Elidel Cream 10mg/g

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

PIMECROLIMUS

Available from:

Mylan IRE Healthcare Limited Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, 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
8
PACKAGE LEAFLET
Page
2
of
8
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
13
SUMMARY OF PRODUCT CHARACTERISTICS
Page
2
of
13
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
Page
3
of
13
pimecrolimus when signs and symptoms resolve. Treatment should be
intermittent, short-term and
not continuous.
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