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Aldara - Information Sheet for Patients

Aldara^™

Imiquimod Cream 5%

What is in this Leaflet

This leaflet answers some common questions about Aldara. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. If you need any more information about Aldara, please ask your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risk of your using Aldara against the benefits it can have for you. If you have any concerns about using this medicine, ask your doctor or pharmacist. Keep this leaflet with the medicine. You may want to read it again.

Your Medicine

The name of your medicine is Aldara. Aldara cream contains the active ingredient imiquimod. Imiquimod is an immune response modifier. It causes your body to produce more interferon. Interferon is a substance which your body produces naturally to help fight viruses. Although the exact way that Aldara gets rid of genital warts is unknown, it is believed to be due to its effects on the immune system.

What Aldara is used for

Aldara is used to treat warts (condyloma acuminata) on the surface of the penis or vulva (external female sexual organ) and around the anus.

Aldara is not recommended for use in patients under the age of 18 years as there have been no studies of its effects in this age group.

Your doctor may prescribe Aldara for another purpose. If you are not sure why you are using this medicine ask your doctor.

Before using Aldara

When you must not use Aldara

Do not use Aldara:

if you are allergic to imiquimod or to any of the ingredients listed under "Product Description"
on warts inside the vagina or inside the anus or inside the urethra (where you pass urine). The use of Aldara cream on these areas has not been studied.
if the packaging is torn or shows signs of tampering.
after the "use by" date shown on the box or sachet.

Before you start to use Aldara

Tell your doctor if:

you are pregnant or intend to become pregnant.
you are breast feeding or intend to breast feed.
you are or you think you are HIV positive.
you have been using other preparations to treat your warts .

Using Aldara

Dosage

Aldara is to be applied once a day, at bed time, three times a week or as recommended by your doctor. For three times a week application, Aldara can be applied on Monday, Wednesday and Friday or Tuesday, Thursday and Saturday.
Treatment with Aldara should continue until the warts are completely gone. Aldara should not be used for more than 16 weeks at one time. It usually takes 8-10 weeks for your warts to disappear but warts may clear as early as 4 weeks.
If your warts reappear, talk to your doctor.

How to use Aldara

Before going to bed, wash your hands and open a new sachet. Squeeze Aldara cream onto your fingertip.

Apply a thin layer of Aldara cream onto clean, dry wart area and rub gently into the skin until the cream vanishes. One sachet contains enough cream to cover a wart area of 20cm² (approximately 3 square inches).

After application of the cream, carefully dispose of the unused Aldara cream in the sachet , where children cannot reach it. Wash hands with mild soap and water.

Leave Aldara cream on the warts for 6 to 10 hours. Do not shower or bathe during this time.

After 6-10 hours, the area where Aldara cream was applied should be washed with mild soap and water.

While you are using Aldara

Sexual (genital, anal or oral) contact should be avoided. If you decide to have sexual relations, apply Aldara cream after, not before, sexual activity. If you have already applied the cream, it should be washed off before sexual activity.
Aldara cream may weaken condoms and diaphragms, therefore the cream should be washed off before using a condom or diaphragm during sexual activity.
The effect of Aldara cream on the transmission of genital warts is not known.
Do not cover warts with bandages or other dressings after you have applied Aldara cream
Uncircumcised men with warts under the foreskin should pull the foreskin back each day and wash underneath it. If daily washing under the foreskin is not carried out, tightness of the foreskin may occur. Early signs of tightness include swelling and wearing away of the skin, or difficulty in pulling back the foreskin. If these symptoms occur, stop the treatment immediately and call your doctor.
Do not use more than the recommended amount of Aldara cream. A thin layer that completely covers the wart is enough.
Stop using Aldara cream if you become pregnant, and do not use if you are breastfeeding.
Aldara cream has been prescribed for your use only. Do not give it to anyone else even if you think their condition is the same as yours.

If you forget to use Aldara

If you forget a dose, apply the missed dose of cream as soon as you remember and then continue on the regular schedule. Do not double the dose at any time to make up the missed dose.

Side Effects

All medicines can have side effects and this may occur with the normal use of Aldara. Tell your doctor as soon as possible if you do not feel well while you are using Aldara.

More Common Side Effects of Aldara

The following effects have occurred during clinical trials with Aldara cream. If the following occur and are severe enough to worry you, tell your doctor.

redness, wearing away of the skin, flakiness, swelling, hardening under the skin, small open sores, crust that forms during healing, small bubbles under the skin, itching, burning, pain, tenderness, irritation, rash, soreness, stinging, sensitivity, skin colour becomes lighter on the warts or on the skin around the warts. Most of these skin reactions are mild to moderate. These may be signs that the product is working. If your skin reacts badly or the skin reaction becomes too uncomfortable when using Aldara cream, wash the cream off with mild soap and water and contact your doctor.
flu symptoms, tiredness, headache, diarrhoea and muscle pain.

Some patients have experienced changes in skin colour (lighter or darker) in the area where Aldara cream was applied. These changes may be permanent in some cases.

If you experience other side effects or you do not feel well while you are using Aldara please tell your doctor.

If you use too much Aldara

Using too much Aldara cream could cause severe skin reactions. If too much cream is applied, simply wash away the extra cream with mild soap and water. When any skin reaction has settled, you may then continue with your treatment.

If the cream is accidentally swallowed, nausea, vomiting, headache, muscle pain, and fever could occur.

Storage Conditions

Aldara cream should be kept in a cool dry place where the temperature stays below 25�C. Do not freeze. Keep the sachets of Aldara where children cannot reach them.

Product Description

What Aldara cream looks like

Aldara cream is a white to slightly yellow cream, packed in a single-use foil sachet. Each sachet contains 250mg of Aldara cream which is enough to cover a wart area of 20cm². Each box contains 12 sachets.

Ingredients

Each 250mg of Aldara cream 5% contains 12.5mg of the active ingredient, imiquimod. Aldara cream also contains isostearic acid, benzyl alcohol, cetyl alcohol, stearyl alcohol, white soft paraffin, polysorbate 60, sorbitan monostearate, glycerol, methyl hydroxybenzoate, propyl hydroxybenzoate, xanthan gum, purified water.

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