Consumer Medicine Information (CMI) summary
The full CMI on the next page has more details. If you are worried about using this
medicine, speak to your doctor or pharmacist.
1. Why am I using Aldara?
Aldara contains the active ingredient imiquimod. Aldara is used to treat solar keratosis
(also known as actinic keratoses), superficial basal cell carcinoma and external genital/perianal
warts (also known as condyloma acuminata).
2. What should I know before I use Aldara?
Do not use if you have ever had an allergic reaction to Aldara or any of the ingredients
listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section
2. What should I know before I use Aldara? in the full CMI.
3. What if I am taking other medicines?
4. How do I use Aldara?
Your doctor will tell you where to apply Aldara, how often and for how long to apply
it. Apply Aldara just before bedtime and leave on the skin for 6-10 hours. Sufficient
cream should be applied to cover the treatment area.
More instructions can be found in Section
4. How do I use Aldara? in the full CMI and in the instruction leaflet provided in the carton.
5. What should I know while using Aldara?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using Aldara
Call you doctor straight away if you become pregnant .
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Things you should not do
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Do not use more than the recommended amount of Aldara
Do not cover the treatment area with bandages or other dressings after you have applied
Aldara
Do not use sunlamps or tanning beds, and avoid going into the sun as much as possible
Do not apply on the eyes, lips, nostrils or to lesions on hands and arms when treating
solar keratosis
Do not apply on the hairline, eyes, ears, nose, or lips when treating superficial
basal cell carcinoma
Do not apply Aldara before any sexual (genital, anal or oral) contact when treating
genital warts
Do not use Aldara for more than one course if you have problems with your immune system
either due to illness or because of the medicines you are already taking when treating
genital warts.
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Looking after your medicine
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Keep Aldara in a cool dry place where the temperature stays below 25°C. Do not freeze.
Keep out of reach of children.
When using Aldara pump discard any remaining medicine 4 weeks after opening.
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6. Are there any side effects?
Common side effects: • Application site reactions including 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, changes in skin colour, bleeding,
lumps on the skin, infection and pimples • Other side effects include flu symptoms,
tiredness, fever, headache, diarrhoea, back pain, muscle pain, and swollen glands
in the neck, armpit and groin.
Active ingredient(s):
Imiquimod
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using Aldara. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using Aldara.
Where to find information in this leaflet:
1. Why am I using Aldara?
Aldara 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.
Aldara is used to treat the following skin conditions:
Solar keratosis (SK) on the face and scalp. Solar keratoses are thickened, scaly patches
of skin caused by too much sun exposure. Solar keratosis is also known as actinic
keratosis.
Superficial basal cell carcinoma (sBCC) a type of skin cancer.
External genital/perianal warts (condyloma acuminata) are warts that appear on the
surface of the penis or vulva and around the anus.
2. What should I know before I use Aldara?
Warnings
Do not use Aldara:
If you are allergic to imiquimod, or any of the ingredients listed at the end of this
leaflet.
Always check the ingredients to make sure you can use this medicine.
On skin where there are open sores or wounds.
On warts inside the vagina, anus or the urethra (where you pass urine).
On sunburnt skin.
On children under the age of 18 years.
If the packaging is torn or shows signs of tampering.
After the "use by" date shown on the box or sachet or after 4 weeks from first opening
the Aldara pump.
Check with your doctor if you:
Have any other medical conditions including but not limited to HIV, problems with
your immune system or an abnormal blood count.
Take any medicines for any other condition.
Have previously used Aldara cream or other similar preparations to treat your condition.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or breastfeeding or intend to become pregnant
or breastfeed.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines may interfere with Aldara and affect how it works.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect Aldara.
4. How do I use Aldara?
How much to use
Aldara is used to treat several skin conditions. Follow the specific instructions
provided by your doctor on using Aldara for your skin condition. Sufficient cream
should be applied to cover the treatment area. Talk to your doctor if your condition re-appears after treatment.
When using Aldara to treat Solar Keratosis (SK)
Apply to the affected areas 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.
Your doctor may tell you to 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.
Alternatively, your doctor may want you to continue applying Aldara cream for up to
16 weeks. Do not continue treatment for longer than 16 weeks at a time.
New SK lesions may develop during treatment with Aldara cream. These lesions may resolve
during the treatment period. Even though the initial SK lesions may clear with treatment,
new lesions may also develop in the future and require further treatment. Aldara cream
is not a cure since SK is considered to be a chronic skin condition.
