Imunocare 50 mg/g cream
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Imunocare 50 mg/g cream imiquimod
Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, consult your doctor or pharmacist.
- This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
Leaflet contents:
- What IMUNOCARE is and what it is used for
- What you need to know before using IMUNOCARE
- How to use IMUNOCARE
- Possible adverse effects
- Storage of IMUNOCARE
- Contents of the pack and other information
1. What IMUNOCARE is and what it is used for
Imunocare is indicated for three distinct conditions. Your doctor may prescribe Imunocare for the treatment of:
- Genital warts (condyloma acuminatum) on the genital skin (sex organs) and around the anus (posterior duct).
- Superficial basal cell carcinoma. This is a common type of skin cancer that grows slowly and is very unlikely to spread to other parts of the body. It usually occurs in middle-aged and older individuals, especially those with fair skin due to excessive sun exposure. If left untreated, basal cell carcinoma can lead to disfigurement, particularly on the face, so early detection and treatment are essential.
- Actinic keratosis. Actinic keratosis consists of rough skin patches that develop in individuals who have had significant sun exposure throughout life. Some patches are pigmented, others are grayish, pink, red, or brown. They may be flat and scaly, or raised, hard, and warty. Imunocare should be used exclusively for flat actinic keratoses on the face and scalp in immunocompetent patients when your doctor determines that Imunocare is the most appropriate treatment.
Imunocare helps your body's own immune system produce natural substances that assist in fighting your basal cell carcinoma, actinic keratosis, or the virus that caused the warts to develop.
2. What you need to know before using IMUNOCARE
Do not use Imunocare
- If you are allergic to imiquimod (the active substance) or to any of the other components of this medicine (listed in section 6).
Warnings and precautions
- If you have previously used Imunocare or other similar preparations, 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 any 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 has recommended.
- Do not cover the treated area with bandages or other dressings after applying Imunocare.
- If excessive irritation occurs in the treated area, remove the cream with a mild soap and water. Once the problem has resolved, you may resume applying the cream.
- Inform your doctor if you have any blood count abnormalities.
Due to the mechanism of action of Imunocare, there is a possibility that the cream may worsen existing inflammation in the treatment area.
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If you are being treated for genital warts, follow these additional precautions:
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Men with warts under the foreskin should retract the foreskin daily and wash underneath. If daily cleaning is not performed, signs of tightness, swelling, and skin peeling are more likely to occur, which may lead to difficulty in retracting the foreskin. If these symptoms occur, stop treatment immediately and contact your doctor.
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If you have open ulcers: do not start using Imunocare until the ulcers have completely healed.
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If you have internal warts: do not use Imunocare in the urethra (the opening through which urine passes), inside the vagina (birth canal), cervix (internal female organ), or any area inside the anus (rectum).
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You should not use this medication for longer than one treatment cycle if you have immune system problems, whether due to disease or medications you are taking. If you think this may apply to you, consult your doctor.
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If you are infected with HIV (AIDS), inform your doctor, as the effectiveness of Imunocare treatment has not been proven in these patients.
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If you decide to have sexual intercourse while still having warts, apply Imunocare after, never before, sexual activity. Imunocare may weaken condoms and diaphragms, so the cream should not be left on during sexual activity. Remember that Imunocare does not protect against transmission of HIV or other sexually transmitted infections to others.
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If you are being treated for basal cell carcinoma or actinic keratosis, follow these additional precautions:
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Do not use sunlamps or tanning devices, and avoid sunlight as much as possible during treatment with Imunocare cream. When going outdoors, wear protective clothing and wide-brimmed hats.
During the use of Imunocare and until healing is complete, the treated area may look noticeably different from normal skin.
Children and adolescents
Not recommended for use in children and adolescents.
Use of IMUNOCARE with other medicines
Tell your doctor or pharmacist if you are using, have recently used, or might need to 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine so they can assess the risks and benefits of using Imunocare during pregnancy. Animal studies do not indicate direct or indirect harmful effects during pregnancy.
Do not breastfeed while using Imunocare, as it is not known whether imiquimod passes into breast milk.
