Audavate 0.1% ointment

País: Reino Unido

Idioma: inglés

Fuente: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes activos:

Betamethasone valerate

Disponible desde:

Accord-UK Ltd

Código ATC:

D07AC01

Designación común internacional (DCI):

Betamethasone valerate

Dosis:

1mg/1gram

formulario farmacéutico:

Cutaneous ointment

Vía de administración:

Cutaneous

clase:

No Controlled Drug Status

tipo de receta:

Valid as a prescribable product

Resumen del producto:

BNF: 13040000; GTIN: 5060032242880 5060032242873

Información para el usuario

PATIENT INFORMATION LEAFLET
AUDAVATE™ 0.1% W/W OINTMENT
(BETAMETHASONE 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.
WHAT IS IN THIS LEAFLET:
1. What is Audavate and what is it used for?
2. What you need to know before you use Audavate
3. How to use Audavate
4. Possible side effects
5. How to store Audavate
6. Contents of the pack and other information
continued on the other side
BBBA4406
1. WHAT IS AUDAVATE AND WHAT IS IT USED FOR?
Audavate contains a medicine called betamethasone valerate. It belongs
to a group of medicines called steroids. It helps to
reduce swelling and irritation.
Audavate is used to help reduce the redness and itchiness of certain
skin problems. These skin problems include eczema,
psoriasis and dermatitis.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE AUDAVATE
DO NOT USE AUDAVATE:
• if you are allergic to betamethasone valerate or any of the other
ingredients of this medicine (listed in Section 6)
• on a child under 1 years old
• to treat any of the following skin problems, it could make them
worse:
• acne
• severe flushing of skin on and around your nose (rosacea)
• spotty red rash around your mouth (perioral dermatitis)
• circular to oval red plaques found over the body and the scalp
(plaque psoriasis)
• itching around your back passage or private parts - unless your
doctor has told you to do so
• itchy skin which is not inflamed
• viral infections, such as cold sores, herpes or chicken pox
• fungal infections, such as ringworm, athletes foot or thrush
• skin blis

Ficha técnica

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Audavate 0.1% w/w Ointment
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
One gram of ointment contains 1 mg of betamethasone (0.1% w/w) as
valerate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Ointment
Opaque ointment.
4.1
THERAPEUTIC INDICATIONS
Audavate preparations are indicated for the treatment of: eczema in
children over 1
year elderly and adults; including atopic and discoid eczemas; prurigo
nodularis;
psoriasis (excluding widespread plaque psoriasis); neurodermatoses,
including lichen
simplex, lichen planus; seborrhoeic dermatitis; contact sensitivity
reactions; discoid
lupus erythematosus and they may be used as an adjunct to systemic
steroid therapy
in generalised erythroderma.
In general, ointment preparations are particularly appropriate for
dry, lichenified or
scaly skin conditions whereas a cream preparation may be more suitable
in the case of
moist or weeping lesions.
_4.2 _
_POSOLOGY AND METHOD OF ADMINISTRATION _
Posology
_Adults, adolescents and the elderly _
A small quantity of Audavate should be applied to the affected area
one to
three times daily or as directed by physician until improvement
occurs. It may
then be possible to maintain improvement by applying once a day, or
even less
often, or by using the appropriate ready diluted (1 in 4) preparation,
Audavate
RD 0.025% Ointment.
Allow adequate time for absorption after each application before
applying an
emollient. If no improvement is seen within two to four weeks,
reassessment
of the diagnosis or referral, may be necessary.
In the more resistant lesions, such as the thickened plaques of
psoriasis on
elbows and knees, the effect of Audavate 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 occlusion.
Therapy with betamethasone valerate s