Aldara

• Used for genital warts
• Also used for certain skin disorders
• Apply cream before sleeping

Aldara is a cream containing the active substance imiquimod. This medicine slows down cell growth and improves skin resistance. Aldara is used in adults to treat the following skin diseases:

• Genital warts, a sexually transmitted disease (STD), caused by a virus. The STD produces warts on the genitals and around the anus.
• Small basal cell carcinomas. These are slowgrowing types of skin cancer caused by excessive, long-term exposure to sunlight.
• Actinic keratoses of the face and scalp. These are rough, abnormal skin growths that develop after too much exposure to sunlight.

When applied to the skin, Aldara cream acts locally on the immune system to trigger the release of natural substances. These substances help to kill the viruses that cause warts or the abnormal cells in the skin that develop into skin cancer or keratoses.

Aldara cream comes in single-use sachets. Dispose of the sachet immediately after use. Do not re‑use a sachet once you have opened it.

The treatment frequency and duration differ for genital warts, basal cell carcinoma and actinic keratosis. If you are being treated for genital warts, apply Aldara cream three times a week. For example, on Monday, Wednesday and Friday. Do not use Aldara cream for more than 16 weeks in the treatment of each episode of warts.

Apply a thin layer of Aldara cream onto clean, dry wart area. Leave Aldara cream on the warts for the prescribed number of hours. Do not shower or bathe during this time. After this time has passed, wash the area where Aldara cream was applied with mild soap and water.

Wash hands carefully after use or use a finger cot to apply the cream. Do not apply the cream to broken skin or on any mucosa. Do not cover the treated area with bandages or other dressings after you have applied Aldara cream.

If you are being treated for genital warts follow these additional precautions:

• Men with warts under the foreskin should pull the foreskin back each day and wash underneath it. If not washed daily the foreskin may be more likely to show signs of tightness, swelling and wearing away of the skin and result in difficulty in pulling it back. If these symptoms occur, stop the treatment immediately and contact your doctor.
• If you have open sores: do not start using Aldara cream until after the sores have healed.
• If you have internal warts: do not use Aldara cream in the urethra (the hole from which urine is passed), the vagina (birth canal), the cervix (internal female organ), or anywhere inside your anus (rectum).

If you are being treated for basal cell carcinoma or actinic keratosis follow these additional precautions:

• Do not use sunlamps or tanning beds, and avoid sunlight as much as possible during treatment with Aldara cream. Wear protective clothing and wide brimmed hats when outdoors.

For more information on how to use Aldara, please see the package leaflet.

Dosage

Dosage varies per person and is determined by a doctor for each specific patient depending on the condition and symptoms. The recommended dose in adultsis:

For genital warts:

• Apply Aldara cream three times a week. For example, on Monday, Wednesday and Friday. Apply a thin layer of Aldara cream onto clean, dry wart area and rub gently into the skin until the cream vanishes. Leave Aldara cream on the warts for 6 to 10 hours.

Continue to use the cream as instructed until your warts have completely gone. (Half the females who clear will do so in eight weeks; half the males who clear will do so in 12 weeks. In some patients, warts may clear as early as in four weeks.) Do not use Aldara cream for more than 16 weeks in the treatment of each episode of warts.

For basal cell carcinoma:

• Apply Aldara cream five times a week (from Monday to Friday). Do not apply the cream on Saturday and Sunday. Apply Aldara cream thinly to the affected area and 1 cm around the affected area. Rub gently into the skin until the cream vanishes. Leave Aldara cream on the skin for eight hours.

Apply the cream each day for five consecutive days each week for six weeks.

For actinic keratosis:

• Apply Aldara cream three times a week. For example, on Monday, Wednesday and Friday. Apply the cream thinly to the affected area. Rub gently into the area until the cream vanishes. Leave Aldara cream on the skin for eight hours.

Continue using the cream three days a week for four weeks. Four weeks after finishing this first treatment, your doctor will assess your skin.

Alcohol/driving

This medicine does not interact with alcohol and has no or negligible influence on the ability to drive and use machines.

If you use too much/forget to use/stop using Aldara cream

If you use more Aldara cream than you were told to, wash the extra away with mild soap and water. If you accidentally swallow Aldara cream, consult your doctor or pharmacist.

If you miss a dose, apply cream as soon as you remember and then continue your regular schedule. If it's almost time for your next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.

Do not stop using Aldara cream without consulting a doctor first.

Do not use this Aldara cream if you are allergic to any of the ingredients in this medicine (see section 'What Aldara contains').

When should this medicine be used with caution?

Special care should be taken with using Aldara cream in the following situations:

• If you have previously used Aldara cream or other similar preparations, tell your doctor before starting this treatment.
• Tell your doctor if you have problems with your immune system.
• After previous drug or surgical treatment. Do not use Aldara cream until the area to be treated has healed.
• If you have skin problems at the application site, wash the skin with mild soap and water. As soon as the problem has stopped you may restart to apply the cream.
• Tell your doctor if you have an abnormal blood count.

For more information on warnings, please see the package leaflet.

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. Your doctor will discuss the risks and benefits of using Aldara cream.

Other medicines and Aldara

Tell your doctor if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription and herbal medicines.

Medicines can cause side effects, although some people may not experience any. Side effects that are known to be associated with Aldara cream include:

• Skin irritation (redness, burning sensation, itching, swelling, thinning of the skin, rash) in the areas where the cream was applied.
• Headache.
• Tingling feelings in limbs (pins and needles).

The side effect may differ depending on the condition being treated. See the package leaflet for a list of all possible side effects. Consult a doctor if the side effects are severe or if you experience side effects that are not listed in the package leaflet.

The active substance is imiquimod. Each sachet contains 250 mg cream (100 mg cream contains 5 mg imiquimod).

The other ingredients are: isostearic acid, benzyl alcohol, cetyl alcohol, stearyl alcohol, white soft paraffin, polysorbate 60, sorbitan stearate, glycerol, methylhydroxybenzoate (E218), propyl hydroxybenzoate (E216), xanthan gum, purified water.

The manufacturer of Aldara cream is:

3M Health Care Limited
Derby Road
Loughborough
Leicestershire LE11 5SF
United Kingdom

Read the package leaflet before use. The official package leaflet of Aldara cream is available for download here.