Aldara
Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Patient Information leaflet
(PIL)
16-06-2017
Summary of Product characteristics
(SPC)
05-09-2017
Active ingredient:
Imiquimod 5%{relative};
Available from:
iNova Pharmaceuticals (New Zealand) Limited
INN (International Name):
Imiquimod 5% w/w
Dosage:
5% w/w
Pharmaceutical form:
Topical cream
Composition:
Active: Imiquimod 5%{relative} Excipient: Benzyl alcohol Cetyl alcohol Glycerol Methyl hydroxybenzoate Polysorbate 60 Propyl hydroxybenzoate Purified water Sorbitan stearate Stearic acid Stearyl alcohol White soft paraffin Xanthan gum
Units in package:
Pump, PP body and cap with PE pump, 2 g
Class:
Prescription
Prescription type:
Prescription
Manufactured by:
Orgapharm SAS
Product summary:
Package - Contents - Shelf Life: Pump, PP body and cap with PE pump - 2 g - 24 months from date of manufacture stored at or below 25°C - Pump, PP body and cap with PE pump, 2 x 2g - 4 g - 24 months from date of manufacture stored at or below 25°C - Sachet, 250mg Physician's starter pack - 1 dose units - 24 months from date of manufacture stored at or below 25°C - Sachet, 250mg - 3 dose units - 24 months from date of manufacture stored at or below 25°C - Sachet, 250mg - 6 dose units - 24 months from date of manufacture stored at or below 25°C - Sachet, 250mg - 12 dose units - 24 months from date of manufacture stored at or below 25°C - Sachet, 250mg - 30 dose units - 24 months from date of manufacture stored at or below 25°C
Authorization date:
1996-12-16
Patient Information leaflet
ALDARA™ CREAM 5%
1
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
Read the complete document
Summary of Product characteristics
Aldara
Page 1 of 15
NEW ZEALAND DATA SHEET
ALDARA™
_IMIQUIMOD 5 % W/W CREAM_
PRESENTATION
ALDARA is a white cream with a uniform appearance and is supplied in:
•
Pack containing one or two pumps. Each 250 mg of ALDARA 5 % cream
contains 12.5
mg of imiquimod. This is equivalent to four actuations of the pump
•
Single use sachet containing 250 mg of ALDARA 5 % cream. Available in
a box of 12
sachets
INDICATIONS
ALDARA cream is indicated for the topical treatment of:
•
actinic keratosis on the face and scalp in immunocompetent adults.
•
superficial basal cell carcinoma where surgical excision is considered
inappropriate.
•
external genital and perianal warts (condyloma acuminata).
DOSAGE AND ADMINISTRATION
Before applying ALDARA cream, the patient should wash the treatment
area with mild soap and
water, and allow the area to dry thoroughly. ALDARA cream should be
applied prior to normal
sleeping hours and should remain on the skin for 8 (6-10) hours.
ALDARA should be applied with the fingertip and rubbed into the
affected area until the cream
vanishes. Showering or bathing during the period that the cream is on
the affected area should be
avoided. The affected area should be washed with soap and water after
the treatment period.
Four actuations of the pump is sufficient to cover a treatment area of
20 cm². Cream in a single
use sachet is sufficient to cover a treatment area of 20 cm² and
should not be reused after
opening.
Hand washing before and after cream application is recommended.
Where ALDARA is used to treat genital/perianal warts, the cream should
be applied after, rather
than before, sexual activity.
Aldara
Page 2 of 15
Local skin reactions such as erythema, erosion, excoriation/flaking
and oedema at the treatment
site area are common. These reactions may be due to the
pharmacological response of the body's
immune system to ALDARA. A rest period of several days may be taken if
required due to the
patient's discomfort or severity of the local skin reaction. These
local skin reactions generally
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