Eumovate Ointment

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CLOBETASONE BUTYRATE

Available from:

Glaxo Wellcome UK Limited 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

ATC code:

D07AB01

INN (International Name):

CLOBETASONE BUTYRATE 0.05 % (W/W)

Pharmaceutical form:

OINTMENT

Composition:

CLOBETASONE BUTYRATE 0.05 % (W/W)

Prescription type:

POM

Therapeutic area:

CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS

Authorization status:

Withdrawn

Authorization date:

2005-09-12

Patient Information leaflet

Reason for Update: Article 46 & QRD version 10
Market: UK
Agency Approval Date: 05/10/2016
Text Date: 20/09/2016
Text Issue and Draft No.: Issue 3, draft 3
PACKAGE LEAFLET: INFORMATION FOR THE USER
EUMOVATE
® OINTMENT
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.
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. It belongs
to a group of
medicines called steroids. It helps to reduce swelling and irritation.
Eumovate is used to:

help reduce the redness and itchiness of certain skin problems. It is
used for mild
skin problems or to keep your skin problem under control. These skin
problems
include eczema, dermatitis, nappy rash or insect bites.

help reduce inflammation of the outer ear.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE EUMOVATE
DO NOT USE EUMOVATE:

if you are allergic to clobetasone butyrate or any of the other
ingredients of this
medicine (listed in Section 6)

to treat any of the following skin problems, it could make them worse:
-
infected skin (unless the infection is being treated with an
anti-infective
medicine at the same time)
-
acne
-
severe flushing of skin on and around your nose (rosacea)
-
itchy skin which is not inflamed
Do not use if any of the above apply to you. If you are not sure, t

Summary of Product characteristics

Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Eumovate Ointment
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
0.05% w/w clobetasone butyrate.
3.
PHARMACEUTICAL FORM
Paraffin based ointment.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Eumovate ointment 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
-
Nappy rash
-
Photodermatitis
-
Otitis externa
-
Prurigo nodularis
-
Insect bite reactions
Eumovate may be used as maintenance therapy between courses of one of
the more potent
topical steroids.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
ROUTE OF ADMINISTRATION: Cutaneous
ADULTS, ELDERLY, CHILDREN AND INFANTS
Ointments are especially appropriate for dry, lichenified or scaly
lesions.
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.
Page 2 of 8
Therapy with topical corticosteroids should be gradually discontinued
once control is
achieved and an emollient continued as maintenance therapy.
Rebound of pre-existing dermatoses can occur with abrupt
discontinuation of topical
corticosteroids especially with potent preparations.
DURATION OF TREATMENT FOR ADULTS AND ELDERLY
Continuous daily treatment for longer than four weeks is not
recommended. If the
condition worsens or does not improve within four weeks, treatment and
diagnosis
should be re-evaluated.
PAEDIATRIC POPULATION
Use in children under 12 years should be on the advice of a doctor.
Care should be taken when using clobetasone to ensure the amount
applied is the
minimum that provides therapeutic benefit.
DURATION O