Betnovate Ointment 0.1% w/w

Land: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Betamethasone valerate

Fáanlegur frá:

GlaxoSmithKline (Ireland) Limited

ATC númer:

D07AC; D07AC01

INN (Alþjóðlegt nafn):

Betamethasone valerate

Skammtar:

0.1 percent weight/weight

Lyfjaform:

Ointment

Gerð lyfseðils:

Product subject to prescription which may be renewed (B)

Lækningarsvæði:

Corticosteroids, potent (group III); betamethasone

Leyfisstaða:

Marketed

Leyfisdagur:

1983-12-13

Upplýsingar fylgiseðill

Reason for Update: Project Pine – Update to Manufacturing Details
Market: Ireland
Agency Approval Date:
Text Date: 06-Jun-2022
Text Issue and Draft No.: Issue 11, Draft 1
PACKAGE LEAFLET: INFORMATION FOR THE USER
BETNOVATE OINTMENT 0.1% W/W
betamethasone (as 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.

In this leaflet, Betnovate Ointment 0.1% w/w will be called Betnovate.
WHAT IS IN THIS LEAFLET
1
What Betnovate is and what it is used for
2
What you need to know before you use Betnovate
3
How to use Betnovate
4
Possible side effects
5
How to store Betnovate
6
Contents of the pack and other information
1
WHAT BETNOVATE IS AND WHAT IT IS USED FOR
Betnovate
contains
the
active
substance
betamethasone
valerate
which
belongs to a group of medicines called corticosteroids that help to
reduce
redness, swelling and irritation of the skin in adults, the elderly
and children over
the age of 1 year. These should not be confused with “anabolic”
steroids
misused by some body builders and athletes and taken as tablets and
injections.
Betnovate is used to help reduce the redness and itchiness of certain
skin
problems, such as:

eczema

prurigo nodularis (itchy nodules on the arms or legs)

psoriasis (thickened patches of inflamed, red skin, often covered by
silvery
scales) excluding widespread plaque psoriasis

lichen simplex chronicus (patches of thickened, itchy skin, caused by
scratching)

lichen planus (a skin disease that causes itchy, reddish-purple,
flat-topped
bumps on the wrists, forearms

Vara einkenni

Health Products Regulatory Authority
18 September 2020
CRN009Y34
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Betnovate Ointment 0.1% w/w
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of ointment contains 1 mg of betamethasone (0.1% w/w) as
betamethasone valerate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cutaneous Ointment.
An off-white, homogeneous ointment.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Betnovate Ointment 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
- Miliaria (prickly heat)
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults, Elderly and Children over 1 year_
Ointments are especially appropriate for dry, lichenified or scaly
lesions.
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 Betnovate 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
witho