Package Insert: Information for the Patient

Actikerall 5 mg/g + 100 mg/g Topical Solution

fluorouracil/salicylic acid

Read this entire package insert carefully before starting to use this medication, because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1.What is Actikerall and how is it used

2.What you need to knowbefore starting touse Actikerall

3.How to use Actikerall

4.Possible adverse effects

5Storage of Actikerall

6. Contents of the package and additional information

Actikerall contains two active ingredients: fluorouracil and salicylic acid.

Fluorouracil belongs to a group of medicines known as antimetabolites that inhibit cell growth (cytostatic agent). Salicylic acid is a substance that softens thick 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, brittle, or crusted skin. They can be red or light brown in color or the same color as your skin. They can be dry or rough to the touch,and sometimes feel better with touch than with sight.

These skin changes usually occur in people who have been exposed to the sun for a long time.

No use Actikerall

-if you are allergic to fluorouracil, salicylic acid, or any of the other components of this medication (listed in section 6).

- during lactation.

- during pregnancy or if there is a possibility of becoming pregnant.

- if you have kidney problems.

-if it can come into contact with the eyes, the inside of the mouth or nose, or the genitals (mucous membranes).

Determined medications may intensify the adverse effects of Actikerall or produce other adverse effects. See the section “Other medications and Actikerall” below.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Actikerall

-ifyou know that you have no activity of the dihydropyrimidine dehydrogenase enzyme (DPD) (complete DPD deficiency).It is essential that you do not apply more than the indicated amount of Actikerall as specified in section 3 of this prospectus.

-if your ability to notice physical contact, pain, or temperature is reduced (for example, if you have diabetes). In this case, the treated lesions should be strictly controlled by your doctor.

• Actikerall should not be used on bleeding lesions.

• The treated area must be protected from direct sunlight as much as possible during the use of Actikerall, and the patient should not use sunlamps or tanning beds.

• No experience is available with Actikerall in the treatment of skin cancers such as basal cell carcinoma and Bowen's disease, so they should not be treated with the medication.

• When treating an area with actinic keratosis that is also affected by another skin disease, it should be taken into account that the treatment result may vary.

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

• No experience is available with Actikerall in repeated treatment courses in patients with actinic keratosis or in re-treatment in case of recurrence of a lesion.

Children and adolescents

Actikerall should not be used in children or adolescents under 18 years old. Actinic keratosis usually does not occur in children.

Other medications and Actikerall

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication. If you take several medications simultaneously, the effect of each one may be intensified or reduced.

Especially, inform your doctorif you are taking one of the following medications:

• medications used for the treatment of viruses, such as chickenpox or herpes (brivudine, sorivudine, or similar medications). Do not use Actikerall if you are taking or have taken one of these medications in the last 4 weeks, as they may increase the adverse effects.
• medications for the treatment of epilepsy (phenytoin). The use of Actikerall may lead to elevated levels of phenytoin in the blood.
• medications for the treatment of cancer and autoimmune diseases (methotrexate). This medication may interact with Actikerall, causing adverse effects.
• medications for the treatment of diabetes (sulfonylureas). This medication may interact with Actikerall, causing adverse effects.

Pregnancy, lactation, and fertility

Do not use Actikerall during lactation, during pregnancy, or if there is a possibility of becoming pregnant.

Driving and operating machines

No special precautions are necessary.

Actikerall contains dimethyl sulfoxide and ethanol.

Dimethyl sulfoxide may irritate the skin.

This medication contains 160 mg of alcohol (ethanol) per gram. It may cause a burning sensation on damaged skin.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Dosage

It is recommended to apply Actikerall once a day, unless your doctor has indicated otherwise.

If you have actinic keratosis in a thin skin area, for example, around the eyes and on the temple, your doctor may instruct you to apply Actikerall less frequently. If severe side effects occur, reduce the application frequency of the medication to three times a week until they improve. Your doctor may also need to monitor your treatment more frequently.

Administration form

For use on the skin (cutaneous use).

