Betnovate Cream 0.1% w/w

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Betamethasone

Available from:

GlaxoSmithKline (Ireland) Limited

ATC code:

D07AC; D07AC01

INN (International Name):

Betamethasone

Dosage:

0.1 percent weight/weight

Pharmaceutical form:

Cream

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Corticosteroids, potent (group III); betamethasone

Authorization status:

Marketed

Authorization date:

1983-12-13

Patient Information leaflet

Reason for Update: Project Pine – Update to Manufacturing Details
Market: Ireland
Agency Approval Date:
Text Date: 06/06/2022
Text Issue and Draft No.: Issue 10, Draft 1
PACKAGE LEAFLET: INFORMATION FOR THE USER
BETNOVATE CREAM 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 Cream 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 or
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 or low

Summary of Product characteristics

Health Products Regulatory Authority
28 September 2020
CRN009Y81
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Betnovate Cream 0.1% w/w
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of cream contains 1 mg of betamethasone (0.1% w/w) as
betamethasone valerate.
Excipients with known effect:
Chlorocresol 0.1% w/w
Cetostearyl Alcohol 7.2% w/w
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cutaneous cream.
A white, homogenous, aqueous based cream.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Betnovate Cream 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_
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 Betnovate can be
enhanced, if necessary, by occluding the treatment area with polythene
film. Overnight occlusion only is usually adequate to
Health Products Regulatory Authority
28 September 2020
CRN009Y81
P