Prospecto: information for the user

Imunocare 50 mg/g cream
imiquimod

Read this prospect carefully before starting to use this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you and should not be given to other people, 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 prospect. See section 4.

1.What is IMUNOCARE and how it is used

2.What you need to know before starting to use IMUNOCARE

3.How to use IMUNOCARE

4.Possible adverse effects

5Storage of IMUNOCARE

6.Contents of the package and additional information

Imunocare is indicated for three different diseases. Your doctor may prescribe Imunocare for the treatment of:

• Warts (condylomas acuminados) on the surface of the genitals (sex organs) and around the anus (posterior canal).
• Superficial basal cell carcinoma.This is a common form of slow-growing skin cancer that is very unlikely to spread to other parts of the body. It usually appears in older and middle-aged people,especially those with fair skin due to excessive sun exposure. If left untreated, basal cell carcinoma can cause disfigurement, especially on the face, so early detection and treatment are crucial.
• Actinic keratosisActinic 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. Imunocare should only be used for smooth actinic keratoses on the face and scalp of patients with a healthy immune system when their doctor decides that Imunocare is the most appropriate treatment.

Imunocarehelps the body's own immune system to produce natural substances thathelp to combat basal cell carcinoma, actinic keratosis, or the virus that caused the wart to appear.

Do not use Imunocare

• If you are allergic to imiquimod (the active ingredient) or to any of the other components of this medication (including in section 6).

Warnings and precautions

• If you have used Imunocare or other similar preparations before, consult your doctor before starting this treatment.
• Consult your doctor if you have problems with your immune system.
• Do not use Imunocare until the area to be treated has healed after a previous pharmacological or surgical treatment.
• Avoid contact with the eyes, lips, and nasal passages. 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 applying Imunocare.
• If the treated area becomes too uncomfortable, remove the cream with a mild soap and water. As soon as the problem is resolved, you can reapply the cream.
• Inform your doctor if you experience changes in your blood count.

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

• If you are being treated for genital warts, follow these additional precautions:

• Men with warts under the foreskin should push the foreskin back every day and wash underneath. If daily washing of the foreskin is not done, it is more likely that signs of tension, swelling, and skin peeling will occur, and as a result, it will be more difficult to push the foreskin back. If these symptoms occur, stop treatment immediately and contact your doctor.

• If you are being treated for basal cell carcinoma or actinic keratosis, follow these additional precautions:

• Do not use sunlamps or tanning devices and avoid direct sunlight as much as possible during treatment with Imunocare cream. To go outside, use protective screens and wide-brimmed hats.

During the use of Imunocare and until healing, it is likely that the treatment area will have a notably different appearance from normal skin.

Children and adolescents

Not recommended for use in children and adolescents.

Use of IMUNOCARE with other medications

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

No incompatible medications with Imunocare are known.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication to evaluate the risks and benefits of using Imunocare during pregnancy. Animal studies do not indicate that harmful direct or indirect effects occur during pregnancy.

Do not breastfeed your baby while using Imunocare, as it is not known if imiquimod passes into breast milk.

Driving and operating machinery

According to the described adverse effects in section 4, it is unlikely that treatment will have any effect on the ability to drive and operate machinery.

Imunocare contains parahydroxybenzoic acid methyl ester, parahydroxybenzoic acid propyl ester, cetyl alcohol, stearyl alcohol, and benzyl alcohol.

May cause allergic reactions (possibly delayed) because it contains parahydroxybenzoic acid methyl ester (E 218) and parahydroxybenzoic acid propyl ester (E 216).

This medication may cause local skin reactions (such as contact dermatitis) because it contains cetyl alcohol and stearyl alcohol.

This medication contains 5 mg of benzyl alcohol per gram. Benzyl alcohol may cause allergic reactions.

Benzyl alcohol may cause moderate local irritation.

Children and Adolescents

Not recommended for use in children and adolescents

Adults

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. 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 applying Imunocare.

Open a new package each time you apply the cream. Dispose of any remaining cream in the package after application. Do not store the opened package for use another day.

