Consumer Medicine Information
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.
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.
Solar keratoses are thickened, scaly patches of skin caused by too much sun exposure.
Solar keratosis is also known as actinic keratosis.
Basal cell carcinoma is a type of skin cancer.
External genital/perianal warts (condyloma acuminata) are warts that appear 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
on skin where there are open sores or wounds. Do not start using Aldara until after
the area has healed.
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.
on areas that are sunburnt
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.
Before you start to use Aldara
Tell your doctor if:
you are pregnant or intend to become pregnant.
you are breastfeeding or intend to breastfeed.
you are or you think you are HIV positive.
you are taking any other medicines
you have previously used Aldara cream or other similar preparations to treat your
you have problems with your immune system
you have an abnormal blood count
you currently have, or in the past have had, any other medical conditions.
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.
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
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, Each treatment should continue for no more than 16 weeks at a time.
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 your hands and treatment area with mild soap and water
and allow it to dry thoroughly. If you are using Aldara pump remove the protective
cap and prime several times until cream appears at the nozzle. Alternatively, 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.
If using the pump, four actuations of the pump is equivalent to the content of one
250 mg sachet of Aldara cream..
One sachet contains enough cream to cover a treatment area of 20 square centimetres
(approximately 3 square inches).
3. If using the pump, replace the protective cap back on the pump after application of
the cream. Carefully store where children cannot reach it. Wash your hands with mild
soap and water. If using the sachet after application of the cream, carefully dispose
of the unused Aldara cream in the sachet where children cannot reach it.
Once opened, the contents of the pump are to be used within 4 weeks.
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
Do not use more than the recommended amount of Aldara cream. A thin layer 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 cream. Cotton gauze dressings are okay to use, if needed.
Stop using Aldara cream if you become pregnant, and do not use it if you are breastfeeding.
If you are using Aldara to treat SK:
Aldara cream should not be applied in or near the eyes, lips or nostrils.
Do not use sunlamps or tanning beds, and avoid going into the sun as much as possible
during treatment with Aldara cream. Wear protective clothing if you go outside during
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 develop in the future and require further treatment. Aldara cream
is not a cure, since SK is considered to be a chronic skin condition.
There is not enough data to support the use of Aldara to treat SK on the hands and
Aldara cream should not be applied to an area greater than 25 square centimetres.
If you are using Aldara to treat sBCC:
Aldara cream should not be applied in or near the hairline, eyes, ears, nose or lips.
Do not use sunlamps or tanning beds, and avoid going into the sun as much as possible
during treatment with Aldara cream.
Wear protective clothing if you go outside during daylight.
Visit your doctor regularly if you are treating more than one sBCC lesion at the same
If you are using Aldara to treat genital warts:
Avoid sexual (genital, anal or oral) contact. 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. Alternate forms of
contraception should be considered.
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 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. If you think
this applies to you, talk to your doctor.
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
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.
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, skin colour becomes lighter, bleeding, lumps on the
skin, infection and pimples. Most of these skin reactions are mild to moderate, and
are 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 stop treatment
for a few days.
Flu symptoms, tiredness, fever, headache, diarrhoea, back pain, muscle pain, and swollen
glands in the neck, armpit and groin.
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 Australia call 131126; in New Zealand
call toll free 0800 POISON or 0800 764 766) or go to the Accident and Emergency department
at the nearest hospital.
After Using Aldara Cream
Aldara cream should be kept in a cool dry place where the temperature stays below
25°C. Do not freeze.
Discard Aldara pump 4 weeks after opening.
Do not store Aldara cream or any other medicine in the bathroom or near a sink. Do
not leave it in the car or on window sills.
Keep Aldara pump and sachets of Aldara where children cannot reach them.
A locked cupboard at least one-and-a-half metres above the ground is a good place
to store medicines.
If your doctor tells you to stop using Aldara or it has past its expiry date, ask
your pharmacist what to do with any that is left over.
What Aldara cream looks like
Aldara cream is a white to slightly yellow cream, packed in a pump or single-use foil
sachet. Four actuations of the pump is approximately equivalent to one sachet containing
250 mg of Aldara cream. In both cases this is enough cream to cover a treatment area
of 20 square centimetres. In Australia Aldara cream is supplied in a pack containing
one or two pumps and is also available in a wallet of 1 sachet and boxes of 6 and
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.
Aldara is distributed in Australia by:
iNova Pharmaceuticals (Australia) Pty Limited
(ABN 13 617 871 539)
Level 10, 12 Help St,
Chatswood NSW 2067
Tel (Australia): 1800 630 056
Tel (New Zealand): 0508 375 394
Made in the United Kingdom
AUST R 191815
AUST R 64798
This leaflet was prepared in
Date last updated November 2017.