Betamethasone valerate 0.1% cream

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Betamethasone valerate

Available from:

Waymade Healthcare Plc

ATC code:

D07AC01

INN (International Name):

Betamethasone valerate

Dosage:

1mg/1gram

Pharmaceutical form:

Cutaneous cream

Administration route:

Cutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 13040000

Patient Information leaflet

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 BETAMETHASONE CREAM IS AND WHAT IT IS USED
FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU USE
BETAMETHASONE CREAM
3. HOW TO USE BETAMETHASONE CREAM
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE BETAMETHASONE CREAM
6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT BETAMETHASONE CREAM IS AND WHAT IT IS USED FOR
Betamethasone Valerate 0.1%w/w Cream (hereinafter
referred to as Betamethasone cream) contains a topical
steroid. ‘Topical’ means that it is put on the skin. Topical
steroids are used on certain types of inflamed skin, to
reduce the redness and itchiness. Betamethasone cream is
used to treat inflamed skin conditions, such as eczema, in
patients unresponsive to less potent creams or ointments.
These steroids should not be confused with “anabolic”
steroids misused by some body builders and athletes and
taken as tablets or injections. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE BETAMETHASONE CREAM
DO NOT USE BETAMETHASONE CREAM:
if you are allergic (hypersensitive) to betamethasone
valerate or any of the other ingredients of
Betamethasone cream (listed in section 6)
on infants under one year of age
on areas of skin which have the following conditions:
acne
rosacea (redness and spots or blisters in the centre
of the face around the nose)
peri-oral dermatitis (spotty red rash around the mouth)
skin infections caused by viruses, bacteria or fungi,
such as cold sores, herpes, chickenpox, impetigo,
ringworm, athlete’s foot, thrush
on areas of itchiness where the sk

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Betamethasone Valerate 0.1%w/w Cream
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
0.1% betamethasone B.P. as the valerate ester
Excipients with known effect:
Chlorocresol
Cetostearyl alcohol
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Aqueous Cream
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
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
Route of administration: Cutaneous
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 betamethasone valerate 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.
If the condition worsens or does not improve within 2-4 weeks,
treatment and diagnosis
should be re-evaluated.
Therapy with