IMUNOCARE 50 mg/g CREAM

Introduction

Package Leaflet: Information for the User

Imunocare 50 mg/g Creamimiquimod

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, 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 pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is IMUNOCARE and what is it used for
2. What you need to know before you use IMUNOCARE
3. How to use IMUNOCARE
4. Possible side effects

5 Storage of IMUNOCARE

1. Contents of the pack and other information

1. What is IMUNOCARE and what is it used for

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

• Warts (genital warts) on the surface of the genitals (sex organs) and around the anus (rectal area).
• 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 essential.
• Actinic keratosis. Actinic keratosis consists of rough areas of the skin that occur in people who have been exposed to a lot of sunlight during their lifetime. Some are colored, others are grayish, pink, red, or brown. They can be smooth and scaly or thickened, hard, and wart-like. Imunocare should be used exclusively for smooth actinic keratosis on the face and scalp of patients with a healthy immune system when your doctor decides that Imunocare is the most appropriate treatment.

Imunocare helps the body's own immune system to produce natural substances that help fight basal cell carcinoma, actinic keratosis, or the virus that caused the wart.

2. What you need to know before you use IMUNOCARE

Do not use Imunocare

• If you are allergic to imiquimod (the active substance) or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

• If you have used Imunocare or similar preparations before, you should 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 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 applying Imunocare.
• If the treated area becomes too irritated, remove the cream with mild soap and water. As soon as the problem is resolved, you can reapply the cream.
• Tell your doctor if you have 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 pull the foreskin back every day and wash underneath. If the foreskin is not washed daily, it is more likely that signs of tightness, swelling, and skin peeling will occur, and as a result, it will be more difficult to pull the foreskin back. If these symptoms occur, stop treatment immediately and contact your doctor.

• If you have open sores: do not start using Imunocare until the sores have healed completely.

• If you have internal warts: do not use Imunocare in the urethra (the opening through which urine passes), vagina (birth canal), cervix (internal female organ), or any area inside the anus (rectum).

• Do not use this medication for more than one treatment cycle if you have immune system problems, either due to a disease or medications you are taking. If you think this may be your case, consult your doctor.

• If you are infected with HIV (AIDS), inform your doctor, as it has not been demonstrated that treatment with Imunocare is equally effective in these patients.
• If you decide to have sex while you still have warts, apply Imunocare after, never before, sexual activity. Imunocare can weaken condoms and diaphragms, so the cream should not be left on during sexual activity. Remember that Imunocare does not protect against the transmission of HIV or other sexually transmitted diseases to other people.

• 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 sunlight as much as possible during treatment with Imunocare cream. When going outside, use protective clothing and wide-brimmed hats.

During the use of Imunocare and until healing, it is likely that the treated area will look noticeably different from normal skin.

Children and adolescents

It is not recommended for use in children and adolescents.

Using IMUNOCARE with other medicines

Tell your doctor or pharmacist if you are using or have recently used or might use any other medicines.

No medicines are known to be incompatible with Imunocare.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy.

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

Driving and using machines

Based on the side effects described in section 4, it is unlikely that treatment will affect your ability to drive or use machines.

Imunocare contains methylparaben, propylparaben, cetyl alcohol, stearic alcohol, and benzyl alcohol.

It may cause allergic reactions (possibly delayed) because it contains methylparaben (E 218) and propylparaben (E 216).

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

This medicine contains 5 mg of benzyl alcohol in each gram. Benzyl alcohol may cause allergic reactions.

Benzyl alcohol may cause moderate local irritation.

3. How to use IMUNOCARE

Children and adolescents

It is not recommended for use in children and adolescents.

Adults

Follow the instructions for administration of this medicine exactly as told by your doctor or pharmacist. If you are unsure, 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 sachet each time you apply the cream. Discard any leftover cream in the sachet after application. Do not save an opened sachet for use on another day.

The frequency and duration of treatment differ for 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 medicine: (Monday, Wednesday, and Friday)

1. Before bedtime, wash your hands and the treatment area with mild soap and water. Dry well.
2. Open a new sachet and place 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 sachet and wash your hands with water and soap.
5. Let the cream act on the warts for 6 to 10 hours. During this time, do not shower or bathe.
6. After 6-10 hours, wash the area where you applied Imunocare with water and mild soap.

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

Uncircumcised men who are treating warts under the foreskin should pull the foreskin back and wash the area every day (see section 2 "What you need to know before you use Imunocare").

Continue using Imunocare as directed until your warts have completely disappeared (in half of the women whose warts disappear, it happens within 8 weeks; in half of the men whose warts disappear, it happens within 12 weeks. However, in some patients, warts may disappear within 4 weeks).

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

If you think the action of Imunocare is too strong or too weak, tell your doctor or pharmacist.

