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CLARELUX 500MICROGRAMS/G CUTANEOUS FOAM IN PRESSURISED CONTAINER

Active substance: CLOBETASOL PROPIONATE

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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

PANTONE

NOIR

PACKAGE LEAFLET: INFORMATION FOR THE USER

500

micrograms/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.
• On any area of your body or face (included
the eyelids), apart from your scalp.
Warnings and precautions
Talk to your doctor or pharmacist before using
CLARELUX®.
Stop treatment immediately and talk to your doctor if
an allergic reaction occurs, signs of which may include
skin rash, itching or painless tissue swelling (oedema).
As with all topical corticosteroids, CLARELUX® can be
absorbed through the skin and can cause side effects
such as adrenocortical suppression - see Section 4 for
all possible side effects. Due to this:
• Long-term treatment with CLARELUX® should
be avoided;
• CLARELUX® should not be applied to a large surface
area;
• The treated areas should not be bandaged or covered
unless directed by your doctor;
• The use of CLARELUX® on wounds or ulcerations is not
recommended.
Inform your doctor:
• If your condition does not improve after 2 weeks
of treatment.
• If an infection occurs, as this may require discontinuation
of treatment with CLARELUX®.
• If you start to experience problems with your vision,
as this type of medicine may increase the development
of cataracts and glaucoma.
Wash your hands carefully after each application.

185

In the event of accidental contact with the face or eyes,
rinse thoroughly with plenty of water.
Children and adolescents
Treatment is not recommended in children and
adolescents.
Other medicines and CLARELUX®
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be
pregnant or planning to have a baby, ask your doctor or
pharmacist for advice before taking this medicine.
CLARELUX® should not be used during pregnancy or
breast-feeding unless advised by your doctor.
Driving and using machines
CLARELUX® should not affect your ability to drive or
operate machines.
Important information about some of the ingredients
in CLARELUX®
This medicine contains propylene glycol, which may
cause skin irritation. It also contains cetyl and stearyl
alcohol, which may cause local skin reactions (e.g.
contact dermatitis).
3. How to use CLARELUX®
WARNINGS:
The canister contains a pressurised, flammable
liquid.
Do not use or store near a naked flame, source of
ignition, any heat generating material or electrical
device in use.
Do not smoke whilst using or holding this can.
Always use CLARELUX® exactly as your doctor has told
you. You should check with your doctor or pharmacist
if you are not sure.
Use this medication only for the condition for which
it was prescribed. CLARELUX® must only be applied
to the scalp and should not be swallowed.
Dispensing directly onto hands is not recommended,
as the foam will begin to melt immediately upon contact
with warm skin.
Apply CLARELUX® to the affected area of the scalp twice
a day, once in the morning and once at night, as
follows:
Attention: for proper dispensing of foam, it is important
to hold the container upside down!

1. Shake the can well.

1

2. Turn the can upside down and squirt
a small amount (the size of a walnut)
2
either directly onto the scalp, or into the
cap of the can, onto a saucer or other
cool surface and then onto the scalp.
CLARELUX® should always be applied
thinly, so use as little as possible when covering the
affected areas. The exact amount you need depends
on the size of the affected area.
Do not apply to the eyelids and take care to avoid
contact with eyes, nose, and mouth.
Do not squirt CLARELUX® onto your hands, as the foam
will begin to melt immediately upon contact with warm
skin.
3. Move the hair away from the foam
and gently massage into the scalp,
until it disappears and is absorbed.
Repeat if necessary, to treat the entire
affected area.

3

Wash your hands after applying CLARELUX® and discard
any unused foam.
Do not use CLARELUX® on your face. If some foam
accidentally gets into your eyes, nose or mouth, rinse
immediately with cold water. You may feel a stinging
sensation. Contact your doctor, if the pain continues.
The treated areas should not be bandaged or covered
unless directed by your doctor.
Do not wash or rinse the treated scalp areas immediately
after applying CLARELUX®.

