Elidel Cream 10mg/g

Country: Malta

Language: English

Source: Medicines Authority

Available from:

Viatris Healthcare Limited Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN , Ireland

ATC code:

D11AH02

INN (International Name):

PIMECROLIMUS 10 mg/g

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

Page 1 of 7
PACKAGE LEAFLET
Page 2 of 7
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 3 months – 17 years 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 6 weeks.
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 CREAM:
-
if you are
ALLERGIC
to pimecrolimus or any of the other ingredients of thi

Summary of Product characteristics

Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
Page 2 of 12
1.
NAME OF THE MEDICINAL PRODUCT
Elidel 10 mg/g cream
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g of cream contains 10 mg of pimecrolimus.
Excipients with known effect
10 mg benzyl alcohol, 40 mg cetyl alcohol, 40 mg stearyl alcohol, and
50 mg propylene glycol (E 1520) in
1 g of cream.
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 3 months of age and older 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
Posology
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.
Pimecrolimus should be used for as short
period as possible during flares of disease. The patient or caregiver
should stop using pimecrolimus when
signs and symptoms resolve. Treatment should be intermittent,
short-term and not continuous.
Page 3 of 12
If no improvement occurs after 6 weeks, or in case of disease
exacerbation, treatment 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 pimecrolimus