Dermovate 0.5 mg/g Cream

Χώρα: Μάλτα

Γλώσσα: Αγγλικά

Πηγή: Medicines Authority

Διαθέσιμο από:

NeoFarma Pharmaceuticals Limited 42-46, Mill Street, Qormi, QRM 3105, Malta

Φαρμακολογική κατηγορία (ATC):

D07AD01

INN (Διεθνής Όνομα):

CLOBETASOL PROPIONATE 0.5 mg/g

Φαρμακοτεχνική μορφή:

CREAM

Σύνθεση:

CLOBETASOL PROPIONATE 0.5 mg/g

Τρόπος διάθεσης:

POM

Θεραπευτική περιοχή:

CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS

Περίληψη προϊόντος:

Licence number in the source country: Romania - 2229/2009/01

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2022-08-03

Φύλλο οδηγιών χρήσης

PACKAGE LEAFLET: INFORMATION FOR THE USER
DERMOVATE 0.5 MG/G 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.
• In this leaflet, Dermovate 0.5 mg/g Cream will be called
Dermovate.
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 the active substance clobetasol propionate 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).
Dermovate is used to help reduce the redness and itchiness of certain
skin problems in adults, the elderly and children over the age of 1
year.
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)
• conditions that have not responded to milder steroid creams or
ointments.
For children

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Dermovate 0.5 mg/g Cream
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of cream contains 0.5 mg of clobetasol propionate
(equivalent to 0.05% w/w).
Excipients with known effect:
Each gram of cream contains 84 mg of cetostearyl alcohol (equivalent
to 8.4% w/w)
Each gram of cream contains 475 mg ofpropylene glycol (equivalent to
47.50% w/w)
Each gram of cream contains 0.75 mg of chlorocresol (equivalent to
0.075% w/w)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Cream.
A white to off-white homogenous cream.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Dermovate is a very potent topical corticosteroid indicated for
adults, elderly and children over 1
year for the relief of the inflammatory and pruritic manifestations of
steroid responsive
dermatoses.
These include the following:
-
Psoriasis (excluding widespread plaque psoriasis)
-
Recalcitrant dermatoses
-
Lichen planus
-
Discoid lupus erythematosus
-
Other skin conditions which do not respond satisfactorily to less
potent steroids
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
CLOBETASOL PROPIONATE BELONGS TO THE MOST POTENT CLASS OF TOPICAL
CORTICOSTEROIDS (CLASS
IV) AND PROLONGED USE MAY RESULT IN SERIOUS UNDESIRABLE EFFECTS (SEE
SECTION 4.4). IF
TREATMENT WITH A LOCAL CORTICOSTEROID IS CLINICALLY JUSTIFIED BEYOND 4
WEEKS, A LESS POTENT
CORTICOSTEROID PREPARATION SHOULD BE CONSIDERED. REPEATED BUT SHORT
COURSES OF
CLOBETASOL PROPIONATE MAY BE USED TO CONTROL EXACERBATIONS (SEE
DETAILS BELOW).
Creams are especially appropriate for moist or weeping surfaces.
Posology
Apply thinly and gently rub in using only enough to cover the affected
area once or twice daily for
up to 4 weeks 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.
Repeated short courses of Dermovate may be used to control
exacerbations.
In