Contains the active ingredient imiquimod
Consumer Medicine Information
What is in this leaflet
Read this leaflet carefully before taking your medicine.
This leaflet answers some common questions about imiquimod. It does not contain all
the available information. It does not take the place of talking to your doctor or
The information in this leaflet was last updated on the date listed on the last page.
More recent information on this medicine may be available.
Ask your doctor or pharmacist:
if there is anything you do not understand in this leaflet,
if you are worried about taking your medicine, or
to obtain the most up-to-date information.
You can also download the most up to date leaflet from www.apotex.com.au.
All medicines have risks and benefits. Your doctor has weighed the risks of you using
this medicine against the benefits they expect it will have for you.
Pharmaceutical companies cannot give you medical advice or an individual diagnosis.
Keep this leaflet with your medicine. You may want to read it again.
What this medicine is used for
The name of your medicine is APO-Imiquimod. It contains the active ingredient imiquimod.
It is used to treat:
Solar keratosis on the face and scalp.
Solar keratosis is thickened, scaly patches of skin caused by too much sun exposure.
It is also known as actinic keratosis.
Superficial basal cell carcinoma (a type of skin cancer).
External genital/perianal warts (condyloma acuminate). They appear on the surface
of the penis or vulva (external female sexual organ) and around the anus.
Ask your doctor if you have any questions about why this medicine has been prescribed
for you. Your doctor may have prescribed this medicine for another reason.
This medicine is available only with a doctor's prescription.
How it works
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 imiquimod works is unknown, it is believed to be due to
its effects on the immune system.
There is no evidence that this medicine is addictive.
Use in children
This medicine should not be used in patients under the age of 18 years.
Before using this medicine
When you must not use it
Do not use this medicine:
If you are allergic to, or have had an allergic reaction to, imiquimod or any of the
ingredients listed at the end of this leaflet.
Symptoms of an allergic reaction may include cough, shortness of breath, wheezing
or difficulty breathing; swelling of the face, lips, tongue, throat or other parts
of the body, rash, itching or hives on the skin; fainting or hay fever-like symptoms.
If you think you are having an allergic reaction, do not take any more of the medicine
and contact your doctor immediately or go to the Accident and Emergency department
at the nearest hospital
On skin where there are open sores or wounds. Do not start using imiquimod cream 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 imiquimod cream on these areas has not been studied.
On areas that are sunburnt
The expiry date (EXP) printed on the pack has passed.
The packaging is torn, shows signs of tampering or it does not look quite right.
Before you start to use it
Before you start using this medicine, tell your doctor if:
1. You have allergies to:
any other medicines
any other substances, such as foods, preservatives or dyes.
2. You have or have had any medical conditions, especially the following:
sun damaged skin
open sores, wounds or broken skin
inflammatory skin conditions
you are or you think you are HIV positive
3. You have previously used imiquimod cream or other similar preparations to treat your
4. You are currently pregnant or you plan to become pregnant. Do not take this medicine
whilst pregnant until you and your doctor have discussed the risks and benefits involved.
5. You are currently breast-feeding or you plan to breast-feed. Do not take this medicine
whilst breast-feeding until you and your doctor have discussed the risks and benefits
6. You are planning to have surgery or an anaesthetic.
7. You are currently receiving or are planning to receive dental treatment.
8. You are taking or are planning to take any other medicines. This includes vitamins
and supplements that are available from your pharmacy, supermarket or health food
9. You have problems with your immune system.
10. You have an abnormal blood count.
11. You currently have, or in the past have had, any other medical conditions.
Some medicines may interact with imiquimod. These include:
medicines containing methyl hydroxybenzoate, propyl hydroxybenzoate, cetyl alcohol
or stearyl alcohol.
If you are taking any of these you may need a different dose or you may need to take
Other medicines not listed above may also interact with imiquimod.
How to use this medicine
Follow carefully all directions given to you by your doctor. Their instructions may
be different to the information in this leaflet.