Driving and use of machines
Based on the adverse effects described in section 4, it is unlikely that the treatment will affect your ability to drive or operate machinery.
Imunocare contains methyl parahydroxybenzoate, propyl parahydroxybenzoate, cetyl alcohol, stearyl alcohol, and benzyl alcohol.
It may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216).
This medicine may cause local skin reactions (such as contact dermatitis) because it contains cetyl alcohol and stearyl alcohol.
This medicine contains 5 mg of benzyl alcohol per gram. Benzyl alcohol may cause allergic reactions.
Benzyl alcohol may cause moderate local irritation.
3. How to use IMUNOCARE
Children and adolescents
Not recommended for use in children and adolescents.
Adults
Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Wash your hands thoroughly before and after applying the cream. Do not cover the treated area with bandages or other dressings after Imunocare has been applied.
Open a new sachet each time you apply the cream. Discard any remaining cream in the sachet after application. Do not save the opened sachet for use on another day.
The frequency and duration of treatment differ depending on whether you are being treated for genital warts, basal cell carcinoma, or 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: (Mon, Wed, Fri)
- Before going to bed, wash your hands and the treatment area with mild soap and water. Dry thoroughly.
- Open a new sachet and place the cream on the tip of your finger.
- Apply a thin layer of Imunocare to the clean, dry warty area and gently spread it over the skin until the cream is absorbed.
- After applying Imunocare, discard the opened sachet and wash your hands with water and soap.
- Leave the cream on the warts for 6 to 10 hours. During this time, do not shower or bathe.
- After 6–10 hours, wash the area where Imunocare was applied 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 warty area of 20 cm².
Uncircumcised men treating warts located under the foreskin should retract the foreskin and clean the area daily (see section 2 “What you need to know before starting to use Imunocare”).
Continue using Imunocare as directed until your warts have completely disappeared (half of women see their warts disappear within 8 weeks; half of men see theirs disappear within 12 weeks; however, in some patients, warts may disappear as early as 4 weeks).
Do not use Imunocare for longer than 16 weeks for the treatment of each episode of warts.
If you feel that the effect of Imunocare is too strong or too weak, speak to your doctor or pharmacist.
If you are being treated for basal cell carcinoma:
Instructions for correct use of the medicine (Mon, Tue, Wed, Thu, Fri)
- Before going to bed, wash your hands and the treatment area with mild soap and water. Dry thoroughly.
- Open a new sachet and place a small amount of cream on the tip of your finger.
- Apply Imunocare to the affected area and to an area extending 1 cm beyond it (approximately the width of a finger), gently spreading it over the skin until the cream is absorbed.
- After applying the cream, discard the opened sachet and wash your hands with water and soap.
- Leave Imunocare on the skin for approximately 8 hours. During this time, do not shower or bathe.
- After approximately 8 hours, wash the area where Imunocare was applied with mild soap and water.
Apply enough Imunocare to cover the treatment area and an additional 1 cm around it, 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: (Mon, Wed, Fri)
- Before going to bed, wash your hands and the treatment area with mild soap and water. Dry thoroughly.
- Open a new sachet and place a small amount of cream on the tip of your finger.
- Apply Imunocare to the affected area. Gently spread it over the area until the cream is absorbed.
- After applying the cream, discard the opened sachet and wash your hands with water and soap.
- Leave Imunocare on the skin for approximately 8 hours. During this time, do not shower or bathe.
- After approximately 8 hours, wash the area where Imunocare was applied 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 course of treatment, your doctor will evaluate your skin. If not all lesions have disappeared, an additional 4 weeks of treatment may be necessary.
If you use more Imunocare than you should
Remove any excess with water and mild soap. Once the skin reaction has subsided, you may resume treatment.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount taken.
If you forget to use Imunocare
If you miss a dose, apply the cream as soon as possible and then continue with your regular schedule.
Do not apply the cream more than once a day.
If you have any further questions about the use of this product, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everybody gets them.