The frequency and duration of treatment differ in the case of genital warts, basal cell carcinoma, and actinic keratosis (see specific instructions for each indication).

Imunocare Application Instructions

If you are being treated for genital warts:

Instructions for correct use of the medication: (Monday, Wednesday, and Friday)

1. Before going to bed, wash your hands and the treatment area with a mild soap and water. Dry well.

2. Open a new package and deposit the cream on the tip of your finger.

3. Apply a thin layer of Imunocare to a clean and dry wart area and spread it smoothly over the skin until the cream is absorbed.

4. After applying Imunocare, discard the opened package and wash your hands with water and soap.

5. Leave the cream to act on the warts for 6 to 10 hours. During this time, do not bathe or shower.

6. After 6-10 hours, wash the area where you applied Imunocare with soap and water.

Apply Imunocare 3 times a week. For example, apply the cream on Mondays, Wednesdays, and Fridays. A package contains enough cream to cover a wart area of 20 cm2.

Men who are not circumcised and are being treated for warts located under the foreskin should push it back and wash the area daily (see section 2 "What you need to know before starting to use Imunocare").

Continue using Imunocare as instructed until your warts have completely disappeared (half of the women whose warts disappear do so in 8 weeks, half of the men whose warts disappear do so in 12 weeks, however, in some patients, warts may disappear up to 4 weeks).

Do not use Imunocare for more than 16 weeks for each episode of warts.

If you estimate that the action of Imunocare is too strong or too weak, inform your doctor or pharmacist.

If you are being treated for basal cell carcinoma:

Instructions for correct use of the medication (Monday, Tuesday, Wednesday, Friday, and Friday)

1. Before going to bed, wash your hands and the treatment area with mild soap and water. Dry well.

2. Open a new package and deposit a small amount of cream on the tip of your finger.

3. Apply Imunocare to the affected area and 1 cm around the affected area (approximately a finger), spreading it smoothly over the skin until the cream is absorbed.

4. After applying the cream, discard the opened package and wash your hands with water and soap.

5. Leave Imunocare to act on the skin for 8 hours. During this time, do not bathe or shower.

6. After 8 hours, wash the area where you applied Imunocare with mild soap and water.

Apply enough Imunocare to cover the treatment area and 1 cm additional around the treatment area daily, for 5 consecutive days each week, for 6 weeks. For example, apply the cream from Monday to Friday. Do not apply the cream on Saturday or Sunday.

If you are being treated for actinic keratosis:

Instructions for correct use of the medication: (Monday, Wednesday, and Friday)

1. Before going to bed, wash your hands and the treatment area with mild soap and water. Dry well.

2. Open a new package and deposit a small amount of cream on the tip of your finger.

3. Apply Imunocare to the affected area. Spread it smoothly over the area until the cream is absorbed.

4. After applying the cream, discard the opened package and wash your hands with water and soap.

5. Leave Imunocare to act on the skin for 8 hours. During this time, do not bathe or shower.

6. After 8 hours, wash the area where you applied Imunocare with mild soap and water.

Apply Imunocare 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 not all lesions have disappeared, additional 4 weeks of treatment may be necessary.

If you use more Imunocare than you should:

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

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 administered.

If you forgot to use Imunocare:

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

Do not apply the cream more than once a day.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The frequencies of side effects are defined as:

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

Some patients have presented skin color changes in the area where Imunocare 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 Imunocare, 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 can 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 Imunocare cream.

In rare cases, severe dermatological reactions have occurred. Discontinue treatment with Imunocare and inform your doctor immediately if you notice skin lesions or patches on the skin that start as small red areas and evolve into small targets possibly with inflammation, fever, general feeling of 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 surrounding area.

•If you are being treated for genital warts:

Many of the side effects of Imunocare are due to its local action on the skin.

Very common side effects:redness (61% of patients), skin peeling (30% of patients), scaly formation and swelling. They may also cause subcutaneous hardening, small open ulcers, scabs formed during healing or small blisters under the skin. You may also feel itching (32% of patients), burning sensation (26% of patients), or pain in the areas where you apply Imunocare (8% of patients). Most of these skin reactions are moderate, and the skin returns to normal in approximately two weeks after completing treatment.

