Actikerall 5 mg/g + 100 mg/g cutaneous solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Actikerall 5 mg/g + 100 mg/g cutaneous solution

fluorouracil/salicylic acid

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

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 thickened skin.

Actikerall is a solution for the treatment of actinic keratosis (grade I/II) in adult patients with a healthy immune system.

Actinic keratosis lesions are small areas of scaly, fragile, or crusted skin. They may be red, light brown, or the same color as your skin. They may feel dry or rough to the touch, and sometimes they are more easily felt than seen.

These skin changes typically occur in individuals who have had prolonged exposure to sunlight.

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 other components of this medicine (listed in section 6).
• during breastfeeding.
• during pregnancy or if you might have become pregnant.
• if you have kidney problems.
• if it may come into contact with the eyes, inside of the mouth or nose, or genitals (mucous membranes).

Certain medicines may increase the adverse effects of Actikerall or cause other side effects. See the section “Other medicines and Actikerall” below.

Warnings and precautions

Talk to your doctor or pharmacist before starting to use Actikerall

• if you know you have no activity of the enzyme dihydropyrimidine dehydrogenase (DPD) (complete DPD deficiency). It is important that you do not apply more Actikerall than indicated in section 3 of this leaflet.

• if your ability to feel touch, pain, or temperature is reduced (for example, if you have diabetes). In such cases, the lesions being treated must be closely monitored by your doctor.

• Actikerall must not be used on bleeding lesions.

• The treated area must be protected from direct sunlight as much as possible during treatment with Actikerall, and patients must not use sunlamps or sunbeds.

• There is no experience with Actikerall in the treatment of skin cancers such as basal cell carcinoma and Bowen's disease, and therefore these conditions should not be treated with this medicine.

• When treating an area of actinic keratosis that is also affected by another skin condition, it should be noted that the treatment outcome may vary.

• Currently, there are no data available on treatment with Actikerall of body areas other than the face, forehead, and bald scalp.

• There is no experience with repeated treatment cycles of Actikerall in patients with actinic keratosis or with retreatment in case of recurrence of a lesion.

Children and adolescents

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

Other medicines and Actikerall

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. If you take several medicines at the same time, the effect of each may be increased or decreased.

In particular, tell your doctor if you are taking any of the following medicines:

• medicines used to treat viral infections such as chickenpox or herpes (brivudine, sorivudine, or similar medicines). Do not use Actikerall if you are taking or have taken any of these medicines within the last 4 weeks, as they may increase adverse effects.
• medicines used to treat epilepsy (phenytoin). Use of Actikerall may lead to elevated levels of phenytoin in the blood.
• medicines used to treat cancer and autoimmune diseases (methotrexate). This medicine may interact with Actikerall, causing adverse effects.
• medicines used to treat diabetes (sulfonylureas). This medicine may interact with Actikerall, causing adverse effects.

Pregnancy, breastfeeding, and fertility

You must not use Actikerall during breastfeeding, during pregnancy, or if you might have become pregnant.

Driving and using machines

No special precautions are required.

Actikerall contains dimethyl sulfoxide and ethanol.

Dimethyl sulfoxide may irritate 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

Follow exactly the instructions for administration of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Dosage

It is recommended to apply Actikerall once daily unless your doctor has instructed otherwise.

If you have actinic keratosis in an area of thin skin, for example around the eyes or on the temple, your doctor may advise you to apply Actikerall less frequently. If serious side effects occur, reduce the frequency of application to three times per week until they improve. It may also be necessary for your doctor to monitor your treatment more frequently.

Method of administration

For topical use (cutaneous application).

