Aldara 5% cream

Patient Information Leaflet

Introduction

Patient Information Leaflet

Aldara 5% cream

imiquimod

Package leaflet contents:

1. What Aldara cream is and what it is used for.
2. What you need to know before using Aldara cream.
3. How to use Aldara cream.
4. Possible side effects.
5. How to store Aldara cream.
6. Contents of the pack and other information.

1. What Aldara cream is and what it is used for

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

• Warts (genital warts) on the surface of the genital skin (sex organs) and around the anus (back passage).

• 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 people, especially those with fair skin due to excessive sun exposure. If left untreated, basal cell carcinoma can cause disfigurement, particularly on the face, so early detection and treatment are essential.

• Actinic keratosis.

Actinic keratosis consists of rough skin patches that develop in people who have had significant sun exposure over their lifetime. Some patches are pigmented, others are grayish, pink, red, or brown. They may be flat and scaly, or raised, hard, and warty. Aldara cream should only be used for flat actinic keratoses on the face and scalp in immunocompetent patients when your doctor decides that Aldara is the most appropriate treatment.

Aldara cream helps your body's own immune system to produce natural substances that help fight your basal cell carcinoma, actinic keratosis, or the virus that caused the warts to develop.

2. What you need to know before using Aldara cream

Do not use Aldara cream

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

Warnings and precautions

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

• If you have previously used Aldara cream or other similar preparations, you should 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 following any previous medical 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 advised.

• Do not cover the treated area with bandages or other dressings after applying Aldara cream.

• If excessive discomfort occurs in the treated area, remove the cream with mild soap and water. As soon as the problem has resolved, you may resume applying the cream.

• Inform your doctor if you experience changes in blood cell counts.

Due to the mechanism 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 retract the foreskin daily and wash underneath. If daily cleaning under the foreskin is not performed, signs of tightness, swelling, and skin peeling are more likely to occur, which may result in increased difficulty retracting the foreskin. 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 completely healed.

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

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.

If you are infected with HIV (AIDS), inform your doctor, as it has not been proven that treatment with Aldara cream is equally effective in these patients.

If you decide to have sexual intercourse while still having warts, apply Aldara after, never before, sexual activity. 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 transmission of HIV or other sexually transmitted infections 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 Aldara cream. When going outdoors, wear protective clothing and wide-brimmed hats.

During the use of Aldara cream and until healing, the treated area may look noticeably different 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 taking, have recently taken, or might need to take any other medicines.

No medicines are known to be incompatible with Aldara cream.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

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. Your doctor will assess the risks and benefits of using Aldara cream during pregnancy. Animal studies do not indicate direct or indirect harmful effects during pregnancy.

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

Driving and using machines

This medicine has no effect or a negligible effect on the ability to drive and use machines.

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

Methyl hydroxybenzoate (E 218) and propyl hydroxybenzoate (E 216) may cause allergic reactions (possibly delayed). Cetyl alcohol and stearyl 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.

3. How to use Aldara cream

Children and adolescents:

Not recommended for use in children and adolescents.

Adults:

Follow exactly the administration instructions given by your doctor for this medicine. 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 Aldara cream has been applied.

Open a new sachet each time you apply the cream. Discard any remaining cream in the sachet after use. 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).

Instructions for Application of Aldara Cream

• If you are being treated for genital warts:

Instructions for correct use of the medicine: (Mon, Wed, Fri)

1. Before going to bed, wash your hands and the treatment area with mild soap and water. Dry thoroughly.
2. Open a new sachet and place the cream on the tip of your finger.
3. Apply a thin layer of Aldara cream to one clean, dry wart-affected area, spreading it gently over the skin until the cream disappears.
4. After applying the cream, discard the opened sachet and wash your hands with water and soap.
5. Leave the cream 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 the cream was applied with water and mild soap.

Apply Aldara three 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.

Men treating warts located under the foreskin should retract it and clean the area daily (see section 2 “Warnings and precautions”).

Continue using Aldara cream as directed until your warts have completely disappeared (half of women see complete clearance by 8 weeks, half of men by 12 weeks; however, in some patients, warts may clear as early as 4 weeks).

Do not use Aldara cream for longer than 16 weeks for the treatment of each episode of warts.

If you think the effect of Aldara cream is too strong or too weak, discuss this with 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)

1. Before going to bed, wash your hands and the treatment area with mild soap and water. Dry thoroughly.
2. Open a new sachet and place a small amount of cream on the tip of your finger.
3. Apply Aldara cream to the affected area and to an area extending 1 cm beyond it (approximately the width of one finger), spreading it gently over the skin until the cream disappears.
4. After applying the cream, discard the opened sachet and wash your hands with water and soap.
5. Leave Aldara cream on the skin for approximately 8 hours. During this time, do not shower or bathe.
6. After approximately 8 hours, wash the area where Aldara cream was applied with mild soap and water.