When using Aldara to treat Superficial Basal Cell Carcinoma (sBCC)
Apply to the affected area once a day at bedtime for five consecutive days per week
(Monday to Friday), or as recommended by your doctor. Use enough cream to cover the
treatment area, including one centimetre of skin surrounding the tumour. Continue
treatment for 6 weeks unless your doctor tells you otherwise.
Apply enough cream to cover the lesion and about 1 cm of the surrounding skin
When using Aldara to treat External Genital or Perianal Warts
Apply a thin layer of cream 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. Continue treatment until the warts are
completely gone.
Do not use Aldara 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
Follow the step-by-step instructional leaflet provided in the carton on how to apply
Aldara.
Before applying Aldara, wash your hands and the treatment area with mild soap and
water and allow it to dry thoroughly.
After applying Aldara leave on the affected area for 6 to 10 hours. Do not shower
or bathe during this time.
After 6-10 hours, wash the area where Aldara was applied with mild soap and water.
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.
If you use too much Aldara
Using too much Aldara could cause skin reactions. If you think that you have used
too much Aldara, wash away the extra cream with mild soap and water. Continue treatment
once any skin reaction has settled.
If the cream is accidentally swallowed, nausea, vomiting, headache, muscle pain, and
fever could occur. You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while using Aldara?
Things you should know
Aldara may weaken condoms and diaphragms. Wash the cream off before using a condom
or diaphragm during sexual activity. Using an alternate form of contraception is recommended.
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.
Things you should do
Follow your doctor’s instructions on where to apply Aldara, how often to apply it
and for how long to apply it for your specific skin condition. Use Aldara until your
doctor tells you to stop.
Visit your doctor regularly if you are treating more than one Superficial Basal Cell
Carcinoma (sBCC) lesion at the same time.
Call your doctor straight away if you:
Become pregnant while using Aldara.
Remind any doctor, dentist or pharmacist you visit that you are using Aldara.
Things you should not do
Do not use more than the recommended amount of Aldara. A thin layer (maximum 20 square
centimetres) that completely covers the treatment area and surrounding skin is enough.
Do not cover the treatment area with bandages or other dressings after you have applied
Aldara unless your doctor tells you to. Cotton gauze dressings may be used, if needed.
Do not use sunlamps or tanning beds and avoid going into the sun as much as possible
while using Aldara. Wear protective clothing such as a wide-brimmed hat, long sleeve
shirts, trousers or a long skirt if you go outside during daylight.
Do not apply Aldara in or near the eyes, lips, nostrils or to lesions on the hands
and arms or to an area greater than 20 square centimetres when treating Solar Keratosis
(SK).
Do not apply Aldara in or near the hairline, eyes, ears, nose or lips when treating
Superficial Basal Cell Carcinoma (sBCC).
Do not engage in sexual (genital, anal or oral) contact when treating Genital Warts.
If you decide to have sexual relations, apply Aldara cream after, not before, sexual
activity. If you have already applied the cream, wash it off before sexual activity.
Do not use Aldara for more than one course if you have problems with your immune system
either due to illness or because of the medicines you are already taking when treating
Genital Warts. If you think this applies to you, talk to your doctor.
Looking after your medicine
Store Aldara below 25°C. Do not freeze.
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do
not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Keep it where young children cannot reach it.
When to discard Aldara Pump
Aldara pump must be discarded 4 weeks after opening.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not use Aldara after the expiry date.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Some patients have experienced changes in skin colour (lighter or darker) in the area
where Aldara was applied. These changes may be permanent in some cases.
Less serious side effects
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What Aldara contains
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Active ingredient
(main ingredient)
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imiquimod
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Other ingredients
(inactive ingredients)
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benzyl alcohol
methyl hydroxybenzoate
propyl hydroxybenzoate
isostearic acid
cetyl alcohol
stearyl alcohol
white soft paraffin
polysorbate 60
sorbitan monostearate
glycerol
xanthan gum
purified water
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Potential allergens
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benzyl alcohol
methyl hydroxybenzoate
propyl hydroxybenzoate
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Do not take this medicine if you are allergic to any of these ingredients.
What Aldara looks like
Aldara cream is a white to slightly yellow cream supplied in a pump pack or sachet..
The pump pack is supplied in a pack containing one or two pumps (AUST R 191815).
The sachets are supplied in a wallet containing 1 single-use foil sachet and in boxes
of 6 and 12 single-use foil sachets (AUST R 64798).
Who distributes Aldara
iNova Pharmaceuticals (Australia) Pty Limited
Level 10, 12 Help Street
Chatswood NSW 2067
Tel: 1800 630 056
This leaflet was prepared in November 2021.