CLARELUX 0.05% %w/w Cutaneous Foam

Land: Irland

Språk: engelska

Källa: HPRA (Health Products Regulatory Authority)

Aktiva substanser:

CLOBETASOL PROPIONATE

Tillgänglig från:

PIERRE FABRE DERMATOLOGIE

ATC-kod:

D07AD01

INN (International namn):

CLOBETASOL PROPIONATE

Dos:

0.05% %w/w

Läkemedelsform:

Cutaneous Foam

Receptbelagda typ:

Product subject to prescription which may not be renewed (A)

Terapiområde:

Corticosteroids, very potent (group IV)

Bemyndigande status:

Authorised

Tillstånd datum:

2005-03-18

Bipacksedel

CLARELUX 500 mg/g - Notice - Format : 185 x 350 mm - Taille du texte
: 9 pt, interl. 10,8 pt
Version UK - Dossier 4609 - 20/02/2015 
NOIR
PANTONE
185
PACKAGE LEAFLET: INFORMATION FOR THE USER
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 your pharmacist.
• This medicine has been prescribed for you. Do not
pass it on to others. It may harm them, even if their 
symptoms 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 CLARELUX
®
 is and what it is used for
2. What you need to know before you use CLARELUX
®
3. How to use CLARELUX
®
4. Possible side effects
5. How to store CLARELUX
®
6. Contents of the pack and other information
1. WHAT CLARELUX
®
 IS AND WHAT IT IS USED FOR
CLARELUX
®
 contains the active substance clobetasol 
propionate which belongs to a group of medicines 
known as topical corticosteroids. CLARELUX
®
 is a highly 
potent topical corticosteroids.
CLARELUX
®
 is a foam to be applied to the skin.
CLARELUX
®
 is used as a short-term treatment for scalp 
conditions, e.g. psoriasis of the scalp, which do not 
respond satisfactorily to weaker corticosteroids.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE 
CLARELUX
®
DO NOT USE CLARELUX
®
:
• If you are allergic to clobetasol propionate, to other
corticosteroids or any of the other ingredients of 
CLARELUX
®
;
• If you have an infectious skin disease, either viral 
(e.g. herpes, shingles, chickenpox…), bacterial 
(e.g. impetigo …), fungal (caused by microscopic 
fungi) or parasitic;
• If you suffer from burns, ulcerated lesions or other skin
condition such as rosacea, acne, skin inflammation 
around the mouth, itching (pruritus) around the anus 
or genitals.
• On an

Produktens egenskaper

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
CLARELUX 500 micrograms/g cutaneous foam in pressurised container.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of cutaneous foam contains 500 micrograms clobetasol
propionate.
Excipients with known effect:
cetyl alcohol 11.5 mg/g, stearyl alcohol 5.2 mg/g and propylene glycol
20.9 mg/g.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cutaneous foam in pressurised container.
White foam that breaks down upon contact with skin.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Short-course treatment of steroid responsive dermatoses of the scalp
such as psoriasis, which do not respond
satisfactorily to less active steroids.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Use in adults_
CLARELUX is a highly potent topical corticosteroid; therefore,
treatment should be limited to 2 consecutive weeks
and amounts greater than 50 g/week should not be used.
Route of administration: for cutaneous use.
CLARELUX should be applied to the affected area twice daily. There are
no data from clinical studies evaluating the
efficacy of once daily application.
_Paediatric population_
As there are no data regarding the use of CLARELUX in children and
adolescents, use in these patients is not
recommended.
Method of administration
The foam application has been designed so that the preparation spreads
easily without being too fluid and allows easy
application direct to the affected area.
_Note: for proper dispensing of foam, hold the container upside down
and depress the actuator._
Invert the container and dispense a small amount (of the size of a
walnut or one teaspoon) of CLARELUX directly on
the lesions, or dispense a small amount into the cap of the container,
onto a saucer or other cool surface, taking care to
avoid contact with eyes, nose, and mouth. Dispensing directly onto
hands is not recommended, as the foam will begin
to melt immediately upon contact with warm skin. Gently massage into
affected area until the foam disappear