The frequencies of adverse effects are defined as:
Very common adverse effects | May affect more than 1 in 10 people |
Common adverse effects | May affect up to 1 in 10 people |
Uncommon adverse effects | May affect up to 1 in 100 people |
Rare adverse effects | May affect up to 1 in 1,000 people |
Very rare adverse effects | May affect up to 1 in 10,000 people |
Consult your doctor or pharmacist if you do not feel well during treatment with Imunocare.
Some patients have experienced 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 has an adverse reaction when using Imunocare, stop applying the cream, wash the area with water and a mild soap, and contact your doctor or pharmacist.
In some individuals, a decrease in blood cell counts has been detected. A reduction in blood cell counts may make you more susceptible to infections, cause you to bruise more easily, or lead to fatigue. If you notice any of these symptoms, inform your doctor.
Some patients with autoimmune disorders may experience worsening of their condition. Consult your doctor if you notice any changes during treatment with Imunocare cream.
In rare cases, severe dermatological reactions have occurred. Discontinue treatment with Imunocare and contact your doctor immediately if you notice skin lesions or spots that start as small red areas and evolve to resemble small targets, possibly with swelling, fever, general malaise, vision problems, burning sensation, swollen or painful eyes, or mouth inflammation.
A small number of patients have experienced hair loss in the treated area or in the surrounding region.
•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), scaling and swelling. Skin hardening, small open ulcers, scabs formed during healing, or small blisters under the skin may also occur. You may also experience 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 usually returns to normal in approximately two weeks after treatment ends.
Common adverse effects: some patients (4% or fewer) have experienced headache.
Uncommon adverse effects: fever, flu-like symptoms, joint and muscle pain, uterine prolapse, pain during intercourse in women, erectile difficulties, increased sweating, dizziness, gastrointestinal and intestinal symptoms, tinnitus, flushing, fatigue, vertigo, migraine, tingling, insomnia, depression, loss of appetite, gland inflammation, bacterial, viral and fungal infections (e.g., cold sores), vaginal infection (including candidiasis), 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, in very rare cases, caused some women difficulty urinating. If this occurs, seek medical help 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 intended.
Very common adverse effects: treated skin may experience 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. Your doctor may advise you to stop applying Imunocare for a few days (i.e., a brief treatment break). If pus or other signs of infection appear, inform your doctor. Apart from skin reactions, other common effects include gland inflammation and back pain.
Uncommon adverse effects: some patients experience changes at the application site (discharge, inflammation, swelling, scaling, 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 intended.
Very common adverse effects: treated skin may experience mild itching.
Common adverse effects: pain, burning, irritation, or redness.
If any skin reaction becomes too bothersome during treatment, consult your doctor.
Your doctor may advise you to stop applying Imunocare for a few days (i.e., a brief treatment break).
If pus or other signs of infection appear, inform your doctor. Apart from skin reactions, other common effects include headache, anorexia, nausea, muscle and joint pain, and fatigue.
Uncommon adverse effects: some patients experience changes at the application site (bleeding, inflammation, discharge, sensitivity, swelling, small inflamed skin areas, tingling, scaling, scarring, ulceration, or sensation of heat or discomfort), or inflammation of the skin lining the nose, nasal congestion, flu or pseudoflu-like symptoms, depression, eye irritation, eyelid inflammation, sore throat, diarrhea, actinic keratosis, redness, facial swelling, ulcers, limb pain, fever, weakness, or tremors.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of IMUNOCARE
Keep out of the sight and reach of children.
No special storage conditions required.
Do not use Imunocare after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.
After opening, the sachets must not be reused.
Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused containers and medicines at the pharmacy's PUNTO SIGRE
. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This helps protect the environment.
6. Contents of the pack and other information
Composition of Imunocare
- The active substance 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 soft paraffin, polysorbate 60, sorbitan monostearate, glycerol, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), xanthan gum, and purified water.
Appearance of the product and contents of the pack
Each sachet contains 250 mg of a light white or almost white cream.
Each pack contains 12 or 24 single-use laminated foil sachets (PET/ALU/PET/LDPE) with 4 layers.
Not all pack 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 most recent revision of this leaflet: January 2024
Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/