How much to use
Your doctor will tell where to apply imiquimod cream, how often and for how long to
apply it for your condition. This will depend on your condition and whether you are
taking any other medicines. Imiquimod cream 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
Do not stop taking your medicine or change your dosage without first checking with
If your doctor has prescribed this medicine for the treatment of Solar Keratosis,
the usual dosage is once a day, at bedtime, three times a week. For three times a
week application, it can be applied, for example, on Monday, Wednesday and Friday,
or Tuesday, Thursday and Saturday.
Your doctor may tell you to continue applying this medicine for 4 weeks, followed
by a period of 4 weeks without any treatment. Your doctor will then check your skin
condition. If any Solar Keratosis lesions remain, the treatment should be repeated
for another four weeks.
Alternatively, your doctor may want you to continue applying this medicine 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 this medicine for the treatment of Superficial Basal
Cell Carcinoma, 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 this medicine 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, this medicine can be applied on Monday, Wednesday
and Friday; or Tuesday, Thursday and Saturday. Treatment should continue until the
warts are completely gone. This medicine 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 this medicine, 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 it
Apply the cream as per your doctor's instructions.
Imiquimod cream is provided in single use sachets. A new sachet should be opened for
each treatment, and cream from a previously opened sachet should not be used.
One sachet contains enough cream to cover a treatment area of 20 square centimetres
(approximately 3 square inches).
1. Before applying the cream, wash your hands and the treatment area with mild soap and
water and allow the area to dry thoroughly.
2. Open a sachet of imiquimod cream and squeeze some cream onto your fingertip. Apply
a thin layer of cream onto the treatment area and rub it gently into the skin until
it is no longer visible.
Sufficient cream should be applied to cover the treatment area.
For treatment of superficial basal cell carcinoma, enough cream should be applied
to cover the lesion and about 1cm of surrounding skin.
3. The cream is to be applied to the affected area prior to normal sleeping hours and
should be left on the skin for approximately 8 hours (6-10 hours). During the 6-10
hours treatment period, showering or bathing should be avoided.
4. Carefully dispose of the unused imiquimod cream in the sachet where children cannot
reach it. Wash your hands with mild soap and water.
5. Following the treatment period, the cream should be removed by washing the treated
area with mild soap and water.
Hand washing before and after cream application is recommended.
Contact with the eyes, ears, lips, nostrils and hairline should be avoided.
The cream should not be applied to the affected area more than once a day.
How long to use it for
Continue taking your medicine for as long as your doctor tells you.
Make sure you have enough to last over weekends and holidays.
If you forget to use it
If it is almost time to take your next dose, skip the missed dose and take your next
dose at the usual time. Otherwise take it as soon as you remember and then go back
to taking your medicine as you would normally.
Do not take a double dose to make up for missed doses.
This may increase the chance of you experiencing side effects.
If you have trouble remembering to take your medicine, ask your pharmacist for some
hints to help you remember.
If you use too much imiquimod cream (overdose)
Using too much imiquimod 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 you think that you or anyone else may have used too much of this medicine, or this
medicine has been accidentally swallowed, immediately telephone your doctor or the
Poisons Information Centre (Tel: 13 11 26 in Australia) for advice. Alternatively
go to the Accident and Emergency Department at your nearest hospital.
Do this even if there are no signs of discomfort or poisoning. You may need urgent
While you are using this medicine
Things you must do
Stop using this medicine if you become pregnant, and do not use it if you are breastfeeding.
Tell your doctor that you are taking this medicine if:
you are about to be started on any new medicine
you are pregnant or are planning to become pregnant
you are breast-feeding or are planning to breast-feed
you are about to have any blood tests
you are going to have surgery or an anaesthetic or are going into hospital.
Your doctor may occasionally do tests to make sure the medicine is working and to
prevent side effects.
Go to your doctor regularly for a check-up.
Tell any other doctors, dentists and pharmacists who are treating you that you take
Things you must not do
Give this medicine to anyone else, even if their symptoms seem similar to yours
Take your medicine to treat any other condition unless your doctor or pharmacist tells
Stop taking your medicine, or change the dosage, without first checking with your
Do not use more than the recommended amount of imiquimod 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
imiquimod cream. Cotton gauze dressings are okay to use, if needed.
