Betnovate RD (Ready Diluted) 0.025% w/w Cream

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Betamethasone valerate

Available from:

GlaxoSmithKline (Ireland) Limited

ATC code:

D07AC; D07AC01

INN (International Name):

Betamethasone valerate

Dosage:

0.025 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:

Not marketed

Authorization date:

1984-08-24

Patient Information leaflet

Reason for Update: Project Pine – Update to Manufacturing Details
Market: Ireland
Agency Approval Date:
Text Date: 06-June-2022
Text Issue and Draft No.: Issue 9, Draft 1
PACKAGE LEAFLET: INFORMATION FOR THE USER
BETNOVATE RD (READY DILUTED) 0.025% W/W CREAM
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 RD (Ready Diluted) 0.025% Cream will be
called
Betnovate RD.
WHAT IS IN THIS LEAFLET
1
What Betnovate RD is and what it is used for
2
What you need to know before you use Betnovate RD
3
How to use Betnovate RD
4
Possible side effects
5
How to store Betnovate RD
6
Contents of the pack and other information
1
WHAT BETNOVATE RD IS AND WHAT IT IS USED FOR
Betnovate RD 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 RD 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,

Summary of Product characteristics

Health Products Regulatory Authority
20 May 2021
CRN009YX7
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Betnovate RD (Ready Diluted) 0.025% w/w Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of cream contains 0.25 mg of betamethasone (0.025% w/w) as
betamethasone valerate.
Excipients with known effect:
Cetostearyl Alcohol 7.20% w/w
Chlorocresol 0.10% w/w
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cream
A white, homogeneous aqueous based cream.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Betamethasone valerate ready diluted (Betnovate RD) preparations are
indicated for maintenance treatment once an acute
episode has been treated effectively with a continuous course of
betamethasone valerate (Betnovate).
Betamethasone valerate 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
- Milaria (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.
Once an acute episode has been treated effectively with a continuous
course of betamethasone valerate, improvement may be
maintained with a small amount of ready diluted betamethasone valerate
applied once or twice a day.
This regime should be combined with routine daily use of emollients.
The condition and the benefits and risks of continued
treatment must be re-evaluated on a regular basis.
Administration