Dermovate Cream

Pays: Malte

Langue: anglais

Source: Medicines Authority

Ingrédients actifs:

CLOBETASOL PROPIONATE

Disponible depuis:

Glaxo Wellcome UK Limited

Code ATC:

D07AD01

DCI (Dénomination commune internationale):

CLOBETASOL PROPIONATE

forme pharmaceutique:

CREAM

Composition:

CLOBETASOL PROPIONATE 0.525 % (W/W)

Type d'ordonnance:

POM

Domaine thérapeutique:

CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS

Statut de autorisation:

Authorised

Date de l'autorisation:

2005-11-15

Notice patient

Reason for Update: PRAC recommendation – blurred vision
Market: UK
Agency Approval Date: 18/10/2017
Text Date: 18/09/2017
Text Issue and Draft No.: Issue 4 Draft 4
PACKAGE LEAFLET: INFORMATION FOR THE USER
DERMOVATE CREAM
CLOBETASOL PROPIONATE
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 Dermovate is and what it is used for
2 What you need to know before you use Dermovate
3 How to use Dermovate
4 Possible side effects
5 How to store Dermovate
6 Contents of the pack and other information
1.
WHAT DERMOVATE IS AND WHAT IT IS USED FOR
Dermovate contains a medicine called clobetasol propionate. It belongs
to a group of
medicines called steroids. It helps to reduce swelling and irritation.
Dermovate is used to help reduce the redness and itchiness of certain
skin
problems. These skin problems include:
•
frequently relapsing eczema
•
psoriasis (thickened patches of inflamed, red skin, often covered by
silvery
scales), excluding widespread plaque psoriasis
•
lichen planus, (a skin disease that causes itchy, reddish-purple,
flat-topped
bumps on the wrists, forearms or lower legs)
•
discoid lupus erythematosus (a disease of the skin most often
affecting the face,
ears and scalp causing scarring and increased sensitivity of the
affected skin to
sunlight)
•
dermatitis and other skin conditions that have not responded to milder
steroid
creams or ointments.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE DERMOVATE
DO NOT USE DERMOVATE:
•
if you are allergic (hypersensitive) to clobetasol propi

Résumé des caractéristiques du produit

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Dermovate Cream
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Clobetasol propionate 0.0525% w/w
Excipients with known effect:
Cetosteryl alcohol
Clorocresol
Propylene glycol
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Cream
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Clobetasol is a very potent topical corticosteroid indicated for
adults, elderly
and
children
over
1
year
for
the
short
term
treatment
only
of
more
resistantrelief
of
the
inflammatory
and
pruritic
manifestations
of
steroid
responsive
dermatoses
unresponsive
to
less
potent
corticosteroids.
These
include the following:
-
Psoriasis (excluding widespread plaque psoriasis)
-
Recalcitrant dermatoses
-
Lichen planus
-
Discoid lupus eythematosus
-
Other skin conditions which do not respond satisfactorily to less
potent
steroids
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration: Cutaneous
Creams are especially appropriate for moist or weeping surfaces.
ADULTS, ELDERLY AND CHILDREN OVER 1 YEAR
Apply thinly and gently rub in using only enough to cover the entire
affected
area once or twice a day until improvement occurs (in the more
responsive
conditions this may be within a few days), 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.
Repeated short courses
of clobetasol propionate may be used to
control
exacerbations.
In more resistant lesions, especially where there is hyperkeratosis,
the effect of
clobetasol can be enhanced, if necessary, by occluding the treatment
area with
polythene film. Overnight occlusion only is usually adequate to bring
about a
satisfactory response. Thereafter improvement can usually be
maintained by
application without occlusion.
If the condition worsens or does not improve within 2-4 weeks,
treatment and
diagnosis should be re-evaluated.
Treatment should not be continued for more than 4 w