Apply enough Aldara cream 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)

1. Before going to bed, wash your hands and the treatment area with mild soap and water. Dry thoroughly.
2. Open a new sachet and place a small amount of cream on the tip of your finger.
3. Apply Aldara cream to the affected area, spreading it gently over the area until the cream disappears.
4. After applying the cream, discard the opened sachet and wash your hands with water and soap.
5. Leave Aldara cream on the skin for approximately 8 hours. During this time, do not shower or bathe.
6. After approximately 8 hours, wash the area where Aldara cream was applied with mild soap and water.

Apply Aldara cream three 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 assess your skin. If not all lesions have cleared, an additional 4 weeks of treatment may be necessary.

If you use more Aldara cream than you should

Remove any excess cream with water and mild soap. Once the skin reaction has subsided, you may resume treatment.

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

If you forget to use Aldara cream

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 medicine, ask your doctor or pharmacist.

4. Possible adverse effects

The frequencies of adverse effects are defined as follows:

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

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

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

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

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

Like all medicines, this medicine may cause adverse effects, although not everybody experiences them.

Consult your doctor or pharmacist if you feel unwell during treatment with Aldara cream.

Some patients have experienced skin discoloration in the area where Aldara was applied. Although these changes tend to improve over time, they could be permanent in some patients. If you experience an adverse skin reaction while using Aldara cream, stop applying the cream, wash the area with water and a mild soap, and contact your doctor or pharmacist.

A reduction in blood cell counts has been observed in some individuals. A decrease 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 Aldara cream.

In rare cases, severe dermatological reactions have occurred. Discontinue treatment with Aldara and contact your doctor immediately if you notice skin lesions or spots that start as small red areas and progress to resemble small target-like lesions, possibly with swelling, fever, general malaise, visual disturbances, 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 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.

Very common effects include redness (61% of patients), skin flaking (30% of patients), scaling, 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 experience 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 usually returns to normal within approximately two weeks after completing treatment.

Commonly, some patients (4% or fewer) have experienced headache, uncommonly 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, swollen glands, bacterial, viral, and fungal infections (e.g., cold sores), vaginal infections (including candidiasis), cough, and colds with sore throat.

Very rarely, severe and painful reactions have occurred, particularly when more cream than recommended was used. Painful skin reactions at the vaginal opening have very rarely caused some women difficulty urinating. If this occurs, seek medical assistance immediately.

• If you are being treated for basal cell carcinoma:

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

Very commonly, the treated skin may experience mild itching.

Common effects include: 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 Aldara cream for a few days (i.e., a brief treatment break). If pus or any other sign of infection appears, inform your doctor. Apart from skin reactions, other common effects include swollen glands and back pain.

Uncommonly, 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 Aldara cream are due to its local action on your skin. Local skin reactions may be a sign that the medicine is working as intended.

Very commonly, the treated skin may experience mild itching.

Common effects include: 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 Aldara cream for a few days (i.e., a brief treatment break).

If pus or any other sign of infection appears, inform your doctor. Apart from skin reactions, other common effects include headache, anorexia, nausea, muscle and joint pain, and fatigue.

Uncommonly, some patients experience changes at the application site (bleeding, inflammation, discharge, sensitivity, swelling, small inflamed areas on the skin, tingling, scaling, scarring, ulceration, or sensation of heat or discomfort), or inflammation of the skin lining the nose, nasal congestion, flu or flu-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 adverse effects, 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 national reporting system listed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Aldara cream

Keep this medicine out of the sight and reach of children.

Do not store above 25 °C.

Do not use this medicine after the expiry date stated on the outer packaging and label following EXP.

After opening, the sachets must not be reused.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Aldara cream

• The active substance is imiquimod. Each sachet contains 250 mg of cream (100 mg of cream contain 5 mg of imiquimod).
• The other components are isostearic acid, benzyl alcohol, cetyl alcohol, stearyl alcohol, white soft paraffin, polysorbate 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”).

Nature of the product and contents of the pack

• Each sachet of Aldara 5% cream contains 250 mg of a white or yellowish cream.
• Each pack contains 12 or 24 single-use aluminium/polyester foil sachets. Only certain pack sizes may 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 further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder.

Date of the most recent review of this leaflet: {MM/YYYY}

Detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu.