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INFORMATION FOR CONSUMERS

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Consumer Medicine Information

Aldara™ Cream 5%

Imiquimod

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 you 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 as 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 activates immune cells in the body. The immune cells then proceed to kill and remove the virus-infected or cancer cells. Although the exact way that Aldara works 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 solar keratosis (SK) on the face and scalp, superficial basal cell carcinoma (sBCC), and genital/perianal warts.

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:

Before you start to use Aldara

Tell your doctor if:

Using Aldara

Dosage

Aldara is used to treat several skin conditions. Your doctor will tell you where to apply Aldara cream, how often and for how long to apply it for your condition. Aldara should be applied just before bedtime and left on the skin for 6-10 hours. Sufficient cream should be applied to cover the treatment area. Talk to your doctor if your condition re-appears after treatment.

Solar Keratosis

If your doctor has prescribed Aldara for the treatment of SK, the usual dosage is once a day, at bedtime, three times a week. For three times a week application, Aldara can be applied, for example, on Monday, Wednesday and Friday, or Tuesday, Thursday and Saturday.

Continue applying Aldara cream for 4 weeks, followed by a period of 4 weeks without any treatment. Your doctor will then check your skin condition. If any SK lesions remain, the treatment should be repeated for another four weeks.

Superficial Basal Cell Carcinoma

If your doctor has prescribed Aldara for the treatment of sBCC, it should be applied to the affected area once a day at bedtime for five consecutive days per week (Monday to Friday), or as recommended by your doctor. Treatment should continue for 6 weeks unless your doctor tells you otherwise.

External Genital or Perianal Warts

If your doctor has prescribed Aldara for the treatment of external genital or perianal warts, it is to be applied once a day, at bedtime, 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 should continue until the warts are completely gone. Aldara should not be used for more than 16 weeks at a 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.

If your skin reacts badly to Aldara, your doctor may recommend that you stop treatment for a few days. It is not necessary to make up the doses that you missed or to prolong the treatment period.

How to use Aldara

  1. Before applying Aldara, wash the treatment area with mild soap and water and allow it to dry thoroughly. Open a sachet of Aldara and squeeze some cream onto your fingertip.
  2. Apply a thin layer of Aldara cream onto the treatment area and rub it gently into the skin until the cream vanishes. For sBCC lesions enough cream should be applied to cover the lesion and about 1cm of surrounding skin. One sachet contains enough cream to cover a treatment area of 20 square centimetres (approx-imately 3 square inches).
  3. After application of the cream, carefully dispose of the unused Aldara cream in the sachet where children cannot reach it. Wash your hands with mild soap and water.
  4. Leave Aldara cream on the affected area for 6 to 10 hours. Do not shower or bathe during this time.
  5. After 6-10 hours, the area where Aldara cream was applied should be washed with mild soap and water.

While you are using Aldara

If you are using Aldara to treat SK:

If you are using Aldara to treat sBCC:

If you are using Aldara to treat genital warts:

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.

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.

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

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. If you or someone else accidentally swallows Aldara cream, contact your doctor or Poisons Information Centre (in New Zealand call toll free 0800 POISON or 0800 764 766; in Australia call 131126) or go to the Accident and Emergency department at the nearest hospital.

Storage Conditions

Aldara cream should be kept in a cool dry place where the temperature stays below 25 degrees 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 treatment area of 20cm squared. In Australia Aldara cream is available in boxes of 6 and 12 sachets.

Ingredients

Each 250mg of Aldara cream 5% (AUST R 64798) 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.

Sponsor

Aldara is distributed in Australia by:
iNova Pharmaceuticals (Australia) Pty. Limited.
(ABN 88 000 222 408)
9-15 Chilvers Road
Thornleigh NSW 2120

Distributed in New Zealand by:
Douglas Pharmaceuticals Limited, Auckland.

Made in the United Kingdom

This leaflet was prepared in November 2009.