Aldara

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

imiquimod

Available from:

Viatris Healthcare Limited

ATC code:

D06BB10

INN (International Name):

imiquimod

Therapeutic group:

Antibiotics and chemotherapeutics for dermatological use

Therapeutic area:

Condylomata Acuminata; Keratosis; Keratosis, Actinic; Carcinoma, Basal Cell

Therapeutic indications:

Imiquimod cream is indicated for the topical treatment of :External genital and perianal warts (condylomata acuminata) in adults.Small superficial basal cell carcinomas (sBCCs) in adults.Clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses (AKs) on the face or scalp in immunocompetent adult patients when size or number of lesions limit the efficacy and/or acceptability of cryotherapy and other topical treatment options are contraindicated or less appropriate.

Product summary:

Revision: 31

Authorization status:

Authorised

Authorization date:

1998-09-18

Patient Information leaflet

24
B. PACKAGE LEAFLET
25
PACKAGE LEAFLET: INFORMATION FOR THE USER
ALDARA 5% CREAM
IMIQUIMOD
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, please ask your doctor or your
pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If any get any side effects talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Aldara cream is and what it is used for
2. What you need to know before you use Aldara cream
3. How to use Aldara cream
4. Possible side effects
5. How to store Aldara cream
6. Contents of the pack and other information
1.
WHAT ALDARA CREAM IS AND WHAT IT IS USED FOR
Aldara cream may be used for three different conditions. Your doctor
may prescribe Aldara cream for
the treatment of:
•
Warts (condylomata acuminata) on the surface of the genitals (sexual
organs) and around the
anus (back passage)
•
Superficial basal cell carcinoma.
This is a common slow-growing form of skin cancer with a very small
likelihood of spread to
other parts of the body. It usually occurs in middle-aged and elderly
people, especially those
who are fair-skinned and is caused by too much sun exposure. If left
untreated, basal cell
carcinoma can disfigure, especially on the face – therefore early
recognition and treatment are
important.
•
Actinic keratosis
Actinic keratoses are rough areas of skin found in people who have
been exposed to a lot of
sunshine over the course of their lifetime. Some are skin coloured,
others are greyish, pink,
red or brown. They can be flat and scaly, or raised, rough, hard and
warty. Aldara should only
be used for flat actinic keratoses on the face and scalp in patients
with a healthy immune
system where your doctor has decided that Aldara

Summary of Product characteristics

1
_ _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
ALDARA 5% cream
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
Each sachet contains 12.5 mg of imiquimod in 250 mg cream (5 %).
100 mg of cream contains 5 mg of imiquimod.
Excipients with known effects:
Methyl hydroxybenzoate (E 218) 2.0 mg/g cream
Propyl hydroxybenzoate (E 216) 0.2 mg/g cream
Cetyl alcohol 22.0 mg/g cream
Stearyl alcohol 31.0 mg/g cream
Benzyl alcohol 20.0 mg/g cream
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Cream.
White to slightly yellow cream.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Imiquimod cream is indicated for the topical treatment of:
•
External genital and perianal warts (condylomata acuminata) in adults.
•
Small superficial basal cell carcinomas (sBCCs) in adults.
•
Clinically typical, nonhyperkeratotic, nonhypertrophic actinic
keratoses (AKs) on the face or
scalp in immunocompetent adult patients when size or number of lesions
limit the efficacy
and/or acceptability of cryotherapy and other topical treatment
options are contraindicated or
less appropriate.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The application frequency and duration of treatment with imiquimod
cream is different for each
indication.
External genital warts in adults:
Imiquimod cream should be applied 3 times per week (example: Monday,
Wednesday, and Friday; or
Tuesday, Thursday, and Saturday) prior to normal sleeping hours, and
should remain on the skin for
6 to 10 hours. Imiquimod cream treatment should continue until the
clearance of visible genital or
_ _
perianal warts or for a maximum of 16 weeks per episode of warts.
For quantity to be applied see section 4.2 Method of administration.
_ _
3
Superficial basal cell carcinoma in adults:
Apply imiquimod cream for 6 weeks, 5 times per week (example: Monday
to Friday) prior to normal
sleeping hours, and leave on the skin for approximately 8 hours.
For quantity to be applied see 4.2 Method of administration.
Actinic keratosis