Aldara Cream 5% 12 Sachets

ALDARA 5% Cream Applied on the skin

Active ingredient
Each sachet contains 12.5 mg of imiquimod (5%) in 250 mg of cream

Excipients
Methylhydroxybenzoate (E218), propylhydroxybenzoate (E216), cetyl alcohol, stearyl alcohol1.

1. What ALDARA is and what it is used for

ALDARA is a product containing 12 sachets, each containing 250 mg of cream. ALDARA contains imiquimod as the active ingredient.

Imiquimod is an immune response modulator. It is an effective agent against wart-forming viruses and tumors (antitumor).

ALDARA can be used in three different situations. Your doctor may prescribe you ALDARA for the treatment of the following conditions:

• Warts on the skin surface of the genital area (genital organs) and around the anus (condyloma acuminata)

• Superficial basal cell carcinoma

This is a common, slow-growing skin cancer that is very unlikely to spread to other parts of the body. It usually occurs in middle-aged and elderly people, especially in fair-skinned people, and is caused by exposure to too much sunlight. If left untreated, basal cell carcinoma can cause facial disfigurement, especially. Therefore, early diagnosis and treatment is important.

• Actinic keratosis

Actinic keratosis are areas of rough skin found in people who have been exposed to a lot of sun rays during their lifetime. Some are skin colored, may be greyish, rosy red or brown. Lesions may be flat and scaly or raised, rough, hard, and warty-like. ALDARA is used only for flat actinic keratosis of the face and scalp in patients with a healthy immune system.

ALDARA helps your body's own immune system produce natural substances that play a role in fighting the virus that causes basal cell carcinoma, actinic keratosis or warts.

2. How is ALDARA used?

Always use as directed by your doctor.
Instructions for proper use and dose/frequency of administration

Wash your hands thoroughly before and after application. After applying ALDARA, do not cover it with a bandage or similar material.

Always open a new sachet when you use it. Throw away any remaining cream after use. After use, do not store the opened sachet for later use.

The frequency and duration of application of ALDARA are different for genital warts, basal cell carcinoma or actinic keratosis.

3. What are the possible side effects?

Like all medicines, there may be side effects in people who are sensitive to the substances contained in ALDARA.

If any of the following occur, stop using ALDARA and IMMEDIATELY inform your doctor or go to the nearest hospital emergency department:

• 'swelling of the hands, feet, ankles, face, lips, or especially swelling of the mouth or throat that makes it difficult to swallow or breathe'

'These are all very serious side effects. If you have one of these, you have a serious allergy to ALDARA. You may need urgent medical attention or hospitalization.'

'All of these very serious side effects are very rare.'

Tell your doctor if you notice any of the following:

• Skin lesions or spots that begin as small red areas on your skin and progress to look like small targets, accompanied by the following symptoms:

4. Things to consider before using ALDARA

DO NOT USE ALDARA in the following situations

If you have imiquimo (active ingredient) or any of the ingredients of the cream

if you have allergies.

USE ALDARA CAREFULLY in the following situations

• If you have used ALDARA or other similar drugs before, tell your doctor before starting this treatment.

• Tell your doctor if you have problems with your immune system.

• If you have used a medicine or had surgery on the area to be applied, do not use ALDARA until the area has healed.

• Avoid contact with the nostril, lips and eyes. In case of accidental contact, wash with water and remove the cream from that area.

• ALDARA is for use on the skin only, do not apply to the inside of the vagina or anus.

• Do not use more cream than your doctor recommends.

• After applying ALDARA, do not cover it with a bandage or similar material.

• If the treated area becomes very uncomfortable, wash off the cream with soap and water. As soon as the problem disappears, you can start applying the cream again.

• Tell your doctor if you have an abnormality in your blood count.

Due to the mode of action of ALDARA, there is a possibility of worsening existing inflammation in the treated area.

• If you are using it for warts in the genital area, follow the warnings below: