Betnovate-C 0.1% / 3% w/w Cream

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Betamethasone; Clioquinol

Available from:

GlaxoSmithKline (Ireland) Limited

ATC code:

D07BC; D07BC01

INN (International Name):

Betamethasone; Clioquinol

Dosage:

0.1 %w/w + 3.0 percent weight/weight

Pharmaceutical form:

Cream

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Corticosteroids, potent, combinations with antiseptics; betamethasone and antiseptics

Authorization status:

Not marketed

Authorization date:

1983-10-27

Patient Information leaflet

Reason for update: Project Pine – Update to Manufacturing Details
Market: Ireland
Agency Approval Date:
Text Date: 09-Jun-2022
Text Issue and Draft No.: Issue 8; Draft 1
PACKAGE LEAFLET: INFORMATION FOR THE USER
BETNOVATE-C 0.1% / 3% W/W CREAM
Betamethasone (as valerate) and Clioquinol
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 Betnovate-C is and what it is used for
2
What you need to know before you use Betnovate-C
3
How to use Betnovate-C
4
Possible side effects
5
How to store Betnovate-C
6
Contents of the pack and other information
1
WHAT BETNOVATE-C IS AND WHAT IT IS USED FOR
The name of your medicine is Betnovate-C Cream. Betnovate-C Cream
(called ‘Betnovate-C’ in this leaflet) contains the active
substances
betamethasone valerate and clioquinol.
Betamethasone belongs to a group of medicines called corticosteroids
that
help to reduce redness, swelling and irritation of the skin. They
should not be
confused with “anabolic” steroids misused by some body builders
and athletes
and taken as tablets or injections.
Betnovate-C also contains clioquinol, an anti-infective agent, which
may help
to prevent or clear up some bacterial and fungal infections of the
skin.
Betnovate-C is a strong and rapidly effective treatment for inflamed
skin
conditions in which infection may be a problem, 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

Summary of Product characteristics

Health Products Regulatory Authority
22 January 2021
CRN009Z2S
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Betnovate-C 0.1% / 3% w/w Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Betamethasone 0.1% w/w (as betamethasone valerate)
Clioquinol 3% w/w
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
Cream
A pale yellow, homogenous, aqueous based cream.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Betnovate-C cream is indicated in the management of corticosteroid
sensitive dermatoses, actually or potentially complicated
by infection due to micro-organisms sensitive to the anti-infective
contained therein.
Betnovate-C cream is indicated for the treatment of the following
conditions where secondary bacterial and/or fungal infection
is present, suspected or likely to occur:
- 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
- Insect bite reactions
- Miliaria (prickly heat)
- Anal and genital intertrigo
- Otitis externa
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Apply thinly and gently rub in using only enough to cover the entire
affected area once or twice daily for up to four 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-C 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
without occ