• Remove the white film from the skin of the previous day's application by simply peeling it off (unless it is the first time you apply this medication). Warm water facilitates the removal of the film.
• To open the bottle, press the cap down and turn it.
• Remove excess solution from the brush by sliding it down the neck of the bottle.
• Apply once a day the solution to the actinic keratosis and a small area of healthy skin around the affected area. The border of healthy skin should not be more than 0.5 cm wide.
• Up to 10 lesions of actinic keratosis can be treated simultaneously, although it is recommended to avoid applying the product to extensive areas of skin. The total area of skin treated simultaneously with Actikerall should not exceed 25 cm2(5 cm x 5 cm).
• Let the solution dry and form a film.
• Do not cover with a dressing.
• Closely close the bottle to prevent the product from drying out. If Actikerall dries out, do not use the product anymore. Do not use Actikerall if you notice the formation of crystals.
• Do not apply to hairy skin, as it may cause hair agglutination in the affected area. If applied to hairy areas, consider shaving or other suitable hair removal methods before application.

Other instructions

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

Actikerall solution may permanently stain clothing, textiles, or acrylics (e.g., acrylic bathtubs), so avoid contact with these materials.

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

Consult your doctor regularly during treatment.

Treatment duration

Actikerall is applied once a day to the actinic keratosis lesions until they completely disappear or for a maximum of 12 weeks. Improvement of actinic keratosis will start to be seen from the fourth week of treatment and will continue to improve over a period of up to 12 weeks. The elimination of actinic keratosis may continue for up to 8 weeks after treatment completion. 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, it is more likely that skin reactions will occur and be more severe. In this case, contact your doctor.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to use Actikerall

Do not apply a double dose to compensate for the missed doses. Continue your treatment as instructed by your doctor or as described in this leaflet.

If you interrupt treatment with Actikerall

Contact your doctor if you want to interrupt treatment.

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

Like all medications, Actikerall may produce adverse effects, although not all people will experience them.

Most patients treated with Actikerall present mild to moderate irritation and inflammation in the application area. If these reactions worsen, contact the attending physician.

As this medication 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 sensitive skin patients or 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 Frequent, may affect more than 1 in 10 people

• reactions at the application site

• skin redness (erythema), inflammation, irritation (including burning), pain, itching

Frequent, may affect up to 1 in 10 people

• headache
• skin peeling (exfoliation)
• reactions at the application site

• bleeding, skin surface loss (erosion), crusts

Rare, may affect up to 1 in 100 people

• eye dryness, eye itching, increased tear production (lacrimation)
• reactions at the application site

• skin inflammation (dermatitis), swelling (edema), ulcer

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the label and on the box after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C. Do not refrigerate or freeze.

Keep the bottle perfectly closed to prevent the content from drying out.

Do not use this medication after 3 months of opening the bottle.

Do not use this medication if you observe the formation of crystals.

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

Medications should not be disposed of through drains or in the trash. Deposit containers and unused medications at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and unused medications. In this way, you will help protect the environment.

Composition of Actikerall

The active principles are fluorouracil and salicylic acid.

1 g (equivalent to1.05ml) of topical solution contains 5 mg of fluorouracil and 100 mg of salicylic acid.

The other components are: dimethylsulfoxide; anhydrous ethanol; ethyl acetate; pyroxylin; poly(butyl methacrylate, methyl methacrylate).

Appearance of the product and contents of the packaging

Actikerall is a transparent, colorless, slightly yellowish-white topical solution.

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 an applicator brush that serves to apply the solution. The applicator brush is made of plastic (polyethylene) with nylon hairs attached to the steel (V2A) rod.

Packaging size: bottle with a content of 25 ml of topical solution.

Holder of the marketing authorization and responsible manufacturer

Almirall Hermal GmbH

Scholtzstraße 3

21465 Reinbek

Germany

Local representative

Almirall, S.A.

General Mitre, 151

08022 Barcelona - Spain

This medicine is authorized in the member states of the European Economic Area with the following trade names:

Last review date of this leaflet: October 2020

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