Eumovate Eczema and Dermatitis 0.05% cream

Country: Միացյալ Թագավորություն

language: անգլերեն

source: MHRA (Medicines & Healthcare Products Regulatory Agency)

active_ingredient:

Clobetasone butyrate

MAH:

Haleon UK Ltd

ATC_code:

D07AB01

INN:

Clobetasone butyrate

dosage:

500microgram/1gram

pharmaceutical_form:

Cutaneous cream

administration_route:

Cutaneous

class:

No Controlled Drug Status

prescription_type:

Valid as a prescribable product

leaflet_short:

BNF: 13040000; GTIN: 5000347079016

PIL

Eczema & Dermatitis 0.05% Cream
Clobetasone Butyrate
PLEASE READ RIGHT THROUGH THIS LEAFLET BEFORE YOU START USING THIS
MEDICINE.
This medicine is available without prescription, but you still need to
use Eumovate
Eczema & Dermatitis 0.05% Cream carefully to get the best results from
it.
• Keep this leaflet you may need to read it again.
• If you have any questions, or if there is anything you do not
understand, ask
your pharmacist.
10000000145753
IN THIS LEAFLET:
1. What Eumovate does
2. Check before you use Eumovate
3. How to use Eumovate
4. Possible side effects
5. How to store Eumovate
6. Further information
7. More about managing eczema and dermatitis
1. What Eumovate does
EUMOVATE IS USED FOR THE SHORT TERM TREATMENT AND
CONTROL OF PATCHES OF RED, ITCHY SKIN CAUSED BY ECZEMA
AND DERMATITIS. The cream works to stop the skin’s
over-reaction to the triggers that cause skin flare-ups
such as eczema or dermatitis. The active ingredient is
clobetasone butyrate which is a topical corticosteroid to
control inflammation of the skin. The cream base also has
moisturising properties.
2. Check before you use
Eumovate
DO NOT USE EUMOVATE
• IF YOU HAVE EVER HAD AN ALLERGIC REACTION to clobetasone
butyrate or to any of the other ingredients (listed in
Section 6)
• ON CUTS and OPEN WOUNDS
• TO TREAT ANY OF THE FOLLOWING SKIN PROBLEMS, AS IT CAN
MAKE THEM WORSE:
• INFECTED skin (e.g. cold sores, herpes, chickenpox,
impetigo, athletes foot or thrush)
• ACNE
• ROSACEA (a facial skin condition where the nose,
cheeks, chin, forehead or entire face are unusually
red, with or without tiny visible blood vessels, bumps
(papules) or pus-filled bumps (pustules).
• itchy skin which is not red or inflamed
• TO TREAT ECZEMA AROUND A LEG ULCER.
• if you are UNDER 12 YEARS unless your doctor tells you
to.
TAKE SPECIAL CARE WITH EUMOVATE
• DO NOT use OVER LARGE AREAS OF SKIN
• DO NOT use on the face, groin, genital area or BETWEEN
THE TOES
• TAKE CARE to ensure the cream DOES NOT GET INTO THE
EYE.
• Use on IN

SPC

OBJECT 1
EUMOVATE ECZEMA & DERMATITIS 0.05% CREAM
Summary of Product Characteristics Updated 12-Dec-2017 |
GlaxoSmithKline Consumer Healthcare
1. Name of the medicinal product
Eumovate Eczema & Dermatitis 0.05% Cream
2. Qualitative and quantitative composition
Clobetasone butyrate 0.05 % w/w
Excipients with known effect:
Ceostearyl alcohol
Chlorocresol
For the full list of excipients, see section 6.1
3. Pharmaceutical form
Cream
4. Clinical particulars
4.1 Therapeutic indications
Eumovate Eczema & Dermatitis Cream is suitable for the short-term
treatment and control of patches of
eczema and dermatitis including atopic eczema and primary irritant and
allergic dermatitis.
4.2 Posology and method of administration
This product is suitable for use in adults and children aged 12 years
or older.
This product should be applied sparingly (see section 6.6) and gently
rub in, using only enough to cover
the affected area once or twice a day for up to 7 days. If the
condition resolves within 7 days, treatment
with this product should be stopped. If the condition does not improve
in the first 7 days or becomes
worse the consumer should see a doctor. If after 7 days of treatment
improvement is seen but further
treatment is required, the consumer should see a doctor.
CHILDREN
Use in children under 12 years only on the advice of a doctor.
Children are more likely to develop local
and systemic adverse reactions of topical corticosteroids and, in
general, require shorter courses and less
potent agents than adults.
Care should be taken when using this product to ensure the amount
applied is the minimum that provides
therapeutic benefit.
ELDERLY
Clinical studies have not identified differences in responses between
the elderly and younger patients. The
greater frequency of decreased hepatic or renal function in the
elderly may delay elimination if systemic
adsorption occurs. Therefore the minimum quantity should be used for
the shortest duration to achieve the
desired clinical benefit.
RENAL/HEPATIC IMPAIRMENT
In case of systemic abs