Betamethasone valerate 0.1% ointment

Country: United Kingdom

Bahasa: Inggeris

Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)

Bahan aktif:

Betamethasone valerate

Boleh didapati daripada:

Teva UK Ltd

Kod ATC:

D07AC01

INN (Nama Antarabangsa):

Betamethasone valerate

Dos:

1mg/1gram

Borang farmaseutikal:

Cutaneous ointment

Laluan pentadbiran:

Cutaneous

Kelas:

No Controlled Drug Status

Jenis preskripsi:

Valid as a prescribable product

Ringkasan produk:

BNF: 13040000; GTIN: 5017007299837 5017007299844

Risalah maklumat

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 OINTMENT IS AND WHAT IT IS
USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU USE
BETAMETHASONE OINTMENT
3. HOW TO USE BETAMETHASONE OINTMENT
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE BETAMETHASONE OINTMENT
6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT BETAMETHASONE OINTMENT IS AND WHAT IT IS USED FOR
Betamethasone Valerate 0.1%w/w Ointment (hereinafter
referred to as Betamethasone ointment) 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 ointment
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 OINTMENT
DO NOT USE BETAMETHASONE OINTMENT:
if you are allergic (hypersensitive) to betamethasone
valerate or any of the other ingredients of
Betamethasone ointment (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
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Ciri produk

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