If you are using this medicine to treat solar keratosis:
Imiquimod 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 imiquimod cream. Wear protective clothing if you go outside
New solar keratosis lesions may develop during treatment with imiquimod cream. These
lesions may resolve during the treatment period. Even though the initial solar keratosis
lesions may clear with treatment, new lesions may develop in the future and require
further treatment. Imiquimod cream is not a cure, since solar keratosis is considered
to be a chronic skin condition.
There is not enough data to support the use of imiquimod cream to treat solar keratosis
on the hands and arms.
Imiquimod cream should not be applied to an area greater than 25 square centimetres.
If you are using imiquimod cream to treat superficial basal cell carcinoma:
Imiquimod cream should not be applied in or near the hairline, eyes, ears, nose or
Do not use sunlamps or tanning beds, and avoid going into the sun as much as possible
during treatment with imiquimod cream.
Wear protective clothing if you go outside during daylight.
Visit your doctor regularly if you are treating more than one superficial basal cell
carcinoma lesion at the same time.
If you are using imiquimod cream to treat genital warts:
Avoid sexual (genital, anal or oral) contact. If you decide to have sexual relations,
apply imiquimod cream after, not before, sexual activity. If you have already applied
the cream, it should be washed off before sexual activity.
Imiquimod 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 imiquimod 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 imiquimod 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 imiquimod cream 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.
Possible side effects
Tell your doctor as soon as possible if you do not feel well while you are taking
imiquimod cream or if you have any questions or concerns.
Do not be alarmed by the following lists of side effects. You may not experience any
of them. All medicines can have side effects. Sometimes they are serious but most
of the time they are not.
More common side effects of imiquimod cream
Tell your doctor if you notice any of the following:
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
If your skin reacts badly or the skin reaction becomes too uncomfortable when using
imiquimod 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 imiquimod cream was applied. These changes may be permanent in some cases.
Other side effects not listed above may occur in some patients.
If you think you are having an allergic reaction to imiquimod, do not take any more
of this medicine and tell your doctor immediately or go to the Accident and Emergency
department at your nearest hospital.
Symptoms of an allergic reaction may include some or all of the following:
cough, shortness of breath, wheezing or difficulty breathing.
swelling of the face, lips, tongue, throat or other parts of the body
rash, itching or hives on the skin
hay fever-like symptoms.
Storage and disposal
Keep your medicine in its original packaging until it is time to take it.
If you take your medicine out of its original packaging it may not keep well.
Keep your medicine in a cool dry place where the temperature will stay below 25°C.
Do not freeze.
Do not store your medicine, or any other medicine, in the bathroom or near a sink.
Do not leave it on a window sill or in the car. Heat and dampness can destroy some
Keep this medicine where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place
to store medicines.
If your doctor or pharmacist tells you to stop taking this medicine or it has passed
its expiry date, your pharmacist can dispose of the remaining medicine safely.
What APO-Imiquimod looks like
APO-Imiquimod is a white, soft cream, packed in a single-use foil sachet.
Each sachet contains 250 mg of APO-Imiquimod cream, which is enough to cover a treatment
area of 20 cm squared.
APO-Imiquimod cream is available in boxes of 1, 3, 6, 12 and 30 sachets*.
* Not all strengths, pack types and/or pack sizes may be available.
Each 250 mg of APO-Imiquimod 50 mg/g (5% w/w) cream contains 12.5 mg of imiquimod,
as the active ingredient.
APO-Imiquimod cream also contains the following inactive ingredients:
white soft paraffin
This medicine is gluten-free, lactose-free, sucrose-free, tartrazine-free and free
of other azo dyes.
Australian Registration Numbers
APO-Imiquimod 50 mg/g
(5% w/w) cream:
AUST R 168101.
Apotex Pty Ltd
16 Giffnock Avenue
Macquarie Park NSW 2113
Apotex Pty Ltd is the licensee of the registered trademarks APO and APOTEX from the
registered proprietor, Apotex Inc.
This leaflet was last updated in: