Zyclara

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

imiquimod

Saatavilla:

Viatris Healthcare Limited

ATC-koodi:

D06BB10

INN (Kansainvälinen yleisnimi):

imiquimod

Terapeuttinen ryhmä:

Antibiotics and chemotherapeutics for dermatological use

Terapeuttinen alue:

Keratosis; Keratosis, Actinic

Käyttöaiheet:

Zyclara is indicated for the topical treatment of clinically typical, non-hyperkeratotic, non-hypertrophic, visible or palpable actinic keratosis of the full face or balding scalp in immunocompetent adults when other topical treatment options are contraindicated or less appropriate.

Tuoteyhteenveto:

Revision: 15

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2012-08-23

Pakkausseloste

19
B. PACKAGE LEAFLET
20
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZYCLARA 3.75% 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, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their sign of illness are the same as yours.
-
If you 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 Zyclara is and what it is used for
2. What you need to know before you use Zyclara
3. How to use Zyclara
4. Possible side effects
5. How to store Zyclara
6. Content of the pack and other information
1.
WHAT ZYCLARA IS AND WHAT IT IS USED FOR
Zyclara 3.75% cream contains the active substance imiquimod, which is
an Immune Response
Modifier (to stimulate the human immune system).
This medicine is prescribed for the treatment of actinic keratosis in
adults.
This medicine stimulates your body’s own immune system to produce
_ _
natural substances which help
fight your actinic keratosis.
Actinic keratosis appears as rough areas of skin found in people who
have been exposed to a lot of
sunshine over the course of their lifetime. These areas can be the
same colour as your skin or are
greyish, pink, red or brown. They can be flat and scaly, or raised,
rough, hard and warty.
This medicine should only be used for actinic keratosis on the face or
scalp if your doctor has decided
that it is the most appropriate treatment for you.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ZYCLARA
DO NOT USE ZYCLARA
-
if you are allergic to imiquimod or any of the other ingredients of
this medicine (listed in section
6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Zyclara:
•
if you have previously used this medicine or other similar
preparations in a differen

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Zyclara 3.75% cream
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
Each sachet contains 9.375 mg of imiquimod in 250 mg cream (3.75%).
Each gram of cream contains 37.5 mg of imiquimod.
Excipients with known effects:
Methyl parahydroxybenzoate (E 218) 2.0 mg/g cream
Propyl parahydroxybenzoate (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 faintly yellow cream with a uniform appearance.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Zyclara is indicated for the topical treatment of clinically typical,
nonhyperkeratotic, nonhypertrophic,
visible or palpable actinic keratosis (AK) of the full face or balding
scalp in immunocompetent adults
when other topical treatment options are contraindicated or less
appropriate.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Zyclara (per application: up to 2 sachets, 250 mg imiquimod cream per
sachet) should be applied once
daily before bedtime to the skin of the affected treatment field
(area) for two treatment cycles of 2
weeks each separated by a 2-week no-treatment cycle or as directed by
the physician.
The treatment area is the full face or balding scalp.
Local skin reactions in the treatment area are in part anticipated and
common due to its mode of action
(see section 4.4). A rest period of several days may be taken if
required by the patient’s discomfort or
severity of the local skin reaction. However, neither 2-week treatment
cycle should be extended due to
missed doses or rest periods.
A transient increase in actinic keratosis counts may be observed
during treatment due to the likely
effect of imiquimod to reveal and treat subclinical lesions. Response
to treatment cannot be adequately
assessed until resolution of local skin reactions. Patients should
continue treatment as prescribed.
Treatment should be continued for the fu