Product Information for the User

Aldara 5% Cream

Imiquimod

Contents of the package and additional information.

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

• Genital warts (condylomas acuminata) on the surface of the genitals (sex organs) and around the anus (rectum).

• Superficial basal cell carcinoma.

This is a common type 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, making early detection and treatment crucial.

• 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, while others are grayish, pink, red, or brown. They can be smooth and scaly or raised, hard, and wart-like. Aldara 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 Aldara is the most appropriate treatment.

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

Do not use Aldara cream

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

Warnings and precautions

Consult your doctor or pharmacist before starting to use Aldara cream.

• If you have used Aldara cream or other similar preparations before, consult your doctor before starting this treatment.
• If you have autoimmune disorders.
• If you have had an organ transplant.

• Do not use Aldara cream 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 applying Aldara cream.
• 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 blood counts.

Due to the mode of action of Aldara, 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 have open ulcers: do not start using Aldara cream until the ulcers have fully healed.

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

Do not use this medication for more than one treatment cycle if you have immune system problems, whether 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 Aldara cream is equally effective in these patients.

If you decide to have sex while still having warts, apply Aldara after, never before, the act of sex. Aldara cream may weaken condoms and diaphragms, so the cream should not be left on during sexual activity. Remember that Aldara cream does not protect against the transmission of HIV or other sexually transmitted diseases to others.

• 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 Aldara cream. When going outside, use protective clothing and wide-brimmed hats.

During the use of Aldara cream and until healing, the treatment 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 Aldara cream

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

No incompatible medicines with Aldara cream are known.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

If you are pregnant or breastfeeding, or think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medicine. They will evaluate the risks and benefits of using Aldara cream during pregnancy. Animal studies do not indicate that harmful direct or indirect effects occur during pregnancy.

Do not breastfeed your baby while using Aldara cream, as it is not known if imiquimod is excreted in breast milk.

Driving and operating machines

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

Aldara cream contains methyl hydroxybenzoate, propyl hydroxybenzoate, cetyl alcohol, stearic alcohol, and benzyl alcohol.

Methyl hydroxybenzoate (E 218) and propyl hydroxybenzoate (E 216) may cause allergic reactions (possibly delayed). Cetyl alcohol and stearic alcohol may cause local skin reactions (such as contact dermatitis).

This medicine contains 5 mg of benzyl alcohol in each sachet. Benzyl alcohol may cause allergic reactions and 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. 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 Aldara cream.

Open a new package each time you apply the cream. Dispose of any remaining cream in the package after application. Do not save 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).

Aldara Cream Application Instructions

• If you are being treated for genital warts:

Instructions for correct use of the medication: (Monday, Wednesday, 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 Aldara cream to a clean and dry verruca area and spread it smoothly over the skin until the cream disappears.

4. After applying the cream, discard the opened package 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 bathe or shower.

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

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

Males being treated for warts located under the foreskin should push it back and wash the area daily (see section 2 “Warnings and Precautions”).

Continue using Aldara cream 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 in as little as 4 weeks).

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

If you think the action of Aldara cream 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, Saturday)

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 Aldara cream to the affected area and 1 cm around the affected area (approximately one finger). Spread it smoothly over the skin until the cream disappears.

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

5. Let Aldara cream 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 Aldara cream with mild soap and water.

Apply enough Aldara cream to cover the treatment area and 1 cm 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, 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 Aldara cream to 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. Let Aldara cream 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 Aldara cream with mild soap and water.

Apply Aldara cream 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 Aldara cream than you should

Dispose of the excess with water and mild soap. When the skin reaction has disappeared, you may continue treatment.

In case of accidental ingestion of Aldara cream, consult your doctor.

If you forgot to use Aldara cream

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 medication, ask your doctor or pharmacist.

Adverse effect frequencies are defined as:

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

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

Uncommon adverse effects (observed in less than 1 in 100 patients).

Rare adverse effects (observed in less than 1 in 1,000 patients).

Very rare adverse effects (observed in less than 1 in 10,000 patients).

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

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

Some patients have presented skin color changes in the area where Aldara 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 Aldara cream, discontinue the cream application, 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 changes during treatment with Aldara cream.

In rare cases, severe dermatological reactions have occurred. Discontinue treatment with Aldara and inform your doctor immediately if you notice skin lesions or patches on your 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 adverse effects of Aldara cream are due to its local action on the skin.

The very common effects include redness (61% of patients), skin peeling (30% of patients), scaly formation, and swelling. They may also cause skin hardening under the skin, 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 Aldara cream (8% of patients). Most of these skin reactions are moderate, and the skin returns to normal in approximately two weeks after completing treatment.

Commonlysome patients (4% or less) have experienced headaches,with infrequentfever, flu-like symptoms, joint and muscle pain, uterine prolapse, pain during intercourse in women, difficulties with erection, increased sweating, dizziness, gastrointestinal and intestinal symptoms, ringing in the ears, flushing, fatigue, dizziness, migraine, tingling, 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 rarelysevere and painful reactions have occurred, 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 immediate medical assistance.

• If you are being treated for basal cell carcinoma:

Many of the adverse effects of Aldara cream are due to its local action on the skin. Local skin reactions may be a sign that the drug is acting as intended.

Very frequentlythe treated skin may present mild itching.

Common effectsare: 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 Aldara 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 effects are gland inflammation and back pain.

Infrequentlysome patients experience changes 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 adverse effects of Aldara cream are due to its local action on the skin. Local skin reactions may be a sign that the drug is acting as intended.

Very frequentlythe treated skin may present mild itching.

The common effectsinclude: pain, burning, irritation, or redness.

If any skin reaction becomes too bothersome during treatment, consult your doctor. They may advise you to stop applying Aldara 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 effects are headache, loss of appetite, nausea, muscle and joint pain, and fatigue.

Infrequentlysome patients experience changes at the application site (bleeding, inflammation, secretion, sensitivity, swelling, small inflamed areas on the skin, tingling, scaly formation, scarring, ulceration, or sensation of heat or discomfort), or facial 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 adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, evenif it is apossibleadverse effect that does not appear in this prospectus. You can also report them directly through thenational notification system included in theAppendix V. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

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 CAD.

Once opened, the sachets should not be reused.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. By doing so, you will help protect the environment.

Active Ingredient Composition of Aldara Cream

• 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, cetyl alcohol, stearyl alcohol, white vaseline, polisorbate 60, sorbitan stearate, glycerol, methyl hydroxybenzoate (E 218), propyl hydroxybenzoate (E 216), xanthan gum, and purified water (see also section 2 “Aldara cream contains methyl hydroxybenzoate, propyl hydroxybenzoate, cetyl alcohol, stearyl alcohol, and benzyl alcohol”).

Appearance of the Product and Contents of the Package

• Each sachet of Aldara 5% cream contains 250 mg of a white or yellowish cream.
• Each package contains 12 or 24 single-use sachets of polyester/aluminum foil. Some package sizes may only be marketed.

Marketing Authorization Holder

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart

Dublin 15

DUBLIN

Ireland

Manufacturer

Swiss Caps GmbH

Grassingerstraße 9

83043 Bad Aibling

Germany

For more information about this medicine, please contact the local representative of the marketing authorization holder.

Last review date of this leaflet: {MM/AAAA}

For more detailed information about this medicine, please visit the website of the European Medicines Agency: http://www.ema.europa.eu.