Aldara

Main information

  • Trade name:
  • Aldara 5% w/w Topical cream
  • Dosage:
  • 5% w/w
  • Pharmaceutical form:
  • Topical cream
  • Units in package:
  • Pump, PP body and cap with PE pump, 2 g
  • Class:
  • Prescription
  • Prescription type:
  • Prescription
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug
  • Manufactured by:
  • Orgapharm SAS

Documents

Localization

  • Available in:
  • Aldara 5% w/w Topical cream
    New Zealand
  • Language:
  • English

Other information

Status

  • Source:
  • Medsafe - Medicines Safety Authority - New Zealand
  • Authorization number:
  • 7886
  • Authorization date:
  • 16-12-1996
  • Last update:
  • 09-05-2018

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

ALDARA™ CREAM 5%

Aldara™ Cream 5%

Imiquimod

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.

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.

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

Description"

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

condition.

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.

Using Aldara

Dosage

Aldara is used to treat several skin

conditions. Your doctor will tell you

ALDARA™ CREAM 5%

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.

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

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.

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).

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.

Leave Aldara cream on the

affected area for 6 to 10 hours.

Do not shower or bathe during

this time.

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 daylight.

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 arms.

Aldara cream should not be

applied to an area greater than 25

square centimetres.

ALDARA™ CREAM 5%

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 time.

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

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.

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 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.

After Using Aldara

Cream

Storage

Aldara cream should be kept in a

cool dry place where the temperature

stays below 25°C. Do not freeze.

ALDARA™ CREAM 5%

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.

Disposal

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.

Product Description

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 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 Australia by:

iNova Pharmaceuticals (Australia)

Pty. Limited.

(ABN 88 000 222 408)

Level 10, 12 Help St,

Chatswood NSW 2067

New Zealand Toll Free: 0508 375

Made in the United Kingdom

AUST R 191815

AUST R 64798

This leaflet was prepared in

November 2009 and updated in

November 2014.

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