If you are being treated for basal cell carcinoma:

Instructions for correct use of the medicine: (Monday, Tuesday, Wednesday, Thursday, and Friday)

1. Before bedtime, wash your hands and the treatment area with mild soap and water. Dry well.
2. Open a new sachet and place 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 one finger), spreading it smoothly over the skin until the cream is absorbed.
4. After applying the cream, discard the opened sachet and wash your hands with water and soap.
5. Let Imunocare act on the skin for about 8 hours. During this time, do not shower or bathe.
6. After about 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 around the treatment area, once 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 medicine: (Monday, Wednesday, and Friday)

1. Before bedtime, wash your hands and the treatment area with mild soap and water. Dry well.
2. Open a new sachet and place a small amount of cream on the tip of your finger.
3. Apply Imunocare to the affected area, spreading it smoothly over the area until the cream is absorbed.
4. After applying the cream, discard the opened sachet and wash your hands with water and soap.
5. Let Imunocare act on the skin for about 8 hours. During this time, do not shower or bathe.
6. After about 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. One sachet 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, another 4 weeks of treatment may be necessary.

If you use more Imunocare than you should

Remove the excess with water and mild soap. When the skin reaction disappears, you can continue treatment.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount administered.

If you forget to use Imunocare

If you miss a dose, apply the cream as soon as possible and continue your usual routine.

Do not apply the cream more than once a day.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

The frequencies of adverse effects are defined as:

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

Some patients have presented changes in skin coloration in the area where Imunocare was applied. Although these changes tend to improve over time, they could be permanent in some patients.

If your skin presents an adverse reaction when using Imunocare, interrupt the application of the cream, wash the area with water and 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 who suffer from 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. Interrupt treatment with Imunocare and inform your doctor immediately if you notice skin lesions or spots on the skin that start as small red areas and evolve to resemble small targets, possibly with inflammation, fever, feeling of general malaise, 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 adverse effects of Imunocare are due to its local action on the skin.

Very Common Adverse Effects:redness (61% of patients), skin peeling (30% of patients), scale formation, and swelling. Hardening under the skin, small open ulcers, scabs formed during healing, or small blisters under the skin may also occur. 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 its normal appearance in approximately two weeks after finishing treatment.

Common Adverse Effects:some patients (4% or less) have experienced headache.

Uncommon Adverse Effects:fever, flu-like symptoms, joint and muscle pain, uterine prolapse, pain during intercourse in women, erection difficulties, increased sweating, dizziness, stomach and intestinal symptoms, ringing in the ears, flushing, fatigue, vertigo, migraine, tingling, insomnia, depression, loss of appetite, gland inflammation, bacterial, viral, and fungal infections (e.g., cold sores), vaginal infection (including thrush), cough, and colds with sore throat.

Very Rare Adverse Effects:severe and painful reactions, particularly when more cream than recommended has been used. Painful skin reactions at the vaginal opening have rarely caused some women to have difficulty urinating. If this happens, seek medical attention immediately.

• If you are being treated for basal cell carcinoma:

Many of the adverse effects of Imunocare are due to its local action on your skin. Local skin reactions may be a sign that the drug is working as expected.

Very Common Adverse Effects:the treated skin may present mild itching.

Common Adverse 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 other signs of infection appear, inform your doctor. Apart from skin reactions, other common effects are gland inflammation and back pain.

Uncommon Adverse Effects:some patients experience alterations at the application site (discharge, inflammation, swelling, scale formation, cracked skin, blisters, dermatitis) or irritability, dizziness, dry mouth, flu-like symptoms, and fatigue.

• If you are being treated for actinic keratosis:

Many of the adverse effects of Imunocare are due to its local action on your skin. Local skin reactions may be a sign that the drug is working as expected.

Very Common Adverse Effects:the treated skin may present mild itching.

Common Adverse 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 other signs of infection appear, inform your doctor. Apart from skin reactions, other common effects are headache, anorexia, nausea, muscle and joint pain, and fatigue.

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of IMUNOCARE

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 the sachets are opened, they should not be reused.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Imunocare

• The active ingredient 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, stearic alcohol, white petrolatum, polysorbate 60, sorbitan monostearate, glycerol, methylparaben (E 218), propylparaben (E 216), xanthan gum, and purified water.

Appearance of the Product and Package Contents

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

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

Not all sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

INDUSTRIAL FARMACÉUTICA CANTABRIA, S.A.

Barrio Solía 30

La Concha de Villaescusa

39690 Cantabria (Spain)

Manufacturer

INDUSTRIAL FARMACÉUTICA CANTABRIA, S.A.

C/ Pirita, 9

Torrejón de Ardoz

28850 Madrid

Spain

Date of the Last Revision of this Prospectus: January 2024

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