of fluorouracil and 100 mg of salicylic acid.
The other components are: dimethyl sulfoxide; anhydrous ethanol; ethyl acetate; pyroxylin; poly(butyl methacrylate-co-methyl methacrylate).

Description of the appearance of Actikerall and contents of the package
Actikerall is a transparent cutaneous solution, colourless to slightly white-orange.
This medicinal product is packaged in a brown glass bottle with a child-resistant closure system made of white propylene, contained in a cardboard box. The bottle cap is connected to a brush for applying the solution. The applicator brush (CE marked) is composed of plastic (polyethylene) with nylon bristles fixed to a stainless steel (V2A) shaft.
Pack size: bottle containing 25 ml of cutaneous solution.

Marketing Authorisation Holder and Manufacturer
Almirall Hermal GmbH
Scholtzstrasse 3
D-21465 Reinbek
Germany
Tel: +49 (0)40 72704-0
Fax: +49 (0)40 7229296
e-mail: [email protected]

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

This leaflet was last approved in
May 2018