Eumovate 0.05% cream

Land: Vereinigtes Königreich

Sprache: Englisch

Quelle: MHRA (Medicines & Healthcare Products Regulatory Agency)

Wirkstoff:

Clobetasone butyrate

Verfügbar ab:

GlaxoSmithKline UK Ltd

ATC-Code:

D07AB01

INN (Internationale Bezeichnung):

Clobetasone butyrate

Dosierung:

500microgram/1gram

Darreichungsform:

Cutaneous cream

Verabreichungsweg:

Cutaneous

Klasse:

No Controlled Drug Status

Verschreibungstyp:

Valid as a prescribable product

Produktbesonderheiten:

BNF: 13040000; GTIN: 5000123104253 5000123104017

Gebrauchsinformation

PACKAGE LEAFLET: INFORMATION FOR THE USER
EUMOVATE 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.
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, talk
to your doctor or
pharmacist before using Eumovate.
WARNING AND PRECAUTIONS
Talk to your doctor or pharmacist before using Eumovate if:
•
you have previously

Fachinformation

OBJECT 1
EUMOVATE CREAM
Summary of Product Characteristics Updated 18-Oct-2017 |
GlaxoSmithKline UK
1. Name of the medicinal product
Eumovate Cream
2. Qualitative and quantitative composition
0.05% w/w clobetasone butyrate.
Excipients with known effect:
Cetostearyl alcohol
Chlorocresol
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Water miscible 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
- 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
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.
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 doct