Audavate RD 0.025% cream

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Betamethasone valerate

Available from:

Accord-UK Ltd

ATC code:

D07AC01

INN (International Name):

Betamethasone valerate

Dosage:

250microgram/1gram

Pharmaceutical form:

Cutaneous cream

Administration route:

Cutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 13040000; GTIN: 5060032242842

Patient Information leaflet

PATIENT INFORMATION LEAFLET
AUDAVATE™ RD 0.025% W/W CREAM
(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 RD and what is it used for
2. What you need to know before you use Audavate RD
3. How to use Audavate RD
4. Possible side effects
5. How to store Audavate RD
6. Contents of the pack and other information
continued on the other side
BBBA5610
1. WHAT IS AUDAVATE RD AND WHAT IS IT USED FOR
Audavate RD contains a medicine called betamethasone valerate. It
belongs to a group of medicines called steroids. It helps to
reduce swelling and irritation.
Audavate RD is used to help reduce the redness and itchiness of
certain skin problems. These skin problems include eczema,
psoriasis and dermatitis.
RD stands for ‘Ready Diluted’. It contains less active ingredient
than Audavate 0.1% preparations. It is used:
• For milder skin problems, or
• To keep your skin problem under control after Audavate 0.1% has
improved it.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE AUDAVATE RD
DO NOT USE AUDAVATE RD:
• 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 year 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 yo

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Audavate RD 0.025% w/w Cream
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
One gram of cream contains 0.25 mg of betamethasone (0.025% w/w) as
valerate.
Also contains 72 mg of cetostearyl alcohol and 1 mg of chlorocresol.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Cream
White to almost white cream.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Betamethasone valerate ready diluted (Audavate RD) preparations are
indicated for
maintenance treatment once an acute episode has been treated
effectively with a
continuous course of betamethasone valerate (Audavate).
Betamethasone valerate 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.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Creams are especially appropriate for moist or weeping surfaces.
Once an acute episode has been treated effectively with a continuous
course of
betamethasone valerate, improvement may be maintained with a small
amount of
ready diluted betamethasone valerate applied once or twice a day.
This regimen should be combined with routine daily use of emollients.
The condition
and the benefits and risks of continued treatment must be re-evaluated
on a regular
basis.
_Paediatric population_
Betamethasone valerate is contraindicated in children under one year
of age.
Children are more likely to develop local and systemic side effects of
topical
corticosteroids and, in general, require shorter cou