Actikerall

Package Leaflet: Information for the Patient

Actikerall

(5 mg + 100 mg)/g, cutaneous solution
Fluorouracil + Salicylic Acid

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• 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 symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Actikerall and what is it used for
• 2. Important information 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 is Actikerall and what is it used for

Actikerall contains two active substances: fluorouracil and salicylic acid. Fluorouracil belongs to a group of medicines called antimetabolites, which inhibit cell growth (cytostatic factor). Salicylic acid is a substance that softens hardened skin. Actikerall is a cutaneous solution used to treat solar keratosis (senile) (type I/II) in adult patients with normal immunity. Skin changes called solar keratosis (senile) are small, fragile, flaking fragments of skin, with a tendency to crumble. They can be red or light brown or the same color as the skin. The changes can be dry or rough to the touch and sometimes easier to feel than see. Such skin changes are common in people who have been exposed to significant sunlight.

2. Important information before using Actikerall

When not to use Actikerall

• if you are allergic to fluorouracil, salicylic acid, or any of the other ingredients of this medicine (listed in section 6),
• during breastfeeding,
• during pregnancy and in women who cannot be sure that they are not pregnant,
• if you have kidney function disorders,
• if there is a risk of the medicine coming into contact with the eyes, mucous membranes of the mouth, nose, or genital organs.

Some other medicines may increase the side effects of Actikerall or cause other side effects. See the section "Actikerall and other medicines" below.

Warnings and precautions

Before starting treatment with Actikerall, discuss it with your doctor or pharmacist.

• If you have been diagnosed with a lack of dihydropyrimidine dehydrogenase (DPD) enzyme activity (complete DPD deficiency). It is important not to use a higher dose of Actikerall than indicated in section 3 of this leaflet.
• If you have sensory, pain, and temperature disorders (e.g., due to diabetes). In such cases, the treated skin areas must be carefully controlled by the doctor.
• Actikerall should not be used on bleeding skin changes.
• During therapy with Actikerall, the treated areas should be protected from direct sunlight, and the patient should not use a solarium or quartz lamps.
• There is no data on the use of Actikerall in the treatment of skin cancers, such as basal cell carcinoma and Bowen's disease, so it should not be used to treat these diseases.
• In the case of treating areas affected by solar keratosis and other concurrent skin disease, it should be taken into account that the treatment effect may be different from expected.
• There is no experience with the use of Actikerall in subsequent treatment cycles in patients with solar keratosis or its reuse in case of recurrence of skin changes.

Children and adolescents

Actikerall should not be used in children and adolescents under 18 years of age. Solar keratosis (senile) usually does not occur in children.

Actikerall and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take. The effect of some medicines may be increased or decreased if you take several different medicines at the same time. In particular, tell your doctorif you are taking:

• medicines used to treat chickenpox or shingles (brivudine, sorivudine, or similar medicines). You should not use Actikerall if you are or have been treated with any of these medicines in the last 4 weeks, as this may increase the risk of side effects.
• a medicine used to treat epilepsy (phenytoin). Using Actikerall may lead to increased phenytoin levels in the blood.
• a medicine used to treat cancer and autoimmune diseases (methotrexate). Methotrexate may interact with Actikerall, causing side effects.
• medicines used in diabetes therapy (sulfonylurea derivatives). Sulfonylurea derivatives may interact with Actikerall, causing side effects.

Pregnancy, breastfeeding, and fertility

Actikerall should not be used during breastfeeding, pregnancy, or in women who cannot be sure that they are not pregnant.

Driving and using machines

No special precautions are necessary. Actikerallcontains dimethyl sulfoxide and ethanol. Dimethyl sulfoxide may cause skin irritation. This medicine contains 160 mg of alcohol (ethanol) per gram. It may cause burning of damaged skin.

3. How to use Actikerall

This medicine should always be used exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Dosage

Actikerall should be applied once a day, unless your doctor has told you otherwise. If the skin changes are located in areas with a thin layer of skin (e.g., around the eyes, on the temples), your doctor may recommend less frequent use of Actikerall. In case of severe side effects, the frequency of application should be reduced to three times a week until the side effects subside. Your doctor may decide on more frequent monitoring of the therapy if necessary.

Method of administration

For cutaneous use (application to the skin).

