Almirall

Cutaneous solution 5 mg / g + 100 mg / g 
(clear, colorless to pale orange-white)

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
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 packaging 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 called antimetabolites that inhibit cell growth ( cytostatics ). Salicylic acid is a substance that softens hard skin. 
Actikerall is a solution for treating actinic keratosis (grade I / II) in adult patients with a healthy immune system. 
Actinic keratosis is small hard, scaly, or rough spots on the skin. They can be red or light brown or have the same color as your skin. They can feel dry or uneven and they are sometimes easier to feel than to see. 
These skin changes often occur in people who have been exposed to too much sun.

Fluorouracil and salicylic acid contained in Actikerall may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

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 ingredients of this medicine (listed in section 6).
  • if you are breast-feeding
  • if you are pregnant, or if there is a possibility that you may be pregnant.
  • if you have kidney disease
  • if it may come in contact with your eyes, the inside of your mouth or your nose, or your genitals (mucous membranes).

Some other medicines may aggravate the side effects of Actikerall or cause other side effects. See “Other medicines and Actikerall” below.

Warnings and cautions

Talk to your doctor or pharmacist before using Actikerall

  • if you have decreased levels or decreased activity of an enzyme in your body called dihydropyridine dehydrogenase (DPD). This enzyme plays an important role in the breakdown of an active component of this medicine (fluorouracil) and it can result in this active component being stored in your body. It may be necessary to check your DPD level or activity before starting treatment with Actikerall.
  • If you suffer from a reduced ability to feel when you move, pain, and temperature (if you have diabetes for example). In this case, the treated areas should be carefully checked by your doctor.
  • Actikerall should not be used on bleeding changes.
  • The area being treated should be protected from direct sunlight as much as possible when using Actikerall and the patient should not use a sun lamp or solarium.
  • There is no experience with Actikerall and skin cancer such as basal cell carcinoma (BCC) and Bowen’s disease, which should therefore not be treated with Actikerall.
  • When treating an area with actinic keratosis that is also affected by another skin disease, keep in mind that the treatment result may differ.
  • There is no experience with Actikerall and its use in repeated rounds of treatment in patients with actinic keratosis or for repeated treatment if a change returns.

Children and young people

Actikerall should not be used by children or young people under 18 years of age. Children do not usually get actinic keratosis.

Other medicines and Actikerall

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. If several drugs are used at the same time, the effect of individual drugs can be enhanced or weakened.

Be especially careful to tell your doctor if you take any of the following:

  • medicines used to treat viruses such as chickenpox or shingles (brivudine, sorivudine, or similar medicines). You should not use Actikerall if you are taking or have used any of these medicines in the last 4 weeks as it may cause increased side effects.
  • antiepileptic drugs ( phenytoin ). Use of Actikerall may lead to increased levels of phenytoin in the blood if you have decreased activity of an enzyme (DPD) that breaks down one of the active substances in this medicine (fluorouracil). In this case, your phenytoin concentrations should be monitored.
  • drugs used to treat cancer and autoimmune diseases (methotrexate). This medicine may affect Actikerall and cause side effects.
  • drugs used to treat diabetes (sulfonylureas). This medicine may affect Actikerall and cause side effects.

Pregnancy, breastfeeding, and fertility

You should not use Actikerall during breast-feeding or in pregnancy or if you suspect pregnancy.

Driving and using machines

No special precautions are required.

Actikerall contains dimethyl sulfoxide which may be irritating to the skin.

3. How to use Actikerall

Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

Dosage 
Actikerall should be applied once a day unless your doctor tells you otherwise. If you have actinic keratosis in an area with thin skin e.g. around the eyes and on the temple, your doctor may advise you to use Actikerall less often. If serious side effects occur, reduce the frequency of administration of the medicine to three times a week until the side effects subside. It may also be necessary for your doctor to monitor your treatment more often.

Instructions 
for use on the skin ( cutaneous use).

