ClobaDerm Cream 0.05% w/w

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CLOBETASOL PROPIONATE

Available from:

Teva Pharma B.V. Swensweg 5, 2031 GA Haarlem, Netherlands

ATC code:

D07AD01

INN (International Name):

CLOBETASOL PROPIONATE 0.05 % (W/W)

Pharmaceutical form:

CREAM

Composition:

CLOBETASOL PROPIONATE 0.05 % (W/W)

Prescription type:

POM

Therapeutic area:

CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS

Authorization status:

Withdrawn

Authorization date:

2014-06-23

Patient Information leaflet

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PACKAGE LEAFLET
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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CLOBADERM 500 MICROGRAMS/G CREAM & OINTMENT
(clobetasol propionate)
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.
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If you have any further questions, ask your doctor or pharmacist.
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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 ClobaDerm is and what is it used for
2.
What you need to know before you use ClobaDerm
3.
How to use ClobaDerm
4.
Possible side effects
5.
How to store ClobaDerm
6.
Contents of the pack and other information
1.
WHAT CLOBADERM IS AND WHAT IT IS USED FOR
ClobaDerm belongs to a group of medicines called steroids. It helps to
reduce swelling and
irritation.
ClobaDerm is used to help reduce the redness and itchiness of certain
skin problems. These skin
problems include eczema, psoriasis and dermatitis that have not
responded to milder steroid creams
or ointments.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE CLOBADERM
DO NOT USE CLOBADERM:
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if you are allergic to clobetasol propionate or any of the other
ingredients of this medicine
(listed in Section 6)
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on a child under 1 year old
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to treat any of the following skin problems, it could make them worse:
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acne
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severe flushing of skin on and around your nose (rosacea)
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spotty red rash around your mouth (perioral dermatitis)
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itching around your back passage or private parts - unless your doctor
has told you to do
so
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viral infections, such as cold sores, herpes or chicken pox
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fungal infections, such as ringworm, athletes foot or thrush
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skin blisters or sores that are caused by an infection.
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Do not use this medicine if any of the above ap

Summary of Product characteristics

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1.
NAME OF THE MEDICINAL PRODUCT
ClobaDerm 500 micrograms/g Cream
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g of cream contains 0.5 mg of clobetasol propionate (500
micrograms/g).
Excipients with known effect
Also contains 80 mg of cetostearyl alcohol, 475 mg of propylene glycol
and 0.75 mg of
chlorocresol in each gram of the cream.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Cream
White or almost white cream.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Short courses for the treatment of more resistant dermatoses such as
psoriasis (excluding
widespread plaque psoriasis), recalcitrant eczemas, lichen planus,
discoid lupus erythematosus, and
other skin conditions which do not respond satisfactorily to less
active steroids.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adult and children
Apply sparingly to the affected area once or twice daily until
improvement occurs. As with other
highly active topical steroid preparations, therapy should be
discontinued when control is achieved.
In the more responsive conditions this may be within a few days. The
application frequency should
be gradually reduced.
Repeated short courses of ClobaDerm may be used to control
exacerbations. If continuous steroid
treatment is necessary, a less potent preparation should be used.
In very resistant lesions, especially where there is hyperkeratosis,
the anti-inflammatory effect of
ClobaDerm can be enhanced, if necessary, by occluding the treatment
area with polythene film.
Overnight occlusion only is usually adequate to bring about a
satisfactory response. Thereafter
improvement can usually be maintained by application without
occlusion.
Rarely, occlusion is necessary. In cases where an occlusive dressing
is applied, caution is needed in
order to avoid the risk of local and systemic adverse events.
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ClobaDerm should only be used for no more than 5 days on the face and
eyelids.
Method of administration
For topical administration.
Application of cream in adults:
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two finge