Betnovate RD 0.025% cream

Kraj: Wielka Brytania

Język: angielski

Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)

Składnik aktywny:

Betamethasone valerate

Dostępny od:

GlaxoSmithKline UK Ltd

Kod ATC:

D07AC01

INN (International Nazwa):

Betamethasone valerate

Dawkowanie:

250microgram/1gram

Forma farmaceutyczna:

Cutaneous cream

Droga podania:

Cutaneous

Klasa:

No Controlled Drug Status

Typ recepty:

Valid as a prescribable product

Podsumowanie produktu:

BNF: 13040000; GTIN: 5000123101047

Ulotka dla pacjenta

PACKAGE LEAFLET: INFORMATION FOR THE USER
BETNOVATE RD CREAM
BETAMETHASONE 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.
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 a medicine called betamethasone valerate. It
belongs to a
group of medicines called steroids that reduce swelling and
irritation.
Betnovate RD is used to help reduce the redness and itchiness of
certain skin
problems, such as eczema, psoriasis and dermatitis.
RD stands for ‘Ready Diluted’, it contains less active ingredient
than Betnovate. It is
used:

for milder skin problems, or

to keep your skin problem under control after Betnovate has improved
it.
2
WHAT YOU NEED TO KNOW BEFORE YOU USE BETNOVATE RD
DO NOT USE BETNOVATE RD:

if you are allergic (hypersensitive) to betamethasone valerate or any
of the other
ingredients of Betnovate RD (listed in Section 6)

on a child under 1 year

to treat any of the following skin problems, it could make them worse:
-
acne
-
severe flushing of skin on and around your nose (rosacea)
-
spotty red rash around your mouth (perioral dermatitis)
-
itching around your back passage or private parts
-
infected skin (unless the infection is being treated with an
anti-infective
medicine at the same time)
-
itchy skin which is not infl

Charakterystyka produktu

OBJECT 1
BETNOVATE RD CREAM
Summary of Product Characteristics Updated 13-Sep-2017 |
GlaxoSmithKline UK
1. Name of the medicinal product
Betnovate RD Cream
2. Qualitative and quantitative composition
Betamethasone Valerate B.P. Equivalent to Betamethasone 0.025%.
Excipients with known effect:
Chlorocresol
Cetostearyl alcohol
For the full list of excipients, see section 6.1
3. Pharmaceutical form
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
4.2 Posology and method of administration
Route of administration: Cutaneous
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 regimen 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.
PAEDIATRIC POPULATION
Betamethasone valerate is contraindicated in children under one year
of age.
Children are more likely to develop local and systemic side effects of
topical corticosteroid