Betnovate Cream 0.1% w/w

País: Malta

Idioma: inglés

Fuente: Medicines Authority

Ingredientes activos:

BETAMETHASONE VALERATE

Disponible desde:

Glaxo SmithKline Ireland Limited 12, Riverwalk, Citywest Business Campus, Dublin 24, Ireland

Código ATC:

D07AC01

Designación común internacional (DCI):

BETAMETHASONE VALERATE 0.1 % (W/W)

formulario farmacéutico:

CREAM

Composición:

BETAMETHASONE VALERATE 0.1 % (W/W)

tipo de receta:

POM

Área terapéutica:

CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS

Estado de Autorización:

Authorised

Fecha de autorización:

2005-09-12

Información para el usuario

PACKAGE LEAFLET: INFORMATION FOR THE USER
BETNOVATE CREAM 0.1% W/W
betamethasone (as valerate)
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, Betnovate Cream 0.1% w/w will be called Betnovate.
WHAT IS IN THIS LEAFLET
1
What Betnovate is and what it is used for
2
What you need to know before you use Betnovate
3
How to use Betnovate
4
Possible side effects
5
How to store Betnovate
6
Contents of the pack and other information
Betnovate contains the active substance betamethasone valerate which
belongs to a group of medicines called corticosteroids that help to
reduce
redness, swelling and irritation of the skin in adults, the elderly
and children
over the age of 1 year. These should not be confused with
“anabolic” steroids
misused by some body builders and athletes and taken as tablets or
injections.
Betnovate is used to help reduce the redness and itchiness of certain
skin
problems, such as:
•
eczema
•
prurigo nodularis (itchy nodules on the arms or legs)
•
psoriasis (thickened patches of inflamed, red skin, often covered by
silvery
scales), excluding widespread plaque psoriasis
•
lichen simplex chronicus (patches of thickened, itchy skin, caused by
scratching)
•
lichen planus (a skin disease that causes itchy, reddish-purple,
flat-topped
bumps on the wrists, forearms or lower legs)
•
seborrhoeic dermatitis (a red, scaly, itchy rash that develops on the
face,
scalp, chest and back)
•
discoid lupus erythematosus (a disease of the skin most often
affecting the
face, ears and scalp cau

Ficha técnica

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Betnovate Cream 0.1% w/w
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of cream contains 1 mg of betamethasone (0.1% w/w) as
betamethasone valerate.
Excipients with known effect:
Chlorocresol 0.1% w/w
Cetostearyl alcohol 7.2% w/w
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Cutaneous cream.
A white, homogenous, aqueous based cream.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Betnovate Cream is a 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:
-
Atopic dermatitis (including infantile atopic dermatitis)
-
Nummular dermatitis (discoid eczema)
-
Prurigo nodularis
-
Psoriasis (excluding widespread plaque psoriasis)
-
Lichen simplex chronicus (neurodermatitis) and lichen planus
-
Seborrhoeic dermatitis
-
Irritant or allergic contact dermatitis
-
Discoid lupus erythematosus
-
Adjunct to systemic steroid therapy in generalised erythroderma
-
Insect bite reactions
-
Miliaria (prickly heat)
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults, Elderly and Children over 1 year _
Creams are especially appropriate for moist or weeping surfaces.
Apply thinly and gently rub in using only enough to cover the entire
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.
In the more resistant lesions, such as the thickened plaques of
psoriasis on elbows and knees, the effect of
Betnovate 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 in such lesions, thereafter
improvement can usually be maintained by regular application without
occlu