Eumovate Cream 0.05% w/w

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

CLOBETASONE BUTYRATE

Dostupné z:

GlaxoSmithKline (Ireland) Limited

ATC kód:

D07AB; D07AB01

INN (Medzinárodný Name):

CLOBETASONE BUTYRATE

Dávkovanie:

0.05 percent weight/weight

Forma lieku:

Cream

Typ predpisu:

Product subject to prescription which may be renewed (B)

Terapeutické oblasti:

Corticosteroids, moderately potent (group II); clobetasone

Stav Autorizácia:

Marketed

Dátum Autorizácia:

1976-06-03

Príbalový leták

Reason for Update:
Type Iain Project Pine CMC update (PZN address is grey shaded
therefore
no live artwork impacted thus no change to date in PIL)
Market: Ireland
Agency Approval Date: 30/06/2022 (imp date for Type IAINs)
Text Date: 10/06/2022
Text Issue and Draft No.: Issue 9 draft 1
PACKAGE LEAFLET: INFORMATION FOR THE USER
EUMOVATE CREAM 0.05% W/W
clobetasone butyrate
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, Eumovate Cream 0.05% w/w will be called Eumovate.
WHAT IS IN THIS LEAFLET
1 What Eumovate is and what it is used for
2 What you need to know before you use Eumovate
3 How to use Eumovate
4 Possible side effects
5 How to store Eumovate
6 Contents of the pack and other information
1.
WHAT EUMOVATE IS AND WHAT IT IS USED FOR
Eumovate contains a medicine called clobetasone butyrate which belongs
to a group
of medicines called corticosteroids. It helps to reduce redness,
swelling and irritation
of the skin. (These should not be confused with “anabolic”
steroids misused by some
body builders and athletes and taken as tablets or injections).
Eumovate relieves the symptoms of certain skin problems including:
-
eczema including seborrhoeic eczema (red skin with greasy looking
white or
yellowish-coloured scales) and a type of skin reaction triggered by
exposure
to sunlight (photodermatitis)
-
skin rash due to allergy or a substance that irritates your skin
(irritant or
allergic contact dermatitis)
-
dermatitis
-
inflammation of the outer ear (otitis externa)
-
itchy nodules on the arms or le

Súhrn charakteristických

Health Products Regulatory Authority
09 March 2021
CRN009Z2W
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Eumovate Cream 0.05% w/w
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of cream contains 0.5 mg clobetasone butyrate (equivalent to
0.05% w/w)
Excipients with known effect:
cetostearyl alcohol 40-60 mg /g
chlorocresol 1 mg /g
This product contains paraffin, see section 4.4.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Cream
A smooth white cream.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Eumovate Cream is a moderately potent topical corticosteroid indicated
for adults, elderly, children and infants for the relief of
the inflammatory and pruritic manifestations of steroid responsive
dermatoses.
These include the following:
- Atopic dermatitis
- Irritant or allergic contact dermatitis
- Seborrhoeic dermatitis
- Photodermatitis
- Otitis external
- Prurigo nodularis
- Insect bite reactions
Clobetasone may be used as maintenance therapy between courses of one
of the more potent topical steroids.
Continuous daily treatment for longer than 4 weeks in adults is not
recommended (see section 4.2).
Extreme caution should be used in the treatment of dermatoses in
children under 12 years of age and should not normally
exceed 7 days (see section 4.2).
Patients should be closely monitored for side effects.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ _
_Adults, Elderly, Children and Infants_
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 a day 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.
Health Products Regulatory Authority
09 March 2021
CRN009Z2W
Page 2 of 7
Continuous daily treatment for longer than 4 weeks is not recommended.
If the condition worsens or does not imp