  • Remove the white film on the skin from the previous day’s administration by gently peeling it off (unless it is the first time you are using this medicine). Hot water can make it easier to remove the film.
  • To open the bottle, press the lid down and turn it.
  • Remove the excess solution from the brush by wiping it against the neck of the bottle. However, make sure you have enough solution on the brush to form a film when the solution dries.
  • Dab the solution on the actinic keratosis once a day.
  • Multiple actinic keratoses (up to 10 changes) can be treated at the same time, but do not use it on large areas of skin.
  • The total skin area treated with Actikerall at the same time must not exceed 25 cm 2 (5 cm x 5 cm).
  • Let the solution dry and form a film.
  • Do not cover with a bandage.
  • Close the bottle tightly to prevent drying out. If Actikerall dries out, it should no longer be used. Do not use Actikerall if you discover crystals.
  • You should not apply Actikerall to hairy skin areas as this may cause the hair to stick to the skin area where Actikerall is applied, making it difficult to remove the film. If Actikerall is applied to hairy skin, shaving, or other suitable hair removal methods should be considered before use.

Additional instructions 
Actikerall must not come into contact with the eyes, the inside of the mouth or the nose, or the genitals (mucous membranes). 
Actikerall solution can give permanent stains on clothes, fabrics, or acrylic (such as acrylic bathtubs), and therefore contact with these materials should be avoided. 
Warning: Flammable – keep away from fire or open flames. 
Consult your doctor regularly during treatment.


Duration of treatment Actikerall is applied to the actinic keratosis once a day until the change has healed completely or for a maximum of 12 weeks. Improvement of actinic keratosis can be seen as early as 4 weeks after the start of treatment and the improvement increases over time up to 12 weeks. The improvement in actinic keratosis can continue for up to 8 weeks after stopping treatment. Treatment should be continued even if no improvement occurs during the first four weeks.

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

If you apply Actikerall more than once a day, you will probably get skin reactions that may be more serious. If this happens, 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 the doctor’s instructions or as described in this leaflet.

If you stop using Actikerall

Contact your doctor if you want to stop treatment.

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

4. Possible side effects

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

Mild to moderate irritation and inflammation at the application site occur in most patients treated with Actikerall. If these reactions become serious, consult your doctor.

As this medicine has a strong emollient effect on the skin, white discoloration and flaking of the skin may occur.

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

Side effects can occur with the following frequencies:

Very common affects more than 1 user in 10

  • Reactions at the application site
    • redness ( erythema ), inflammation, irritation (including burning sensation), pain, itching

Common, affects less than 1 user in 10

  • headache
  • flaky skin (exfoliation)
  • reactions at the application site
    • light bleeding, loss of upper skin layer ( erosion ), scabs.

Uncommon affects less than 1 user in 100

  • Dry eyes, itchy eyes, increased watery eyes ( lacrimation )
  • Reactions at the application site
    • Skin inflammation ( dermatitis ), swelling ( edema ), ulcers

The frequency of light bleeding, loss of the upper layer of skin ( erosion ), scabs, swelling ( edema ), ulcers, and dermatitis ( dermatitis ) was a category higher in a study where Actikerall was applied to a skin surface of 25 cm 2.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

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 label and carton after EXP. date. The expiration date is the last day of the specified month.

Do not store above 25 ° C. Store in a cold place. Do not freeze. Close the bottle tightly to prevent drying out.

Use Actikerall within 3 months after first opening the bottle.

Do not use Actikerall if you discover crystals in the solution.

Warning: Flammable – keep away from fire or open flames.

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. Contents of the packaging and other information

Content declaration

  • 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 dimethyl sulfoxide; ethanol, anhydrous; ethyl acetate; pyroxylin; 
    poly (butyl methacrylate, methylate acrylate).

What the medicine looks like and the contents of the pack

Actikerall is a clear, colorless to the pale orange-white cutaneous solution.

This medicine is packaged in a brown glass bottle with a child-resistant closure of white polypropylene in a cardboard box. The closure of the bottle is connected to a brush used to apply the solution.

The application brush (CE marked) consists of plastic (polyethylene) with nylon bristles attached to a stainless steel shaft (V2A).

Pack size: a bottle containing 25 ml cutaneous solution.

Marketing Authorization Holder and Manufacturer

Almirall Hermal GmbH 
Scholtzstrasse 3 
D-21465 Reinbek 
Germany

This medicinal product is authorized under the European Economic Area under the names:

Country Product name
Germany Actikerall-Almirall 5 mg / g + 100 mg / g solution for use on the skin
Denmark, Finland, Norway, Sweden, Iceland, Lithuania, Latvia, Estonia, Portugal, Italy Actikerall
Spain Actikerall 5 mg / g + 100 mg / g Solution Cutánea

Muhammad Nadeem

Leave a Reply