EUMOVATE CREAM

Land: Israel

Språk: engelska

Källa: Ministry of Health

Aktiva substanser:

CLOBETASONE BUTYRATE

Tillgänglig från:

GLAXO SMITH KLINE (ISRAEL) LTD

ATC-kod:

D07AB01

Läkemedelsform:

CREAM

Sammansättning:

CLOBETASONE BUTYRATE 0.05 %W/W

Administreringssätt:

DERMAL

Receptbelagda typ:

Required

Tillverkad av:

GLAXO OPERATIONS (UK) LIMITED

Terapeutisk grupp:

CLOBETASONE

Terapiområde:

CLOBETASONE

Terapeutiska indikationer:

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- 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.

Tillstånd datum:

2014-11-30

Bipacksedel

PATIENT PACKAGE INSERT IN ACCORDANCE WITH
THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed with a physician’s prescription only
Eumovate Cream
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
Cream
is
indicated
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 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 clobetasone
butyrate or 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:
-
infected skin (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 Cream.
Special warnings regarding the use of the medicine
Talk to your physician or pharmacist before using Eumovate Cream if:
•
you have previously had an allergic reaction with another steroid.
•
you are using Eumovate Cream for a chronic leg ulcer as you may be at
increased
risk of a local allergic reaction or infection.
•
you have been instructed b

Produktens egenskaper

_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