4. Possible side effects
Like all medicines, CLARELUX® can cause side effects,
although not everybody gets them.
Stop using CLARELUX® and contact your doctor
immediately if hypersensitivity reactions occur, such
as local irritation.
The side effects may include:
Common side effects (occurring in less than 1 in
10 people but more than 1 in 100):
• Burning sensation
• Other skin reaction when applied to the skin
Very rare effects (occurring in less than 1 in 10,000
people):
• Sensation of tingling or pricking
• Eye irritation
• Swollen veins
• Skin irritation and tenderness
• Skin tightness
• Itchy skin rash (contact dermatitis)
• Aggravated scaly skin rash (psoriasis aggravated)
• Redness at the application site
• Itching and sometimes with pain at the application site
• Presence of blood, protein and nitrogen in your urine
may be detected by a doctor
Additional side effects may include:
• Changes in hair growth (abnormal hair growth away
from the application site and on unusual parts of the
body )
• Changes in skin colour
• Irritation of the hair follicules e.g. pain, heat and
redness
• Mouth rashes
• Redness and eruptions on the face
• Delay in wound healing
• Effects on the eyes (cataract, high pressure in the eye)
Side effects caused by prolonged use include:
• White markings on skin (striae) and dilatation of
the blood vessels of the skin
• As with other topical corticosteroids, when CLARELUX®
is used in large amounts and for a long period of time,
this can lead to a disorder called Cushing’s syndrome
which symptoms include a red, puffy and rounded
face (called a moon face), high blood pressure, weight
gain and changes in sugar levels in the blood and
urine.
• Prolonged treatment with steroids may cause thinning
of the skin.
In rare instances, treatment of psoriasis with
corticosteroids (or on stopping treatment) may
make the condition worse and a pustular form
of the disease may occur. On stopping treatment
with corticosteroids, sometimes, the scalp condition
may return. Also pre existing infections may
worsen if CLARELUX® is not used according to
the instructions.
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side effects
directly via
Ireland
HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2

Tel: +353 1 6764971, Fax: +353 1 6762517,
Website: www.hpra.ie,
e-mail: medsafety@hpra.ie
United Kingdom
Yellow Card Scheme ,
Website: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more
information on the safety of this medicine.
5. How to store CLARELUX®
• The canister contains a pressurised, flammable
liquid.
• Do not store near a naked flame, source of
ignition, any heat generating material or electrical
device in use.
• Do not expose to temperatures higher than 50ºC
or to direct sunlight.
• Do not pierce or burn the can even when empty.
• When you have finished your treatment, dispose
of the can safely.
Keep out of the sight and reach of children.
Do not use CLARELUX® after the expiry date which
is stated on the can and the outer carton after EXP.
The expiry date refers to the last day of that month.
Do not store above 25°C. Do not refrigerate. Store
upright.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures
will help to protect the environment.
6. Contents of the pack and other information
What CLARELUX® contains
1 g of cutaneous foam CLARELUX® contains
500 micrograms of clobetasol propionate as active
substance.
The other ingredients are: ethanol anhydrous, purified
water, propylene glycol, cetyl alcohol, stearyl alcohol,
polysorbate 60, citric acid anhydrous, potassium citrate
and a propane/n-butane/isobutane propellant mixture.
What CLARELUX® looks like and contents of the pack
CLARELUX® is a cutaneous white foam in pressurised
container. Each can contains 50 or 100 grams.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
PIERRE FABRE DERMATOLOGIE
45 PLACE ABEL-GANCE
92100 BOULOGNE
FRANCE
Manufacturer
AEROSOL SERVICE ITALIANA S.R.L. (ASI)
VIA DEL MAGLIO, 6
23868 VALMADRERA (LC)
ITALY
This medicinal product is authorised in the Member
States of the EEA under the following names:
CLARELUX® 500 micrograms/g cutaneous foam in
Austria, Belgium, Czech Republic, France, Germany,
Greece, Ireland, Luxemburg, The Netherlands, Poland,
Portugal, Slovakia, United-Kingdom and Spain.
OLUX® 500 micrograms/g cutaneous foam in Italy.
Other formats: To listen to or request a copy of this
leaflet in Braille, large print or audio please call,
United Kingdom: 0800 198 5000
Ireland: +44 (0) 1733 375370
Please be ready to give the following information:
Clarelux foam
For United Kingdom: PL 20693/0004 – For Ireland: PA
1230/1/1
This is a service provided by the Royal National Institute
of the Blind.
Clarelux is a trademark of Pierre Fabre Dermatologie.
Sold under Stiefel License - Patent n° GB 9504265
This leaflet was last approved in 01/2015.

000 000

Do not use more than 50g of CLARELUX® foam per week.
Treatment should not be given for more than 2 weeks.
After this period CLARELUX® may be used occasionally
if needed. Alternatively your doctor may prescribe a
weaker steroid to control your condition.
If you use more CLARELUX® than you should
If you use CLARELUX® Foam in a larger quantity or for
a long period of time without your doctor’s knowledge
you should tell your doctor immediately.
If you forget to use CLARELUX®
Use it as soon as you remember, then continue as
before. If you only remember at the time of your next
dose, use a single dose and continue as before (do not
apply a double dose to make up for the forgotten dose).
If you miss several doses, tell your doctor.
If you stop using CLARELUX®
Do not stop using CLARELUX® suddenly as this may
harm you. Your doctor may need to discontinue
the treatment gradually and you may need regular
check-ups.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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