Dermovate 0.05% w/w Cream

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Clobetasol propionate

Available from:

GlaxoSmithKline (Ireland) Limited

ATC code:

D07AD; D07AD01

INN (International Name):

Clobetasol propionate

Dosage:

0.05 percent weight/weight

Pharmaceutical form:

Cream

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Corticosteroids, very potent (group IV); clobetasol

Authorization status:

Marketed

Authorization date:

1983-10-27

Patient Information leaflet

Reason for Update: Project Pine – Update to Manufacturing Details
Market: Ireland
Agency Approval Date:
Text Date: 16/03/2021
Text Issue and Draft No.: Issue 12, Draft 1
PACKAGE LEAFLET: INFORMATION FOR THE USER
DERMOVATE 0.05% W/W 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 0.05% w/w 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

Summary of Product characteristics

Health Products Regulatory Authority
27 July 2021
CRN00CGKN
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dermovate 0.05% w/w 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 of propylene 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 (GROUP 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.