Betamesol 0.05% cream

País: Malta

Idioma: inglés

Fuente: Medicines Authority

Ingredientes activos:

BETAMETHASONE DIPROPIONATE

Disponible desde:

Proge Farm S.r.l. Baluardo La Marmora, 4 - 28100 - Novara, Italy

Código ATC:

D07AC01

Designación común internacional (DCI):

BETAMETHASONE DIPROPIONATE 0.05 % (W/W)

formulario farmacéutico:

CREAM

Composición:

BETAMETHASONE DIPROPIONATE 0.05 % (W/W)

tipo de receta:

POM

Área terapéutica:

CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS

Estado de Autorización:

Withdrawn

Fecha de autorización:

2006-09-18

Información para el usuario

 
BETAMESOL 
B
ETAMETHASONE 
D
IPROPIONATE 

Cream 0.05% tube 30 g 

COMPOSITION 

100 g of cream contain: 

Active ingredient: 
Betamethasone dipropionate   
g 0.064 
Equal to betamethasone alcohol  
g 0.05 

Excipients: 
Chlorocresol, Monobasic sodium phosphate, Phosphoric acid, White
vaseline, Liquid paraffin, 
Polyethylene glycol monocetylether (Cetomacrogol 1000), Cetostearyl
alcohol, Deionized water.

PHARMACEUTICAL FORM – PACKAGING  

0.05% cream in a 30 g tube  

PHARMACO-THERAPEUTICAL CLASS  

Glucocorticoid for topical use  

MARKETING AUTHORISATION HOLDER  

PROGE FARM S.r.l. - Baluardo La Marmora, 4 - Novara 

AUTHORISED MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE 

Omicron Pharma S.r.l. - Via Follereau, 25 – Nembro (BG) 
Francia Farmaceutici S.r.l. - Via dei Pestagalli, 7 - Milano 
Lachifarma S.r.l. – S.S. 16 Zona Industriale - Zollino (LE) 

THERAPEUTICAL INDICATIONS  

Corticosteroid-sensitive dermatosis, especially when affecting thin
and delicate skin areas.  
Contact eczema (caused by detergents, beauty products or
related to occupational causes), 
constitutional eczema, adult and infant
seborrhoic eczema (milk-crust), stasis eczema, dyshidrosis, 
generalized and anus-genital pruritus, intertrigo, sun-rash, primary
irritative forms (caused by 
plants, insects or chemicals). 
This preparation is also recommended for psoriasis and other
types of deep inflammatory 
dermatosis like Vidal - Brocq lichen simplex and lichen ruber
planus. 

CONTRAINDICATIONS 

Topical cortison-based products are contraindicated in case
of known hypersensitivity to 
corticosteroids or other product components, in patients suffering
from cutaneous tuberculosis, 
herpes simplex or skin viral diseases (smallpox, chickenpox). The
occlusive therapy is 
contraindicated in patients suffering from atopical dermatitis.
Application on eyes or eyelids is 
contraindicated.  
 

Ficha técnica

Page 1 of 4 
SUMMARY OF PRODUCT CHARACTERISTICS 

1. NAME OF THE MEDICINAL PRODUCT 

BETAMESOL 0,05 % cream 30 g – ATC D07AC01 Betamethasone
dipropionate 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 

100 g cream contain: 
Active ingredient: Betamethasone dipropionate 0.064 g equal to
Betamethasone alcohol 0.05 g. 

3. PHARMACEUTICAL FORM 

Cream. 

4. CLINICAL PARTICULARS 

4.1. THERAPEUTIC INDICATIONS 

Dermatoses sensitive to corticosteroids and particularly
the forms localised in the sites with thinner 
and more delicate skin. 
- Contact eczema (caused by detergents, cosmetics, or related to
occupational causes) 
- Constitutional eczema 
- Seborrhoic eczema in the adult and in the suckling (milk-crust) 
- Stasis eczema 
- Dyshidrosis 
- Generalised and anal-genital itching 
- Intertrigo 
- Sunburn erythema 
- Primary irritative forms (caused by vegetables, insects, chemical
substances) 
Further indications for the preparation are psoriasis and other
deep inflammatory dermatoses, such 
as Vidal-Brocq lichen simplex and lichen ruber planus. 

4.2. POSOLOGY AND METHOD OF ADMINISTRATION 

Apply 1 – 2 times daily in a sufficient quantity to cover the
interested area and massage delicately 
until the absorption is complete. 
Do not exceed the advised doses. 

4.3. CONTRAINDICATIONS 

Topical cortisones are contraindicated in patients with already
known hypersensitivity towards 
corticosteroids, in patients with skin tuberculosis and
herpes simplex and with viral diseases with 
skin localisation (smallpox, chicken-pox). The occlusive therapy is
contraindicated in patients with 
atopic dermatitis. The application on the eye and on the eyelids is
contraindicated. 

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4.4. SPECIAL WARNINGS AND CAUTIONS FOR USE 

The epicutaneous application of cortisone in the treatment
of wide dermatitis and for prolonged 
time may cause a systemic absorption; such case occ