Consumer Medicine Information

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, 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 causes your body to produce more interferon. Interferon is a substance which your body produces naturally to help fight viruses and some skin diseases. 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 actinic keratoses, basal cell carcinomas and external genital/perianal warts.

• Actinic keratoses are thickened, scaly, pre-cancerous patches of skin on the face and scalp, usually caused by too much sun exposure. Actinic keratoses are also known as solar keratoses.
• Basal cell carcinomas are the most common form of skin cancer, and can look like small patches of dry skin or raised lumps on the skin.
• External genital/perianal warts (condyloma acuminata) are warts that appear on the surface of the genitals and around the anus.

Aldara is recommended for use in adults.

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 (female reproductive tract) 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 skin condition, including medicines or remedies that you buy without a prescription.

Using Aldara

Dosage

General advice

• Aldara is used for several skin conditions. Your doctor will tell you where to apply Aldara cream, and 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.
• If your skin condition reappears, talk to your doctor.

For the treatment of actinic keratoses

• For actinic keratoses, Aldara is to be applied once daily, two days per week, for example Monday and Thursday, or Tuesday and Friday. Treatment should continue for up to 16 weeks unless your doctor tells you otherwise.

For the treatment of basal cell carcinomas

• For basal cell carcinomas, Aldara is to be applied once daily for five consecutive days per week, for example Monday, Tuesday, Wednesday, Thursday and Friday. Sufficient cream should be applied to cover the tumour and one centimetre of skin surrounding the tumour. Treatment should continue for 6 weeks unless your doctor tells you otherwise.

For the treatment of external genital/perianal warts

• For external genital/perianal warts, Aldara is to be applied once daily, three days 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 a time. It usually takes 8-10 weeks for your warts to disappear but warts may clear as early as 4 weeks.

How to use Aldara

1. Before applying Aldara, wash your hands and the treatment area with mild soap and water and 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 gently into the skin until the cream vanishes. Do not use more Aldara cream than is needed to cover the treatment area.
   
   
3. After applying 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

General advice

• Do not cover the treatment area with airtight bandages or other dressings after you have applied Aldara cream. Cotton gauze dressings can be used if needed.
• Do not use more than the recommended amount of Aldara cream. A thin layer that completely covers the treatment area is enough. Using too much Aldara cream could increase the risk of severe skin reactions.
• Stop using Aldara cream if you become pregnant, and do not use it 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.
• Your doctor may recommend that you take a rest period of several days if you experience a severe skin reaction while using Aldara.

For the treatment of actinic keratoses

• Do not apply Aldara cream in or near the eyes, lips and nostrils.
• Do not use sunlamps or tanning beds, and avoid going into the sun as much as possible during treatment with Aldara cream.

For the treatment of basal cell carcinomas

• Do not apply Aldara cream in or near the eyes, nose, mouth or ears

For the treatment of external genital/perianal warts

• Avoid sexual (genital, anal or oral) contact. If you decide to have sex, 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.
• 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.
• Female patients should take special care if applying Aldara cream at the opening of the vagina because local skin reactions on the delicate moist surfaces can result in pain or swelling, and may cause difficulty in passing urine. Do not put Aldara cream inside the vagina.

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.

Common Side Effects of Aldara

The most common side effects with Aldara cream are skin reactions at the treatment site including:

• Redness
• Swelling
• A sore, blister, or ulcer
• Skin that becomes hard or thickened
• Skin peeling
• Scabbing and crusting
• Pain
• Tenderness
• Itching
• Burning

Less Common and Rare Side Effects of Aldara

• Changes in skin colour that do not always go away.
• Headache
• Back pain
• Muscle aches
• Tiredness
• Flu-like symptoms
• Swollen lymph nodes
• Diarrhoea

Most of these skin reactions are mild to moderate and they disappear when treatment is completed. They 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. Your doctor may recommend that you have a treatment rest period of several days.

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

Actinic keratoses

During treatment and until the skin has healed, your skin in the treatment area is likely to appear noticeably different from normal skin. Side effects, such as redness, flaking and scabbing are common at the site where Aldara cream is applied, and sometimes the side effects go outside of the area where Aldara cream was applied. Swelling, small open sores and oozing may also be experienced with use of Aldara cream. You may also experience itching and/or burning. Actinic keratoses that were not seen before may appear during treatment and may later go away. If you have questions regarding treatment or skin reactions, please talk with your doctor.

Basal cell carcinomas

During treatment and until the skin has healed, your skin in the treatment area is likely to appear noticeably different from normal skin. Side effects, such as redness, flaking and scabbing are common at the site where Aldara cream is applied, and sometimes the side effects go outside of the area where Aldara cream was applied. Swelling, small open sores and oozing may also be experienced with use of Aldara cream. You may also experience itching and/or burning. If you have questions regarding treatment or skin reactions, please talk with your doctor.

External genital/perianal warts

Many people see reddening or swelling on or around the application site during the course of treatment. If you have questions regarding treatment or local skin reactions, please talk with 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. 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 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°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. Aldara cream is available in boxes of 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.

Sponsor

Aldara is distributed in New Zealand by:

iNova Pharmaceuticals (New Zealand) Limited
c/o Simpson Grierson
Level 27
88 Shortland Street
AUCKLAND

Made in the United Kingdom

This leaflet was prepared in July 2004.

3M and Aldara are trademarks of 3M