Elidel 1% cream

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Pimecrolimus

Available from:

Mawdsley-Brooks & Company Ltd

ATC code:

D11AH02

INN (International Name):

Pimecrolimus

Dosage:

10mg/1gram

Pharmaceutical form:

Cutaneous cream

Administration route:

Cutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 13050300

Patient Information leaflet

148 mm
594 mm
50 mm
Sens de
Sens de lecture
6. CONTENTS OF THE PACK AND OTHER
INFORMATION
WHAT ELIDEL CREAM CONTAINS
• The active substance is pimecrolimus. 1
gram of Elidel cream contains 10mg of
pimecrolimus.
• The other ingredients are: medium chain
triglycerides, oleyl alcohol, propylene
glycol (E 1520), stearyl alcohol, cetyl
alcohol, mono-and di-glycerides, sodium
cetostearyl sulphate, benzyl alcohol,
citric acid anhydrous, sodium hydroxide,
purified water.
• This medicine contains 10 mg benzyl
alcohol and 50 mg propylene glycol (E
1520), in 1 g of cream. See section 2.
WHAT ELIDEL LOOKS LIKE AND CONTENTS OF
THE PACK
Elidel is a whitish, odourless, non-staining
and easily spreadable cream. The cream is
available in tubes of 5g, 15 g, 30 g, 60 g
and 100 g. Not all pack sizes are
necessarily available in your country.
MARKETING AUTHORISATION HOLDER
Mylan Products Ltd,
Station Close, Potters Bar,
Hertfordshire, EN6 1TL, UK
MANUFACTURER
Meda Pharma GmBH & Co. KG.
Benzstrasse 1, 61352 Bad Homburg,
Germany
MEDA Manufacturing,
Avenue J. F. Kennedy,
33700 Merignac,
France
THIS MEDICINAL PRODUCT IS AUTHORISED IN
THE MEMBER STATES OF THE EEA UNDER THE
FOLLOWING NAMES:
Austria:
Elidel 10 mg/g Creme
Belgium:
Elidel 10 mg/g crème
Bulgaria
Елидел 10 mg/g крем
Croatia:
Elidel 10 mg/g krema
Cyprus:
Elidel cream 10 mg/g
Czech Republic:
Elidel 10 mg/g krém
Denmark:
Elidel 10 mg/g Creme
Estonia:
Elidel 10 mg/g kreem
Finland:
Elidel 10 mg/g
emulsiovoide
Germany
Elidel 10mg/g Creme
Greece:
Elidel , κρέµα 10 mg/g
Hungary:
Elidel 10 mg/g krém
Iceland:
Elidel 10 mg/g krém
Italy:
Elidel 10 mg/g crema
Latvia:
Elidel 10 mg/g krēms
Lithuania:
Elidel 10 mg/g kremas
Luxembourg:
Elidel 10 mg/g Creme
Malta:
Elidel 10 mg/g cream
Netherlands:
Elidel, 10 mg/g crème
Norway:
Elidel 10 mg/g krem
Poland:
Elidel 10 mg/g krem
Portugal:
Elidel 10 mg/g creme
Romania:
Elidel 10 mg/g cremă
Slovakia:
Elidel 10 mg/g krém
Slovenia:
Elidel 10 mg/g krema
Spain:
Elidel 10 mg/g crema
Sweden:
Elidel 10 mg/g kräm
United Kingdom:
E

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
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 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.
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 treate