• Before each application of Actikerall, gently remove the white coating left after the previous application (if this is not the first use of the medicine). Using warm water may be helpful when removing the coating.
• To open the bottle, press the cap and turn it (fig. 1).
• Before applying the medicine, clean the brush on the inner side of the bottle neck. At the same time, the amount of medicine applied to the skin should be sufficient to form a coating after drying.
• The solution should be applied to the surface of the solar keratosis (senile) once a day.
• Several solar keratosis (senile) lesions can be treated at the same time (up to 10 lesions), but it should not be applied to larger areas of skin.
• The total size of the skin area treated with Actikerall at the same time should not be larger than 25 cm (5 cm x 5 cm).
• The applied solution should be left to dry, which will allow the formation of a coating at the site of application.
• The treated area should not be covered with a dressing.
• After use, the bottle should be tightly closed to prevent the medicine from drying out (Fig. 2). If the medicine dries out, it is no longer suitable for use. Do not use Actikerall if crystals appear in it.

• Actikerall should not be applied to hairy skin areas. This may lead to the sticking of hair to the treated skin area, making it difficult to remove the coating. If the medicine is applied to a hairy skin area, it should be shaved or other suitable hair removal methods should be used first.

Additional information

Actikerall should not come into contact with the eyes, the inside of the mouth or nose, or the genital organs (mucous membranes). Actikerall may cause permanent stains on clothing, fabrics, or objects made of acrylic (such as acrylic bathtubs), so contact with these objects should be avoided. Note - the medicine is flammable. It should be kept away from fire and not used near an open flame, lit cigarette, or certain devices (e.g., hair dryers). During treatment, you should regularly contact your doctor.

Duration of treatment

Actikerall is applied to the solar keratosis (senile) lesions once a day until they are completely healed or for no longer than 12 weeks. Improvement may be visible after 4 weeks of treatment and increases over time up to 12 weeks. The disappearance of solar keratosis (senile) lesions may be visible up to 8 weeks after the end of treatment. Treatment should be continued even if there are no signs of treatment effect within the first four weeks. If you feel that the effect of Actikerall is too strong or too weak, you should consult your doctor or pharmacist.

Using more than the recommended dose of Actikerall

If Actikerall is used more frequently than once a day, skin reactions are more likely to occur and may be more severe. In such cases, you should contact your doctor.

Missing a dose of Actikerall

You should not take a double dose to make up for a forgotten dose. Continue treatment as advised by your doctor or as described in this leaflet.

Stopping treatment with Actikerall

If you want to stop treatment, you should contact your doctor. If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Actikerall can cause side effects, although not everybody gets them. In most patients using Actikerall, mild to moderate irritation and inflammation occur at the site of application. If these reactions are severe, you should contact your doctor. Due to its strong softening effect on the skin, the medicine may cause the appearance of white discoloration and flaking of the skin. Due to the content of salicylic acid, the use of this medicine may cause mild irritation, such as skin inflammation and contact allergic reactions in patients with sensitive skin or allergy to salicylic acid. Symptoms of contact allergic reactions may include: itching, redness, and small blisters, even outside the application site. Side effects may occur with the following frequencies: Very common- may occur more frequently than in 1 in 10 people

• reactions at the application site
• redness of the skin (erythema), inflammation, irritation (including burning), pain, itching.

Common- may occur in less than 1 in 10 people

• headache,
• flaking of the skin,
• reactions at the application site
• mild bleeding, erosion, crust.

Uncommon- may occur in less than 1 in 100 people

• dry eye, itching of the eye, increased tearing,
• reactions at the application site
• skin inflammation, swelling, ulceration.

The frequency of such side effects as mild bleeding, erosion, crust, swelling, ulceration, and skin inflammation was one category higher in one study after applying Actikerall to a diseased area of 25 cm.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. 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 carton and on the label after EXP. The expiry date refers to the last day of that month. Do not store above 25°C. Do not store in a refrigerator or freeze. Keep the bottle tightly closed to prevent the contents from drying out. Note - the medicine is flammable. Keep it away from fire and do not use near an open flame, lit cigarette, or certain devices (e.g., hair dryers). Shelf life after opening the bottle: 3 months. Do not use Actikerall if crystals appear in it. 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 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: ethyl acetate, anhydrous ethanol, dimethyl sulfoxide 70, copolymer of butyl methacrylate and methyl methacrylate, pyroxylin.

What Actikerall looks like and contents of the pack

Actikerall is a clear, colorless to slightly orange-white cutaneous solution. The pack of Actikerall: a brown glass bottle with a child-resistant closure made of white polypropylene, placed in a cardboard box. The bottle cap contains an applicator with a brush for applying the product, made of HDPE/LDPE/nylon. Pack size: a bottle containing 25 ml of cutaneous solution.

Marketing authorization holder and manufacturer

Almirall Hermal GmbH

Scholtzstrasse 3
21465 Reinbek
Germany
To obtain more detailed information, please contact the representative of the marketing authorization holder: Egis Pharmaceuticals PLC Phone: +48 22 417 92 00

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

Date of last revision of the leaflet: