Label: information for the user

Imikeraderm 50 mg/g cream

Imiquimod

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who 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 label.See section 4.

Imikeraderm is indicated for the treatment of actinic keratosis.

Actinic keratosis consists of rough skin areas found in people who have been exposed to a lot of sunlight throughout their lives. Some are pigmented, others are grayish, pink, red, or brown. They can be smooth and scaly, or raised, hard, and wart-like. Imikeraderm should be used exclusively for smooth actinic keratoses on the face and scalp of patients with a healthy immune system when their doctor decides that Imikeraderm is the most appropriate treatment.

Imikeraderm helps the body's own immune system to produce natural substances that help combat actinic keratosis.

Do not use Imikeraderm

• if you are allergic to imiquimod or any of the other ingredients of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to useimiquimodcream.

• If you have usedimiquimodcream or other similar preparations before, you must consult your doctor before starting this treatment.
• If you have autoimmune disorders.
• If you have had an organ transplant.
• You should not useimiquimodcream until the area to be treated has healed after a previous pharmacological or surgical treatment.
• Avoid contact with the eyes, lips, and nostrils. In case of accidental contact, remove the cream by washing with water.
• Do not apply the cream internally.
• Do not use more cream than your doctor advises.
• Do not cover the treated area with bandages or other dressings after applyingimiquimodcream.
• If the treated area becomes too uncomfortable, remove the cream with a mild soap and water.

Once the problem has been resolved, you can reapply the cream.

• Inform your doctor if you experience changes in your blood count.

Due to the mode of action ofimiquimodcream, there is a possibility that the cream may worsen existing inflammation in the treatment area.

You should not use sunlamps or tanning devices and avoid sunlight as much as possible during treatment withimiquimodcream. When going outside, use protective clothing and wide-brimmed hats.

During the use ofimiquimodcream and until healing, the treated area is likely to have a notably different appearance from normal skin.

Children and adolescents

Not recommended for use in children and adolescents.

Other medicines and Imikeraderm

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medicine.

No incompatible medicines withimiquimodcream are known.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medicine.

You must inform your doctor if you are pregnant or intend to become pregnant. They will evaluate the risks and benefits of usingimiquimodcream during pregnancy. Animal studies do not indicate the presence of direct or indirect harmful effects during pregnancy.

Do not breastfeed your baby while usingimiquimodcream, as it is not known whether imiquimod is excreted in breast milk.

Driving and operating machinery

This medicine has no or insignificant effect on the ability to drive and operate machinery.

Imikeraderm contains parahydroxybenzoic acid methyl ester and parahydroxybenzoic acid propyl ester (E218 and E216)

Parahydroxybenzoic acid methyl ester (E218) and parahydroxybenzoic acid propyl ester (E216) may cause allergic reactions (possibly delayed).

Imikeraderm contains cetyl alcohol and stearic alcohol

Cetyl alcohol and stearic alcohol may cause local skin reactions (such as contact dermatitis).

Imikeraderm contains benzyl alcohol

This medicine contains 5 mg of benzyl alcohol in each sachet. Benzyl alcohol may cause allergic reactions and moderate local irritation.

Imikeraderm contains butylhydroxytoluene (E321)

Butylhydroxytoluene (E321) may cause local skin reactions (such as contact dermatitis) or irritation of the eyes and mucous membranes.

Children and Adolescents:

Not recommended for use in children and adolescents.

Adults:

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

Wash your hands carefully before and after applying the cream. Do not cover the treated area with bandages or other dressings after applyingimiquimodcream.

Open a new package each time you apply the cream. Dispose of all remaining cream in the package after application. Do not save the opened package for future use.

Instructions for Imikeraderm Application

Application Instructions:- (Lu, Mi and Vi)

1. Before going to bed, wash your hands and the treatment area with mild soap and water.Dry thoroughly.
2. Open a new package and deposit a small amount of cream on the tip of your finger.
3. Applyimiquimod creamto the affected area. Spread it smoothly over the area until the cream disappears.
4. After applying the cream, discard the opened package and wash your hands with water and soap.
5. Leaveimiquimodcream to act on the skin for about 8 hours.Do not bathe or shower during this time.
6. After 8 hours, wash the area where you appliedimiquimodcream with mild soap and water.