• Remove the white film from the skin from the previous day's application simply by peeling it off (unless it is the first time you are applying this medicine). Warm water facilitates removal of the film.
• To open the bottle, press the cap down and turn it.
• Remove excess solution from the brush by drawing it across the neck of the bottle.
• Apply the solution once daily to the actinic keratosis lesion and a small surrounding area of healthy skin. The border of healthy skin should not exceed 0.5 cm in width.
• Multiple actinic keratosis lesions (up to 10 lesions) may be treated simultaneously, although application over extensive skin areas should be avoided. The total area of skin treated simultaneously with Actikerall must not exceed 25 cm² (5 cm x 5 cm).
• Allow the solution to dry and form a film.
• Do not cover with a dressing.
• Close the bottle tightly to prevent the product from drying out. If Actikerall dries out, do not use it further. Do not use Actikerall if you notice crystal formation.
• Do not apply to hairy skin, as hair clumping may occur in the affected area. If application to hairy areas is necessary, shaving or other appropriate hair removal methods should be considered before application.

Other instructions

Avoid direct contact of Actikerall with the eyes, inside of the mouth or nose, or genital areas (mucous membranes).

Actikerall solution may permanently stain clothing, fabrics, or acrylic materials (e.g. acrylic bathtubs); therefore, contact with these materials should be avoided.

Warning: flammable product. Keep away from fire and do not use near flames, lit cigarettes, or certain appliances (e.g. hair dryers).

Consult your doctor regularly during treatment.

Duration of treatment

Actikerall should be applied once daily to actinic keratosis lesions until complete disappearance or for a maximum of 12 weeks. Improvement in actinic keratosis typically becomes noticeable from the fourth week of treatment and progresses gradually over up to twelve weeks. Clearance of actinic keratosis may continue for up to 8 weeks after completion of treatment. Treatment should be continued even if no effect is observed after 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, skin reactions are more likely to occur and may be more severe. In this case, contact your doctor.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, stating the medicine and the amount ingested.

If you forget to use Actikerall

Do not apply a double dose to make up for missed doses. Continue your treatment as directed by your doctor or as described in this leaflet.

If you stop using Actikerall

Contact your doctor if you wish to discontinue treatment.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Actikerall can cause adverse effects, although not everyone will experience them.

Most patients treated with Actikerall experience mild to moderate irritation and inflammation at the application site. If these reactions worsen, contact your treating physician.

Since this medicine has a strong skin-softening effect, whitish discolorations and skin peeling may occur.

The salicylic acid contained in Actikerall may cause mild irritation, such as skin inflammation (dermatitis) and contact allergic reactions in patients with sensitive skin or in individuals allergic to salicylic acid. Symptoms of contact allergic reactions may include itching, redness, and small blisters, even outside the application area.

Adverse 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 sensation), pain, itching

Common: may affect up to 1 in 10 people

• headache
• skin peeling (exfoliation)
• reactions at the application site
• bleeding, loss of the upper layer of skin (erosion), crusting

Uncommon: may affect up to 1 in 100 people

• dry eyes, itchy eyes, increased tear production (lacrimation)
• reactions at the application site
• skin inflammation (dermatitis), swelling (edema), ulcer

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 the carton, following CAD. The expiry date refers to the last day of the month indicated.

Do not store above 25°C. Do not refrigerate or freeze.

Keep the bottle tightly closed to prevent the contents from drying out.

Do not use this medicine more than 3 months after opening the bottle.

Do not use this medicine if you notice crystal formation.

Warning: flammable product. Keep away from fire and do not use near flames, lit cigarettes, or certain electrical appliances (e.g. hair dryers).

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be taken to the SIGRE point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Actikerall

The active substances are fluorouracil and salicylic acid.

1 g (equivalent to 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, methyl methacrylate).

Appearance of the product and contents of the pack

Actikerall is a transparent, colourless cutaneous solution tending slightly to orange-yellow.

This medicine is packaged in a brown glass bottle with a child-resistant polypropylene cap in a cardboard box. The bottle cap is attached to a brush used to apply the solution. The applicator brush is made of plastic (polyethylene) with nylon bristles fixed to a stem made of stainless steel (V2A).

Pack size: bottle containing 25 ml of cutaneous solution.

Marketing Authorization Holder and Manufacturer

Almirall Hermal GmbH

Scholtzstraße 3

21465 Reinbek

Germany

Local representative

Almirall, S.A.

General Mitre, 151

08022 Barcelona - Spain

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

Date of the last revision of this leaflet: October 2020

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es