Clarelux 500micrograms/g foam

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv ingrediens:

Clobetasol propionate

Tilgjengelig fra:

Pierre Fabre Ltd

ATC-kode:

D07AD01

INN (International Name):

Clobetasol propionate

Dosering :

500microgram/1gram

Legemiddelform:

Cutaneous foam

Administreringsrute:

Cutaneous

Klasse:

No Controlled Drug Status

Resept typen:

Valid as a prescribable product

Produkt oppsummering:

BNF: 13040000; GTIN: 3592619069044

Informasjon til brukeren

UK/IE_CLARELUX 500 microgram/g cutaneous foam in pressurised
container: PL 20693/0004 & PA 1230/1/1
Date last approved: 27/01/2015 (UK-RMP)
UK/H/0619/001/II/022
1/6
PACKAGE LEAFLET: INFORMATION FOR THE USER
CLARELUX 500 MICROGRAM/G CUTANEOUS FOAM IN PRESSURISED CONTAINER
(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.
-
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.

Preparatomtale

OBJECT 1
CLARELUX 500 MICROGRAM/G CUTANEOUS FOAM IN
PRESSURISED CONTAINER
Summary of Product Characteristics Updated 26-Feb-2018 | Pierre Fabre
Dermo-Cosmetique
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, a