Applyimiquimodcream 3 times a week. For example, apply the cream on Mondays, Wednesdays, and Fridays. A package contains enough cream to cover an area of 25 cm2. Continue treatment for 4 weeks. Four weeks after completing the first treatment, your doctor will evaluate your skin. If all lesions have not disappeared, additional 4 weeks of treatment may be necessary.

If you use more Imikeraderm than you should

Wash off the excess with water and mild soap. Once the skin reaction has subsided, you can continue treatment.

In case of accidental ingestion ofimiquimod, consult 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 Imikeraderm

If you forgot a dose, apply the cream as soon as possible and continue with the regular schedule.

Do not apply the cream more than once a day.

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

Like all medications, this medication may cause side effects, although not everyone will experience them.

Consult your doctor or pharmacist if you do not feel well during the administration of imiquimod.

Some patients have presented skin color changes in the area where imiquimod was applied. Although these changes tend to improve over time, they may be permanent in some patients. If your skin presents an adverse reaction when using imiquimod cream, discontinue the application of the cream, wash the area with water and a mild soap, and contact your doctor or pharmacist.

In some individuals, a decrease in blood counts has been detected. A decrease in blood counts may make you more susceptible to infections, cause you to bruise more easily, or cause fatigue. If you notice any of these symptoms, inform your doctor.

Some patients with autoimmune disorders may experience worsening of their disease. Consult your doctor if you experience any change during treatment with imiquimod cream.

In rare cases, severe dermatological reactions have occurred. Discontinue treatment with imiquimod cream and inform your doctor immediately if you notice skin lesions or patches on the skin that begin as small red areas and evolve into small targets possibly with inflammation, fever, general discomfort, visual problems, burning, swollen or painful eyes, and inflamed mouth.

A reduced number of patients have experienced hair loss in the treated area or in the area surrounding it.

Many of the side effects of imiquimod cream are due to local action on your skin. Local skin reactions may be a sign that the medication is acting as intended.

Very common (observed in more than 1 in 10 patients).

Common skin irritation may occur on the treated skin.

Common (observed in less than 1 in 10 patients).

Common side effects include: pain, burning, irritation, or redness.

If any skin reaction becomes too bothersome during treatment, consult your doctor. They may advise you to stop applying imiquimod cream for a few days (i.e., a brief treatment break). If pus or another sign of infection appears, inform your doctor. Apart from skin reactions, other common side effects are headache, anorexia, nausea, muscle and joint pain, and fatigue.

Rare (observed in less than 1 in 100 patients).

Some patients experience alterations at the application site (bleeding, inflammation, discharge, sensitivity, swelling, small inflamed areas on the skin, tingling, scabbing, scarring, ulceration, or a sensation of heat or discomfort), or facial skin inflammation, nasal obstruction, flu-like symptoms, depression, eye irritation, eyelid inflammation, sore throat, diarrhea, actinic keratosis, redness, facial swelling, ulcers, limb pain, fever, weakness, or tremors.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting side 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 store at a temperature above 25 °C.

Do not use this medication after the expiration date that appears on the outer packaging and on the label after EXP. The expiration date refers to the last day of that month.

Once opened, the sachets should not be reused.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Imikeraderm

The active ingredient is:

Imiquimod

Each sachet contains 250 mg of cream (100 mg of cream contains 5 mg of imiquimod).

The other components are:

Isostearic acid, benzyl alcohol, white vaseline (stabilized with butylhydroxytoluene E321), cetyl alcohol, stearic alcohol, polisorbate 60, sorbitan type I stearate, glycerol, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), xanthan gum, and purified water (see also section 2 “Imikeraderm 50 mg/g cream contains methyl parahydroxybenzoate, propyl parahydroxybenzoate, cetyl alcohol, stearic alcohol, benzyl alcohol, and butylhydroxytoluene”).

Appearance of the product and contents of the packaging

Each sachet of Imikeraderm contains 250 mg of a white or yellowish cream. Each pack contains 12 or 24 single-use sachets of polyester/aluminium foil.

Only some pack sizes may be marketed.

Marketing authorization holder and responsible person for manufacturing

Marketing authorization holder:

Mibe Pharma España S.L.U.

C/Amaltea 9, 4th floor, letter B,

28045, Madrid

Spain

Responsible person for manufacturing

Mibe GmbH Arzneimittel

Münchener Straße 15

06796 Brehna

Germany

or

Sun-Farm Sp. z o.o.

Ul. Dolna 21, Lomianki

05-092 Mazowieckie

Poland

Last review date of this leaflet: May 2022

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