Eumovate 0.05% cream

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Clobetasone butyrate

Available from:

Mawdsley-Brooks & Company Ltd

ATC code:

D07AB01

INN (International Name):

Clobetasone butyrate

Dosage:

500microgram/1gram

Pharmaceutical form:

Cutaneous cream

Administration route:

Cutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 13040000

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
EUMOVATE
®
0.05% CREAM
(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.
The name of your medicine is Eumovate 0.05% Cream but
will be referred to as Eumovate throughout this leaflet.
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
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.
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, talk to your doctor or pharmacist before using
Eumovate.
WARNING AND PRECAUTIONS
Talk to your doctor or pharmacist before using

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Eumovate Eczema & Dermatitis 0.05% Cream
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Clobetasone butyrate 0.05% w/w
Excipients with known effect:
Cetostearyl alcohol
Chlorocresol
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Cream
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Eumovate Eczema & Dermatitis Cream is suitable for the short-term
treatment and
control of patches of eczema and dermatitis including atopic eczema
and primary
irritant and allergic dermatitis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
This product is suitable for use in adults and children aged 12 years
or older.
This product should be applied sparingly (see section 6.6) and gently
rub in, using
only enough to cover the affected area once or twice a day for up to 7
days. If the
condition resolves within 7 days, treatment with this product should
be stopped. If the
condition does not improve in the first 7 days or becomes worse the
consumer should
see a doctor. If after 7 days of treatment improvement is seen but
further treatment is
required, the consumer should see a doctor
CHILDREN
Use in children under 12 years only on the advice of a doctor.
Children are more
likely to develop local and systemic adverse reactions of topical
corticosteroids and,
in general, require shorter courses and less potent agents than
adults.
Care should be taken when using this product to ensure the amount
applied is the
minimum that provides therapeutic benefit.
ELDERLY
Clinical studies have not identified differences in responses between
the elderly and
younger patients. The greater frequency of decreased hepatic or renal
function in the
elderly may delay elimination if systemic adsorption occurs. Therefore
the minimum
quantity should be used for the shortest duration to achieve the
desired clinical
benefit.
RENAL/HEPATIC IMPAIRMENT
In case of systemic absorption (when application is over a large
surface area for a
prolonged period) metabolism and elimination may be