DiproSone

País: Malta

Idioma: inglés

Fuente: Medicines Authority

Ingredientes activos:

BETAMETHASONE

Disponible desde:

Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

Código ATC:

D07AC01

Designación común internacional (DCI):

BETAMETHASONE 0.05 % (W/W)

formulario farmacéutico:

OINTMENT

Composición:

BETAMETHASONE 0.05 % (W/W)

tipo de receta:

POM

Área terapéutica:

CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS

Estado de Autorización:

Withdrawn

Fecha de autorización:

2006-11-06

Información para el usuario

SUBMISSION
2.1                   06U209312IN
PRODUCTNAME
Diprosone Ointment
CONCENTRATION
0.05 %
PRESENTATION
30/100g
CODE
Read all of this leafl et carefully before you start using this
medicine.
−  Keep this leafl et. 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. Do not pass it on to
others. It may harm them, even 
if their symptoms are the same as yours.
−  If any of the side effects gets serious, or if you notice any
side effects not listed in this leafl et, 
please tell your doctor or pharmacist.
In this leafl et:
1.  What Diprosone Ointment is and what it is used for
2.  Before you use Diprosone Ointment
3.  How to use Diprosone Ointment
4. Possible side effects
5.  How to store Diprosone Ointment
6. Further information
1. WHAT DIPROSONE OINTMENT IS AND WHAT IT IS USED FOR
Diprosone Ointment contains the active ingredient 0.064% w/w
betamethasone dipropionate.
Betamethasone dipropionate belongs to a group of medicines called
topical corticosteroids 
which are used on the surface of the skin to reduce the redness and
itchiness caused by certain 
skin problems.
In adults and children, Diprosone Ointment is used to treat skin
problems, including eczema, all 
types of dermatitis and psoriasis of the scalp, hands and feet.
Eczema is a common skin disease, which causes the skin to become red
and itchy. Dermatitis is 
infl ammation of the skin. Psoriasis is a skin disease in which
itchy, scaly, pink patches develop on 
the elbows, knees, scalp and other parts of the body.
2. BEFORE YOU USE DIPROSONE OINTMENT
Do not use Diprosone Ointment
−  if you are allergic (hypersensitive) to betamethasone
dipropionate or any of the other 
ingredients of Diprosone Ointment. Refer to section 6 for a full list
of ingredients.
−  on any other skin problem as it could make it worse especially
rosacea (a skin condition affecting 
the face), acne, dermatitis (skin infl

Ficha técnica

Page 1 of 5 
SUMMARY OF PRODUCT CHARACTERISTICS 

1. 
NAME OF THE MEDICINAL PRODUCT 

Diprosone Ointment 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Betamethasone Dipropionate 0.064% w/w* 

(* equivalent to 0.05% Betamethasone) 

3. 
PHARMACEUTICAL FORM 

Ointment 

4. 
CLINICAL PARTICULARS 

4.1 
THERAPEUTIC INDICATIONS 

Betamethasone Dipropionate is a synthetic fluorinated corticosteroid.  It is active topically 
and produces a rapid and sustained response in eczema and dermatitis of all types, including 
atopic eczema, photodermatitis., lichen planus, lichen simplex, prurigo nodularis, discoid 
lupus erythematosus, necrobiosis lipoidica, pretibial myxodemea and erythroderma.  It is 
also effective in the less responsive conditions such as psoriasis of the scalp and chronic 
plaque psoriasis of the hands and feet, but excluding widespread plaque psoriasis. 

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 

Adults and Children :  

Once to twice daily.  In most cases a thin film of Diprosone Ointment should be applied to 
cover the affected area twice daily.  For some patients adequate maintenance therapy may be 
achieved with less frequent application. 

Control over the dosage regimen may be achieved during intermittent and maintenance 
therapy by using Diprobase Cream or Ointment, (PL 0201/0076 and 0201/0075), the base 
vehicles of Diprosone Cream and Ointment.  Such control may be necessary in mild and 
improving dry skin conditions requiring low dose steroid treatment. 

4.3 
CONTRAINDICATIONS 

Rosacea, acne, perioral dermatitis, perianal and genital pruritus.  Hypersensitivity to any of 
the ingredients of the Diprosone presentations contra-indicates their use as does tuberculous 
and most viral lesions