Betamethasone valerate 0.025% cream

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Betamethasone valerate

Available from:

A A H Pharmaceuticals 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

Patient Information leaflet

ACCORD LOGO
PACKAGE LEAFLET: INFORMATION FOR THE USER
BETAMETHASONE VALERATE 0.025% W/W CREAM &
BETAMETHASONE VALERATE 0.025% W/W OINTMENT
READ ALL OF THIS LEAFLET CAREFULLY 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. Do not pass it on to
others. It may harm them, even
if their symptoms are the same as yours.
•
If any of the side effects become serious, or if you notice any side
effects not listed in this
leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET
1.
What is Betamethasone Valerate Cream/Ointment and what is it used for?
2.
Before you use Betamethasone Valerate Cream/Ointment
3.
How to use Betamethasone Valerate Cream/Ointment
4.
Possible side effects
5.
Storing Betamethasone Valerate Cream/Ointment
6.
Further information
1.
WHAT IS BETAMETHASONE VALERATE CREAM/OINTMENT AND WHAT IS IT USED FOR?
Betamethasone Valerate Cream/Ointment contains a medicine called
betamethasone valerate. It
belongs to a group of medicines called steroids. It helps to reduce
swelling and irritation.
Betamethasone Valerate Cream/Ointment is used to help reduce the
redness and itchiness of certain
skin problems. These skin problems include eczema, psoriasis and
dermatitis.
Betamethasone Valerate 0.025% w/w preparations contains less active
ingredient than
Betamethasone Valerate 0.1% preparations. It is used:
•
For milder skin problems, or
•
To keep your skin problem under control after Betamethasone Valerate
0.1% has improved it.
2.
BEFORE YOU USE BETAMETHASONE VALERATE CREAM/OINTMENT
DO NOT USE BETAMETHASONE VALERATE CREAM/OINTMENT:
•
if you are allergic (hypersensitive) to betamethasone valerate or any
of the other ingredients of
Betamethasone Valerate Cream/Ointment (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

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Betamethasone Valerate 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 a 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 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.
Betamethasone Valerate 0.025% preparations are indicated for
maintenance treatment
when control has been achieved with Betamethasone Valerate 0.1%.
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
For topical use only.
If no improvement is seen after two to four weeks, the diagnosis
should be
reconsidered and specialist referral may be necessary.
This regimen should be combined with routine daily use of emollients.
Adults, adolescents and the elderly
A small quantity of Betamethasone Valerate Cream 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,
Betamethasone
Valerate 0.025% Cream.
In the more resistant lesions, such as the thickened plaques of
psoriasis on elbows and
knees, the effect of Betamethasone V