EUMOVATE OINTMENT

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

CLOBETASONE BUTYRATE

Available from:

GLAXO SMITH KLINE (ISRAEL) LTD

ATC code:

D07AB01

Pharmaceutical form:

OINTMENT

Composition:

CLOBETASONE BUTYRATE 0.05 %W/W

Administration route:

DERMAL

Prescription type:

Required

Manufactured by:

GLAXO OPERATIONS (UK) LIMITED

Therapeutic group:

CLOBETASONE

Therapeutic area:

CLOBETASONE

Therapeutic indications:

Eumovate ointment 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- Nappy rash- Photodermatitis- Otitis externa- Prurigo nodularis- Insect bite reactionsEumovate may be used as maintenance therapy between courses of one of the more potent topical steroids.

Authorization date:

2014-11-30

Patient Information leaflet

PATIENT PACKAGE INSERT IN ACCORDANCE
WITH THE PHARMACISTS’ REGULATIONS
(PREPARATIONS) - 1986
The medicine is dispensed according to a
physician's prescription only
EUMOVATE OINTMENT
Each 1 g contains:
0.5 mg of clobetasone butyrate 0.05% w/w.
A list of the additional ingredients is detailed in
section 6.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE
USING THE MEDICINE. This leaflet contains concise
information about the medicine. If you have further
questions, refer to the physician or pharmacist.
This medicine has been prescribed for you. Do not
pass it on to others. It may harm them even if it seems
to you that their medical condition is similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
Eumovate Ointment is indicated for the relief of the
inflammatory and pruritic manifestations of steroid
responsive dermatoses.
These include the following: Atopic dermatitis,
Contact dermatitis, Seborrhoeic dermatitis, Nappy
rash, Photodermatitis, Otitis externa, Prurigo
nodularis and Insect bite reactions.
THERAPEUTIC GROUP: Corticosteroids
2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE:
∙
if you are sensitive (allergic) to the active
ingredient or to any of the additional ingredients
contained in the medicine (as listed in section
6).
∙
to treat any of the following skin problems; it
could make them worse:
-
skin infection (unless the infection is being
treated concurrently with an anti-infective
medicine)
-
acne
-
severe flushing of the skin on and around
the nose (rosacea)
-
itchy skin which is not inflamed
Do not use if any of the above apply to you. If you
are not sure, talk to your physician or pharmacist
before using Eumovate Ointment.
SPECIAL WARNINGS REGARDING THE USE OF THE
MEDICINE
Before treatment with Eumovate Ointment, tell the
physician if:
∙
you have previously had an allergic reaction to
another steroid.
∙
you are using Eumovate Ointment for a chronic
leg ulcer as you may be at increased risk of a
local allergic reaction or infection.
∙
you have been instructed by your physician to
apply th

Summary of Product characteristics

_Page 1 of 9_
_The format of this leaflet was determined by the Ministry of Health
and its content was checked and approved in September _
_2016,_
_was updated according to the guidelines of the Ministry of Health in
November 2017 _
EUMOVATE CREAM
1.
NAME OF THE MEDICINAL PRODUCT
Eumovate Cream
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
0.05% w/w clobetasone butyrate.
Excipients with known effect:
Cetostearyl alcohol
Chlorocresol
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Cream.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Topical treatment for corticosteroids responsive dermatosis
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
ROUTE OF ADMINISTRATION: CUTANEOUS
ADULTS, ELDERLY, CHILDREN AND INFANTS FROM THE AGE OF 3 MONTH
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.
Therapy with topical corticosteroids should be gradually discontinued
once control is
achieved and an emollient continued as maintenance therapy.
_Page 2 of 9_
Rebound of pre-existing dermatoses can occur with abrupt
discontinuation of topical
corticosteroids especially with potent preparations.
DURATION OF TREATMENT FOR ADULTS AND ELDERLY
Continuous daily treatment for longer than four weeks is not
recommended. If the
condition worsens or does not improve within four weeks, treatment and
diagnosis
should be re-evaluated.
PAEDIATRIC POPULATION
Use in children under 12 years should be on the advice of a doctor.
Care should be taken when using clobetasone to ensure the amount
applied is the
minimum that provides therapeutic benefit.
DURATION OF TREATMENT FOR CHILDREN AND INFANTS
When clobetasone is used in the treatment of dermatoses in children,
extreme caution is
required and treatment should no