Elidel 10mg/g cream

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

PIMECROLIMUS

Available from:

Meda Pharmaceuticals Limited

ATC code:

D11AH02

INN (International Name):

PIMECROLIMUS

Pharmaceutical form:

CREAM

Composition:

PIMECROLIMUS 10 mg/g

Prescription type:

POM

Therapeutic area:

OTHER DERMATOLOGICAL PREPARATIONS

Authorization status:

Authorised

Authorization date:

2007-01-10

Patient Information leaflet

PACKAGE LEAFLET:  
INFORMATION FOR THE PATIENT
ELIDEL 10 MG/G CREAM
pimecrolimus
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU 
START USINGTHIS 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 signs 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 Elidel cream is and what it is used for 
2.  What you need to know before you use Elidel cream 
3.  How to use Elidel cream 
4.  Possible side effects 
5.  How to store Elidel cream 
6.  Contents of the pack and other information
1. WHAT ELIDEL CREAM IS AND WHAT IT IS 
USED FOR
Elidel cream contains a medicine called pimecrolimus. 
It does not contain any steroids. 
Elidel cream specifically treats an inflammation of the 
skin called atopic dermatitis (eczema). It works in the 
cells in the skin that cause the inflammation and 
characteristic redness and itching of eczema.
The cream is used to treat signs and symptoms of mild 
or moderate eczema (e.g. redness and itch) in children 
(aged 2 years and above), teenagers and adults When 
used to treat early signs and symptoms it can prevent 
progression to severe flare-ups.
Elidel cream is for use only after other prescription 
medicines or emollients have not worked for you or if 
your doctor recommends that other prescription 
medicines should not be used.
You must talk to a doctor if you do not feel better or if 
you feel worse after 42 days.
2. WHAT YOU NEED TO KNOW BEFORE YOU 
USE ELIDEL CREAM
Carefully follow all instructions given to you by your 
doctor. 
Read the following information before you use Elidel 
cream.
DO NOT USE ELIDEL CR

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Elidel® 10mg/g cream.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g of cream contains 10 mg of pimecrolimus.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Cream.
Whitish and homogeneous.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of patients aged 2 years and over with mild or moderate
atopic dermatitis where
treatment with topical corticosteroids is either inadvisable or not
possible. This may include:
•
Intolerance to topical corticosteroids
•
Lack of effect of topical corticosteroids
•
Use on the face and neck where prolonged intermittent treatment with
topical
corticosteroids may be inappropriate
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Elidel should be initiated by physicians with experience in the
diagnosis and treatment of atopic
dermatitis.
Elidel can be used in the short term for the treatment of the signs
and symptoms of atopic eczema
and intermittently in the long term for the prevention of progression
to flares.
Elidel treatment should begin at the first appearance of signs and
symptoms of atopic dermatitis.
Elidel should only be applied to areas affected with atopic
dermatitis. Elidel should be used for as
short period as possible during flares of disease. The patient or
caregiver should stop using Elidel
when
signs
and
symptoms
resolve.
Treatment
should
be
intermittent,
short-term
and
not
continuous. Elidel should be applied thinly to the affected areas
twice daily.
Data from clinical studies support intermittent treatment with Elidel
for up to 12 months.
If no improvement occurs after 6 weeks, or in case of disease
exacerbation, Elidel should be
stopped. The diagnosis of atopic dermatitis should be re-evaluated and
further therapeutic options
considered.
Adults
Apply a thin layer of Elidel to the affected skin twice daily and rub
in gently and completely. Each
affected region of the skin should be treated with Elidel until
clearance occurs and then treatment
should be discontinue