Common side effects:some patients (4% or less) have experienced headaches.

Uncommon side effects:fever, flu-like symptoms, joint and muscle pain, uterine prolapse, pain during intercourse in women, difficulty achieving an erection, increased sweating, dizziness, gastrointestinal and intestinal symptoms, ringing in the ears, flushing, fatigue, dizziness, migraine, numbness, insomnia, depression, loss of appetite, gland inflammation, bacterial, viral, and fungal infections (e.g., cold sores), vaginal infection (including aphthae), cough and cold with sore throat.

Very rare side effects:severe and painful reactions, particularly when more cream than recommended has been used. Painful skin reactions in the vaginal opening have, in very rare cases, made some women have difficulty urinating. If this happens, seek medical attention immediately.

•If you are being treated for basal cell carcinoma:

Many of the side effects of Imunocare are due to its local action on the skin. Local skin reactions can be a sign that the drug is acting as expected.

Very common side effects:the treated skin may present mild itching.

Common side effects:tingling, small inflamed areas on the skin, pain, burning, irritation, bleeding, redness, or rash. If any skin reaction becomes too bothersome during treatment, consult your doctor. They may advise you to stop applying Imunocare for a few days (i.e., a brief break from treatment). If pus or another sign of infection appears, inform your doctor. Apart from skin reactions, other common effects are gland inflammation and back pain.

Uncommon side effects:some patients experience alterations at the application site (secretion, inflammation, swelling, scaly formation, skin cracking, blisters, dermatitis) or irritability, dizziness, dry mouth, flu-like symptoms, and fatigue.

•If you are being treated for actinic keratosis:

Many of the side effects of Imunocare are due to its local action on the skin. Local skin reactions can be a sign that the drug is acting as expected.

Very common side effects:the treated skin may present mild itching.

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

If any skin reaction becomes too bothersome during treatment, consult your doctor.

They may advise you to stop applying Imunocare for a few days (i.e., a brief break from treatment).

If pus or another sign of infection appears, inform your doctor. Apart from skin reactions, other common effects are headache, loss of appetite, nausea, muscle and joint pain, and fatigue.

Uncommon side effects:some patients experience alterations at the application site (bleeding, inflammation, secretion, sensitivity, swelling, small inflamed areas on the skin, tingling, scaly formation, scar formation, ulceration, or sensation of heat or discomfort), or facial skin inflammation, nasal obstruction, flu or flu-like symptoms, depression, eye irritation, eyelid inflammation, sore throat, diarrhea, actinic keratosis, redness, facial swelling, ulcers, pain in a limb, fever, weakness, or tremors.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if they are possible side effects 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 side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of sight and reach of children.

No special storage conditions are required.

Do not use Imunocare after the expiration date shown on the packaging. The expiration date is the last day of the month indicated.

Once opened, the packets should not be reused.

Do not dispose of medications through drains or in the trash. Deposit the packaging and unused medications at the PHARMACY DROP-OFF POINT. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. This will help protect the environment.

Composition of Imunocare

• The active principle is imiquimod. Each gram of cream contains 50 mg of imiquimod. Each sachet contains 250 mg of cream.
• The other components (excipients) are: isostearic acid, benzyl alcohol, cetyl alcohol, stearyl alcohol, white vaseline, polisorbate 60, sorbitan monostearate, glycerol, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), xanthan gum, and purified water.

Appearance of the product and content of the packaging

Each sachet contains 250 mg of a light-colored white or almost white cream.

Each package contains 12 or 24 single-use sachets of 4-layer laminated (PET/ALU/PET/LDPE).

Not all sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

INDUSTRIAL FARMACÉUTICA CANTABRIA, S.A.

Barrio Solía 30

La Concha de Villaescusa

39690 Cantabria (Spain)

Responsible for manufacturing

INDUSTRIAL FARMACÉUTICA CANTABRIA, S.A.

C/ Pirita, 9

Torrejón de Ardoz

28850 Madrid

Spain

Revision date of this leaflet: January 2024

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