Betamethasone valerate 0.1% ointment

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Betamethasone valerate

Available from:

Sigma Pharmaceuticals Plc

ATC code:

D07AC01

INN (International Name):

Betamethasone valerate

Dosage:

1mg/1gram

Pharmaceutical form:

Cutaneous ointment

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 0.1% 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 Ointment and what is it used for?
2.
Before you use Betamethasone Valerate Ointment
3.
How to use Betamethasone Valerate Ointment
4.
Possible side effects
5.
Storing Betamethasone Valerate Ointment
6.
Further information
1.
WHAT IS BETAMETHASONE VALERATE OINTMENT AND WHAT IS IT USED FOR?
Betamethasone Valerate 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 Ointment is used to help reduce the redness and
itchiness of certain skin
problems. These skin problems include eczema, psoriasis and
dermatitis.
2.
BEFORE YOU USE BETAMETHASONE VALERATE OINTMENT
DO NOT USE BETAMETHASONE VALERATE OINTMENT:
•
if you are allergic (hypersensitive) to betamethasone valerate or any
of the other ingredients of
Betamethasone Valerate 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 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 chick

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Betamethasone Valerate 0.1% w/w Ointment
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
One gram of ointment contains 1mg of betamethasone (0.1% w/w) as
valerate.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Ointment
Opaque ointment.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Betamethasone Valerate Ointment 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
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.
Adults, adolescents and the elderly
A small quantity of Betamethasone Valerate Ointment should be applied
to the
affected area one to three times daily 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% 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 Betamethasone Valerate Ointmentcan be enhanced,
if necessary,
by occluding the treatment area with polythene film. Overnight