Eumovate Cream 0.05%w/w

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CLOBETASONE BUTYRATE

Available from:

Glaxo SmithKline Ireland Limited 12, Riverwalk, Citywest Business Campus, Dublin 24, Ireland

ATC code:

D07AB

INN (International Name):

CLOBETASONE BUTYRATE 0.05 % (W/W)

Pharmaceutical form:

CREAM

Composition:

CLOBETASONE BUTYRATE 0.05 % (W/W)

Prescription type:

POM

Therapeutic area:

CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS

Authorization status:

Authorised

Authorization date:

2005-09-12

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
EUMOVATE CREAM 0.05% W/W
clobetasone butyrate
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 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.
•
In this leaflet, Eumovate Cream 0.05% w/w will be called Eumovate.
WHAT IS IN THIS LEAFLET
1 What Eumovate is and what it is used for
2 What you need to know before you use Eumovate
3 How to use Eumovate
4 Possible side effects
5 How to store Eumovate
6 Contents of the pack and other information
1.
WHAT EUMOVATE IS AND WHAT IT IS USED FOR
Eumovate contains a medicine called clobetasone butyrate which belongs
to a group
of medicines called corticosteroids. It helps to reduce redness,
swelling and irritation
of the skin. (These should not be confused with “anabolic”
steroids misused by some
body builders and athletes and taken as tablets or injections).
Eumovate relieves the symptoms of certain skin problems including:
-
eczema including seborrhoeic eczema (red skin with greasy looking
white or
yellowish-coloured scales) and a type of skin reaction triggered by
exposure
to sunlight (photodermatitis)
-
skin rash due to allergy or a substance that irritates your skin
(irritant or
allergic contact dermatitis)
-
dermatitis
-
inflammation of the outer ear (otitis externa)
-
itchy nodules on the arms or legs (prurigo nodularis)
-
insect bite reactions
For infants and children, Eumovate is used for dermatitis that has not
responded to
milder steroid creams or ointments.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE EUMOVATE
DO NOT USE EUMOVATE:
•
if you are allergic to clobetasone butyrate o

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Eumovate Cream 0.05% w/w
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of cream contains 0.5 mg clobetasone butyrate (equivalent to
0.05% w/w)
Excipients with known effect:
cetostearyl alcohol 40-60 mg /g
chlorocresol
1 mg /g
This product contains paraffin, see section 4.4.
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Cream
A smooth white cream.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Eumovate Cream is a moderately potent topical corticosteroid indicated
for adults, elderly,
children and infants for the relief of the inflammatory and pruritic
manifestations of steroid
responsive dermatoses.
These include the following:
-
Atopic dermatitis
-
Irritant or allergic contact dermatitis
-
Seborrhoeic dermatitis
-
Photodermatitis
-
Otitis externa
-
Prurigo nodularis
-
Insect bite reactions
Clobetasone may be used as maintenance therapy between courses of one
of the more potent
topical steroids.
Continuous daily treatment for longer than 4 weeks in adults is not
recommended (see section
4.2).
Extreme caution should be used in the treatment of dermatoses in
children under 12 years of age
and should not normally exceed 7 days (see section 4.2).
Patients should be closely monitored for side effects.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults, Elderly, Children and Infants _
Creams are especially appropriate for moist or weeping surfaces.
Apply thinly and gently rub in using only enough to cover the entire
affected area once or twice a
day until improvement occurs, then reduce the frequency of application
or change the treatment
to a less potent preparation. Allow adequate time for absorption after
each application before
applying an emollient.
Continuous daily treatment for longer than 4 weeks is not recommended.
If the condition worsens
or does not improve within four weeks, treatment and diagnosis should
be re-evaluated.
Therapy with topical corticosteroids should be gradually discontinued
once